The Food and Drug Administration (FDA) said Friday that it is working quickly towards finalizing its approval for emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine.
The pair also said the FDA has notified the Centers for Disease Control and Prevention (CDC) and the Trump administration's Operation Warp Speed initiative of the vaccine's imminent approval for emergency use so that preparations can be made for its timely distribution.
The U.S. government has pledged to distribute 2.9 million doses of the vaccine to the public within 24 hours of FDA approval.
“In the next couple of days, probably as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine,” Azar said.
The FDA's announcement and Azar's remarks follow a Thursday vote by a 23-member panel of independent medical advisors to support the vaccine for emergency use, after discussing whether scientific evidence supports the view that the product, called BNT162b2, is effective in preventing COVID-19 in people aged 16 and older, and if the known benefits outweigh potential risks.
“I would like to thank the FDA’s advisory committee for recognizing the critical role that our vaccine may play in helping to address this ongoing pandemic. Today’s positive discussion and vote reinforces the potential of our COVID-19 vaccine candidate in helping to protect people against this deadly and devastating disease,” said Ugur Sahin, CEO and Co-founder of BioNTech, in a statement.
The vaccine is purported to immunize against COVID-19, which is the symptomatic disease caused by the virus SARS-CoV-2. The likely regimen is for individuals to receive two doses, administered 21 days apart.
Regarding safety, the FDA reviewed data from some 38,000 participants aged 16 and older, and found "a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA [emergency use authorization]," according to the analysis.
The study did note, however, that, "there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals."
People who took part in the study did experience a number of side effects after taking the vaccine, with the FDA noting the most common were injection site reactions (84.1 percent), fatigue (62.9 percent), headache (55.1 percent), muscle pain (38.3 percent), chills (31.9 percent), joint pain (23.6 percent), and fever (14.2 percent).
The companies were the first to seek emergency approval for a COVID-19 vaccine, with Moderna’s candidate, called mRNA-1273, scheduled for FDA review on Dec. 17.