Tag Archives: boosters

FDA authorizes vaccine boosters for people with weakened immune systems

Some people can get a third shot of the mRNA vaccines, Pfizer or Moderna.

The booster will be targeted specifically for people who did not have an ideal immune response to their initial vaccines, which has proven to be the case for many cancer patients, transplant recipients, people with HIV and people on immunosuppressant drugs.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease,” acting FDA Commissioner Janet Woodcock said in a statement. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.”

The FDA has not yet authorized a booster shot for the general population, a fact reiterated in the agency’s announcement Thursday.

“As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” Woodcock continued. “The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”

The number of people who will be eligible for the third dose is a fraction of those who are fully vaccinated, experts said.

“That encompasses a relatively small proportion of the population, around 3% or so of people would fall into that category,” Dr. Anthony Fauci, chief medical adviser to the White House, said in an interview on ABC’s “Good Morning America” Thursday.

Some immunocompromised people even had no immune response to the vaccines — a disappointment considering the high risk they have for getting severely ill from the virus. For example, in one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%.

But Centers for Disease Control and Prevention data shows that a booster shot could increase antibodies in an immunocompromised person by up to 50%.

Dr. Pablo Sanchez, a member of the CDC’s expert advisory panel that will vote Friday on the details of exactly who should get the third dose and when, said he supported at least allowing immunocompromised Americans to get boosters while the CDC continues to monitor the data.

“We really need to help this population out more,” Sanchez said at a CDC meeting in July, when the committee met to discuss the issue.

The CDC panel is expected to vote to recommend the third dose when it meets Friday at 11 a.m. and CDC Director Rochelle Walensky will likely sign off after a Friday afternoon vote.

Experts and officials have been clear that this third shot for immunocompromised people is separate from booster shots for the general public, which people are expected to need as the protection from the vaccines wane over time. But the CDC, which is monitoring immunity in multiple groups of people across the country, said the U.S. isn’t there yet.

The CDC will make the call when protection falls below a “critical level,” Fauci said.

“If and when it does — and it’s likely that it will because no vaccine is going to last forever — we’re going to be ready and have a plan to be able to give those individuals the additional dose that they might need,” Fauci said Thursday.

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Some in US getting COVID-19 boosters without FDA approval

DENVER (AP) — When the delta variant started spreading, Gina Welch decided not to take any chances: She got a third, booster dose of the COVID-19 vaccine by going to a clinic and telling them it was her first shot.

The U.S. government has not approved booster shots against the virus, saying it has yet to see evidence they are necessary. But Welch and an untold number of other Americans have managed to get them by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated.

Welch, a graduate student from Maine who is studying chemical engineering, said she has kept tabs on scientific studies about COVID-19 and follows several virologists and epidemiologists on social media who have advocated for boosters.

“I’m going to follow these experts and I’m going to go protect myself,” said Welch, a 26-year-old with asthma and a liver condition. “I’m not going to wait another six months to a year for them to recommend a third dose.”

While Pfizer has said it plans to seek U.S. Food and Drug Administration approval for booster shots, health authorities say that for now, the fully vaccinated seem well protected.

Yet health care providers in the U.S. have reported more than 900 instances of people getting a third dose of COVID-19 vaccines in a database run by the Centers for Disease Control and Prevention, an Associated Press review of the system’s data found. Because reporting is voluntary, the full extent of people who have received third doses is unknown. It’s also unknown if all of those people were actively trying to get a third dose as a booster.

“I don’t think that anyone really has the tracking” in place to know how widespread it is, said Claire Hannan, executive director for the Association of Immunization Managers.

One entry in the CDC database shows a 52-year-old man got a third dose from a California pharmacy on July 14 by saying he had never received one and by providing his passport, rather than a driver’s license, as identification. But when the pharmacy contacted the patient’s insurance provider, it was told he had received two doses in March.

In Virginia, a 39-year-old man got a third shot from a military provider on April 27 after he showed a vaccine card indicating he had received only one dose. A review of records turned up his previous vaccines. The patient then told the provider that the time between his first and second doses was more than 21 days, “so they spoke to their provider, who ‘authorized’ them to get a third shot,” an entry states.

Colorado Gov. Jared Polis said at a recent news briefing that he knew of residents who had received third dose by using fake names, but neither his office nor the state health department could provide any evidence.

Despite a lack of FDA approval, public health officials in San Francisco said Tuesday that they will provide an extra dose of the Pfizer or Moderna vaccine for people who got the single-shot Johnson & Johnson variety — referring to it as a supplement, rather than a booster.

Several studies are looking at booster shots for certain at-risk groups — people with weakened immune systems, adults over 60 years old and health care workers. But the verdict is still out on whether the general population might need them, said Dr. Michelle Barron, senior medical director for infection prevention at UCHealth, a not-for-profit health care system based in Aurora, Colorado. She said the best data in favor of possible boosters is for people whose immune systems are compromised.

Israel is giving boosters to older adults and several countries, including Germany, Russia and the U.K. have approved them for some people. The head of the World Health Organization recently urged wealthier nations to stop administering boosters to ensure vaccine doses are available to other countries where few people have received their first shots.

