6 things to know before FDA panel votes today


A vial of the Pfizer/BioNTech COVID-19 vaccine.

Liam McBurney | Reuters

A Food and Drug Administration panel is scheduled to vote Thursday on whether to recommend the approval of Pfizer and BioNTech‘s coronavirus vaccine for emergency use.

The non-binding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, an outside group of experts in infectious diseases and vaccines, is the last step before the FDA is likely to give the final OK to distribute the potentially lifesaving doses throughout the United States.

While the FDA does not have to follow the advisory committee’s recommendation, the agency often takes its advice. Emergency use approval would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.3 million Americans and killed at least 288,000 as of Wednesday, according to data compiled by Johns Hopkins University. Hospitals across the U.S. already have a higher load of Covid patients than ever before, and the country’s outbreak is primed to set even more grim records.

Pfizer’s vaccine would be the first approved for use in the U.S.

Here’s what to expect:

1.) When are they voting?

2.) What happens next?

3.) How soon will the vaccine be distributed?

4.) When will I get the vaccine?

Initial doses of the vaccine will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. The vaccine is expected to be distributed in phases, with the Centers for Disease Control and Prevention asking states to prioritize health-care workers and nursing homes first.

Dr. Moncef Slaoui, who is leading President Donald Trump’s vaccine program Operation Warp Speed, has said the U.S. should be able to distribute enough vaccine doses to immunize 100 million Americans by the end of February, nearly a third of the U.S. population. He has said the entire U.S. population could be vaccinated against Covid-19 by June.

5.) Should I get the vaccine if I’ve had Covid?

The FDA said Tuesday that patients who have had Covid-19 may still be at risk of reinfection and could benefit from the vaccine. 

The World Health Organization said last week that researchers are still trying to determine how long an antibody response lasts after someone is infected with the virus. In a recent Oxford study, researchers found that people who have contracted the coronavirus are “highly unlikely” to contract the disease again for at least six months.

“We have seen the number of people infected continue to grow, but we’re also seeing data emerge that protection may not be lifelong, and therefore we may see reinfections begin to occur,” Dr. Mike Ryan, executive director of the WHO’s health emergencies program, said on Dec. 4. “So the question is: What are the levels of protection in society?”

6.) What about side effects?

Most people don’t have serious side effects from vaccines, and severe reactions are extremely rare, according to the Department of Health and Human Services. Slaoui has said says Pfizer’s and Moderna’s vaccines are safe, with only 10% to 15% of volunteers reporting side effects that were “significantly noticeable.”

Participants in Moderna’s and Pfizer’s coronavirus vaccine trials told CNBC in September that they were experiencing high fever, body aches, bad headaches, daylong exhaustion and other symptoms after receiving the shots. While the symptoms were uncomfortable, and at times intense, the participants said they often went away after a day, sometimes sooner, and that it was better than getting Covid-19.

The FDA notes there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems.

U.K. drug regulator warned Wednesday that people who have a history of “significant” allergic reactions should not receive the coronavirus vaccine developed by Pfizer.



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