WASHINGTON — The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.
By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.
The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.
To speed up deliveries, the government is scrambling to find another firm to take over some of the bottling, capping and labeling of frozen bulk vaccine that is being stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. Because that final manufacturing phase, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to gear up. Negotiations are ongoing with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce Covid-19 vaccines, to bottle 2.5 million of the doses now on order, hopefully shaving months off the timetable, according to people familiar with the situation.
Health and Human Services officials so miscalculated the need that on May 23, they allowed Bavarian Nordic to deliver about 215,000 fully finished doses that the federal government had already bought to European countries instead of holding them for the United States.
At the time, the nation had only eight confirmed monkeypox cases, agency officials said. And it could not have used those doses immediately because the Food and Drug Administration had not yet certified the plant where the vaccine, Jynneos, was poured into vials.
But it could now. Some states are trying to stretch out doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available slot for a monkeypox shot is taken.
Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted with the White House about monkeypox, said the government’s response has been hobbled by “the same kinds of bureaucratic delays and forgetfulness and dropping the ball that we did during the Covid pandemic.”
The obstacles to filling and finishing vials follow other missteps that have limited vaccine supply. The United States once had some 20 million doses in a national stockpile but failed to replenish them as they expired, letting the supply dwindle to almost nothing. It had 372,000 doses ready to go in Denmark but waited weeks after the first case was identified in mid-May before requesting the delivery of most of those doses. Another roughly 786,000 doses were held up by an F.D.A. inspection of the manufacturer’s new fill-and-finish plant but have now been shipped.
The government also owns the equivalent of about 16.5 million doses of bulk vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses worth to be vialed on June 10, other countries with outbreaks had submitted their own orders and the earliest delivery date was October.
Another order for 110,000 doses for European nations soon followed. When the United States came back with two more orders of 2.5 million doses each on July 1 and July 15, the bulk could only be delivered next year.
Mr. Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help “light a fire” under federal health agencies. The White House announced Tuesday that Robert Fenton, an administrator at the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a C.D.C. official, will lead the response.
Mr. Gostin said the nation’s public health agencies have been “kind of asleep at the wheel on this,” and the new coordinators should help with “unblocking all of the obstacles to procuring and delivering vaccines and drugs, which has been deeply frustrating.”
Two senior federal officials, who requested anonymity in order to speak frankly, said Mr. Biden is upset by the vaccine shortage. His administration has often touted its success delivering hundreds of millions of coronavirus shots to Americans, and is stung by criticism that a lack of foresight and management has left gay men — the prime risk group for monkeypox — unprotected.
Some critics blame a failure of leadership at the Health and Human Services Department, saying the department’s secretary, Xavier Becerra, has taken a hands-off approach to an increasingly serious situation. His department not only oversees both the C.D.C. and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and buys vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards.
During a press call on monkeypox last week, Mr. Becerra said his department is doing all it can to ensure that “we not only stay ahead of this virus but that we end this outbreak.” He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.
Sarah Lovenheim, his spokeswoman, said in a statement: “Our response has accelerated to meet evolving needs on the ground, and it will keep accelerating. We will use every lever possible to continue allocating doses ahead of timelines, as possible.”
So far, according to the C.D.C., 6,326 cases of monkeypox have been reported. For now, the virus is spreading almost entirely among gay and bisexual men, and those with multiple or anonymous partners are considered especially at risk. Mr. Becerra noted that while more than a million Americans have died of Covid-19, no one in the United States has died of monkeypox.
The official case count is widely considered an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top medical official in Louisiana, said that monkeypox can be hard to diagnose. “It can be one or two solitary lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.
With too few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that figured heavily in the early stages of the Covid pandemic. As the pandemic escalated, the sheer torrent of cases overwhelmed the ability of health officials to contact people who might have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.
Through early June, Health and Human Services officials appeared firmly convinced that the United States had more than enough supply of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.
Bavarian Nordic was able to develop the vaccine, which also works against smallpox, largely thanks to the federal government’s backing, which surpassed $1 billion in 2014 and is now edging toward $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has Jynneos because we invested in it.”
The company opened a new $75 million fill-and-finish plant in 2021 that is now bottling as many as 200,000 to 300,000 doses a week. At the time, the United States was counting on Jynneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No F.D.A. inspection was scheduled until after the monkeypox outbreak, and it did not conclude until July 27.
In early June, Health and Human Services officials agreed to essentially loan back about 215,000 finished doses of vaccine to Bavarian Nordic so the firm could supply them to European countries that were suffering outbreaks.
“It didn’t make sense while we were waiting for F.D.A. to get the inspection done — which is coming — that we sit on doses that our international colleagues in Europe could actually use,” Ms. O’Connell said on June 10. Now the government is trying to reschedule delivery of those doses for later this year, a company spokesman said.
The final stage of putting the liquid vaccine into vials accounts for a substantial share of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for that work because officials at BARDA argued they were short on funds.
When the demand for vaccines became an outcry, though, the agency found the money to pay for five million more doses to be vialed. Officials are now contemplating shifting half the work to another firm that may be able to finish and fill doses more than twice as fast.
Some experts say it can take as long as six to nine months for a plant to gear up to handle a vaccine like Jynneos, which contains a live virus in a weakened state. Carlo de Notaristefani, who oversaw coronavirus vaccine manufacturing for the federal government until last year, said that such factories must operate at a high “biological safety level,” including a fully enclosed, segregated manufacturing line.
But he and other experts said it should be possible to streamline the transfer of Bavarian Nordic’s process so another plant could be ready in about three months. A company spokesperson said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.
Less than a decade ago, the United States had some 20 million doses of a new smallpox vaccine — also effective against monkeypox — sitting in freezers in a national stockpile.
Such vast quantities of the vaccine, known today as Jynneos, could have slowed the spread of monkeypox after it first emerged in the United States in mid-May. Instead, the supply, known as the Strategic National Stockpile, had only some 2,400 usable doses left at that point, enough to fully vaccinate just 1,200 people.
The rest of the doses had expired.
Now, some 10 weeks into the outbreak, many people at high risk who want to get vaccinated have been unable to find a dose and may not be able to find one for months.
The chain of events that led the stockpile of a now-critical vaccine to dwindle to near nothing in the United States is only now emerging.
At several points federal officials chose not to quickly replenish doses as they expired, instead pouring money into developing a freeze-dried version of the vaccine that would have substantially increased its three-year shelf life.
As the wait for a freeze-dried vaccine to be approved by the Food and Drug Administration dragged on over the last decade, the United States purchased vast quantities of raw vaccine product, which has yet to be filled into vials.
The raw, unfinished vaccine remains stored in large plastic bags outside Copenhagen, at the headquarters of the small Danish biotech company Bavarian Nordic, which developed Jynneos and remains its sole producer.
For nearly 20 years, the United States government has helped fund the company’s development of the vaccine, clinical trials and manufacturing process, at a cost that passed the $1 billion mark by 2014 and is hurtling toward $2 billion. Despite this, the United States now finds itself unable to procure enough doses to quickly launch a widespread vaccination campaign for those at highest risk: men who have sex with men, and in particular, those who have multiple partners.
One reason for the reduction in the U.S. stockpile of Jynneos is that the federal officials overseeing it had not viewed monkeypox as much of a problem, or at least as their problem. They were focused on the most dangerous and deadly scenarios, such as a bioterror attack involving smallpox or anthrax.
“We have to prepare against multiple threats with a limited budget,” said Dr. Gary Disbrow, the director of Biomedical Advanced Research and Development Authority, or BARDA, the federal agency that supported the development of Jynneos and other drugs and vaccines to protect against pandemics, bioterrorism and other hazards. “Our planning was for smallpox.”
What to Know About the Monkeypox Virus
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What is monkeypox? Monkeypox is a virus similar to smallpox, but symptoms are less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research. The virus was primarily found in parts of Central and West Africa, but in recent weeks it has spread to dozens of countries and infected tens of thousands of people, overwhelmingly men who have sex with men. On July 23, the World Health Organization declared monkeypox a global health emergency.
How does it spread? The monkeypox virus can spread from person to person through close physical contact with infectious lesions or pustules, by touching items — like clothing or bedding — that previously touched the rash, or via the respiratory droplets produced by coughing or sneezing. Monkeypox can also be transmitted from mother to fetus via the placenta or through close contact during and after birth.
I fear I might have monkeypox. What should I do? There is no way to test for monkeypox if you have only flulike symptoms. But if you start to notice red lesions, you should contact an urgent care center or your primary care physician, who can order a monkeypox test. Isolate at home as soon as you develop symptoms, and wear high-quality masks if you must come in contact with others for medical care.
What is the treatment for monkeypox? If you get sick, the treatment for monkeypox generally involves symptom management. Tecovirimat, an antiviral drug also known as TPOXX, occasionally can be used for severe cases. The Jynneos vaccine, which protects against smallpox and monkeypox, can also help reduce symptoms, even if taken after exposure.
I live in New York. Can I get the vaccine? Adult men who have sex with men and who have had multiple sexual partners in the past 14 days are eligible for a vaccine in New York City, as well as close contacts of infected people. Eligible people who have conditions that weaken the immune system or who have a history of dermatitis or eczema are also strongly encouraged to get vaccinated. People can book an appointment through this website.
Now, monkeypox has emerged as a serious public health threat. As of the end of July, more than 5,000 cases were reported in the United States, and there were nearly 1,300 in New York City.
“We were required to have vaccines for smallpox, based on a material threat determination that simply didn’t exist for monkeypox, specifically,” said a Health and Human Services spokeswoman in a statement. “Today, now that we’re in response mode of facing a public health threat, we’re working swiftly around the clock to accelerate the number of doses available.”
The limited supply of Jynneos available shows that a new approach to preparing for biological threats and pandemics is needed, said a former federal official, Dr. Ali S. Khan, who until 2014 ran the Centers for Disease Control and Prevention office that managed the stockpile. “I want people to know how poorly this went given the amount of money and resources put into it,” he said.
9/11 and Fears of a Bioterrorism Attack
Following the Sept. 11, 2001, terrorist attacks and the subsequent anthrax letter attacks, the United States government redoubled its efforts to prepare against future threats. One clear danger was smallpox, with a 30 percent fatality rate. Though the virus was declared eradicated in 1980, lab samples of it existed, and there had long been concern that a foreign country or terrorist group might weaponize it.
In the years since Sept. 11, the United States stockpiled well over 100 million doses of smallpox vaccines — versions of the vaccine that eradicated the virus. With names like Dryvax and ACAM2000, they use a live virus that replicates and can have dangerous side effects, including inflammation of the heart in about six recipients out of 1,000. One or two people of every million vaccinated are expected to die.
After 2001, the United States sought an effective smallpox vaccine with fewer side effects. In 2003 it began pumping millions of dollars into Bavarian Nordic, a small company with a promising new smallpox vaccine.
By 2013, Bavarian Nordic had delivered 20 million doses of its new smallpox vaccine to the Strategic National Stockpile, according to the company’s annual report as well as U.S. documents.
The vaccine came in vials in liquid-frozen form, with a three-year shelf life.
The new vaccine, which back then went by the name Imvamune, not Jynneos, was never intended to replace the far larger stockpile of older generations of smallpox vaccines, but to be offered to those at higher risk of complications from the older vaccines and their family members, according to a 2014 report by the U.S. Department of Health and Human Services. That included people with conditions ranging from eczema to H.I.V., and pregnant women and infants.
Some federal health officials were skeptical. Jynneos required two shots — not ideal in the event of a bioterror attack — rather than one.
But Bavarian Nordic executives told shareholders that the long-term U.S. plan was to stockpile enough of the Jynneos vaccine to vaccinate all 66 million eligible people in high-risk households.
