The Food and Drug Administration (FDA) has officially approved the Pfizer COVID-19 vaccine, which was already approved for emergency use. The vaccine will now be marketed as Comirnaty.
FDA officials said, “FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
"Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.”
FDA Commissioner Janet Woodcock said, “This is a pivotal moment for our country in the fight against the pandemic. While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, this is the first FDA approved COVID-19 vaccine.”
She added, “The public can be confident that this vaccine meets the FDA’s gold standards for safety, effectiveness, and manufacturing quality. As we continue to battle the pandemic, we remain acutely aware that vaccines are one of our greatest weapons against the virus. For some, a FDA approved vaccine may instill in them the confidence to get vaccinated.”
She said it took the FDA three months to approve the vaccine, and said that the speed of the process did not mean that standards have been altered or lowered. She said the information the FDA evaluated will be available on the FDA’s website.
Dr. Peter Marks said the FDA analyzed thousands of pages of information taken from 40,000 recipients aged 16 and older who did not have the COVID-19 infection within a week of receiving that second doze. The safety of the vaccine was evaluated in 44,000 people. In both samples, half were given the vaccine, and half were given a placebo.
“I urge you and your loved ones to get vaccinated, and help end this pandemic,” Dr. Woodcock said.
The FDA found that the vaccine is 91 percent effective in preventing COVID-19 and serious outcomes such as hospitalization and death.
Commissioner Woodcock said that the FDA does not have data “on the proper does or safety (of the vaccine) in children, so that would be a great concern that people would vaccinate children.”
She said, “Children are not small adults,” and that the FDA needs to conduct more studies before they recommend that children younger than 12 be vaccinated with the approved vaccine. She said the FDA does not encourage off-label use. Dr. Marks also said there is also real-world evidence that the vaccine is still effective against the Delta variant, and that they are still researching booster shots.
“Data coming out of Israel seems to suggest that over time, immunity from the vaccine does seem to wane,” Dr. Marks said. “We’ll be following that closely and will be leading into consideration of boosters as we move into the fall.”
He said there are still trials ongoing when it comes to vaccinating children younger than 12. He said “The trials need to be finished, and then the data needs to be submitted to us."