FDA Committee Postpones COVID-19 Vaccine Review for Kids Under 5
Parents of young children will need to wait months longer than expected for their kids to receive COVID-19 vaccines. The U.S. Food and Drug Administration (FDA) postponed a decision today on whether to authorize a vaccine for children under the age of 5; they are awaiting data to determine whether a third dose is effective. The meeting, which was scheduled for Feb. 15, has been pushed back to an unspecified date. Pfizer-BioNTech said in a press release today that it had asked the FDA to extend the timeline for an emergency use authorization for the vaccine in this age group while it waits for the additional data.
It’s only the latest twist in Pfizer’s complicated quest for vaccine authorization for the youngest Americans, my colleague Jamie Ducharme reports. While researchers found that their two-series vaccine (at a smaller dosage) is safe in young children, the efficacy data is mixed. Two doses of the vaccine produced a strong immune response in kids under two, but not in kids between 2 and 4 years old. Some experts have argued that the FDA should hold off on authorizing the vaccine until data are available on three doses of the shot in kids under 5.
The FDA echoed this concern today. “Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered,” the agency wrote in its statement.
Pfizer said today that the updated data will be available as soon as early April.
The announcement has frustrated many parents. However, more solid data may be worth the wait. “I'm disappointed as a mom, but I'd rather that our regulators play it extra safe and wait for data from 3-doses rather than authorize 2-doses in the meantime,” Dr. Leana Wen, a George Washington University School of Public Health professor, wrote on Twitter.
For now, the FDA emphasizes that the best way to keep kids safe is for their parents and caregivers to get vaccinated and boosted, and to practice social distancing and masking.
More than 405.9 million people around the world had been diagnosed with COVID-19 as of 12 a.m. E.T. today, and nearly 5.8 million people have died. On Feb. 10, there were 2.6 million new cases and 10,954 new deaths confirmed globally.
Here's how the world as a whole is currently trending, in terms of cases:
And in terms of deaths:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
And here's every country that has reported over 5.5 million cases:
The U.S. had recorded more than 77.4 million coronavirus cases as of 12 a.m. E.T. today. More than 915,000 people have died. On Feb. 10, there were 147,416 new cases and 3,175 new deaths confirmed in the U.S.
Here's how the country as a whole is currently trending in terms of cases:
And in terms of deaths:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
All numbers unless otherwise specified are from the Johns Hopkins University Center for Systems Science and Engineering, and are accurate as of Feb. 10, 12 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
The FDA issued an emergency use authorization for Eli Lilly’s monoclonal antibody drug this afternoon, adding a treatment option to help fight the Omicron surge. The Biden Administration has purchased enough doses of the drug to treat 600,000 people, the Associated Press reports. Data have shown that the drug, called bebtelovimab, is effective against Omicron, unlike the two leading antibody treatments that were already authorized. Health and Human Services Secretary Xavier Becerra said yesterday that the treatment would be shipped to states following the authorization.
For now, the restrictions at the Beijing Winter Olympics appear to be working. While about 490 people inside the so-called “closed loop”have tested positive so far, there haven’t been any reports of the virus escaping the Olympic bubble. The restrictions have been stringent: athletes inside the bubble have been asked to wear N95s, distance from one another, and stay away from the city’s bars, restaurants, and historic sites. Athletes are also tested daily, and if they test positive, they’re required to isolate in designated areas. This week, officials promised to improve conditions in these quarantine facilities after athletes complained about bad food, insufficient training equipment, and burdensome testing protocols.
French President Emmanuel Macron refused the Kremlin’s request to take a COVID-19 PCR test when he visited Russian President Vladimir Putin on Monday out of concern that Russia would take his DNA, Reuters reported today. Instead, Macron reportedly took a PCR test in France and a rapid antigen test with his own doctor once he was in Russia. The two leaders maintained a distance from each other and were photographed at opposite ends of a long table. "We knew very well that meant no handshake and that long table. But we could not accept that they get their hands on the president's DNA,” a member of Macron’s entourage told Reuters.
New York City may fire as many as 3,000 municipal workers today who refused to get vaccinated, which the New York Times described as likely “the most drastic example of a work force reduction tied to a coronavirus vaccine mandate.” However, they make up less than 1% of the city’s workers, the Times reported. Since the mandate was announced in October, the number of city workers who are vaccinated rose from 84% to about 95%. Mayor Eric Adams said at a press conference yesterday that the workers understood they needed to be vaccinated in order to work for the city. “We are not firing them,” he said. “People are quitting. The responsibility is clear.”
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Today's newsletter was written by Tara Law and edited by Mandy Oaklander.
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