In 2009, the company received a $95 million contract from the United States to begin developing a freeze-dried formulation with a shelf life of five to 10 years.
As the 20 million Jynneos doses began to expire, and with the free-dried version still in development, the United States ordered another eight million, which were shipped to the nation’s stockpile in 2015, according to Bavarian Nordic and the U.S. Health and Human Services.
Dr. Kahn, the former federal official, remembered “the frustration on why it was taking so long to get a freeze-dried preparation that could be held for longer.”
But the eight million doses were the last substantial shipment for years. From 2015, onward, the United States instead placed orders for hundreds of millions of dollars of bulk vaccine product — basically raw vaccine stored in large bags, which would be converted to freeze-dried doses once the company perfected the process and had the necessary F.D.A. approval.
By 2017, all 27,993,370 doses in the national Jynneos stockpile had expired, although the United States still had a huge stockpile of its other smallpox vaccines.
“In fairness, I’m not sure anybody in their right mind would have thought we needed more smallpox vaccine,” said Dr. Nicole Lurie, who oversaw the stockpile during her eight-year tenure as assistant secretary for preparedness and response within Health and Human Services under President Barack Obama.
Both Jynneos and the older stockpiled smallpox vaccines, such as ACAM2000, are good choices as a smallpox vaccine. Federal officials expect ACAM2000 to protect against monkeypox and have shipped doses to local health authorities for use, but its harsher side effects make many doctors uncomfortable with using it for a mass monkeypox vaccination campaign.
One Delay After Another
The goal of producing freeze-dried vaccine has taken longer than expected, partly because of a slow F.D.A. review process. In recent years Bavarian Nordic also undertook an expansion that would ultimately delay delivery of vaccine doses.
Bavarian Nordic had long relied on outside companies for the final stages of the production process, such as filling the actual vials.
By 2017, the company had plans for building its own “fill-finish” facility to make its vaccine production “more profitable than what we’ve seen in the past,” according to Bavarian Nordic’s chief executive, Paul Chaplin, with the U.S. government funding a portion of this expansion.
In early 2020, the United States placed an order for 1.4 million liquid-frozen doses from Bavarian Nordic, its first significant order for ready-to-use product in years. About 372,000 of those doses were filled by a contractor and shipped back to the United States in recent weeks. They have been the main source of doses for the country’s monkeypox vaccination program so far.
The rest were filled at Bavarian Nordic’s new fill-finish facility, which was up and running in 2021.
But the F.D.A. had not inspected the facility by the time the monkeypox outbreak began. As a result, the bulk of the 1.4 million-dose order sat in Denmark until last month, when F.D.A. inspectors arrived.
Now, the U.S. government has asked Bavarian Nordic to begin sending as many doses as quickly as possible, setting aside the goal of a freeze-dried formulation for the time being.
But it may be months before the company is able to deliver millions of more doses from the bulk vaccine supply that the United States has been paying Bavarian Nordic for years to store, U.S. officials say.
With far too little Jynneos on hand to contain the monkeypox outbreak, federal officials are taking a fresh look at the expired doses, which it still has on hand. Health and Human Services officials have sent samples back to Bavarian Nordic for testing.
It is “very unlikely” they are still viable, officials say. But if they are, the Administration for Strategic Response and Preparedness, a division within H.H.S., said it would make them “available for the response.”
On the Thursday before Pride Weekend last month, hundreds of men dropped what they were doing and raced to a city-run health clinic in Manhattan. Finally, more than a month after monkeypox appeared in New York City, a vaccine was being made available to sexually active gay and bisexual men, among whom the virus was rapidly spreading.
But there was a catch: There were only 1,000 doses available. Within two hours, the only clinic offering the shots began turning people away.
At that same moment, some 300,000 doses of a ready-to-use vaccine owned by the United States sat in a facility in Denmark. American officials had waited weeks as the virus spread in New York and beyond before deciding to ship those doses to the United States.
Even then, there was little apparent urgency: The doses were flown piecemeal, arriving in shipments spread out over more than a week. Many didn’t arrive until July, more than six weeks after the first case was identified in New York City.
By holding back the doses, an early opportunity to contain or slow the largest monkeypox outbreak in the country appears to have slipped by. On Saturday, the World Health Organization declared monkeypox a global health emergency. At least 16,000 cases have been reported around the world, with about 3,000 in the United States. Infections in New York City make up nearly a third of the national case count.
Limited testing means those numbers are likely a significant undercount.
The federal response to monkeypox, including the limited testing capacity, has echoes of how public health authorities initially mismanaged Covid-19.
With monkeypox, however, the federal government had a powerful tool to slow the spread from the start: an effective vaccine.
Yet the government was slow to deploy the vaccine, which was originally developed and stockpiled for use against smallpox, activists say.
“The U.S. government intentionally de-prioritized gay men’s health in the midst of an out-of-control outbreak because of a potential bioterrorist threat that does not currently exist,” said James Krellenstein, a Brooklyn-based gay health activist, who has been urging health officials to make the vaccine more widely available since June.
The federal official in charge of the agency that manages the United States’ supply, Gary Disbrow, said the government was “moving very quickly because we take this very seriously.”
“We thought it prudent to get as many doses as we had available over here, fully understanding that if the doses are not used there would be a potential impact on smallpox,” he added. “We moved very quickly based on the number of cases we saw.”
Called Jynneos, the vaccine is effective against both smallpox, which generally has a 30 percent fatality rate, and monkeypox, which can be severe but has a far lower fatality rate.
When monkeypox was first detected in the United States in mid-May, there were some 2,400 doses on U.S. soil, in the federal government’s strategic national stockpile, used mainly to protect lab workers and Centers for Disease Control and Prevention personnel engaged in research, officials said.
What to Know About the Monkeypox Virus
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What is monkeypox? Monkeypox is a virus similar to smallpox, but symptoms are less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research. The virus was primarily found in parts of Central and West Africa, but in recent weeks it has spread to dozens of countries and infected tens of thousands of people, overwhelmingly men who have sex with men. On July 23, the World Health Organization declared monkeypox a global health emergency.
I fear I might have monkeypox. What should I do? There is no way to test for monkeypox if you have only flulike symptoms. But if you start to notice red lesions, you should contact an urgent care center or your primary care physician, who can order a monkeypox test. Isolate at home as soon as you develop symptoms, and wear high-quality masks if you must come in contact with others for medical care.
What is the treatment for monkeypox? If you get sick, the treatment for monkeypox generally involves symptom management. Tecovirimat, an antiviral drug also known as TPOXX, occasionally can be used for severe cases. The Jynneos vaccine, which protects against smallpox and monkeypox, can also help reduce symptoms, even if taken after exposure.
Can I get the vaccine? Two vaccines originally developed for smallpox can help prevent monkeypox infections. Jynneos is the most commonly used, and consists of two doses given four weeks apart. Because the supply is limited, it has mostly been offered to health care workers and people who have had a confirmed or suspected monkeypox exposure. A few states, including New York, have also made vaccines available among higher-risk populations, including men who have sex with men.
The United States also owned well over a million Jynneos doses in vials — and enough vaccine for millions of more doses that had yet to be filled into vials — in Denmark, where the producer of the vaccine, Bavarian Nordic, is headquartered.
Much of that supply was tied up in bureaucratic red tape because the Food and Drug Administration had yet to inspect and certify a new facility outside Copenhagen where the company now fills the vaccine into vials — an issue that has yet to be fully resolved.
But there were 372,000 doses owned by the United States that were ready to go. These doses, stored at the company’s headquarters, had been filled into vials earlier, at a different facility with the necessary F.D.A. approval.
Rather than quickly transfer those doses back to the United States and begin administering them, however, the federal government adopted a wait-and-see attitude. In the first few weeks after monkeypox was detected in the United States, the government requested only 72,000 of the 372,000 doses.
The job of managing the country’s supply of Jynneos falls largely to the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency that develops and procures drugs and vaccines to protect against pandemics, bioterrorism and other hazards. The authority supported development of the vaccine following the terrorist attacks of Sept. 11, 2001, as the federal government worried about the use of weaponized smallpox.
One reason that federal officials were reluctant to order all available doses early on involved cold storage and shelf life. The storage facilities in America where the doses would be kept weren’t as cold as the Denmark facility, said Dr. Disbrow, a senior official at the Department of Health and Human Services who runs BARDA.
“So if all the doses were not necessary for the outbreak,” he said, “their shelf life would be dramatically shortened.”
Joseph Osmundson, a microbiologist and queer activist, said that the monkeypox outbreak may not have been the emergency that the federal government had prepared for — weaponized smallpox — “but this is an emergency nevertheless.”
“There is no excuse for this level of bureaucratic inaction,” he said.
The first monkeypox case to be detected in the United States this year was identified in Massachusetts on May 18. New York City identified a case the next day. On May 20, BARDA requested that Bavarian Nordic send over 36,000 doses, a spokeswoman for the agency said. They arrived five days later.
On May 27, BARDA requested another 36,000 doses, which arrived two weeks later, Dr. Disbrow said. By then, 16 cases of monkeypox had been detected in New York City, along with cases in 14 other states and the District of Columbia.
Dr. Disbrow said that only so many doses could be transported per flight. In an email, a spokesman for Bavarian Nordic explained that each large order required some lead time. The company has to first receive containers, known as cocoons, from the shippers and then “freeze them to temperature for five days” before packing them with vaccine.
As of June 10, the federal government had distributed just a few thousand doses of monkeypox vaccines to states, officials said in a call that day with reporters. A senior Health and Human Services official, Dawn O’Connell, said the United States would receive 300,000 doses of Jynneos “over the next several weeks.”
Except, the U.S. government hadn’t yet requested them. “That order came in late June,” a Bavarian Nordic spokesman said.
Dr. Disbrow, the BARDA director, gave a similar timeline in an interview, although a spokeswoman for the agency subsequently said the government asked for those doses earlier, on June 14.
By all accounts, the first shipments of the remaining 300,000 doses did not begin arriving until June 29 or 30, several days after the New York City Pride March and related festivities, and they arrived in several shipments, Dr. Disbrow said.
But many of the doses did not arrive until July. Bavarian Nordic said some were delayed in part because they had to be driven from Copenhagen to Germany, because airline pilots were on strike at SAS, the Scandinavian airline.
Asked about the delays, the BARDA spokeswoman, Elleen Kane, said that if one counted only “business days” the time lag was shorter.
Mr. Krellenstein, the activist who leads a group, PrEP4ALL, which works to increase access to daily medication that prevents H.I.V. infection, was one of the first to be vaccinated during New York City’s first window, on June 23. But he received a deluge of text messages from friends who said they’d missed out.
That evening, Mr. Krellenstein called a health activist he knew in Boston: “We said, ‘Oh, my God, the doses aren’t coming. What’s going on?’”
He said he was stunned to learn that most of the doses were stuck in limbo in Denmark awaiting the F.D.A. facility inspection.
Along with several H.I.V./AIDS activists, including some from the group ACT UP, Mr. Krellenstein began demanding meetings with White House and federal health officials to learn more about the hold up.
“Those doses likely would have been sufficient to stem the initial outbreak, if they had been mobilized and administered in the U.S.,” Mr. Krellenstein wrote in an email to several Biden administration officials in mid-July.
A spokeswoman for Health and Human Services, which oversees BARDA, responded by suggesting that more doses hadn’t been needed earlier, noting that initially the C.D.C. had only endorsed the vaccine for a limited group: known contacts of monkeypox patients.
Though New York City had by June 23 decided to offer the vaccine more broadly — to all men who had recently had sex with multiple or anonymous male sexual partners — the federal government did not endorse that move until June 28.
