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FDA gives full approval to Pfizer’s COVID-19 vaccine

Pharmacist Mark Cepeda prepared a dose of the PfizerBioNTech COVID-19 vaccine in June.Pat Greenhouse/Globe Staff

The US Food and Drug Administration granted full approval Monday to Pfizer’s COVID-19 vaccine for people 16 and older, a landmark decision that could boost public confidence in the shots and pave the way for more vaccine mandates by employers, schools, and other organizations.

By licensing the vaccine made by Pfizer and its German partner, BioNTech, the FDA gave the two-shot regimen its strongest possible endorsement for safety and efficacy. Since regulators in December authorized its emergency use, more than 204 million Pfizer doses have been administered in the United States, and hundreds of millions more overseas.

Pfizer’s vaccine, which will be marketed as Comirnaty, was the first of three vaccines cleared by the FDA for emergency use and is the first to be fully approved. Monday’s decision was expected and came as the highly contagious Delta variant is causing COVID-19 cases and hospitalizations to surge in parts of the country, particularly in states with low vaccination rates.

“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,” acting FDA Commissioner Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”


Cambridge-based Moderna has also applied for full approval of its two-shot vaccine, which on Dec. 18 was authorized for emergency use a week after Pfizer’s. Johnson & Johnson, whose one-shot vaccine was cleared on Feb. 27, plans to seek full approval later this year, according to a company spokeswoman.

The Pentagon said Monday it will require service members to receive the vaccine now that FDA has granted full approval.

Some public health officials hope that the agency’s approval removes an obstacle that has prevented some Americans from getting vaccinated. A recent poll by the Kaiser Family Foundation, which has tracked public sentiment during the pandemic, found that 3 of every 10 unvaccinated people said that they would be more likely to seek a shot with a fully approved vaccine.


Jon Hurst, president of the 4,000-member Retailers Association of Massachusetts, said he believes the FDA decision will make it easier for business owners to require workers to get vaccinated as a condition of employment. So far, he was unaware of any retail employers with a mandate.

But some other employers said they were already requiring employees to be vaccinated.

“The emergency use authorization never troubled us, and it was never a factor in our thinking about a mandate,” said Tim Ritchie, president of the Museum of Science, which is requiring all of its roughly 650 employees and volunteers to be vaccinated.

New York City, New Orleans, and San Francisco this month all imposed proof-of-vaccination requirements at restaurants, bars, and other indoor venues. Massachusetts Governor Charlie Baker on Thursday announced that 42,000 state workers would be required to get COVID-19 vaccines or risk being fired, one of the toughest mandates in the nation.

At the federal level, President Biden is requiring government workers to sign forms attesting that they’ve been vaccinated or to submit to regular testing and other requirements.

The FDA said it reviewed safety data from 44,000 people who participated in a clinical trial of Pfizer’s vaccine, half of whom received the vaccine and half of whom received a placebo. More than half of the participants were followed for at least four months after the second dose. Overall, about 12,000 recipients have been followed for at least six months.


The agency said the most commonly reported side effects from the Pfizer shots were pain, redness, and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. Serious side effects — such as chest pain and heart inflammation in teens and young adults — remain extremely rare.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said regulators evaluated hundreds of thousands of pages of scientific data and information submitted by Pfizer. They also performed their own analyses of the vaccine’s safety and effectiveness, and inspected manufacturing facilities.

“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 US,” Marks said in a statement.

The Pfizer and Moderna vaccines use messenger RNA to instruct cells to make a part of the spike protein on the surface of coronavirus to stimulate an immune response. In an illustration of how the FDA is trying to dispel misconceptions about the technology, the agency said that 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,” or DNA.

The approval pleased Dr. Monica Gandhi, an infectious diseases doctor at the University of California, San Francisco, who had wanted the agency to act in May shortly after Pfizer and BioNTech submitted their application.


“I am delighted the FDA at long last approved the Pfizer/BioNTech vaccine,” Gandhi said in an e-mail. “This will go a long way in getting those who are hesitant to take the vaccine as well as allowing employers to issue vaccine mandates with limited exceptions.”

The Pfizer vaccine will continue to be authorized for emergency use for children age 12 to 15 while the company collects 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. So far, more than 92 million Americans — 54 percent of those fully inoculated — have received two Pfizer shots. Most of the other people inoculated in the United States have received Moderna’s vaccine.

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and an authority on vaccines, said he was disappointed that the FDA approval didn’t apply to children age 12 to 15.

“From a vaccine advocacy perspective, having full approval for the adolescents would have really helped,” he said on Twitter. “As it is, there [are] many pediatricians across America now doing damage control explaining why COVID-19 vaccines are still safe and necessary for adolescents.”

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked people 16 and older for at least two months — the time period when serious side effects typically arise.


That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, who were studied the longest.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer’s chief executive, said in a statement. Vaccination, he said, ”remains the best tool we have to help protect lives and achieve herd immunity.”

Six-month tracking of Pfizer’s original study participants showed the vaccine remained 97 percent protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96 percent two months after the second dose to 84 percent by six months.

Those data came before the Delta variant began spreading, but other data from the Centers for Disease Control and Prevention show the vaccine is still doing a good job in preventing severe disease caused by that mutant.

Although the need for booster doses has drawn attention in recent days, the FDA’s licensure doesn’t cover those additional shots. Regulators plan to separately assess that use.

The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who don’t respond as strongly to the usual two shots. For everyone else who got those vaccinations, the Biden administration is planning ahead for boosters starting in the fall — if the FDA and CDC agree.

Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying that age group, with data expected in the fall.

Material from the Associated Press was used in this report.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com. Anissa Gardizy can be reached at anissa.gardizy@globe.com. Follow her on Twitter @anissagardizy8 and on Instagram @anissagardizy.journalism.