Tag Archives: Johnson & Johnson

Business

5 things to know before the stock market opens Monday, April 18

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Here are the most important news, trends and analysis that investors need to start their trading day:

1. Stock futures fall as the 10-year Treasury yield tops a 3-year high

Traders on the floor of the NYSE, April 14, 2022.

Source: NYSE

2. BofA issues stronger earnings as it releases reserves for soured loans

A woman is reflected in a puddle as she passes a Bank of America branch in New York’s Times Square.

Brendan McDermid | Reuters

Bank of America, the last of the major banks to report earnings, on Monday delivered a better-than-expected 80 cents per share profit on revenue of $23.33 billion. BofA’s decision to release $362 million in loan-loss reserves was in contrast to JPMorgan Chase, which disclosed last week that it opted to build reserves by $902 million. JPMorgan said profit also slumped due to losses tied to Russia sanctions. Goldman Sachs, Morgan Stanley and Citigroup each topped expectations with stronger-than-expected trading results. Wells Fargo missed on revenue as mortgage lending declined.

3. Elon Musk’s tweet suggests an appeal directly to Twitter shareholders

Elon Musk posted a tweet Saturday, saying “Love Me Tender,” days after making an unsolicited $43 billion cash offer to buy Twitter. After a TED talk Thursday, Musk hinted at the possibility of a hostile bid, in which he would bypass the social media company’s board and put the offer directly to shareholders.

The tweet seemed to imply Musk, the world’s richest person and CEO of both Tesla and SpaceX, might seek to buy shares from investors in what’s called a tender offer. Twitter on Friday adopted a “poison pill” to limit Musk’s ability to raise his stake in the company. Shares of Twitter rose more than 3.5% in the premarket.

4. China’s first-quarter GDP beats estimates despite Covid lockdowns

A health worker wears a protective suit as he disinfects an area outside a barricaded community that was locked down for health monitoring after recent cases of COVID-19 were found in the area on March 28, 2022 in Beijing, China.

Kevin Frayer | Getty Images

China’s first-quarter gross domestic product grew a faster-than-expected 4.8% despite the impact of Covid lockdowns in March. Beginning last month, China struggled to contain its worst Covid outbreak since the initial phase of the pandemic in 2020. Three people have died as of Sunday, officials of locked-down Shanghai said, attributing the fatalities to preexisting health conditions. Shanghai began a two-stage lockdown and mass virus testing in late March that was supposed to stop after just over a week later. But authorities have yet to set an end date.

5. Russian strikes kill at least 7 people in Lviv, Ukrainian officials say

Dark smoke rises following an air strike in the western Ukrainian city of Lviv, on April 18, 2022.

Yuriy Dyachyshyn | AFP | Getty Images

Russian missiles hit Lviv in western Ukraine on Monday, killing at least seven people, Ukrainian officials said, as Moscow’s troops stepped up strikes on infrastructure in preparation for an all-out assault in the east. Mariupol, the besieged eastern city, has refused Russia’s demand to surrender. The mayor of Mariupol said last week that 10,000 civilians have died there. “The targeting of populated areas within Mariupol aligns with Russia’s approach to Chechnya in 1999 and Syria in 2016,” the U.K. Ministry of Defense said in an intelligence update.

— CNBC’s Hannah Miao, John Melloy, Sarah Min, Tanaya Macheel, Hugh Son, Evelyn Cheng, Natasha Turak and Ted Kemp as well as Reuters and The Associated Press contribute to this report.

— Sign up now for the CNBC Investing Club to follow Jim Cramer’s every stock move. Follow the broader market action like a pro on CNBC Pro.

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Health

Columbia study finds Omicron ‘markedly resistant’ to vaccines, boosters may not do much to help

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Columbia University researchers found that COVID-19 Omicron is noticeably resistant to vaccines and that boosters may not provide adequate protection just as US cases of the variant soared by 32 per cent in the last 24 hours. 

In a study published Wednesday by Dr. David Ho and 20 other researchers, the scientists discovered that Omicron’s ‘extensive’ mutations can ‘greatly compromise’ all major COVID-19 vaccines – Pfizer, Moderna, Johnson & Johnson and AstraZeneca – even neutralizing them. 

The report also found that while booster shots provided an additional layer of protection, the variant ‘may still pose a risk’ for those who get the third shot.’ 

‘These findings are in line with emerging clinical data on the Omicron variant demonstrating higher rates of reinfection and vaccine breakthroughs,’ the scientists wrote. 

‘Even a third booster shot may not adequately protect against Omicron infection.’ 

Columbia researchers found that all four major COVID-19 vaccines (L-R) Pfizer, Moderna, Johnson & Johnson and AstraZenca failed to consistently provide adequate protection against the Omicron variant. Booster shot protection sometimes fell just above the line of acceptance

Experts and health officials warn that COVID-19 cases will soar in the coming weeks

The study looked at the effectiveness of each major vaccine against the Omicron variant, finding several cases where they failed to provide the needed protection against infection. 

 While the booster shots proved to be overall consistent, some recorded instanced put it right at the threshold of actually being effective. 

Columbia University Professor Dr. David Ho

Ho and the Columbia research team, who worked along side the University of Hong Kong, said the study delivers a grave warning about the future of COVID and its variants. 