By early July, it was clear that the spread of monkeypox was accelerating among men who have sex with men in New York City.
Sergio Rodriguez, 39, a transgender queer man who lives in the East Village, said he tried to get vaccinated before Pride Weekend, but was turned away. He hooked up with a few people, and about a week later, began to feel abdominal pain, swollen lymph nodes and body aches. Lesions then spread across his body, and some made it excruciating to urinate.
“I’ve actively been trying to do things to support myself because I knew that I would be at high risk,” he said.
“It’s really frustrating,” he added, that the government “was not set up to adequately meet the demand.”
The situation in New York City had been especially frustrating. By the end of the first week of July, there were already more than 200 known cases in New York, but the city had received only 7,000 doses.
When the city received an additional 14,500 doses the following week, the available vaccination slots were taken within seven minutes of being posted online.
Lawrence Gostin, a former C.D.C. adviser who directs the O’Neill Institute for National and Global Health Law at Georgetown University, said it was clear based on recent conversations he had with White House officials that they were searching for a czar-like figure to run the monkeypox response, in what would be an acknowledgment of the need for more sweeping action by the federal government.
Several administration officials confirmed that such a search was underway. Raj Panjabi, the White House director of pandemic preparedness, has so far overseen monkeypox response efforts.
One White House official familiar with the administration’s response said that while it was also considering declaring a public health emergency, there was still an active discussion about what powers such a declaration might provide. Mr. Gostin said officials were working to determine how such a move could potentially free up funds for research, vaccines and treatments.
The flow of vaccine doses to New York has begun to increase; the city has now received 46,000 of them. But online appointments are still snapped up within minutes. And by now, monkeypox has spread widely enough in New York City that epidemiologists doubt it can be contained anytime soon.
Noah Weiland and Sharon LaFraniere contributed reporting from Washington.
On July 15, 2022, this report was posted online as an MMWR Early Release.
Ruth Link-Gelles, PhD1; Matthew E. Levy, PhD2; Manjusha Gaglani, MBBS3,4; Stephanie A. Irving, MHS5; Melissa Stockwell, MD6,7,8; Kristin Dascomb, MD, PhD9; Malini B. DeSilva, MD10; Sarah E. Reese, PhD2; I-Chia Liao, MPH3; Toan C. Ong, PhD11; Shaun J. Grannis, MD12,13; Charlene McEvoy, MD10; Palak Patel, MBBS1; Nicola P. Klein, MD, PhD14; Emily Hartmann, MPP15; Edward Stenehjem, MD9; Karthik Natarajan, PhD8,16; Allison L. Naleway, PhD5; Kempapura Murthy, MBBS3; Suchitra Rao, MBBS11; Brian E. Dixon, PhD12,17; Anupam B. Kharbanda, MD18; Akintunde Akinseye, MSPH2; Monica Dickerson1; Ned Lewis, MPH14; Nancy Grisel, MPP9; Jungmi Han16; Michelle A. Barron, MD11; William F. Fadel, PhD12,17; Margaret M. Dunne, MSc2; Kristin Goddard, MPH14; Julie Arndorfer, MPH9; Deepika Konatham3; Nimish R. Valvi, DrPH, MBBS12; J. C. Currey15; Bruce Fireman, MA14; Chandni Raiyani, MPH3; Ousseny Zerbo, PhD14; Chantel Sloan-Aagard, PhD15,19; Sarah W. Ball, ScD2; Mark G. Thompson, PhD1; Mark W. Tenforde, MD, PhD1 (View author affiliations)
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Summary
What is already known about this topic?
Little is known about COVID-19 vaccine effectiveness (VE) during the Omicron variant BA.2/BA.2.12.2–predominant period or VE of a fourth COVID-19 vaccine dose in persons aged ≥50 years.
What is added by this report?
VE during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period. A third vaccine dose provided additional protection against moderate and severe COVID-19–associated illness in all age groups, and a fourth dose provided additional protection in eligible adults aged ≥50 years.
What are the implications for public health practice?
Immunocompetent persons should receive recommended COVID-19 booster doses to prevent moderate to severe COVID-19, including a first booster dose for all eligible persons and second dose for adults aged ≥50 years at least 4 months after an initial booster dose. Booster doses should be obtained immediately when persons become eligible.
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The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in the United States in November 2021, with the BA.1 sublineage (including BA.1.1) causing the largest surge in COVID-19 cases to date. Omicron sublineages BA.2 and BA.2.12.1 emerged later and by late April 2022, accounted for most cases.* Estimates of COVID-19 vaccine effectiveness (VE) can be reduced by newly emerging variants or sublineages that evade vaccine-induced immunity (1), protection from previous SARS-CoV-2 infection in unvaccinated persons (2), or increasing time since vaccination (3). Real-world data comparing VE during the periods when the BA.1 and BA.2/BA.2.12.1 predominated (BA.1 period and BA.2/BA.2.12.1 period, respectively) are limited. The VISION network† examined 214,487 emergency department/urgent care (ED/UC) visits and 58,782 hospitalizations with a COVID-19–like illness§ diagnosis among 10 states during December 18, 2021–June 10, 2022, to evaluate VE of 2, 3, and 4 doses of mRNA COVID-19 vaccines (BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) compared with no vaccination among adults without immunocompromising conditions. VE against COVID-19–associated hospitalization 7–119 days and ≥120 days after receipt of dose 3 was 92% (95% CI = 91%–93%) and 85% (95% CI = 81%–89%), respectively, during the BA.1 period, compared with 69% (95% CI = 58%–76%) and 52% (95% CI = 44%–59%), respectively, during the BA.2/BA.2.12.1 period. Patterns were similar for ED/UC encounters. Among adults aged ≥50 years, VE against COVID-19–associated hospitalization ≥120 days after receipt of dose 3 was 55% (95% CI = 46%–62%) and ≥7 days (median = 27 days) after a fourth dose was 80% (95% CI = 71%–85%) during BA.2/BA.2.12.1 predominance. Immunocompetent persons should receive recommended COVID-19 booster doses to prevent moderate to severe COVID-19, including a first booster dose for all eligible persons and second booster dose for adults aged ≥50 years at least 4 months after an initial booster dose. Booster doses should be obtained immediately when persons become eligible.¶
A 2-dose primary COVID-19 mRNA vaccination series followed by a third (booster) dose at least 5 months after dose 2 is recommended for adults aged ≥18 years without immunocompromising conditions. On March 29, 2022, an additional booster dose (dose 4) was authorized for immunocompetent adults aged ≥50 years at least 4 months after dose 3 (4). The VISION Network evaluated the effectiveness of 2, 3, or 4 mRNA vaccine doses during December 2021–June 2022, a period during which different sublineages of Omicron circulated in the United States. VISION methods have been described previously (5); briefly, eligible medical encounters include ED/UC visits and hospitalizations among adults with COVID-19–like illness and a SARS-CoV-2 molecular test during the 14 days before through 72 hours after the encounter. Variant predominance was defined as the period when a variant accounted for ≥75% of all sequenced specimens at a site (i.e., BA.1, December 2021–March 2022** and BA.2/BA.2.12.1, March–June 2022††). Dates when the prevalence of BA.1 declined to <75% of sequenced specimens and the prevalence of BA.2/BA.2.12.1 had not yet reached 75% were considered a “washout” period; encounters through June 10, 2022, were included unless BA.2/BA.2.12.1 prevalence declined to <75% at a site before that date. Patients were excluded if 1) a medical event occurred during the washout period; 2) a likely immunocompromising condition was present; 3) an mRNA vaccine dose was received before it was recommended§§; 4) any doses of a non–mRNA vaccine such as JNJ-78436735 (Janssen [Johnson & Johnson]) were received; 5) <14 days had elapsed since receipt of dose 2 or <7 days since receipt of dose 3 or dose 4; or 6) a previous SARS-CoV-2 infection was documented in the patient’s medical record before the index encounter (to reduce the influence of protection from previous infection).¶¶ VE was estimated using a test-negative case-control design, comparing the odds of being vaccinated (receipt of 2 doses ≥14 days before the encounter, 3 doses ≥7 days before the encounter, or 4 doses ≥7 days before the encounter) versus being unvaccinated (zero doses received) between persons with positive and negative SARS-CoV-2 test results, using multivariable logistic regression, weighted for inverse propensity to be vaccinated, and adjusted for age, calendar time of index date (days since January 1, 2021),*** study site, and local virus circulation. VE for 4 vaccine doses was assessed only for adults aged ≥50 years during the BA.2/BA.2.12.1 period, aligning with the March 29, 2022, authorization for the fourth dose. Nonoverlapping 95% CIs were considered statistically significant. Analyses were conducted using R software (version 4.1.2; R Foundation). The study was reviewed and approved by institutional review boards at participating sites or under reliance agreement with the institutional review board of Westat, Inc. This activity was conducted consistent with applicable federal law and CDC policy.†††
Among 214,487 ED/UC encounters with a COVID-19–like illness diagnosis that met inclusion criteria, 124,033 (57.8%) occurred during the BA.1 period, during which 40,801 (32.9%) patients had a positive SARS-CoV-2 test result; 90,454 (42.2%) occurred during the BA.2/BA.2.12.1 period, during which 10,177 (11.3%) had a positive SARS-CoV-2 test result. During the BA.1 period, 51,359 (41.4%) ED/UC patients were unvaccinated, 40,026 (32.3%) had received 2 mRNA vaccine doses, and 32,648 (26.3%) had received 3 doses (Table 1). During the BA.2/BA.2.12.1 period, 27,907 (30.9%) ED/UC patients were unvaccinated; 22,657 (25.0%) had received 2 mRNA vaccine doses, 35,796 (39.6%) had received 3 doses; and 4,094 (4.5%) had received 4 doses. Receipt of 3 versus 2 doses was associated with a higher VE against an ED/UC encounter during both periods, and VE was higher during the BA.1 period than the BA.2/BA.2.12.1 period (Table 2). During the BA.1 period, VE declined to 73% ≥120 days (median = 132 days) after the third vaccine dose; during the BA.2/BA.12.1 period, VE declined to 26% at ≥120 days (median = 166 days) after the third dose.
Among 58,782 hospitalizations with a COVID-19–like illness diagnosis that met inclusion criteria, 35,399 (60.2%) occurred during the BA.1 period, during which 10,534 (29.8%) patients had a positive SARS-CoV-2 test result; 23,383 (17.9%) occurred during the BA.2/BA.2.12.1 period, during which 1,564 (6.7%) patients had a positive test result (Table 3). During the BA.1 period, 14,742 (41.6%) patients hospitalized with COVID-19–like illness were unvaccinated, 10,086 (28.5%) had received 2 mRNA vaccine doses, and 10,571 (29.9%) had received 3 doses. During the BA.2/BA.2.12.1 period, 6,682 (28.6%) patients hospitalized with COVID-19–like illness were unvaccinated, and 5,461 (23.4%), 10,036 (42.9%), and 1,204 (5.1%) had received 2, 3, and 4 mRNA vaccine doses, respectively. VE against COVID-19–associated hospitalization was 61% ≥150 days after dose 2 during the BA.1 period (median = 289 days) compared with 24% during the BA.2/BA.2.12.1 period (median = 371 days) (Table 2). VE associated with a third mRNA vaccine dose was higher than that associated with a second vaccine dose but declined during both periods at ≥120 days to 85% during the BA.1 period (median = 132 days) and 52% during the BA.2/BA.2.12.1 period (median = 168 days).
Among adults aged ≥50 years eligible to receive a fourth mRNA vaccine dose, VE for COVID-19–associated ED/UC encounters during the BA.2/BA.2.12.1 period was 32% at ≥120 days after the third dose (median interval = 170 days) but increased to 66% ≥7 days after the fourth dose (median interval = 28 days). VE against COVID-19–associated hospitalization was 55% ≥120 days after the third dose but increased to 80% ≥7 days after the fourth dose.
