The Food and Drug Administration is on track to approve Pfizer’s coronavirus vaccine for adults as soon as next week, three people with knowledge of the matter told POLITICO.
The long-anticipated announcement would make Pfizer’s Covid-19 shot the first to receive full licensure from the federal government, a milestone in the nation’s year-and-a-half pandemic battle.
It would also come as the Biden administration grapples with a resurgence of infections fueled by the Delta variant — a worsening situation that has prompted a redoubling of efforts to vaccinate the roughly 85 million Americans who have yet to get a shot.
The available Covid-19 shots have long been considered safe and highly effective. But Biden administration officials are hoping the full approval, which would apply to people 16 and older, will spur a wave of vaccinations among holdouts who have waited months for the FDA to put its formal stamp on the Pfizer vaccine.
Recent Kaiser Family Foundation polling shows that about 30 percent of those still unvaccinated say they would be more likely to get a fully approved vaccine than one authorized for emergency use.
Full approval could also convince more employers to mandate the shot, further increasing vaccination rates. And it is a key step toward implementing the administration’s plan to offer booster shots, beginning in late September, to people who got their initial doses of the Pfizer and Moderna vaccines at least eight months ago.
The White House referred a request for comment to the FDA. The FDA declined to comment.
The FDA’s expected decision comes roughly three months after Pfizer applied for full approval, and nine months after it became the first Covid-19 vaccine authorized for emergency use. The vaccine is currently available to people 12 and older.
The agency had initially targeted early September for finalizing the approval, after accelerating its work as the rise in Delta cases increased pressure on the government to get more people vaccinated. Yet while the people with knowledge of the matter cautioned the FDA could still hit last-minute delays, the agency now appears positioned to come in ahead of schedule.
Infections have skyrocketed in recent weeks, with caseloads hitting highs not seen since February — a resurgence that also includes growing numbers of so-called breakthrough cases among those that are vaccinated.
On Wednesday, the administration disclosed plans to begin giving vaccinated Americans booster shots starting the week of Sept. 20, citing concerns that the shots’ protection against infection had declined. Yet they also stressed that the vaccines remain highly effective at preventing severe disease, with the unvaccinated still accounting for the vast majority of Covid-19 hospitalizations and deaths.
The Biden administration has taken more aggressive steps to boost the vaccination rate of late, including imposing vaccination requirements on federal workers and encouraging employers to follow suit.
The health department is also planning to issue new regulations in late September that would require nursing homes to vaccinate their entire staff or risk losing federal Medicare and Medicaid funding.