Sunday, August 7, 2022 | Back issues
Courthouse News Service Courthouse News Service

Not just for emergencies: Pfizer shot gets full FDA approval

The Food and Drug Administration gave full approval Monday to Pfizer’s Covid-19 vaccine, a landmark the Biden administration hopes will change the minds of Americans who have been reluctant to get the shot.

WASHINGTON (CN) — Setting the stage for more employers and schools to require a Covid-19 vaccine, and also perhaps allaying lingering doubts about the shot in the population, the Food and Drug Administration gave full approval Monday to Pfizer’s coronavirus vaccine.

The country’s first FDA-approved Covid-19 vaccine is a product of Pfizer and its partner BioNTech, which together have distributed more than 200 million doses of the two-shot regimen across the country since being granted emergency use authorization in December.

Pfizer submitted its vaccine for full FDA approval some three months ago as the now-rampant delta variant of the virus began was on the ascent.

President Joe Biden on Monday said any Americans who have not received a vaccine should let Pfizer’s new qualifier put to rest any hesitation about the safety of the vaccine.

“While all three Covid vaccines have met FDA's strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective,” he tweeted Monday. “If you're not vaccinated yet, now is the time.”

Acting FDA Commissioner Janet Woodcock noted in a statement Monday that the vaccine “meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” echoing the president’s statements that this marker should instill additional confidence for Americans to get vaccinated.

Pfizer CEO Albert Bourla also released a statement Monday, saying "vaccination remains the best tool we have to help protect lives and achieve herd immunity." Bourla also pointed to data suggesting that 60% of eligible Americans are fully vaccinated with either Pfizer, Moderna, or Johnson & Johnson.

While U.S. vaccinations leveled out last month, vaccinations have been increasing again as the delta variant has caused hospital bed shortage spikes in communities across the country. On Thursday, Friday, and Saturday of last week, around a million shots were administered per day. 

The FDA’s Monday action could spur additional vaccine mandates from companies, universities and local governments— already the Biden administration has mandated vaccination for the roughly 4 million federal employees in the U.S. Many universities have also implemented mandates for students, while states have done so for health care workers, and cities for dine-in restaurants and gyms.

A recent poll by The Associated Press-NORC Center for Public Affairs Research indicates that close to 60% of Americans favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events.

Looking at the six months of safety data required for full approval, the FDA noted the rarity of serious side effects, like chest pain, in patients among hundreds of millions of Pfizer shots given. It also said that the data suggested the Pfizer jab had proved 97% protective against severe Covid-19, and 84% effective against moderate Covid-19 after six months.

Peter Marks, director of FDA’s center for biologics evaluation and research, emphasized Monday that the administration’s scientific and medical experts had conducted a thorough and thoughtful evaluation of the vaccine in reaching this conclusion. 

“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.,” he said.

U.S. health officials announced a plan earlier this week to recommend that all Americans, but particularly those who are elderly or otherwise at risk of serious infection from Covid-19, obtain vaccine booster shots. Currently, the FDA is only allowing emergency use of a third jab of the Pfizer or Moderna vaccines for people who have extremely weakened immune systems.

A study published last month found that the delta variant is able to spread more readily than past versions of the coronavirus and that it may also be resistant to some of the antibody treatments and even partial vaccination. 

Pending federal authorization, adults 18 years and older will be eligible for a Covid-19 vaccine booster eight months after receiving their second dose of Pfizer or Moderna shots, beginning the week of Sept. 20 with vulnerable populations and frontline workers. Further recommendations for youth ages 18 and below are also under review.

A formal recommendation remains contingent on the results of an independent analysis from the Food and Drug Administration, independent of Monday’s two-shot approval, evaluating the safety and effectiveness of a third Pfizer or Moderna mRNA vaccine, health officials explained in a news conference. A booster for Johnson and Johnson's single-dose vaccine is also being evaluated.

Pfizer's vaccine is still being administered under emergency authorization to children between the ages of 12 and 15olds. For vaccination for children under 12, for both Pfizer and Moderna are still gathering data, a process expected to completed in the fall. 

Follow Alexandra Jones on Twitter.

Read the Top 8

Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.

Loading
Loading...