‘It is not too far-fetched to think that this [COVID-19] is now only a mutation or two away from being pan-resistant to current antibodies,’ the researchers wrote. 

‘We must devise strategies that anticipate the evolutional direction of the virus and develop agents that target better conserved viral elements.’  

The warning came as confirmed US Omicron cases jumped by a third overnight, from 241 on Wednesday to 319 on Thursday. But experts have warned those are the tip of the iceberg, and that American cases likely already number in the tens of thousands.

Scientists warned that COVID variants could soon undermine current vaccines and immunities

White House COVID tsar Dr. Anthony Fauci even remarked on the variant’s ‘extraordinary’ ability to spread, before revealing that cases will double every three days. 

The number of people testing positive in New York also has doubled in three days, from 3.9 per cent of all swabs coming back positive on December 9, to 7.8 per cent on December 12. More than four fifths of New York

Bill de Blasio’s senior public health adviser Dr. Jay Varman, a Cornell epidemiology professor, tweeted the news, saying: ‘Um, we’ve never seen this before in #NYC. Test positivity doubling in three days.’

A total of 81 per cent of New Yorkers are fully-vaccinated, and 18.5 per cent have received their booster shots – but a worrying new study from Columbia University suggests that neither may be sufficient in protecting from Omicron.

Immunologists have also forecast a potential triple-whammy of Omicron, Delta and regular flu infections this winter. Two doctors interviewed by DailyMail.com said those who haven’t received a booster shot should consider returning to Spring 2020-style self-isolation, when COVID’s Alpha variant raged through the US, and no vaccines were available.

Dr Anthony Fauci (pictured), the nation’s top infectious disease expert told Good Morning America on Thursday that Omicron transmits very efficiently, and the current outbreaks overseas are signs of things to come for the U.S. if more people do not get boosted

Speaking on Good Morning America on Thursday, Fauci also confirmed Omicron was on track to be the dominant Covid strain in America within weeks.

He said: ‘Certainly what [Omicron] is showing us in other countries [is that it spreads faster than other variants] and I believe soon in our own country.

‘It has an extraordinary ability to transmit efficiently and spread. It has what we call a doubling time of around three days.

‘And if you do the math on that, if you have just a couple of percentage of the isolates being Omicron, very soon it’s going to be the dominant variant. We’ve seen that in South Africa, we’re seeing it in the U.K. and I’m absolutely certain that’s what we’re going to be seeing here relatively soon.’

The doubling time of three days is slightly longer than the 2.5 days reported by British and South African health officials. On Thursday, the UK recorded its second-consecutive day of record infections – 88,376 – 24 hours after Wednesday’s total of 78,610. That is a 74 per cent jump in a week, with 15 people who’ve been infected with Omicron so-far hospitalized in the UK.

The US is much larger, with most of its landmass not as densely populated as the UK or South Africa.

But Omicron is believed to represent up to 13 per cent of new diagnoses in New Jersey and New York – states with extremely well-populated areas – giving a possible early taste of what’s to come with the new strain. 

Fauci continues to urge Americans to get vaccinated, and boosted, to protect themselves from the virus, especially now with the new threat of Omicron circulating. A total of 16.5 per cent of Americans have so-far had the booster shot. 

‘We need to do everything that we have been talking about up to now, and even more so,’ he said.  

He spoke hours after the CDC agency released forecasts on Wednesday night showing that weekly Covid cases will increase by 55 percent to 1.3 million per week – or 185,714 per day – by Christmas. 

It also predicted deaths with jump by 73 percent to up to 15,600 per day by early January – or 2,228 deaths per day.

Some of that predicted surge is already appearing in parts of the country, with Florida revealing 6,381 new cases on Thursday – the state’s largest single day Covid increase since September.

The Delta variant is still the dominant Covid strain in the U.S., accounting for around 97 percent of sequenced cases. Omicron is quickly making up ground, though, with the newly discovered variant jumping seven-fold in a week from making up 0.4 percent of cases to 2.9 percent of case, according to the most recent CDC data. 

The graphs show the amount of the coronavirus detected in human bronchial cells (left) and lung cells (right) 24 and 48 hours after coming into contact with the original strain of the virus (pink), Delta (orange) and Omicron (red). There was 70 times more Omicron recorded in the bronchus — the main pipe connecting the airways and lungs — compared to previous strains, but 10 times less virus in the lungs when compared to the original version and Delta. Experts from the University of Hong Kong said this suggests the virus is more transmissible but may cause less severe illness

Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, has warned of a nightmare scenario where Delta, Omicron and regular seasonal flu could combine to inflict the winter from hell on US hospitals already struggling to cope with an influx of patients. 

She told CNN: ‘It’s the combination. It’s kind of the perfect storm of public health impacts here with Delta already impacting many areas of the country and jurisdictions. We don’t want to overwhelm systems more.’ 

Early data also shows that people who are only fully vaccinated, but have not yet received their booster, are still extremely vulnerable to the virus, with Johnson & Johnson’s single-dose shot offering effectively no protection. 