Discussion
Data from the Omicron BA.1 sublineage surge in the United States during December 2021–February 2022 determined that VE was reduced compared with that during the previous Delta-predominant period (6). To date, estimates of differences in VE between the Omicron BA.1 and subsequent BA.2/BA.2.12.1 sublineage periods have been limited. In this estimate of VE against ED/UC visits and hospitalizations during the BA.1 and BA.2/BA.2.12.1 periods, VE declined during both periods ≥150 days after the second vaccine dose, highlighting the need for a third dose (i.e., the first booster) for eligible adults. Recent receipt of a third dose increased VE; however, some decline was observed ≥120 days after receipt of the dose. Among eligible adults aged ≥50 years, a fourth vaccine dose ≥120 days after receipt of the third dose improved VE during the BA.2/BA.2.12.1 period, although follow-up time after dose 4 was limited. These findings highlight the importance of staying up to date with COVID-19 vaccination, including recommended booster doses.
Although data on neutralizing antibodies have found BA.1 and BA.2 to be similar, recent data indicate slightly more immune escape for BA.2.12.1 (1). Data reported on Omicron sublineage VE have been limited. A study in the United Kingdom found inconsistent differences in VE for symptomatic COVID-19 and COVID-19–associated hospitalization, with higher VE against symptomatic COVID-19 but larger declines in VE against hospitalization observed during a period of BA.2 predominance versus a period of BA.1 predominance starting 10–14 weeks after a third COVID-19 vaccine dose (7). A study in Qatar found that after a second or third mRNA vaccine dose, declines in VE against symptomatic COVID-19 during BA.1 and BA.2 periods were similar, but the study did not identify enough severe cases to separate VE estimates by predominant variant (8). Differences between the current study and previous studies, including differences in proportions of persons with previous SARS-CoV-2 infection and the absence of BA.2.12.1 infections outside the United States might account for some variability in findings. After the BA.1 surge in the United States, a larger proportion of adults were found to have experienced a recent SARS-CoV-2 infection during the BA.2/BA.2.12.1 period, with antibody evidence of SARS-CoV-2 infection increasing from 33.5% in December 2021 to 57.7% by February 2022 (9). Unvaccinated persons were used as a referent group in VE analyses. If unvaccinated persons were more likely to have experienced recent infection, and infection-induced immunity provides some protection against re-infection, this could result in lower VE observed during the BA.2/BA.2.12.1 period. Although adults with documented past SARS-CoV-2 infection were excluded, infections are likely to be significantly underascertained because of lack of testing or increased at-home testing (10). In addition, although time since receipt of the second or third vaccine dose was stratified by time intervals, on average the time since vaccination was longer during the BA.2/BA.2.12.1 period. These differences were particularly pronounced in the analysis of ≥150 days after the second vaccine dose (median 289 days for hospitalized adults during the BA.1 period compared to 371 days during the BA.2/BA.2.12.1 period), which could account for some differences in VE estimates and highlights the importance of a third dose (first booster) for those who have not yet received it.
The findings in this analysis are subject to at least four limitations. First, previous SARS-CoV-2 infection was likely underascertained and might differentially affect observed VE during the BA.1 and BA.2/BA.2.12.1 periods. Second, residual confounding in VE estimates is possible. Third, no genetic characterization was available for SARS-CoV-2–positive specimens; therefore, date of testing was used to ascribe likely sublineage, and BA.2 and BA.2.12.1 sublineages were combined, given their overlap in circulation. Finally, this report did not assess VE against the most severe COVID-19–associated disease (e.g., respiratory failure) because of smaller numbers of these cases.
VE should continue to be monitored in the setting of newly emerging sublineages and variants, including Omicron sublineages BA.4 and BA.5, which became predominant in the United States in late June 2022. Eligible adults should stay up to date with recommended COVID-19 vaccinations, including a first booster dose for all eligible persons and second booster dose for adults aged ≥50 years. Booster doses should be obtained immediately when persons become eligible.
1CDC COVID-19 Emergency Response Team; 2Westat, Rockville, Maryland.; 3Baylor Scott & White Health, Temple, Texas; 4Texas A&M University College of Medicine, Temple, Texas; 5Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; 6Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; 7Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York; 8New York Presbyterian Hospital, New York, New York; 9Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah; 10HealthPartners Institute, Minneapolis, Minnesota; 11School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado; 12Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana; 13School of Medicine, Indiana University, Indianapolis, Indiana; 14Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, California; 15Paso Del Norte Health Information Exchange, El Paso, Texas; 16Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York; 17Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana; 18Children’s Minnesota, Minneapolis, Minnesota; 19Brigham Young University Department of Public Health, Provo, Utah.
References
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Altarawneh HN, Chemaitelly H, Hasan MR, et al. Protection against the Omicron variant from previous SARS-CoV-2 infection. N Engl J Med 2022;386:1288–90. https://doi.org/10.1056/NEJMc2200133 PMID:35139269
Feikin DR, Higdon MM, Abu-Raddad LJ, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet 2022;399:924–44. https://doi.org/10.1016/S0140-6736(22)00152-0 PMID:35202601
Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
Thompson MG, Stenehjem E, Grannis S, et al. Effectiveness of Covid-19 vaccines in ambulatory and inpatient care settings. N Engl J Med 2021;385:1355–71. https://doi.org/10.1056/NEJMoa2110362 PMID:34496194
Thompson MG, Natarajan K, Irving SA, et al. Effectiveness of a third dose of mRNA vaccines against COVID-19–associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant predominance—VISION Network, 10 States, August 2021–January 2022. MMWR Morb Mortal Wkly Rep 2022;71:139–45. https://doi.org/10.15585/mmwr.mm7104e3 PMID:35085224
Kirsebom FCM, Andrews N, Stowe J, et al. COVID-19 vaccine effectiveness against the omicron (BA.2) variant in England. Lancet Infect Dis 2022;22:931–3. https://doi.org/10.1016/S1473-3099(22)00309-7 PMID:35623379
Chemaitelly H, Ayoub HH, AlMukdad S, et al. Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar. Nat Commun 2022;13:3082. https://doi.org/10.1038/s41467-022-30895-3 PMID:35654888
Clarke KEN, Jones JM, Deng Y, et al. Seroprevalence of infection-induced SARS-CoV-2 antibodies—United States, September 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:606–8. https://doi.org/10.15585/mmwr.mm7117e3 PMID:35482574
Rader B, Gertz A, Iuliano AD, et al. Use of at-home COVID-19 tests—United States, August 23, 2021–March 12, 222. MMWR Morb Mortal Wkly Rep 2022;71:489–94. https://doi.org/10.15585/mmwr.mm7113e1 PMID:35358168
TABLE 1. Characteristics of emergency department and urgent care encounters among adults aged ≥18 years with COVID-19–like illness,* by Omicron subvariant–predominant period,†,§ mRNA COVID-19 vaccination status, and SARS-CoV-2 test result — 10 states, December 2021–June 2022
Characteristic
Total no. (column %)
mRNA COVID-19 vaccination status¶
Positive test result*
No. (row %)
SMD**
No. (row %)
SMD**
Unvaccinated
2 doses
3 doses
4 doses
14–149 days earlier
≥150 days earlier
7–119 days earlier
≥120 days earlier
≥7 days earlier
Omicron BA.1–predominant period†
All ED or UC events
124,033 (100.0)
51,359 (41.4)
7,286 (5.9)
32,740 (26.4)
29,333 (23.6)
3,315 (2.7)
N/A
—
40,801 (32.9)
—
Site
Baylor Scott & White Health
29,978 (24.2)
17,365 (57.9)
1,544 (5.2)
7,799 (26.0)
2,970 (9.9)
300 (1.0)
—
0.745
13,279 (44.3)
0.342
Columbia University
3,116 (2.5)
1,600 (51.3)
333 (10.7)
740 (23.7)
432 (13.9)
11 (0.4)
—
956 (30.7)
HealthPartners
12,579 (10.1)
3,435 (27.3)
730 (5.8)
3,247 (25.8)
4,720 (37.5)
447 (3.6)
—
3,820 (30.4)
