Pfizer and BioNTech are planning to ask the Food and Drug Administration for emergency authorization for their COVID-19 vaccine today. It will be the first coronavirus vaccine to try to get regulatory approval in the U.S.
The two companies issued a statement saying that their COVID-19 vaccine candidate, which has officially been tagged as BNT162b2, could be available to high-risk populations in the U.S. by mid- to late December. The vaccine requires two injections given a few weeks apart. Protection from the coronavirus begins 28 days following the first injection.
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According to CNN, the request for emergency authorization for the Pfizer/ BioNTech vaccine is based on the results of the Phase 3 clinical trial, which started on July 27 and included over 43,000 volunteers. The initial analysis from the trial indicated that the vaccine was 95% effective at preventing infection with COVID-19, including in seniors.
The analysis also suggested that there were no serious safety issues. The trial also included safety details on approximately 100 children between the ages of 12 and 15. Approximately 42% of participants around the globe and 30% of U.S. participants in the Phase 3 trial have ethnically and racially diverse backgrounds, Pfizer and BioNTech said in a press release. Additionally, 41% of global participants and 45% of U.S. participants are between the ages of 56 and 85.
CNN explains that emergency use authorization (EUA) for vaccines is not the same thing as Pfizer receiving full approval for it. When companies secure an EUA, they receive approval for their products to be used under specific circumstances before all the evidence for approval is available. To receive an EUA, the FDA decides whether a products "known and potential benefits outweigh its known and potential risks."
A source reportedly told CNN that the FDA has scheduled a meeting for its Vaccines and Related Biological Products Advisory Committee for Dec. 8, 9 and 10. The agency could decide at the end of the Dec. 10 meeting about whether to extend emergency use authorization for Pfizer's COVID-19 vaccine.
The source said the FDA might consider the applications for both Pfizer's and Moderna's vaccines at the same time. The two vaccines use the same technology and seem to have similar efficacy and safety results from their clinical trials.
What happens next?
If the FDA authorizes the vaccines for emergency use, they can then be distributed to states immediately, However, no one can receive the injections until an advisory committee for the Centers for Disease Control reviews the data, recommends the vaccines and chooses groups to receive it first.
A spokesperson for the CDC said the agency's Advisory Committee on Immunization Practices will meet 24 to 48 hours after the FDA grants emergency use authorization. The committee will then decide whether everyone should receive the vaccine or if some groups should be excluded.
Vice President Mike Pence told a White House Coronavirus Task Force briefing on Thursday that they have a plan in place so that as soon as the FDA decides that a vaccine is safe and effective, the system will start shipping the injections to hospitals and healthcare officials within 24 hours. Then 24 hours after that, the first injections could be given.
States are now developing plans to operate vaccination clinics. Pfizer's vaccine is especially complicated because it must be stored at -75 degrees Celsius, and pharmacies and doctors' offices usually don't have freezers which run that cold. The first to receive the vaccines are expected to be healthcare workers, seniors, essential workers like police officers and anyone with underlying medical conditions.