The US Food and Drug Administration (FDA) today approved full licensure for the two-dose Pfizer-BioNTech COVID-19 vaccine that was given Emergency Use Authorization (EUA) on December 11, 2020, for recipients age 16 and older. It will now be known under the trade name “Comirnaty” (pronounced koe-mir’-na-tee). The identical vaccine will continue to be available under EUA issued May 10, 2021, for recipients ages 12 to 15 and under subsequent EUA as a third dose for immuno-compromised recipients.
About 92 million people in the US have been administered the Pfizer vaccine under EUA. Full approval is expected to persuade some who have been hesitant to get an “experimental” vaccine. Full approval may also smooth legal obstacles to COVID-19 vaccine mandates by public and private employers and schools, where existing vaccines (such as for measles, mumps, and rubella) are already mandated.
In a statement, the FDA said approval was based upon clinical trial data from both before and after the EUA, including one for effectiveness with 40,000 participants and one for safety with 44,000 participants, in each case half receiving the vaccine and half receiving a placebo. The vaccine was found 91% effective in preventing sickness from COVID-19. About 12,000 vaccine recipients were monitored for adverse events for at least six months.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
“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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. 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.”
In Rhode Island, free vaccination sites can be found on the state government web site vaccinateri.org for the general public, as well as more than 100 back-to-school clinics in communities listed at back2schoolri.com.
RI Gov. Dan McKee said in a statement, “To anyone who was on the fence, the science is crystal clear. These vaccines are safe, and they are very effective at keeping people healthy. It is time. It is time to protect yourself. It is time to protect your family. It is time to get vaccinated. We have vaccination opportunities available in communities across Rhode Island. If you have not gotten your shot, get vaccinated today.”
“The FDA did an extremely thorough review of this vaccine and reaffirmed that it absolutely was safe,” said RI Director of Health Nicole Alexander-Scott, MD, MPH, in a statement. “It is undeniable that the COVID-19 vaccines save lives. If you are eligible, get vaccinated today to protect you and your family. It’s easier than it has ever been before.”