Pfizer Vaccine Receives Full FDA Approval, Washington Celebrates

TACOMA, WA — The U.S. Food and Drug Administration has given the Pfizer COVID-19 vaccine it's full approval for patients 16 and older. Now, Washington's leaders are hoping the news may help address lingering vaccine hesitancy.

"The Food and Drug Administration’s full authorization of the Pfizer-BioNTech vaccine today is a great milestone in our fight against this deadly pandemic," said Gov. Jay Inslee in a written statement. "People who get vaccinated should be more confident than ever in the safety and effectiveness of this vaccine. It does not just save the lives of individuals; it can save entire communities from further devastation."

With the FDA's approval, the U.S. has become the first country to fully approve the shot, according to Pfizer. Previously, the vaccine had only been granted for emergency use. Emergency use authorization requires just two months of study. Full approval requires six months of research, which Pfizer pursued, and which the FDA has now reviewed as part of its approval process. The FDA also reviewed real-world evidence, looking at data of the millions of Americans who have received the Pfizer vaccine already.

“More than half of American adults have been fully vaccinated against COVID, either through the Pfizer, Moderna or Johnson & Johnson vaccines," Inslee said. "The result is that at least 170 million Americans, and more than 4 million Washingtonians, have robust protection from this virus. We can already see this in the fact that 95% of COVID hospitalizations in our state are among the unvaccinated."

The approval is also being celebrated by the Washington State Department of Health.

"Great news!" the department tweeted. "After a rigorous review of safety/effectiveness data, FDA has granted full approval to the Pfizer COVID-19 vaccine for ages 16+."

According to the DOH, a CDC committee is set to meet next Monday to review the FDA's approval and update vaccine recommendations. As the Associated Press reports, those updated recommendations may make it easier for businesses and government agencies to mandate vaccines.

“There's the precedent in the past – if you look at public and private organizations mandating vaccines or requiring vaccination for things that are fully approved, there's precedent," said Dr. Joshua Liao, an Internal Medicine Physician with UW Medicine. "I think there's less precedent, because there's less precedent in general, about emergency authorization for vaccines. And so, I do think this milestone will provide a rationale for different organizations and institutions to begin that mandating vaccination.”

Washington state has already issued some vaccine mandates, requiring state employees, health care workers, and school staff to be vaccinated by mid-October. When announcing those mandates, the governor argued they were necessary to boost the state's flagging vaccination rate, and combat the rising tide of new COVID-19 infections driven by the spread of the delta variant.

Washington's vaccination rate has lulled to an average of just over 11,000 vaccine doses administered per day, according to the latest DOH data. At the same time, case counts are also spiking, up to a seven-day rolling average of 2,819 new COVID-19 cases per day the second week of August. Nearly 95 percent of COVID-19 cases, hospitalizations and deaths in Washington have been among the unvaccinated.

Now that the Pfizer vaccine has received full approval, doctors say they're cautiously optimistic that vaccination rates may pick up again.

"This full approval, I'm hoping, will increase the confidence from some people who have yet to get the vaccine, to get vaccinated," Liao said. "But we also have to, at the same time, realize that this is a continual process. And so, this marks a milestone in our journey in understanding, in this case, a particular vaccine. But that journey doesn't stop today or tomorrow. It continues forward."

To those who are still hesitant even with the FDA's full approval, Inslee says to talk to your doctor about vaccination.

"Washingtonians can make informed decisions about getting this preventative treatment," Inslee said. "Talk to your health provider about whether this is the right decision for you."