Will Clart, a 67-year-old patient services employee at a Missouri hospital, got a third dose in May by going to a local pharmacy. Clart said he gave the pharmacist all of his information, but that the pharmacist didn’t realize until after administering the shot that Clart’s name was in the vaccine system.

“It sounded like there was a benefit to it. And there’s also been talk that eventually we’ll need a booster — mine was five or six months out and so I thought well I’ll go ahead, that’ll give me a booster,” Clart said.

Ted Rall, a political cartoonist, explained in a Wall Street Journal op-ed that he got a booster because of a history of lung problems, including asthma, swine flu, and repeated bouts of bronchitis and pneumonia.

“I made up my mind after reading a report that states were likely to toss 26.2 million unused doses due to low demand. My decision had no effect on policy, and I saved a vaccine dose from the garbage,” Rall said.

Welch, the graduate student from Maine, put the blame on people who have refused to get the vaccine for political reasons. About 60% of eligible people in the U.S. are fully vaccinated.

“Their absolute demand and screeches for freedom is trampling our public health and our communal health.”

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Nieberg is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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FDA does not recommend ‘taking things into your own hands’ regarding Covid-19 vaccine boosters, says top agency official

“You can see all from looking at the news that there are people and the jurisdictions that are actually taking things into their own hands … FDA does not recommend taking things into your own hands,” said Marks during a discussion hosted by the Covid-19 Vaccine Education and Equity Project briefing.

“It’s actually not something you’re supposed to do under emergency use authorization,” he said.

Currently, the FDA and the US Centers for Disease Control have no recommendation for booster shots.

US health officials maintain there is no data that indicates the need to do so. Dr. Francis Collins, director of the National Institutes of Health told CNN on Tuesday, “At the present time, though, the data in the United States does not indicate that that’s necessary.”

On Tuesday, the San Francisco Department of Public Health announced that they will be providing people who received the one-dose Johnson & Johnson vaccine with a supplemental dose of an mRNA vaccine, either Pfizer or Moderna.

They will be providing these supplemental doses to those who have consulted with their doctor beforehand.

The health department maintains that it aligns with the CDC and FDA. “We are not recommending, we are accommodating requests,” Dr. Naveena Bobba, deputy director of health for the city’s public health department, said during a media briefing Tuesday.

“We have gotten a few requests based on patients talking to their physicians and that’s why we are allowing for the accommodation.”

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CDC advisory committee voices support for immunocompromised people getting boosters

During the last year and a half, immunocompromised people have been at extremely high risk for the virus. And for many, the COVID vaccine didn’t change that.

That’s why a group of independent Centers for Disease Control and Prevention experts at a Thursday meeting largely voiced support for allowing immunocompromised people to talk to their doctors about getting a third shot, a booster, that could increase their antibody response to vaccines.

But the advisory committee didn’t make a formal recommendation, saying more data was needed and, ultimately, regulatory allowance from the Food and Drug Administration.

About 2.7% of U.S. adults are considered immunocompromised, an umbrella category that includes cancer patients, transplant recipients, people with HIV and patients on high-dose steroids.

“We long for a fuller life,” said Phil Canudo, a kidney transplant recipient from Akron, Ohio, who told the CDC advisory committee on Thursday that he had no antibody response after two Pfizer shots.

“I can’t wait to see my stepdaughter’s new Colorado home,” he said, choking up. “I want to eat a medium rare steak at the Diamond Grill.”

Canudo, who spoke before the CDC advisory panel during the public comment period, said he’d been told he still must behave as if he’s not vaccinated.

“I urge you, beg you even, to recommend that we be able to receive a third vaccine dose,” he said. “The benefit could open up the world to us again.”

At the same time, pressure is mounting as other countries, including France and Israel, already have approved boosters for those who are immunosuppressed. In the U.S., debate over booster shots for the general public has ratcheted up as the delta variant wreaks havoc.

Data presented at the meeting said a booster shot could increase antibodies in an immunocompromised person by up to 50%.

Dr. Sara Oliver, an epidemiologist with the CDC who presented the findings, also explained how immunocompromised people are a priority group for booster research because they’re at greater risk of serious COVID-related consequences.

For example, in one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%. Breakthrough cases, which are expected, refer to people who test positive for COVID-19 while fully vaccinated. The vaccines are highly effective against severe disease and hospitalization, but it’s possible for people to develop mild or asymptomatic illness even when vaccinated.

“We want to vaccinate. During this entire conference, we’ve been saying, vaccinate, vaccinate, vaccinate,” said Dr. Pablo Sanchez, a member of the panel. “These people want to be vaccinated, they’re not vaccine hesitant. And it seems to me that we should promote that.”

He argued that the FDA should “at least allow it while we obtain more data” because “we really need to help this population out more.” Patients, Sanchez argued, could end up taking matters into their own hands.

Phil, of Akron, said he planned to do just that.

“Hundreds of us lie to pharmacies and immunization sites about our previous vaccinations, trying to get an extra unauthorized dose,” he told the committee. “I know that’s what I’ll be doing if additional doses are not sanctioned.”