Intermountain Healthcare
26,950 (21.7)
9,717 (36.1)
2,020 (7.5)
7,398 (27.5)
6,844 (25.4)
971 (3.6)
—
6,696 (24.8)
KPNC
20,383 (16.4)
3,862 (18.9)
1,274 (6.3)
5,952 (29.2)
8,411 (41.3)
884 (4.3)
—
5,252 (25.8)
KPNW
7,929 (6.4)
2,417 (30.5)
385 (4.9)
2,166 (27.3)
2,544 (32.1)
417 (5.3)
—
2,686 (33.9)
PHIX
1,243 (1.0)
647 (52.1)
54 (4.3)
322 (25.9)
196 (15.8)
24 (1.9)
—
318 (25.6)
Regenstrief Institute
14,003 (11.3)
8,007 (57.2)
682 (4.9)
2,968 (21.2)
2,213 (15.8)
133 (0.9)
—
4,986 (35.6)
University of Colorado
7,852 (6.3)
4,309 (54.9)
264 (3.4)
2,148 (27.4)
1,003 (12.8)
128 (1.6)
—
2,808 (35.8)
Age group, yrs
18–49
63,406 (51.1)
33,003 (52.1)
4,909 (7.7)
16,313 (25.7)
8,755 (13.8)
426 (0.7)
—
0.678
23,073 (36.4)
0.219
50–65
24,832 (20.0)
9,229 (37.2)
1,415 (5.7)
7,458 (30.0)
6,305 (25.4)
425 (1.7)
—
8,460 (34.1)
65–74
15,978 (12.9)
4,646 (29.1)
507 (3.2)
3,901 (24.4)
5,953 (37.3)
971 (6.1)
—
4,459 (27.9)
75–84
12,584 (10.1)
2,940 (23.4)
302 (2.4)
3,205 (25.5)
5,179 (41.2)
958 (7.6)
—
3,224 (25.6)
≥85
7,233 (5.8)
1,541 (21.3)
153 (2.1)
1,863 (25.8)
3,141 (43.4)
535 (7.4)
—
1,585 (21.9)
Sex
Male
50,479 (40.7)
22,531 (44.6)
2,536 (5.0)
12,433 (24.6)
11,574 (22.9)
1,405 (2.8)
—
0.107
17,286 (34.2)
0.051
Female
73,554 (59.3)
28,828 (39.2)
4,750 (6.5)
20,307 (27.6)
17,759 (24.1)
1,910 (2.6)
—
23,515 (32.0)
Race or ethnicity
White, NH
74,613 (60.2)
28,365 (38.0)
3,746 (5.0)
19,754 (26.5)
20,145 (27.0)
2,603 (3.5)
—
0.356
21,430 (28.7)
0.255
Black, NH
15,395 (12.4)
8,547 (55.5)
1,295 (8.4)
3,505 (22.8)
1,902 (12.4)
146 (0.9)
—
6,529 (42.4)
Hispanic
19,508 (15.7)
8,893 (45.6)
1,451 (7.4)
5,489 (28.1)
3,446 (17.7)
229 (1.2)
—
7,481 (38.3)
Other,†† NH
9,368 (7.6)
2,802 (29.9)
522 (5.6)
2,754 (29.4)
3,011 (32.1)
279 (3.0)
—
3,061 (32.7)
Unknown
5,149 (4.2)
2,752 (53.4)
272 (5.3)
1,238 (24.0)
829 (16.1)
58 (1.1)
—
2,300 (44.7)
Chronic respiratory condition at discharge§§
No
103,754 (83.7)
43,204 (41.6)
6,287 (6.1)
27,363 (26.4)
24,303 (23.4)
2,597 (2.5)
—
0.065
34,674 (33.4)
0.054
Yes
20,279 (16.3)
8,155 (40.2)
999 (4.9)
5,377 (26.5)
5,030 (24.8)
718 (3.5)
—
6,127 (30.2)
Chronic nonrespiratory condition at discharge¶¶
No
91,182 (73.5)
38,741 (42.5)
5,749 (6.3)
24,157 (26.5)
20,551 (22.5)
1,984 (2.2)
—
0.145
31,826 (34.9)
0.154
Yes
32,851 (26.5)
12,618 (38.4)
1,537 (4.7)
8,583 (26.1)
8,782 (26.7)
1,331 (4.1)
—
8,975 (27.3)
Omicron BA.2/BA.2.12.1–predominant period§
All ED or UC events
90,454 (100.0)
27,907 (30.9)
1,774 (2.0)
20,883 (23.1)
9,142 (10.1)
26,654 (29.5)
4,094 (4.5)
—
10,177 (11.3)
—
Site
Baylor Scott & White Health
12,976 (14.3)
6,786 (52.3)
188 (1.4)
3,687 (28.4)
501 (3.9)
1,720 (13.3)
94 (0.7)
0.925
1,155 (8.9)
0.296
Columbia University
3,430 (3.8)
1,452 (42.3)
130 (3.8)
937 (27.3)
344 (10.0)
551 (16.1)
16 (0.5)
232 (6.8)
HealthPartners
15,234 (16.8)
3,269 (21.5)
346 (2.3)
2,868 (18.8)
1,821 (12.0)
5,944 (39.0)
986 (6.5)
2,057 (13.5)
Intermountain Healthcare
17,134 (18.9)
5,262 (30.7)
469 (2.7)
4,359 (25.4)
1,654 (9.7)
4,986 (29.1)
404 (2.4)
2,318 (13.5)
KPNC
20,732 (22.9)
2,531 (12.2)
374 (1.8)
4,114 (19.8)
3,278 (15.8)
8,446 (40.7)
1,989 (9.6)
1,670 (8.1)
KPNW
7,211 (8.0)
1,588 (22.0)
110 (1.5)
1,464 (20.3)
894 (12.4)
2,695 (37.4)
460 (6.4)
1,084 (15.0)
PHIX
709 (0.8)
338 (47.7)
13 (1.8)
176 (24.8)
59 (8.3)
113 (15.9)
10 (1.4)
43 (6.1)
Regenstrief Institute
6,064 (6.7)
3,188 (52.6)
95 (1.6)
1,299 (21.4)
341 (5.6)
1,103 (18.2)
38 (0.6)
575 (9.5)
University of Colorado
6,964 (7.7)
3,493 (50.2)
49 (0.7)
1,979 (28.4)
250 (3.6)
1,096 (15.7)
97 (1.4)
1,043 (15.0)
Age group, yrs
18–49
42,569 (47.1)
18,429 (43.3)
1,192 (2.8)
11,203 (26.3)
4,132 (9.7)
7,613 (17.9)
0 (0.0)
0.778
5,074 (11.9)
0.099
50–65
17,598 (19.5)
4,755 (27.0)
317 (1.8)
4,253 (24.2)
2,232 (12.7)
5,355 (30.4)
686 (3.9)
2,087 (11.9)
65–74
12,909 (14.3)
2,271 (17.6)
137 (1.1)
2,437 (18.9)
1,185 (9.2)
5,542 (42.9)
1337 (10.4)
1,253 (9.7)
75–84
11,032 (12.2)
1,591 (14.4)
71 (0.6)
1,902 (17.2)
994 (9.0)
5,130 (46.5)
1344 (12.2)
1,174 (10.6)
≥85
6,346 (7.0)
861 (13.6)
57 (0.9)
1,088 (17.1)
599 (9.4)
3,014 (47.5)
727 (11.5)
589 (9.3)
Sex
Male
36,191 (40.0)
11,836 (32.7)
631 (1.7)
8,014 (22.1)
3,406 (9.4)
10,449 (28.9)
1,855 (5.1)
0.090
4,091 (11.3)
0.004
Female
54,263 (60.0)
16,071 (29.6)
1,143 (2.1)
12,869 (23.7)
5,736 (10.6)
16,205 (29.9)
2,239 (4.1)
6,086 (11.2)
Race or ethnicity
White, NH
55,447 (61.3)
15,386 (27.7)
799 (1.4)
12,474 (22.5)
5,296 (9.6)
18,410 (33.2)
3,082 (5.6)
0.361
6,471 (11.7)
0.128
Black, NH
9,797 (10.8)
4,405 (45.0)
368 (3.8)
2,272 (23.2)
898 (9.2)
1,644 (16.8)
210 (2.1)
1,033 (10.5)
Hispanic
13,939 (15.4)
4,780 (34.3)
396 (2.8)
3,693 (26.5)
1,642 (11.8)
3,076 (22.1)
352 (2.5)
1,217 (8.7)
Other,†† NH
8,040 (8.9)
1,769 (22.0)
160 (2.0)
1,670 (20.8)
1,096 (13.6)
2,927 (36.4)
418 (5.2)
1,003 (12.5)
Unknown
3,231 (3.6)
1,567 (48.5)
51 (1.6)
774 (24.0)
210 (6.5)
597 (18.5)
32 (1.0)
453 (14.0)
Chronic respiratory condition at discharge§§
No
75,947 (84.0)
23,604 (31.1)
1,474 (1.9)
17,438 (23.0)
7,708 (10.1)
22,242 (29.3)
3,481 (4.6)
0.024
9,149 (12.0)
0.197
Yes
14,507 (16.0)
4,303 (29.7)
300 (2.1)
3,445 (23.7)
1,434 (9.9)
4,412 (30.4)
613 (4.2)
1,028 (7.1)
Chronic nonrespiratory condition at discharge¶¶
No
67,691 (74.8)
21,424 (31.6)
1,359 (2.0)
15,621 (23.1)
6,903 (10.2)
19,378 (28.6)
3,006 (4.4)
0.050
8,549 (12.6)
0.255
Yes
22,763 (25.2)
6,483 (28.5)
415 (1.8)
5,262 (23.1)
2,239 (9.8)
7,276 (32.0)
1,088 (4.8)
1,628 (7.2)
Abbreviations: ED = emergency department; ICD-9 = International Classification of diseases, Ninth Revision; ICD-10 = International Classification of diseases, Tenth Revision; KPNC = Kaiser Permanente Northern California; KPNW = Kaiser Permanente Northwest; N/A = not applicable; NH = non-Hispanic; PHIX = Paso del Norte Health Information Exchange; RT-PCR = reverse transcription–polymerase reaction; SMD = standardized mean or proportion difference; UC = urgent care. * Medical events with a discharge code consistent with COVID-19–like illness were included; using ICD-9 and ICD-10 codes, COVID-19–like illness diagnoses included acute respiratory illness (e.g., respiratory failure or pneumonia) or related signs or symptoms (e.g., cough, fever, dyspnea, vomiting, or diarrhea). Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days before to <72 hours after the encounter date were included. † Partners contributing data on medical events during dates of estimated ≥75% Omicron BA.1 predominance were in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022). § Partners contributing data on medical events during dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance were in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 26–Jun 4, 2022] and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022). ¶ Vaccination was defined as having received the listed number of doses of an mRNA-based COVID-19 vaccine within the specified range of number of days before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the medical event or the admission date if testing only occurred after the admission. ** An absolute SMD ≥0.20 indicates a nonnegligible difference in variable distributions between medical events for vaccinated versus unvaccinated patients or for patients with SARS-CoV-2–positive test result versus those with SARS-CoV-2–negative results. For mRNA COVID-19 vaccination status, a single SMD was calculated by averaging the absolute SMDs obtained from pairwise comparisons of each vaccinated category versus unvaccinated; more specifically as the average of the absolute value of the SMDs for 1) vaccinated with 2 doses 14–149 days earlier versus unvaccinated, 2) vaccinated with 2 doses ≥150 days earlier versus unvaccinated, 3) vaccinated with 3 doses 7–119 days earlier versus unvaccinated, 4) vaccinated with 3 doses ≥120 days earlier versus unvaccinated, and 5) vaccinated with 4 doses ≥7 days earlier versus unvaccinated. †† Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other, and multiple races. §§ Chronic respiratory condition was defined as the presence of discharge code for asthma, chronic obstructive pulmonary disease, or other lung disease using ICD-9 or ICD-10 diagnosis codes. ¶¶ Chronic nonrespiratory condition was defined as the presence of discharge code for heart failure, ischemic heart disease, hypertension, other heart disease, stroke, other cerebrovascular disease, diabetes type I or II, other diabetes, metabolic disease, clinical obesity, clinically underweight, renal disease, liver disease, blood disorder, immunosuppression, organ transplant, cancer, dementia, neurologic disorder, musculoskeletal disorder, or Down syndrome using ICD-9 and ICD-10 diagnosis codes.
