FDA officials present offered similar support. “FDA has been conducting ongoing review of manufacturing quality, consistency, and control,” said the agency’s deputy director in the office of vaccines research and review, Doran Fink. “We have found this adequate to support emergency use authorization of the vaccine.”
The vaccine will be distributed under an emergency-use authorization, which fast-tracks drugs still under investigation because of extenuating circumstances—in this case, a pandemic that is now claiming the lives of more than 2,000 Americans each day. The agency’s criteria for such authorizations require “reasonable” evidence that the vaccine is effective, and that the “known and potential benefits … outweigh its known and potential risks.”
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“Today’s vote was a significant step in bringing another weapon to the COVID fight,” Stephen Thomas, the chair of infectious diseases at the State University of New York Upstate, who also served as lead principal investigator for the clinical trial, told me. “That being said, we still have the task of bringing this vaccine to the people and earning the trust of the people so they participate in the vaccination process. Vaccines don’t save lives; vaccination saves lives.”
The new authorization does not necessarily mean that the vaccine will ultimately become approved and licensed by the FDA indefinitely. Pfizer will continue to run a phase-three randomized clinical trial with 43,448 participants to evaluate the vaccine’s safety and efficacy. So far, the results—which were published in The New England Journal of Medicine today—have shown that the vaccine is 95 percent efficacious at protecting adults. This greatly exceeded expectations; over the summer, Anthony Fauci, the leading U.S. infectious-disease doctor, said that 50 or 60 percent would be acceptable.
Because the vaccine is still technically an experimental product, the emergency authorization could be revoked if complications arise. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases, told the panel that safety monitoring would be a top priority for the agency. “Information that we get will be shared quickly with the FDA and independent safety-review experts,” she said. Everyone who is vaccinated will be encouraged to download an app called V-SAFE to report their experiences after vaccination.
So far, the vaccine has shown very few serious side effects. Many people experience mild flu-like symptoms that last a day or two. In conversations with patients during the clinical trial, Thomas said, many told him the side effects would be well worth it if they led to lasting protection. It remains to be seen how long this immunity will last: Because Pfizer’s clinical trial began relatively recently, at this point it can show only that the effect lasts two months. But it is widely expected that immunity will last significantly longer. Pfizer will continue to monitor participants to see if and when the protection begins to wane.