Booster shots have been deemed effective against the variant, though, with both Moderna and Pfizer revealing data in recent days showing their vaccines will cause massive increases in antibody levels and up to 75 per cent protection from Covid symptoms.

But confusion remains about just how effective boosters are against a strain that was only identified after Americans began receiving them en-masse.

A new study by Columbia University in New York, published on Thursday, said: ‘Even serum from persons vaccinated and boosted with mRNA-based vaccines exhibited substantially diminished neutralizing activity against (omicron),’

Dr Chris Thompson (pictured), an infectious disease expert at Loyola University of Maryland, said that Americans who have not yet been boosted should bring back some early-pandemic habits

Only around 16.5 percent of Americans have received the additional vaccine dose so far though – as they were not widely available until late November – meaning that more than 80 percent of Americans are at risk from Omicron.

Dr Chris Thompson is an infectious disease expert at Loyola University of Maryland. He told DailyMail.com on Thursday that people who have not received their booster dose yet may want to bring back some early pandemic habits like social distancing, masking, frequent hand washing and more.

‘The data that I’ve seen says that you’re about 33 percent protected after a two dose regimen of either of the mRNA vaccines [the Pfizer or Moderna shots] and we don’t have good data from Johnson and Johnson’s vaccine yet. Then if you get your booster you look like you get back up into the 75 percent protection range and for preventing disease’

Whether Delta or Omicron, U.S. is experiencing yet another surge of Covid cases during the holiday season. The nation is recording 121,188 new cases every day – a 40 percent increase over the past two weeks. Deaths are making a sharp rise as well, up 34 percent to 1,302 per week. 

The number of Americans hospitalized with the virus increased over the past 14 days as well, up 21 percent to 68,079.

The Centers for Disease Control and Prevention projects that the situation will only worsen as well.

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Business

The Big Pivot: Merck Falters on Covid-19 Vaccine, Then Makes One for Rival J&J

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Weeks after

Merck

MRK -0.33%

& Co. scrapped development of its Covid-19 vaccines in January, one of its senior manufacturing officials began phoning his deputies, telling them their work on a pandemic shot wasn’t actually over.

“We’re doing it,” John McGrath told his workers at Merck. “And we’re doing it with J&J.”

The

Johnson & Johnson

-Merck partnership, which the companies announced in March, is now bearing fruit to expand the world’s vaccine supply. After a frantic ramp-up that involved scouting for raw materials, buying equipment and upgrading plants all at the same time, the first Merck-made shots shipped Friday.

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Merck is churning out more than 500,000 doses daily for use outside the U.S., including countries desperate for shots.

J&J’s unusual collaboration with a rival, and Merck’s speedy manufacturing run-up, reflect one of the biggest challenges of the pandemic: making enough Covid-19 vaccines to meet the high demand.

Even in the U.S., early supplies were limited as drugmakers ramped up production lines. To this day, many countries are struggling with short supply.

J&J vials at the Merck plant in West Point, Pa; the first Merck-made shots shipped Friday.

At a sprawling plant in West Point, Pa., Merck is helping J&J with the final stages of its vaccine production, known as fill-finish, which involves thawing frozen doses made by J&J, adding a stabilizer to maintain their potency during storage, then putting them into vials for shipment.

Merck, one of the world’s biggest drugmakers by sales, said it retrofitted its manufacturing facilities in about three months, shaving almost a year off the time it normally takes to ready a plant.

“We broke all sorts of records on construction, on tech transfers, on just getting product ready,” Mr. McGrath said. The federal government, which gave at least $105 million to Merck to retrofit plants, also contributed by moving needed supplies quickly through customs.

Johnson & Johnson’s Covid-19 vaccine hasn’t been embraced by people and health authorities as much as initially expected, partly because of concerns about a rare blood-clotting condition. Manufacturing issues have also played a role in limiting its use.

Yet if enough doses are made, the vaccine still can play an important role in the pandemic because many poor countries lack access to other shots and J&J’s vaccine is easier to handle and store, public-health advocates and Wall Street analysts say.

Workers checking vaccines at the Merck plant in West Point, Pa., which scrambled to get special equipment to manufacture the J&J Covid-19 vaccine.

The J&J vaccine doesn’t require a special freezer to keep it cold, unlike messenger-RNA vaccines, and the primary series is one dose, not two.

“Our vaccine is uniquely positioned to be used in the world,” said Remo Colarusso, J&J’s global pharmaceuticals manufacturing chief. “The world is not completely vaccinated by a long shot.”

J&J and Merck, their headquarters separated by about 18 miles in New Jersey, are normally competitors in areas such as cancer and cardiovascular disease. Last December, at the urging of the federal government, the rivals began discussing whether Merck could help make J&J’s Covid-19 vaccine.

J&J Chief Scientific Officer

Paul Stoffels

was initially reluctant to work with another company, people familiar with the matter said. He was concerned it would stretch his staff too thin because of existing manufacturing partnerships, but agreed after an appeal by National Institutes of Health Director Francis Collins, the people said.

During a Jan. 4 call between U.S. officials, Dr. Stoffels and then-Merck Chief Executive

Ken Frazier,

the companies agreed to assess whether Merck’s plants could adapt to make J&J’s shot, the people said.