TABLE 2. mRNA COVID-19 vaccine effectiveness* against laboratory-confirmed COVID-19–associated† emergency department and urgent care encounters and hospitalizations among adults aged ≥18 years, by Omicron–predominant period, age group, number and timing of vaccine doses,§ and median interval since last dose — VISION Network, 10 states, December 2021–June 2022
Encounter type
Omicron BA.1–predominant period¶
Omicron BA.2/BA.2.12.1–predominant period**
Total
No. (%) of positive test results†
Median interval since last dose, days (IQR)
VE %* (95% CI)
Total
No. (%) of positive test results†
Median interval since last dose days (IQR)
VE %* (95% CI)
ED or UC, age group (days since last dose)
All ages, yrs
Unvaccinated (Ref)
51,359
23,175 (45.1)
—
—
27,907
3,501 (12.6)
—
—
2 doses (14–149)
7,286
2,377 (32.6)
107 (76–129)
47 (44–50)
1,774
110 (6.2)
104 (71–128)
51 (38–60)
2 doses (≥150)
32,740
11,365 (34.7)
267 (232–306)
39 (37–41)
20,883
2,584 (12.4)
352 (278–398)
12 (7–17)
3 doses (7–119)
29,333
3,667 (12.5)
66 (41–89)
84 (83–85)
9,142
441 (4.8)
94 (72–108)
56 (51–61)
3 doses (≥120)
3,315
217 (6.5)
132 (125–142)
73 (68–77)
26,654
3,186 (11.9)
166 (145–190)
26 (21–30)
18–49 yrs
Unvaccinated (Ref)
33,003
14,236 (43.1)
—
—
18,429
2,269 (12.3)
—
—
2 doses (14–149)
4,909
1,621 (33.0)
106 (76–129)
40 (36–44)
1,192
75 (6.3)
105 (72–129)
47 (31–60)
2 doses (≥150)
16,313
5,918 (36.3)
252 (220–288)
24 (21–28)
11,203
1,427 (12.7)
332 (254–379)
7 (0–14)
3 doses (7–119)
8,755
1,259 (14.4)
55 (33–79)
76 (75–78)
4,132
207 (5.0)
91 (69–107)
55 (47–62)
3 doses (≥120)
426
39 (9.2)
130 (124–141)
29 (−1–50)
7,613
1,096 (14.4)
159 (140–182)
17 (10–25)
≥50 yrs
Unvaccinated (Ref)
18,356
8,939 (48.7)
—
—
9,478
1,232 (13.0)
—
—
2 doses (14–149)
2,377
756 (31.8)
109 (77–129)
59 (54–63)
582
35 (6.0)
102 (68–128)
59 (40–71)
2 doses (≥150)
16,427
5,447 (33.2)
283 (248–316)
52 (50–54)
9,680
1,157 (11.9)
376 (319–414)
18 (10–26)
3 doses (7–119)
20,578
2,408 (11.7)
71 (46–93)
87 (86–88)
5,010
234 (4.7)
96 (73–109)
58 (51–64)
3 doses (≥120)
2,889
178 (6.2)
133 (125–143)
81 (77–84)
19,041
2,090 (11.0)
170 (147–193)
32 (26–38)
4 doses (≥7)††
N/A
—
—
—
4,094
355 (8.7)
28 (17–42)
66 (60–71)
Hospitalization, age group (days since last dose)
All ages, yrs
Unvaccinated (Ref)
14,742
6,829 (46.3)
—
—
6,682
494 (7.4)
—
—
2 doses (14–149)
1,236
297 (24.0)
105 (73–129)
68 (63–73)
343
12 (3.5)
102 (71–128)
57 (19–77)
2 doses (≥150)
8,850
2,542 (28.7)
289 (252–322)
61 (58–63)
5,118
393 (7.7)
371 (308–413)
24 (12–35)
3 doses (7–119)
9,146
786 (8.6)
72 (47–93)
92 (91–93)
2,350
72 (3.1)
94 (74–108)
69 (58–76)
3 doses (≥120)
1,425
80 (5.6)
132 (125–142)
85 (81–89)
7,686
519 (6.8)
168 (146–191)
52 (44–59)
18–49 yrs§§
Unvaccinated (Ref)
4,057
1,515 (37.3)
—
—
—
—
—
—
2 doses (14–149)
392
83 (21.2)
101 (67–127)
64 (52–73)
—
—
—
—
2 doses (≥150)
1,304
329 (25.2)
258 (226–294)
52 (43–59)
—
—
—
—
3 doses (7–119)
812
53 (6.5)
57 (36–81)
91 (87–94)
—
—
—
—
3 doses (≥120)
56
1 (1.8)
133 (126–142)
94 (62–99)
—
—
—
—
≥50 yrs§§
Unvaccinated (Ref)
10,685
5,314 (49.7)
—
—
4,595
393 (8.6)
—
—
2 doses (14–149)
844
214 (25.4)
108 (76–129)
71 (65–75)
—
—
—
—
2 doses (≥150)
7,546
2,213 (29.3)
294 (259–325)
63 (60–66)
4,139
352 (8.5)
381 (325–418)
22 (8–34)
3 doses (7–119)
8,334
733 (8.8)
73 (49–94)
92 (91–93)
1,957
57 (2.9)
95 (74–108)
73 (63–81)
3 doses (≥120)
1,369
79 (5.8)
132 (125–142)
86 (82–89)
7,113
480 (6.8)
169 (147–191)
55 (46–62)
4 doses (≥7)††
N/A
—
—
—
1,204
74 (6.2)
27 (17–41)
80 (71–85)
Abbreviations: ED = emergency department; ICD-9 = International Classification of Diseases, Ninth Revision; ICD-10 = International Classification of Diseases, Tenth Revision; N/A = not applicable; PHIX = Paso Del Norte Health Information Exchange; Ref = referent group; RT-PCR = reverse transcription–polymerase chain reaction; UC = urgent care; VE = vaccine effectiveness. * VE was calculated as ([1−odds ratio] x 100%), estimated using a test-negative design, adjusted for age, geographic region, calendar time (days since January 1, 2021), and local virus circulation (percentage of SARS-CoV-2–positive results from testing within the counties surrounding the facility on the date of the encounter) and weighted for inverse propensity to be vaccinated or unvaccinated (calculated separately for each set of VE estimates among ED or UC encounters and hospitalizations by Omicron–predominant period and age group). Generalized boosted regression trees were used to estimate the propensity to be vaccinated based on sociodemographic characteristics, underlying medical conditions, and facility characteristics. † Medical events with a discharge code consistent with COVID-19–like illness were included. COVID-19–like illness diagnoses included acute respiratory illness (e.g., respiratory failure or pneumonia) or related signs or symptoms (e.g., cough, fever, dyspnea, vomiting, or diarrhea) using ICD-9 and ICD-10 codes. Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days before to <72 hours after the encounter date were included. § Vaccination was defined as having received the listed number of doses of an mRNA-based COVID-19 vaccine within the specified range of number of days before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the medical event or the admission date if testing only occurred after the admission. ¶ Partners contributing data on medical events during dates of estimated ≥75% Omicron BA.1 predominance were in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022). ** Partners contributing data on medical events during dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance were in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 6–Jun 4, 2022 and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022). †† For estimation of 4-dose mRNA VE among patients aged ≥50 years during the Omicron BA.2/BA.2.12.1–predominant period, unvaccinated patients whose medical event index date was before Apr 5, 2022 were excluded from the referent group (1,836 ED or UC encounters and 999 hospitalizations excluded among unvaccinated patients) because the earliest medical event index date included among 4-dose mRNA-vaccinated patients was 7 days after Mar 29, 2022 when a second booster mRNA vaccine dose (fourth dose) was first included in recommendations for adults aged ≥50 years (at least 4 months after receiving a third mRNA dose). §§ VE estimates with 95% CIs >50 percentage points are not shown because of imprecision.
TABLE 3. Characteristics of hospitalizations among adults aged ≥18 years with COVID-19–like illness,* by Omicron subvariant–predominant period, mRNA COVID-19 vaccination status, and SARS-CoV-2 test result — 10 states, December 2021–June 2022
Characteristic
Total no. (column %)
mRNA COVID-19 vaccination status, no. of doses received¶
Positive test result*
No. (row %)
SMD**
No. (row %)
SMD**
Unvaccinated
Days since last dose
4 doses
2 doses
3 doses
14–149
≥150
7–119
≥120
≥7
Omicron BA.1–predominant period†
All hospitalizations
35,399 (100.0)
14,742 (41.6)
1,236 (3.5)
8,850 (25.0)
9,146 (25.8)
1,425 (4.0)
N/A
—
10,534 (29.8)
—
Site
Baylor Scott& White Health
8,697 (24.6)
4,480 (51.5)
324 (3.7)
2,528 (29.1)
1,190 (13.7)
175 (2.0)
—
0.551
2,904 (33.4)
0.218
Columbia University
1,419 (4.0)
668 (47.1)
94 (6.6)
367 (25.9)
274 (19.3)
16 (1.1)
—
536 (37.8)
HealthPartners
1,334 (3.8)
378 (28.3)
40 (3.0)
262 (19.6)
586 (43.9)
68 (5.1)
—
322 (24.1)
Intermountain Healthcare
3,224 (9.1)
1,159 (35.9)
148 (4.6)
701 (21.7)
985 (30.6)
231 (7.2)
—
756 (23.4)
KPNC
6,911 (19.5)
1,501 (21.7)
219 (3.2)
1,748 (25.3)
3,036 (43.9)
407 (5.9)
—
1,940 (28.1)
KPNW
1,480 (4.2)
539 (36.4)
56 (3.8)
288 (19.5)
478 (32.3)
119 (8.0)
—
360 (24.3)
PHIX
96 (0.3)
64 (66.7)
1 (1.0)
19 (19.8)
11 (11.5)
1 (1.0)
—
45 (46.9)
Regenstrief Institute
8,980 (25.4)
4,398 (49.0)
276 (3.1)
1,969 (21.9)
2,076 (23.1)
261 (2.9)
—
2,937 (32.7)
University of Colorado
3,258 (9.2)
1,555 (47.7)
78 (2.4)
968 (29.7)
510 (15.7)
147 (4.5)
—
734 (22.5)
Age group, yrs
18–49
6,621 (18.7)
4,057 (61.3)
392 (5.9)
1,304 (19.7)
812 (12.3)
56 (0.8)
—
0.540
1,981 (29.9)
0.126
50–65
7,783 (22.0)
3,847 (49.4)
328 (4.2)
2,008 (25.8)
1,470 (18.9)
130 (1.7)
—
2,664 (34.2)
65–74
8,073 (22.8)
3,059 (37.9)
233 (2.9)
2,041 (25.3)
2,325 (28.8)
415 (5.1)
—
2,370 (29.4)
75–84
7,654 (21.6)
2,329 (30.4)
178 (2.3)
2,054 (26.8)
2,609 (34.1)
484 (6.3)
—
2,137 (27.9)
≥85
5,268 (14.9)
1,450 (27.5)
105 (2.0)
1,443 (27.4)
1,930 (36.6)
340 (6.5)
—
1,382 (26.2)
Sex
Male
17,164 (48.5)
7,549 (44.0)
529 (3.1)
4,075 (23.7)
4,308 (25.1)
703 (4.1)
—
0.098
5,428 (31.6)
0.087
Female
18,235 (51.5)
7,193 (39.4)
707 (3.9)
4,775 (26.2)
4,838 (26.5)
722 (4.0)
—
5,106 (28.0)
Race or ethnicity
White, NH
22,967 (64.9)
8,837 (38.5)
697 (3.0)
5,843 (25.4)
6,479 (28.2)
1,111 (4.8)
—
0.285
6,224 (27.1)
0.199
Black, NH
4,214 (11.9)
2,279 (54.1)
212 (5.0)
976 (23.2)
676 (16.0)
71 (1.7)
—
1,474 (35.0)
Hispanic
3,781 (10.7)
1,801 (47.6)
188 (5.0)
960 (25.4)
759 (20.1)
73 (1.9)
—
1,491 (39.4)
Other,†† NH
2,601 (7.3)
893 (34.3)
81 (3.1)
628 (24.1)
880 (33.8)
119 (4.6)
—
760 (29.2)
Unknown
1,836 (5.2)
932 (50.8)
58 (3.2)
443 (24.1)
352 (19.2)
51 (2.8)
—
585 (31.9)
Chronic respiratory condition at discharge§§
No
14,763 (41.7)
6,116 (41.4)
555 (3.8)
3,693 (25.0)
3,818 (25.9)
581 (3.9)
—
0.023
3,482 (23.6)
0.254
Yes
20,636 (58.3)
8,626 (41.8)
681 (3.3)
5,157 (25.0)
5,328 (25.8)
844 (4.1)
—
7,052 (34.2)
Chronic nonrespiratory condition at discharge¶¶
No
4,685 (13.2)
2,516 (53.7)
166 (3.5)
958 (20.4)
949 (20.3)
96 (2.0)
—
0.200
1,522 (32.5)
0.050
Yes
30,714 (86.8)
12,226 (39.8)
1,070 (3.5)
7,892 (25.7)
8,197 (26.7)
1,329 (4.3)
—
9,012 (29.3)
Omicron BA.2/BA.2.12.1–predominant period§
All hospitalizations
23,383 (100.0)
6,682 (28.6)
343 (1.5)
5,118 (21.9)
2,350 (10.1)
7,686 (32.9)
1,204 (5.1)
—
1,564 (6.7)
—
Site
Baylor Scott & White Health
4,686 (20.0)
2,128 (45.4)
55 (1.2)
1,417 (30.2)
227 (4.8)
813 (17.3)
46 (1.0)
0.945
196 (4.2)
0.268
Columbia University
1,413 (6.0)
491 (34.7)
48 (3.4)
316 (22.4)
169 (12.0)
375 (26.5)
14 (1.0)
81 (5.7)
HealthPartners
1,758 (7.5)
329 (18.7)
37 (2.1)
261 (14.8)
204 (11.6)
760 (43.2)
167 (9.5)
120 (6.8)
Intermountain Healthcare
2,023 (8.7)
571 (28.2)
35 (1.7)
446 (22.0)
179 (8.8)
733 (36.2)
59 (2.9)
167 (8.3)
KPNC
6,866 (29.4)
677 (9.9)
87 (1.3)
1,164 (17.0)
1,095 (15.9)
3,105 (45.2)
738 (10.7)
584 (8.5)
KPNW
1,326 (5.7)
356 (26.8)
17 (1.3)
210 (15.8)
165 (12.4)
488 (36.8)
90 (6.8)
86 (6.5)
PHIX
12 (0.1)
7 (58.3)
0 (0.0)
3 (25.0)
0 (0.0)
2 (16.7)
0 (0.0)
1 (8.3)
Regenstrief Institute
3,947 (16.9)
1,600 (40.5)
48 (1.2)
869 (22.0)
246 (6.2)
1,128 (28.6)
56 (1.4)
235 (6.0)
University of Colorado
1,352 (5.8)
523 (38.7)
16 (1.2)
432 (32.0)
65 (4.8)
282 (20.9)
34 (2.5)
94 (7.0)
Age group, yrs
18–49
4,162 (17.8)
2,087 (50.1)
130 (3.1)
979 (23.5)
393 (9.4)
573 (13.8)
0 (0.0)
