Pfizer’s COVID-19 vaccine became the first to receive full approval from the Food and Drug Administration (FDA) on Monday following what the agency described as a thorough and rigorous review process.
Previously known as the Pfizer-BioNTech COVID-19 vaccine, the two-dose shot now will be marketed under the name Comirnaty and is approved for people 16 and older, FDA says in a release. Meanwhile, the same vaccine remains available under emergency use authorization, including for children aged 12-15 and for a third dose in certain immunocompromised people, FDA adds.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” Acting FDA Commissioner Janet Woodcock, MD, said in the statement.
According to the agency, in reviewing the Pfizer vaccine for approval, FDA used updated data from the clinical trial that supported the original emergency use authorization. The updated data – culled from evaluations of about 22,000 people who received the vaccine and 22,000 who received a placebo – showed the vaccine to be 91% effective in preventing COVID-19.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” Peter Marks, MD, director of FDA’s Center for Biologics Evaluation and Research, said in the release.
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S,” Dr. Marks added.
FDA also says the manufacturer will conduct post-marketing studies related to the risks of myocarditis and pericarditis, and to pregnancy evaluations.
More information and links on the Pfizer approval are available in in the FDA release.