At the time, Merck was searching for a role in the pandemic response. It had begun clinical trials of two Covid-19 vaccines, but they ultimately failed, with Merck halting the programs in late January. Its Covid-19 antiviral, molnupiravir, was still being tested.

Merck fit as a partner because of its decades of manufacturing vaccines, Mr. Colarusso said.

Another key: Merck’s production line in West Point was sitting idle after the Covid-19 vaccines flopped. Merck also wasn’t using a freshly built 4,000-square-foot cold-storage room with 18 specialized freezers that the company had built for its Covid-19 shots. Each freezer could hold 5.5 million J&J doses.

The freezer room at the Merck plant in West Point, Pa.

The West Point plants sit on a leafy campus 30 miles outside Philadelphia. It is Merck’s largest workplace—in terms of space and number of workers—and has its own ZIP Code. Despite the available rooms and equipment, Merck needed to upgrade its facilities, because J&J’s vaccine uses vials smaller than Merck’s failed Covid-19 shots, as well as a newer vaccine technology.

“Our issue then became what equipment do we need, where can we get it, how quickly can we get it, is it available, and if not, then what’s our alternatives?” said Mr. McGrath, an industry veteran who joined Merck in 2019.

Merck found that it needed to quickly secure equipment and raw materials even as other drugmakers required them for their own products. Merck needed about 200 chemicals and devices such as filters. Such items typically take between two and three months to get, but Merck needed them in weeks.

Merck leaned on its relationships with suppliers, such as

Thermo Fisher Scientific Inc.,

which provided specialized plastic bags used to purify and filter the vaccine. Merck also paused production of some non-Covid-19 products, which might have yielded sales to competitors but freed up equipment and materials, Mr. McGrath said.

In April, workers discovered that a screw used to keep vials steady as they moved down the production line wasn’t working. The vials wobbled, and some fell down, jamming the production line. Merck worked with a vendor in Japan to redesign the screws.

In May, Merck workers discovered another issue with the vials while doing test-runs of the production line using water. They became top-heavy with water when filled. To resolve the issue, a Merck machinist designed a plate that held the containers securely, said Kim Dezura, the West Point plant manager.

“Those are the types of little things that you encounter,” she said. “We want to solve those early so that they don’t create bigger issues later.”

Once filled, vials must be transferred from trays to cardboard boxes for shipment without sustaining damage and before they get too warm. J&J didn’t specify how to do this, so its rival honed its own system.

Initially, Merck tried moving vials one by one, but that took too long and was too physically hard for workers. Using 3-D printers, Merck built workstations for workers to release vials from a tray, sort them into rows, scoop out the containers and transfer them 39 at a time.

In August, Merck began manufacturing commercial doses, Ms. Dezura said. It took the companies until recently to receive regulatory approvals clearing shipments. J&J then got the doses at its distribution center in the Netherlands, and released the doses Friday for global distribution.

Merck plans to make doses with J&J at its plant in North Carolina, a more difficult process that is taking longer to finish.

The Merck site in West Point, Pa., is the company’s largest facility.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

Corrections & Amplifications
Remo Colarusso is Johnson & Johnson’s global pharmaceuticals manufacturing chief. An earlier version of this article misspelled his surname as Remo Colaruso. (Corrected on Dec. 11)

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Health

People Who Get Johnson & Johnson Vaccine at Elevated Risk of Guillain-Barré Syndrome: Study

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People who receive the Johnson & Johnson COVID-19 vaccine are at elevated risk of getting a severe autoimmune disorder that can cause paralysis, according to a new study.

Researchers used data from the Vaccine Safety Datalink, which is run by the Centers for Disease Control and Prevention (CDC). They found (pdf) 21 potential cases, 11 of which were confirmed, of Guillain-Barré syndrome (GBS) in people who got the shot. Most happened with 13 days of vaccination.

The incidence rate of confirmed cases per 100,000 person-years was 34.6 during the 1 to 21 days after administration, much higher than the historical background rate of 2 per 100,000 person-years.

Adjusted rates also came in higher than the expected and background rates.

Researchers determined the incidence of GBS was much lower among those who got a messenger-RNA-based vaccine, or a Moderna or Pfizer shot. The rates after those vaccines were similar to background rates.

The study validates findings from the Vaccine Adverse Event Reporting System (VAERS), a passive reporting system run by the CDC and the Food and Drug Administration, the researchers said.

A study published in the Journal of the American Medical Association in October, analyzing data from the system, found a “potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt” of the Johnson & Johnson vaccine.

The number of GBS cases reported to VAERS following receipt of the vaccine through Dec. 8 was 210.

Kayla Hanson of the Marshfield Clinic Research Institute in Wisconsin completed the new study with help from Kaiser Permanente Research scientists, the Ambulatory Care Services in Denver, and HealthPartners Institute in Minneapolis.

The study was sponsored by the CDC. It was published as a preprint, or before peer review, on the Medrxiv server.

Limitations included substantially fewer doses of the Johnson & Johnson shot being administered in the United States relative to Pfizer and Moderna jabs, and the exclusion of booster doses.

Johnson & Johnson did not respond to requests for comment.