Another ACIP member, Dr. Sandra Fryhofer, a liaison of the American Medical Association, pointed out that there are millions of excess vaccine doses right now that aren’t being taken advantage of in the U.S.

At the same time, there are immunocompromised patients doing “all they can” and still not getting protection.

“I really do share the concerns that have been expressed by our ACIP members about, you know, our patients, right now, they’re immunocompromised, that are doing all they can do by getting vaccinated, by having their close contacts vaccinated, and it’s not enough that they’re still not protected,” Fryhofer said.

The work to assess additional studies is ongoing, and the next step would be for the FDA to issue regulatory guidance.

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J&J vaccine and boosters: CDC advisers will meet Thursday to discuss safety issues and need for coronavirus boosters

The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet from 11 a.m. to 4:30 p.m. ET. There are no plans for the panel to vote on issues included on the agenda.

ACIP is a panel composed of outside medical experts in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, virology, public health, infectious diseases and other subspecialties. CDC typically accepts its recommendations once votes have been cast.

ACIP has provided crucial guidance throughout the pandemic including advice on emergency use authorization for the three Covid-19 vaccines currently available in the US, authorization of Pfizer’s vaccine for 12-15 year-olds and, in April, to end the pause of the J&J vaccine due to a rare blood clotting disorder that has occurred in a small number of vaccine recipients.
On Thursday, ACIP will take up several new issues regarding safety and durability of Covid-19 vaccines. To start, ACIP will review recent data on cases of Guillain-Barré Syndrome (GBS) among people who have been vaccinated against Covid-19 with the J&J coronavirus vaccine. Federal health officials say there have been some 100 preliminary reports of cases of GBS — a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes temporary paralysis — among the nearly 13 million people who have received the vaccine.
The US Food and Drug Administration already last week updated the label of the J&J vaccine to list GBS as a rare risk. ACIP’s discussion tomorrow will center on the question of whether, given this adverse event, the benefit of the J&J vaccine still outweighs the risk of GBS. ACIP is expected to say it does.

Tomorrow’s meeting was precipitated by this newly identified adverse event, Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center and ACIP member, told CNN. “There will be no formal votes and will come to the conclusion that the risk of Covid is very high and the risks of the vaccine very low. Real, but very low,” he added.

ACIP will also take on the subject of coronavirus vaccine boosters with priority given to reviewing data on the need for booster vaccines for immunocompromised people. Recent reports have suggested that Covid-19 vaccines are not effective enough in people with weakened immune systems, and last week the CDC revised its guidance for fully vaccinated individuals. It warned people who are immunocompromised that the vaccines may not be as effective for them, and they are encouraged to continue with safety precautions as if they were not vaccinated. However, the CDC has not yet formally recommended boosters for anyone.

ACIP’s goal tomorrow is to weigh in on the need for boosters and review what data is currently available and published. “What [ACIP] will demonstrate tomorrow is that the evidence is very sparse,” says Schaffner, which ultimately means that the group will not vote on boosters.

Earlier this month, Pfizer announced it would be seeking authorization to provide a third dose of its Covid-19 vaccine as a booster, citing data from Israel on the continued spread of the coronavirus and the limited efficacy against the more transmissible Delta variant.

Health officials, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, continue to say the US needs more data before recommending coronavirus vaccine boosters for anyone.

“The CDC and the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci told CNN’s Chris Cuomo last week. “That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions.”

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Fully vaccinated people don’t need Covid boosters, U.S. health agencies say

People who are fully vaccinated do not need Covid-19 boosters, health and drug officials said Thursday.

“We are prepared for booster doses if and when the science demonstrates that they are needed,” the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement.

The agencies said those who are vaccinated are protected from variants, including the surging delta variant. But they urged Americans 12 and older who have not yet been vaccinated to get their shots.

“People who are not vaccinated remain at risk. Virtually all Covid-19 hospitalizations and deaths are among those who are unvaccinated,” the statement said.

The virus has killed more than 4 million people around the world in the year and a half since it was declared a pandemic. The U.S. leads the world with the highest reported death toll, at more than 600,000, followed by Brazil and India.

Pfizer said Thursday that it would seek U.S. authorization for a third dose of its vaccine, saying another shot within 12 months could dramatically boost immunity.

Research shows that two doses of mRNA vaccines offer strong protection against the highly contagious delta variant.

The U.S. agencies said they continue to study vaccines and possible boosters.

The FDA, the CDC and the National Institutes of Health “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the groups said in their statement. “This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed.”

Among U.S. adults, 67 percent are at least partly vaccinated, and 47 percent of the total population is fully vaccinated.

President Joe Biden continues to push for more Americans to get vaccinated.

“We can’t get complacent now,” he said this week. “You can do this. Let’s finish the job.”

Biden has said his administration will shift its focus from mass vaccination sites to a smaller, more community-based approach to try to reach those still holding out on getting the shots.

The delta variant, which is more transmissible and has been linked to more severe illness in younger adults, is now the dominant strain in the U.S., the CDC said last week.

As of Saturday, it accounted for 51.7 percent of new Covid-19 cases that had been genetically sequenced in the country. Two weeks earlier, on June 19, the variant accounted for just more than 30 percent of new cases.

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