Vaccine becomes first to move beyond emergency approval
Full FDA Approval for Pfizer Vax
The Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older on August 23, making it the first such vaccine to move beyond emergency use status in the United States. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee). The approval is expected to launch a plethora of vaccine requirements by hospitals, colleges, corporations and other organizations.
Thus far, more than 92 million Americans, 54 percent of those fully vaccinated, have gotten Pfizer shots. Most of the rest have gotten Moderna’s vaccine.
The regulatory action gives doctors more leeway to prescribe a third shot of the Pfizer vaccine to patients, but federal officials have strongly discouraged people from seeking extra shots until regulators decide that they are safe and effective. Pending regulatory clearance, the federal government plans to start offering booster shots for adults in September.
Pfizer said that it gave the FDA data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. Pfizer said that the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the FDA decided to authorize the vaccine for emergency use in December. Pfizer claimed that the decrease reflected the fact that researchers had more time to catch people who became infected.
The vaccine will still be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away, and Acting FDA Commissioner Dr. Janet Woodcock said no child that age should be given any Covid-19 vaccine until regulators obtain safety data.
She also said, “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. 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. The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
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.