The company said in a press release this week that GBS “has occurred in some people who have received” the company’s vaccine. In most people, the symptoms start appearing with 42 days, it said, adding that “the chance of having this occur is very low.”

Johnson & Johnson urged people to seek immediate medical attention if any of the following symptoms develop after getting the vaccine: Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing, or swallowing; double vision or inability to move eyes; difficulty with bladder control or bowel function.

The Food and Drug Administration in July added a label to Johnson & Johnson’s vaccine warning people about its link to an “observed increased risk” of GBS.

However, regulators say the benefits of the vaccine outweigh the risks associated with it.

Jack Phillips contributed to this report.

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Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.

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US

Andy Slavitt on omicron Covid variant, vaccines

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STR | NurPhoto | Getty Images

The new omicron Covid variant poses a greater risk for the unvaccinated and there’s reason to believe that current vaccines are going to be “quite effective,” a former White House advisor said Monday.

“What we know for sure is that it is a dangerous variant for people who have not been vaccinated,” Andy Slavitt told CNBC’s “Squawk Box Asia.”

“What we have to get to learn is whether or not omicron — how it spreads in an environment where delta is strong,” he said.

Slavitt previously served as a senior advisor on President Joe Biden’s coronavirus response team and ran the Centers for Medicare & Medicaid Services under the Obama administration.

What we know about omicron

The omicron strain was first identified by South African scientists and it has been detected in several countries including the United States, the United Kingdom, Australia and Germany.

Health experts are concerned about the omicron variant’s transmissibility given its unusual constellation of mutations and profile that differs from previous variants of concern. Scientists are also trying to figure out how effective current vaccines are in protecting people against any severe illness due to the new strain.

“I think we have good reason to believe that the vaccines are effective, if not as effective, and that with boosters, they’ll be quite effective,” Slavitt told CNBC. “But pharma’s also going back to the drawing board.”

Covid vaccine makers Pfizer, BioNTech, Moderna, Johnson & Johnson and AstraZeneca said they are investigating and testing the omicron variant.

Slavitt said it is possible that there would be updated vaccines available, if needed, in the next several months, before the omicron variant starts to spread meaningfully.

But the main problem that the world currently faces is vaccine inequity. Information compiled by Our World In Data showed just around 44% of the world population has been fully vaccinated against Covid-19. But only a small percentage of people in low-income countries have received at least one dose.

Slavitt explained that it is still too early to tell how omicron will fare compared with the lethal delta strain.

“We get to a point when we have a variant that replaces delta that is not serious or can be easily treated with medication, then that’ll be a very new day for this pandemic. We can knock on wood that happens now, if it’s not with omicron, it’ll may be the next one,” he said, adding that such a scenario could potentially turn Covid more akin to the common cold.

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Health

Study finds potential cause of blood clots after AstraZeneca Covid jab

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A paramedic prepares doses of AstraZeneca vaccine for patients at a walk-in COVID-19 clinic inside a Buddhist temple in the Smithfield suburb of Sydney on August 4, 2021.

Saeed Khan | AFP | Getty Images

Scientists claim to have discovered a “potential mechanism” that triggers rare blood clots in some people who receive the Oxford-AstraZeneca Covid vaccine.

Links between the vaccine and rare, sometimes fatal, blood clots have prompted some countries to restrict its use to older adults or favor alternative shots.

To be sure, medical experts have repeatedly said the benefits of the vaccine outweigh the risks associated with it, with one study concluding that Covid-19 poses a much bigger threat of blood clots than vaccination.

Scientists from Cardiff University in the U.K. and Arizona State University in the U.S. worked with AstraZeneca to investigate vaccine-induced blood clots, publishing their findings on Wednesday in the journal Science Advances.

The study suggested that the shot’s viral vector — the vaccine ingredient used to transport the coronavirus’ genetic material into a recipient’s cells — could be the issue.

In the Oxford-AstraZeneca vaccine, the viral vector is an adenovirus found in chimpanzees. The adenovirus is engineered to match Covid-19’s spike protein — a key part of its structure used to invade human cells.

Johnson & Johnson’s Covid-19 vaccine also uses an adenovirus to carry spike proteins from the coronavirus into human cells to trigger an immune response and has similarly been linked to rare blood clots.

The team behind the study said they believed the chimpanzee virus used in the Oxford-AstraZeneca vaccine had a specific interaction that could prompt the body’s defenses to act against itself.

According to the study, the viral vector in the Oxford-AstraZeneca vaccine, in rare cases, enters the bloodstream, where it can bind to a protein called platelet factor 4 (PF4).

Once the viral vector has bound to the protein, the immune system views it as foreign, the study’s authors said. “Misplaced immunity” may trigger a release of antibodies against PF4, which then binds to and activates cells that help blood clot, causing those cells to cluster together and generate blood clots.  

The study’s authors emphasized that the phenomenon occurs in “a very small number of people.”

Alan Parker, a professor at Cardiff University’s School of Medicine, said if a procedure responsible for the rare vaccine-induced blood clots was established, it may help to prevent and treat the disorder. 

“Vaccine-induced immune thrombotic thrombocytopenia [blood clots] only happens in extremely rare cases because a chain of complex events needs to take place to trigger this ultra-rare side effect,” he said in a press release Wednesday.