0.585
199 (4.8)
0.340
50–65
4,613 (19.7)
1,621 (35.1)
78 (1.7)
1,171 (25.4)
527 (11.4)
1,077 (23.3)
139 (3.0)
220 (4.8)
65–74
5,171 (22.1)
1,258 (24.3)
63 (1.2)
1,098 (21.2)
506 (9.8)
1,929 (37.3)
317 (6.1)
277 (5.4)
75–84
5,539 (23.7)
1,059 (19.1)
34 (0.6)
1,114 (20.1)
520 (9.4)
2,379 (42.9)
433 (7.8)
468 (8.4)
≥85
3,898 (16.7)
657 (16.9)
38 (1.0)
756 (19.4)
404 (10.4)
1,728 (44.3)
315 (8.1)
400 (10.3)
Sex
Male
10,979 (47.0)
3,304 (30.1)
149 (1.4)
2,315 (21.1)
1044 (9.5)
3,553 (32.4)
614 (5.6)
0.080
796 (7.3)
0.085
Female
12,404 (53.0)
3,378 (27.2)
194 (1.6)
2,803 (22.6)
1306 (10.5)
4,133 (33.3)
590 (4.8)
768 (6.2)
Race or ethnicity
White, NH
14,772 (63.2)
3,817 (25.8)
162 (1.1)
3,236 (21.9)
1,367 (9.3)
5,304 (35.9)
886 (6.0)
0.362
1,076 (7.3)
0.199
Black, NH
2,690 (11.5)
1,157 (43.0)
73 (2.7)
598 (22.2)
266 (9.9)
525 (19.5)
71 (2.6)
117 (4.3)
Hispanic
2,708 (11.6)
815 (30.1)
57 (2.1)
648 (23.9)
353 (13.0)
736 (27.2)
99 (3.7)
139 (5.1)
Other,†† NH
2,115 (9.0)
425 (20.1)
40 (1.9)
376 (17.8)
298 (14.1)
842 (39.8)
134 (6.3)
172 (8.1)
Unknown
1,098 (4.7)
468 (42.6)
11 (1.0)
260 (23.7)
66 (6.0)
279 (25.4)
14 (1.3)
60 (5.5)
Chronic respiratory condition at discharge§§
No
10,015 (42.8)
3,085 (30.8)
147 (1.5)
2,179 (21.8)
980 (9.8)
3,142 (31.4)
482 (4.8)
0.092
604 (6.0)
0.092
Yes
13,368 (57.2)
3,597 (26.9)
196 (1.5)
2,939 (22.0)
1,370 (10.2)
4,544 (34.0)
722 (5.4)
960 (7.2)
Chronic nonrespiratory condition at discharge¶¶
No
3,010 (12.9)
1,243 (41.3)
53 (1.8)
690 (22.9)
226 (7.5)
748 (24.9)
50 (1.7)
0.242
174 (5.8)
0.058
Yes
20,373 (87.1)
5,439 (26.7)
290 (1.4)
4,428 (21.7)
2,124 (10.4)
6,938 (34.1)
1154 (5.7)
1,390 (6.8)
Abbreviations: ICD-9 = International Classification of Diseases, Ninth Revision; ICD-10 = International Classification of Diseases, Tenth Revision; KPNC = Kaiser Permanente of Northern California; KPNW = Kaiser Permanente Northwest; N/A = not applicable; NH = non-Hispanic; PHIX = Paso del Norte Health Information Exchange; RT-PCR = reverse transcription–polymerase chain reaction; SMD = standardized mean or proportion difference. * Hospitalizations with a discharge code consistent with COVID-19–like illness were included. COVID-19–like illness diagnoses included acute respiratory illness (e.g., respiratory failure or pneumonia) or related signs or symptoms (e.g., cough, fever, dyspnea, vomiting, or diarrhea) using diagnosis ICD-9 and ICD-10 codes. Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days before to <72 hours after the encounter date were included. † Partners contributing data on hospitalizations during dates of estimated ≥75% Omicron BA.1 predominance were in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022). § Partners contributing data on hospitalizations during dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance were in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 26–Jun 4, 2022] and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022). ¶ Vaccination was defined as having received the listed number of doses of an mRNA-based COVID-19 vaccine within the specified range of number of days before the hospitalization index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the hospitalization or the admission date if testing only occurred after the admission. ** An absolute SMD ≥0.20 indicates a nonnegligible difference in variable distributions between hospitalizations for vaccinated versus unvaccinated patients or for patients with SARS-CoV-2–positive results versus those with SARS-CoV-2–negative results. For mRNA COVID-19 vaccination status, a single SMD was calculated by averaging the absolute SMDs obtained from pairwise comparisons of each vaccinated category versus unvaccinated; more specifically, as the average of the absolute value of the SMDs for 1) vaccinated with 2 doses 14–149 days earlier versus unvaccinated, 2) vaccinated with 2 doses ≥150 days earlier versus unvaccinated, 3) vaccinated with 3 doses 7–119 days earlier versus unvaccinated, 4) vaccinated with 3 doses ≥120 days earlier versus unvaccinated, and 5) vaccinated with 4 doses ≥7 days earlier versus unvaccinated. †† Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other, and multiple races. §§ Chronic respiratory condition was defined as the presence of discharge code for asthma, chronic obstructive pulmonary disease, or other lung disease using ICD-9 and ICD-10 diagnosis codes. ¶¶ Chronic nonrespiratory condition was defined as the presence of discharge code for heart failure, ischemic heart disease, hypertension, other heart disease, stroke, other cerebrovascular disease, diabetes type I or II, other diabetes, metabolic disease, clinical obesity, clinically underweight, renal disease, liver disease, blood disorder, immunosuppression, organ transplant, cancer, dementia, neurologic disorder, musculoskeletal disorder, or Down syndrome using ICD-9 and ICD-10 diagnosis.
Suggested citation for this article: Link-Gelles R, Levy ME, Gaglani M, et al. Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated — VISION Network, 10 States, December 2021–June 2022. MMWR Morb Mortal Wkly Rep 2022;71:931–939. DOI: http://dx.doi.org/10.15585/mmwr.mm7129e1.
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READING, England — Taking high-dose vitamin B6 supplements may help to reduce feelings of anxiety and depression, a new study reveals. Researchers from the University of Reading in England report that young adults taking a dose 50 times the recommended daily dose reported feeling less anxious and depressed after a month.
What is vitamin B6?
Vitamin B6 helps the body turn protein and carbohydrates into energy and it also plays an important role in the nervous system. It also increases the body’s production of GABA (Gamma-Aminobutyric Acid), a chemical that blocks impulses between nerve cells in the brain.
Vitamin B6 is found naturally in a variety of foods, including salmon, tuna, chickpeas, and bananas.
“The functioning of the brain relies on a delicate balance between the excitatory neurons that carry information around and inhibitory ones, which prevent runaway activity,” says Dr. David Field from the University of Reading in a media release. “Recent theories have connected mood disorders and some other neuropsychiatric conditions with a disturbance of this balance, often in the direction of raised levels of brain activity. Vitamin B6 helps the body produce a specific chemical messenger that inhibits impulses in the brain, and our study links this calming effect with reduced anxiety among the participants.”
The study provides evidence lacking in previous studies as to what exactly drives the stress-reducing effects of marmite and multivitamins.
More than 300 participants took either a placebo or Vitamin B6 or B12 supplements at 50 times the recommended amount – around 70mg. Each participant took one tablet a day with food. Vitamin B12 had little effect compared to the placebo, but B6 showed a statistically reliable difference.
Is there a risk from taking too much?
Visual tests at the end of the trial confirmed the raised levels of GABA in participants taking Vitamin B6, supporting the hypothesis that the supplements reduced anxiety.
The team also detected subtle but harmless changes in visual performance, consistent with controlled levels of brain activity. Health officials in the United Kingdom recommend that people do not take too high a dose – more than 200mg a day – as it can lead to a loss of feeling in the arms and legs. In a few cases, this has become permanent in people who have taken very large doses for several months.
“Many foods, including tuna, chickpeas and many fruits and vegetables, contain Vitamin B6. However, the high doses used in this trial suggest that supplements would be necessary to have a positive effect on mood,” Dr. Field continues. “It is important to acknowledge that this research is at an early stage and the effect of Vitamin B6 on anxiety in our study was quite small compared to what you would expect from medication. However, nutrition-based interventions produce far fewer unpleasant side effects than drugs, and so in the future people might prefer them as an intervention.
“To make this a realistic choice, further research is needed to identify other nutrition-based interventions that benefit mental wellbeing, allowing different dietary interventions to be combined in future to provide greater results,” the study author concludes. “One potential option would be to combine Vitamin B6 supplements with talking therapies such as Cognitive Behavioral Therapy to boost their effect.”
The study is published in the journal Human Psychopharmacology: Clinical and Experimental.
South West News Service writer Danny Halpin contributed to this report.
The Department of Health and Human Services announced Thursday it is rolling out an additional 144,000 doses of a monkeypox vaccine in an effort to curb the outbreak as cases continue to rise.
Those additional JYNNEOS vaccine shots will begin shipping across the country on July 11 from the Strategic National Stockpile, according the agency. HHS and the Centers for Disease Control and Prevention have worked together to release 156,000 doses of the vaccine to states throughout the U.S. since the first cases were reported in May 2022.
“We are using every tool we have to increase and accelerate JYNNEOS vaccine availability in jurisdictions that need them the most,” said Steve Adams, director of the Strategic National Stockpile.
The U.S. has reported 699 monkeypox cases this year as of July 7, according to the CDC.
“In less than ten days, we’ve made available 200,000 JYNNEOS vaccine doses in communities where transmission has been the highest and with high-risk populations, and significantly scaled testing availability and convenience,” Adams said.
Apart from Bavarian Nordic’s JYNNEOS, the U.S. also has access to another monkeypox vaccine, ACAM2000, which is not recommended for everyone “due to significant side effects,” HHS said in June.
Vaccine distribution has not been hassle-free. The first 1,000 doses of the JYNNEOS vaccines were given to a single Manhattan clinic with no advance notice to the public, according to The New York Times. As a result, most of those who queued up at the clinic to receive the vaccine were made aware of the rollout through Twitter.
Gregg Gonsalves, an associate professor of epidemiology at the Yale School of Public Health, told CBS News he has identified weaknesses in the government’s response to the epidemic that mirror those in the country’s handling of the coronavirus pandemic.
“We’re six weeks in, and we’re still having problems with availability of testing and vaccine supply, all these issues that we saw with COVID,” Gonsalves said. “Now, the prospects for containment are receding quickly.”
