The U.S. gave full approval to Pfizer's COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet.
Full approval has been given for people 16 years of age and older. Pfizer’s shot still has emergency authorization for 12 to 15-year-olds.
The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.
Gov. Janet Mills, Maine Center for Disease Control and Prevention (CDC) Director Nirav Shah, and Maine Department of Health and Human Services (DHHS) Commissioner Jeanne Lambrew have all been encouraging Mainers to get vaccinated for months. They released the following statements Monday in reaction to Pfizer getting FDA approval:
Gov. Janet Mills
“The FDA’s full approval of the Pfizer vaccine is a very welcome milestone in our battle against this pandemic, reaffirming that the vaccine is safe and highly effective. With the more dangerous and more transmissible Delta variant driving a surge in cases and hospitalizations and threatening the lives of Maine people, there is no time to waste in getting your shot. Getting vaccinated may save your life, the life of a family member or friend, or the life of a child not yet eligible for a vaccine.”
Maine CDC Director Dr. Nirav Shah
“While Pfizer’s COVID-19 vaccine had already met the rigorous scientific standards of the emergency use authorization, today’s approval should give Maine people even more confidence that this vaccine is safe and effective. If you haven’t yet been vaccinated, there’s no better time than now to roll up your sleeve. We’re still in this pandemic, and vaccination is the best tool we have against the virus.”
Maine DHHS Commissioner Jeanne Lambrew
“Today’s full approval of Pfizer’s COVID-19 vaccine reinforces the robust scientific evidence that the vaccine is safe, effective, and unquestionably better than running the risk of getting COVID-19, especially with the Delta variant circulating across the state. Maine people’s adherence to the science throughout the pandemic has kept our state at the forefront in our COVID-19 response. But we must not let up. I urge all those who haven’t yet been vaccinated to make a plan to get their shot as soon as possible.”
Republican Sen. Susan Collins told NEWS CENTER Maine she hopes full FDA approval of the Pfizer vaccine will "give Americans who have been waiting for full FDA approval the confidence to receive the vaccine."
Sen. Susan Collins
"The FDA’s full authorization of the Pfizer vaccine is good and welcome news for the people of Maine and America.
I hope it will give Americans who have been waiting for full FDA approval the confidence to receive the vaccine.
I would urge anybody who has not been vaccinated to consider doing so as quickly as possible for their health and the health of their family members."
Sen. Angus King, an Independent, and Rep. Chellie Pingree, a Democrat, each took to Twitter in the wake of the announcement, encouraging people to go and get their shots.
Sen. Angus King
Rep. Chellie Pingree
A spokesman for Rep. Jared Golden told NEWS CENTER Maine that Golden has not released a statement on the new authorization.
Full approval means Pfizer's COVID-19 vaccine meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.
Approved vaccines undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products, according to the FDA. For all vaccines, the agency evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).
The FDA 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.
EDITOR'S NOTE: The video below is NEWS CENTER Maine's reporting from Aug. 11, prior to the Pfizer vaccine receiving full FDA approval.