“We hope our findings can be used to better understand the rare side effects of these new vaccines, and potentially to design new and improved vaccines to turn the tide on this global pandemic.”

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US

U.S. tightens travel testing requirements, mask mandates

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US President Joe Biden speaks about the Covid-19 vaccine shots administered in the US in the Eisenhower Executive Office Building in Washington, DC, February 25, 2021.

Saul Loeb | AFP | Getty Images

The Biden administration is tightening travel rules to and within the U.S., requiring all in-bound international passengers to test for Covid within 24 hours of departure and extending its mask requirement on all domestic flights and public transportation through March 18.

The changes were announced Thursday as part of a broader plan to bolster the nation’s arsenal of tools in its fight against the virus as the world enters its third year of the pandemic. 

The plan is also the latest move by the Biden administration to stem the spread of the new, highly mutated omicron Covid-19 variant, which was first reported to WHO by South Africa a week ago. At least 23 countries have identified omicron cases so far, and that number is expected to rise in the coming days and weeks, the WHO said Wednesday. 

The U.S. joined that list after confirming its first case of the variant in Northern California on Wednesday. 

The tightened pre-departure testing protocols will apply to all in-bound international travelers regardless of vaccination status and will begin as early as next week, senior administration officials told reporters during a press call late Wednesday. Previously, the U.S. required proof of a negative Covid test taken within 72 hours of departure, though this was tightened to only vaccinated travelers last month. Unvaccinated travelers had to have a negative Covid test within one day of departure.

“Our doctors believe tightening testing requirements for pre-departure will help catch more cases, potential cases of people who may be positive and inside the country,” a senior administration official said. “And so now is the right time to do it. And we can implement it very quickly.”

The mask mandate, which was originally supposed to expire in January, requires masking while on buses, trains, planes and transportation hubs such as indoor bus terminals and airports. Fines will remain doubled from their initial levels for noncompliance with the requirement, starting at $500, and going up to $3,000 for repeat offenders.

Vaccine mandates

The Biden administration’s new plan also urges businesses to “move forward expeditiously” with requiring workers to get vaccinated or tested weekly, according to the plan. Such protocols are “especially important” given the new omicron variant, the plan added. 

“We’re asking businesses to step forward and do what’s right to protect our workers, our communities — to put in place some sort of vaccination requirement or testing requirements for the workplace,” a senior administration official said during the call. 

The administration had given businesses with 100 or more employees until Jan. 4 to ensure their staff are either vaccinated against Covid-19, or submit a negative test weekly before entering the workplace. Unvaccinated employees were also supposed to start wearing masks indoors at the workplace on Dec. 5.

However, the Occupational Safety and Health administration suspended enforcement and implementation of the requirements earlier this month, after the U.S. Court of Appeal for the Fifth Circuit halted the policy pending review. 

More than two dozen lawsuits have been filed to overturn the Biden policy. But labor unions are asking the courts to expand the requirements to cover smaller businesses and protect more workers.

Home Covid tests

The Biden administration’s winter Covid plan also includes more free at-home tests.

More than 150 million Americans with private insurance will be able to get reimbursed for their at-home tests, according to the plan. Those without private insurance will be able to access at-home tests through community sites such as health centers and rural clinics.

The plan also aims to bolster outreach efforts to get more people vaccinated, ensure the “quitable distribution of Covid -19 treatments to vulnerable populations and launch over 60 rapid response teams to states to help combat the virus.

“While this new variant is a cause for concern, it is not a cause for panic,” a senior administration said. “We have the tools we need to confront this variant and keep making progress in our fight against the virus.”

Last week, Biden ordered precautionary air travel restrictions from South Africa, Botswana, Zimbabwe, Namibia, Lesotho, Eswatini, Mozambique and Malawi. He did not indicate how long the bans, which took effect Monday, will remain in place. 

Those restrictions came into effect three weeks after the U.S. lifted a blanket ban on visitors from more than 30 countries, including the U.K., India, Brazil and South Africa, replacing them with vaccination requirements for tourists. Other countries implemented new travel restrictions last week, sending airline and other travel stocks tumbling.

The president on Monday also said his administration is working with vaccine manufacturers Pfizer, Moderna and Johnson & Johnson to develop contingency plans for additional vaccines or boosters tailored to protect against the new variant. 

He is directing the U.S. Food and Drug Administration and the CDC to use the “fastest process available without cutting any corners” to approve such potential vaccines. 

Current Covid-19 vaccines on the market are believed to provide some protection against omicron, Biden said Monday, adding that booster shots “strengthen that protection significantly.” 

On Wednesday, Fauci noted the profile of the variant suggests its mutations could reduce the effectiveness of current vaccines. However, more data is still needed, he added. 

Omicron has more than 30 mutations to the spike protein alone. Some of the mutations are associated with higher transmission and a decrease in antibody protection, according to the WHO. 

CNBC’s Spencer Kimball and Leslie Josephs contributed to this report.

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World

EU proposes a 9-month expiration date on vaccine pass

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QR code with EU COVID digital certificate displayed on a mobile phone.

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The European Union is considering a nine-month expiration date on its Covid-19 vaccine certificates, which allow tourists certain freedoms to travel while the coronavirus pandemic still rages.