Last week, HHS announced it purchased an additional 2.5 million JYNNEOS doses to be used in current and future monkeypox epidemics. These shots will be added to the Strategic National Stockpile at the end of this year up to early 2023.
“We are working around-the-clock with public health officials in states and large metro areas to provide them with vaccines and treatments to respond to the current monkeypox outbreak,” said HHS Secretary Xavier Becerra on July 1.
The Biden administration also recently expanded the number of people advised to get vaccinated for monkeypox to include those who believe they could have contracted the virus, along with those who had contact with a known monkeypox case or whose sexual partner has been infected.
New York has emerged as a hot spot for a growing monkeypox outbreak, but as the city prepares to receive thousands of doses of vaccine, it is unclear how the city will distribute them equitably to the people most at risk for the disease: sexually active gay, bisexual and other men who have sex with men, among whom the global outbreak has been centered.
Last week, a single clinic in Chelsea offered 1,000 doses of the vaccine that the city’s Department of Health had released from its stock. Hundreds of men turned up as walk-ins, leading the line to close to new people after only about 90 minutes.
The city did not publicly announce the clinic’s opening, at noon on a Thursday, until 30 minutes before. And by Monday, the last shots had been distributed by appointment.
The process led to criticism that those most connected to the world of public health and with the time to take hours off during a workday got most of the first slots.
As of Thursday, 78 cases of monkeypox had been diagnosed in the city, more than double the number that had been reported a week ago, according to the Health Department. And statewide, there were 72 cases as of Wednesday, or 20 percent of the nation’s total of 351 cases.
But more doses are on the way. Gov. Kathy Hochul announced on Thursday that the federal government would soon send the state 8,195 additional doses of the monkeypox vaccine, with about 6,000 going to New York City.
“In New York State, we have seen a disproportionate number of monkeypox cases, especially within our L.G.B.T.Q.+ communities who have been hit especially hard,” Ms. Hochul said in a statement. “I recognize the fear and anxiety this outbreak has caused, especially for L.G.B.T.Q.+ New Yorkers, which is why my team and I will continue to work around the clock to secure as many vaccines as possible for our residents.”
The city has vowed to broaden access to doses once they receive more, but there were no details about the distribution plan as of Thursday afternoon.
“This effort was just the beginning and as supply increases, we hope to expand to other areas of the city,” Michael Lanza, a spokesman for the Health Department, said earlier this week.
He added that the Health Department had selected the Chelsea Sexual Health Clinic, in Manhattan, as the location for the first doses because it was among the best-known sexual health clinics in the city, with “a very long history in the community and providing culturally competent care to L.G.B.T.Q.+ New Yorkers.”
The Department of Health has recommended the monkeypox vaccine for men at high risk of exposure, which they have defined as men who have had multiple or anonymous male sexual partners over the last two weeks.
The vaccine allocation, part of a national distribution plan for hundreds of thousands of doses announced by the White House on Tuesday, comes as monkeypox continues to spread and as experts warn of the quickly closing window for containing the virus.
The U.S. Department of Health and Human Services will provide an immediate 56,000 doses of the monkeypox vaccine, called Jynneos, and an additional 240,000 doses in the coming weeks, the White House announced. Another 750,000 doses are expected to become available over the summer, and a total of 1.6 million doses are expected to be ready by the end of this year.
What to Know About the Monkeypox Virus
Card 1 of 4
What is monkeypox? Monkeypox is a virus endemic in parts of Central and West Africa. It is similar to smallpox, but less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research, according to the Centers for Disease Control and Prevention.
What are the symptoms? Monkeypox creates a rash that starts with flat red marks that become raised and filled with pus. Infected people may also have a fever and body aches. Symptoms typically appear in six to 13 days but can take as long as three weeks after exposure to show, and can last for two to four weeks. Health officials say smallpox vaccines and other treatments can be used to control an outbreak.
How infectious is it? The virus spreads mainly through body fluids, skin contact and respiratory droplets, though some experts suggest that it could occasionally be airborne. Typically it does not lead to major outbreaks, though it has spread in unusual ways this year, and among populations that have not been vulnerable in the past.
“This vaccine currently has some limitations on supply, and for this reason the administration’s current vaccine strategy prioritizes making it available to those who need it most urgently,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said at a news conference.
Federal officials also announced that state health authorities could request doses of an older smallpox vaccine, called ACAM2000, but it is associated with harsh side effects, including death, among immunocompromised people, pregnant women and older adults.
Demand for the vaccine in New York City is expected to outpace the initial supply, raising tricky questions of who should get access to it. Public officials have urged the federal government to provide as much vaccine as possible. The Jynneos vaccine requires two doses to be fully effective, given one month apart.
“When you have a large population that wants to protect itself, I think we need to do everything in our power to allow them to do so,” said State Senator Brad Hoylman, who has been pushing for more doses.
In addition to the vaccine, experts have urged increased education and testing campaigns to make sure that more people are aware of the symptoms of the virus so they can get checked for it.
For now, monkeypox testing remains centralized to a network of public laboratories, making it difficult for some health providers to order tests. The C.D.C. is allowing some commercial labs to conduct the test, however, which should make testing more accessible in July.
Gregg Gonsalves, an epidemiologist at the Yale School of Public Health and a longtime H.I.V./AIDS treatment advocate, warned that the cases that have been picked up by testing were likely “the tip of the iceberg.” He and other experts are concerned that the outbreak may expand into other populations, particularly congregant settings like prisons and homeless shelters, if health officials do not do more soon.
“We have a path between containment of this outbreak or its continued persistence, particularly in the gay community,” he said. “And I think we’re on this road to persistence in the gay community as a new feature of our lives for the time being.”
The agreement, set for fall vaccinations, includes “options for up to 300 million doses,” the agency said in a news release, and adds up to a $3.2 billion contract.
The purchase includes both child and adult vaccines, and may be delivered by early fall, the agency said.
“Vaccines have been a game-changer in our fight against COVID-19, allowing people to return to normal activities knowing that vaccines protect from severe illness,” HHS Secretary Xavier Becerra said in the news release. “The Biden-Harris Administration is committed to doing everything we can to continue to make vaccines free and widely available to Americans — and this is an important first step to preparing us for the fall.”
This announcement comes after a fight in recent weeks between the Biden administration and Congress over funding future Covid-19 response and mitigation measures.
The White House had requested $22.5 billion in funding for the administration’s Covid-19 response — money to pay for vaccines, testing, and treatments — earlier this year. Negotiators had been able to reach a scaled-back agreement on a $10 billion package but left Washington for the Easter recess without passing that bill. Congress has been stalled on reaching a deal ever since.
As a result, $10 billion was reallocated from current Covid-19 response efforts, part of which is being used to fund this new vaccine purchase.
Republican Sen. Mitt Romney of Utah accused the White House of being dishonest about the funding, saying earlier this month that “for the Administration to say they could not purchase these things and then, after several months, divert some funds and then purchase them is unacceptable, and makes our ability to work together and have confidence in what we’re being told very much shaken to the core.”
Wednesday’s announcement also comes a week after vaccinations began in the US for children under 5.
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, a member of the federal Covid-19 response, has warned that the US is likely to face an increase in cases in the fall, and US Surgeon General Dr. Vivek Murthy said on CNN’s “New Day” last week that the possibility of another booster shot for the broader population in the fall is under discussion.
This story has been updated with additional information.
It’s well established that regular exercise benefits our bodies, not least in protecting against obesity, but scientists are continuing to look more closely at why this happens on a molecular level.
In a new study, scientists put mice on intense treadmill workouts and analyzed how the chemicals in the cells of the animals then began to change over time. They found the appearance of a metabolite called Lac-Phe (N-lactoyl-phenylalanine), synthesized from lactate and phenylalanine.
Phenylalanine is an amino acid that combines to make proteins, and you might be familiar with lactate: It is produced by the body after strenuous exercise and causes the post-workout burning sensation that gets felt in the muscles.
The study authors think they’ve found an important biological pathway opened up by exercise, which then has an impact on the rest of the body – specifically in the level of appetite and the amount of food taken in.
Further tests confirmed these results. Researchers gave high doses of Lac-Phe to mice on a high-fat diet, resulting in the mice eating about half as much over the next 12 hours compared to a group of control mice. Meanwhile, the movement and energy expenditure of the animals remained unchanged.
Over a period of 10 days, the Lac-Phe doses led to a drop in food intake, a resulting drop in body weight, and improved glucose tolerance in the mice. Those are positive results when thinking about ways to combat obesity and obesity-related disease.
There were some caveats, though. The differences in appetite suppression caused by Lac-Phe were only noticeable after exercise and in mice on a high-fat diet. The same effects weren’t seen in more sedentary mice fed normally.
The scientists also looked at the effects of exercise in humans and racehorses, finding elevated levels of Lac-Phe here, too, most notably after sprinting in people. However, the knock-on effects weren’t looked into, and more research will be needed to see if these results translate fully into human beings.
By shedding more light on the molecular responses to physical activity, the findings of the study will help in a number of areas of research, including treatments.
There’s likely a lot more to discover. The researchers note that as Lac-Phe is produced in multiple cell types in mice, it’s likely that it’s not just the muscles in the body that know when we’re working out.
“Future work uncovering the downstream molecular and cellular mediators of Lac-Phe action in the brain may provide new therapeutic opportunities to capture the cardiometabolic benefits of physical activity for human health,” write the researchers.
May 24 (Reuters) – Germany has ordered 40,000 doses of a Bavarian Nordic (BAVA.CO) vaccine to be ready to vaccinate contacts of those infected with monkeypox if an outbreak in Germany becomes more severe, but officials are banking on other precautionary measures for now.
Speaking at a press conference, German Health Minister Karl Lauterbach said on Tuesday that measures such as an isolation period of at least 21 days recommended for infected people would suffice for now to contain the outbreak.
“If infections spread further we will want to be prepared for possible ring vaccinations that are not yet recommended at this point but might become necessary,” said Lauterbach, referring to the strategy of vaccinating contacts of an infected person.
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He said the outbreak of monkeypox could be contained and did not signal the start of a new pandemic, adding that early intervention can prevent the pathogen from becoming firmly established in communities.
So far, five cases have been registered in Germany, all men, said Lothar Wieler, the head of Germany’s Robert Koch Institute for infectious diseases, also speaking at the press conference.
An employee of the vaccine company Bavarian Nordic works in a laboratory of the company in Martinsried near Munich, Germany, May 24, 2022. The company, headquartered in Denmark, is the only one in the world to have approval for a smallpox vaccine called Jynneos in the U.S. and Imvanex in Europe, which is also effective against monkeypox. REUTERS/Lukas Barth
Read More
A World Health Organization official on Monday issued similar guidance, saying the outbreak does not require mass vaccinations because measures like hygiene and safe sexual behaviour will help control the spread. read more
The WHO has registered more than 250 confirmed and suspected monkeypox infections, with a geographic spread that is unusual for the disease which is endemic in parts of west and central Africa but rare elsewhere. Many but not all of the cases have been reported in men who have sex with men, with the WHO targeting sexual transmission in particular.
U.S. health officials said this week that there are more than 1,000 doses of the Bavarian Nordic vaccine in the national stockpile and they expect that level to ramp up very quickly in the coming weeks. read more
The vaccine is branded Jynneos in the United States where it is approved for use against smallpox and monkeypox. It is also approved for smallpox in Europe, where it is called Imvanex, but has been provided for off-label use in response to monkeypox cases.
The Danish company said last week it secured a contract with an undisclosed European country to supply Imvanex in response to new cases of monkeypox.
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Reporting by Ludwig Burger and Riham Alkousaa
Editing by Madeline Chambers, Kirsten Donovan
Our Standards: The Thomson Reuters Trust Principles.