The European Commission, the executive arm of the EU, proposed Thursday that the EU Digital Covid Certificate should be updated. This document has allowed people to travel more easily amid the pandemic by outlining their vaccination status, whether they have recently recovered from the virus, or whether they have recently tested negative.

The idea now is that the document has a life span of nine months after the first set of vaccines are administered — so after the second dose for Pfizer-BioNTech shot, for example, or after one dose of the Johnson & Johnson vaccine. The idea is that as immunity wanes, then a vaccine passport will expire.

Thursday’s recommendation does not yet address booster shots. The commission said that “it can reasonably be expected that protection from booster vaccinations may last longer than that resulting from the primary vaccination series.”

As such, a new expiration date could be announced in a couple of week’s time to include the advice for booster shots. In a major policy shift, the European Centre for Disease Prevention and Control suggested Wednesday that all adults should receive vaccine boosters, with priority given to those over 40.

Pandemic is not yet over

“It is evident that the pandemic is not yet over,” European Commissioner Didier Reynders said Thursday. As such, he said, “the travel rules need to take into account this volatile situation.”

Various European nations are facing a high number of Covid infections, notably in the countries where the vaccination rate remains low.

The EU’s inoculation rate is at 67% — this masks differences between nations, like Portugal, where 88% of the population is fully vaccinated and others, where people are more reluctant in getting a coronavirus shot.

Thursday’s announcement comes as the World Health Organization warned earlier this week that the number of deaths from Covid in the region could exceed 2 million by March. The WHO also described the recent increase in cases as “very serious.”

Different European nations have announced measures in recent weeks to contain rising infections. Countries such as Austria and the Czech Republic have taken some of the strictest approaches.

Thursday’s proposal needs to be ratified by the 27 EU member states before being approved.

The proposal also suggests that children below six years of age should be exempt from any travel restrictions. Those aged between 6 and 12 should also be exempt unless they come from a nation with a very high level of contagion and kids above 12 years will have to follow the same rules as adults.

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Business

FDA clears Moderna and Pfizer’s Covid vaccine booster shots for all U.S. adults

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Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with Pfizer COVID-19 vaccine before giving it to people on the first day that people ages 16 and up can receive the vaccine at Kedren Health on Thursday, April 15, 2021 in Los Angeles, CA.

Allen J. Schaben | Los Angeles Times | Getty Images

The Food and Drug Administration authorized Moderna and Pfizer’s Covid booster shots for all U.S. adults on Friday, belatedly fulfilling a critical part of the Biden administration’s plan to administer extra doses to the general public as growing data demonstrates the efficacy of vaccines wanes over time.

The approval comes about two months late — after scientists advising the FDA rejected the administration’s original plans to start distributing boosters to all adults the week of Sept. 20, citing a lack of data supporting the third doses. FDA Acting Commissioner Janet Woodcock also cleared the doses without the usual public meeting to review new data submitted by the companies in the last week. Moderna resubmitted its application just two days ago. The companies announced the decision Friday morning.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement.

The Centers for Disease Control and Prevention still has to authorize distribution of the booster doses before people can start receiving the shots, which could start this weekend. The CDC’s independent panel of vaccine experts is scheduled to meet on Friday to review the new data. CDC Director Rochelle Walensky on Wednesday said the public health agency would “act swiftly” after the FDA OKs the shots.

The FDA originally met in September to consider authorizing Pfizer’s boosters for the general public, but decided against doing so amid concerns from some experts that there wasn’t enough data. They recommended a scaled back distribution plan instead for the elderly and adults who face a high risk from Covid. The CDC approved booster shots for those groups earlier this month.

Broadly distributing booster shots is controversial among public health authorities. The World Health Organization has criticized wealthy nations for rolling out third shots when people in poorer countries have very limited access to Covid vaccines.

The WHO has pushed for a greater focus on assisting immunization efforts in the developing world, warning that new variants of the virus could emerge and undermine protection in countries that have achieved already high levels of vaccination.

Booster shots have also stirred some controversy in the U.S., as they are rolling out at a time when the country is struggling to convince millions of people to even get their first dose. More than 60 million Americans remain unvaccinated.

However, many Americans desire an extra layer of protection as data increasingly shows vaccine effectiveness against infection wears off over time. A study published in the journal Science this month found that the effectiveness of Pfizer’s vaccine, made with German biotech company BioNTech, declined from 86% to 43% from February to October this year. Moderna’s efficacy against symptomatic infection fell from 89% to 58%, and Johnson & Johnson dropped from 86% to 13%.

However, the vaccines still provide a high level of protection against hospitalization and death, scientists say.

Public health experts expect an increase in Covid infections as the weather turns and Americans gather indoors for the holidays and to escape the winter cold. Booster doses could help reduce transmission, which is already high, by helping to prevent breakthrough infections among people already vaccinated, scientists say.

The CDC has already authorized booster doses for people 18 and over who received the single-dose J&J shot. Moderna resubmitted its application for the FDA to approve a third dose of its shot for adults 18 and over on Wednesday.

The U.S. has administered more than 169 million doses of Moderna’s vaccine and more than 258 million doses of Pfizer’s shot. Health officials have administered more than 16 million doses of Johnson & Johnson’s vaccine.

Nearly 80% of Americans ages 12 and older have received at least one dose of the three vaccines, according to CDC data. More than 31.4 million people have already received their booster shots in the U.S., the data shows. President Joe Biden received his booster dose in September.

White House chief medical advisor Dr. Anthony Fauci on Wednesday urged Americans to get vaccinated, and sign up for their booster if they are eligible.

“It is not too late. Get vaccinated now. And importantly, if you are already vaccinated six months or more ago and eligible for a boost, get a boost,” Fauci said. “The Israelis have shown that when you boost, you multifold diminish the likelihood of getting infected, getting sick, or dying.”

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Business

5 things to know before the stock market opens Friday, Nov. 12

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Here are the most important news, trends and analysis that investors need to start their trading day:

1. Dow set to bounce, helped by gains in J&J shares on split plans

Traders on the floor of the NYSE, October 28, 2012.

Source: NYSE

U.S. stock futures rose Friday, helped by premarket strength in Dow component Johnson & Johnson on plans to split into two companies. The U.S. bond market opened back up Friday after the Veterans Day holiday, with the 10-year Treasury yield flat, following this week’s gains after hot inflation data. The government is out with its Job Openings and Labor Turnover Survey at 10 a.m. ET. JOLTS in September is expected to show employment vacancies dropping to 10.2 million after the prior month’s 10.4 million, fueled by record quits. The Nasdaq and the S&P 500 rebounded Thursday. But the Dow Jones Industrial Average fell for a third straight session, pulled down by Disney’s 7% decline on disappointing quarterly results. Dow stock Disney was modestly higher in Friday’s premarket.

2. J&J to separate into two companies: Consumer products, medical

Johnson & Johnson logo

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J&J shares rose roughly 3% in the premarket after the health-care giant announced Friday it’s splitting into two publicly traded companies: one focused on consumer products, such as Band-Aid bandages and baby powder, and the other focused on medical devices and pharmaceuticals, including its Covid vaccine. Johnson & Johnson was already undergoing a major transition, as CEO Alex Gorsky has previously announced that he will step down in January. Joaquin Duato, who was tapped as Gorsky’s successor, will lead the new J&J following the separation of the consumer unit. The announcement is the second time this week that a major U.S. company has revealed intentions to split itself. General Electric on Tuesday said it plans to break up into three companies, focusing on aviation, health care and energy.

3. Rivian founder R.J. Scaringe now worth over $2 billion since IPO

RJ Scaringe, founder and chief executive officer of Rivian Automotive, speaks after unveiling the R1S electric sports utility vehicle (SUV).

Bloomberg | Bloomberg | Getty Images

Shares of Rivian Automotive rose nearly 4% in Friday’s premarket, a move that would add to the newly public electric vehicle maker’s two-day gain of 57%. Since Wednesday’s debut, Rivian’s market value has climbed to $105 billion and CEO R.J. Scaringe’s stake in the company he founded in 2009 was valued at $2.2 billion. Rivian, which has Amazon and Ford as backers, pales in comparison to Tesla’s more than $1 trillion market value. Elon Musk, worth more than $275 billion, took a shot at his rival Thursday, saying high production and break-even cash flow will be the true test for Rivian.

4. Singles Day, while muted by China’s crackdowns, still saw record sales

Delivery workers sort parcels at a makeshift logistics station near the Central Business District (CBD) during Singles’ Day shopping festival in Beijing, China November 11, 2021.

Tingshu Wang | Reuters

Alibaba and JD.com racked up around $139 billion of sales across their platforms on China’s Singles Day shopping event, setting a record. Singles Day used to just be a 24-hour affair, but it has transformed into a multiday extravaganza, ending at midnight on Nov. 11. The all-time high sales come despite worries about the strength of the Chinese consumer and the impact of Beijing’s crackdown on technology companies. Singles Day was slightly more muted this year as Chinese tech companies continued to face scrutiny from regulators and Chinese President Xi Jinping’s push for so-called common prosperity.

5. Chinese President Xi further solidifies leadership of No. 2 economy

Xi Jinping, general secretary of the Communist Party of China CPC Central Committee, Chinese president and chairman of the Central Military Commission, delivers an important speech at a ceremony marking the 100th anniversary of the founding of the CPC in Beijing, capital of China, July 1, 2021.

Ju Peng | Xinhua News Agency | Getty Images

Xi took another step to solidify his hold on China, the world’s second-largest economy, and to advance his vision for a strong Chinese Communist Party-dominated system. On Thursday, he joined the ranks of Mao Zedong and Deng Xiaoping as the country’s third leader to oversee a “historical resolution” at the close of the widely watched meeting of the CCP. Party officials called Xi a “helmsman” and a “people’s leader” on Friday, in a show of support for his continuing leadership. Those terms were descriptions used more than 50 years ago during the cult of personality surrounding Mao. Xi and U.S. President Joe Biden are expected to hold a virtual meeting Monday.

— Reuters contributed to this report. Follow all the market action like a pro on CNBC Pro. Get the latest on the pandemic with CNBC’s coronavirus coverage.

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