FDA approves Pfizer booster for 65 and older, others at high risk

WASHINGTON - The U.S. Food and Drug Administration agreed with a government advisory panel and approved the Pfizer-BioNTech COVID-19 vaccine booster for those who are 65 years and older or run a high risk of severe disease.

The booster is also approved for "individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19."

A U.S. Centers for Disease Control and Prevention advisory panel is also set to weigh in, convening Wednesday and Thursday to review data and help determine who falls into the high-risk category to receive the extra dose. 

The FDA’s partial approval helps salvage part of the White House’s campaign but is a huge step back from the Biden administration’s far-reaching proposal to offer third shots of both the Pfizer and Moderna vaccines to most Americans eight months after they get their second dose.

President Joe Biden announced in August that his administration was planning for boosters to be available by Sept. 20 for all Americans who received mRNA vaccines in an effort to provide enduring protection against the coronavirus and its more transmissible delta variant, pending approvals from the CDC and the FDA. The two mRNA vaccines currently approved for use in the U.S. are Pfizer’s and Moderna’s.

The U.S. has already approved both Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.

But during several hours of vigorous debate on Sept. 17, members of the advisory panel questioned the value of offering boosters to almost everybody 16 and over.

"I don’t think a booster dose is going to significantly contribute to controlling the pandemic," said Dr. Cody Meissner of Tufts University. "And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses."

Dr. Amanda Cohn of the CDC said, "At this moment it is clear that the unvaccinated are driving transmission in the United States."

RELATED: FDA advisory panel OKs Pfizer COVID-19 booster for 65 and older, votes no for younger

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the delta variant.

Most of the 212 million Americans at least partially vaccinated against COVID-19 received Pfizer’s two-dose regimen, and about 80 million received Moderna’s, according to CDC data.

RELATED: COVID-19 booster vaccine: FDA approves 3rd shot for immunocompromised

Even before Biden’s announcement last month, his administration had been preparing for the possibility that boosters would be required, maintaining America’s supply of doses and devising promotion plans with the same "intensity" that it brought to the initial vaccination campaign, White House COVID-19 coordinator Jeff Zients told reporters Sept 2.

Biden on Aug. 18 touted boosters as a protection against the more transmissible delta variant of the virus, which is raging across the country and slowing the economic recovery from the pandemic, as well as against potential variants to come.

"Just remember, as a simple rule: Eight months after your second shot, get a booster shot," he said then.

Dr. Anthony Fauci, the nation’s top infectious disease expert, has become an outspoken champion of the booster campaign as the Biden administration looks to curtail the delta variant.

RELATED: COVID-19 boosters now available for some with compromised immune systems

"From my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses," he said.

A formal determination that the third dose is required for "full vaccination" would have broad implications for schools, businesses and other entities that have implemented vaccination mandates.

Those with compromised immune systems have started getting their third shots. As far as boosters for the broader population, the expectation is healthcare and emergency workers and the elderly will be first in line for the Pfizer booster.

RELATED: Moderna COVID-19 booster shot may not be approved by Sept. 20

Earlier this month, in his most forceful pandemic actions and words, Biden ordered sweeping new federal vaccine requirements for as many as 100 million Americans — private-sector employees as well as health care workers and federal contractors — in an all-out effort to curb the surging COVID-19 delta variant.

Biden sharply criticized the tens of millions of Americans who are not yet vaccinated, despite months of availability and incentives.

"We’ve been patient. But our patience is wearing thin, and your refusal has cost all of us," he said, all but biting off his words. The unvaccinated minority "can cause a lot of damage, and they are," he said.

Republicans swiftly denounced the mandate as government overreach and vowed to sue, and private employers who resist the requirements may do so as well. Texas Gov. Greg Abbott called it an "assault on private businesses" while Gov. Henry McMaster promised to "fight them to the gates of hell to protect the liberty and livelihood of every South Carolinian." The Republican National Committee has also said it will sue the administration "to protect Americans and their liberties."

Meanwhile, according to one official, Moderna produced inadequate data for the FDA and CDC to approve the third dose of its vaccine and the FDA has requested additional data that is likely to delay those boosters into October.

Health officials are also still reviewing data before approving Pfizer’s vaccine in younger Americans. On Monday, Pfizer said its vaccine works for children ages 5-11 and that it will seek U.S. authorization for this age group soon.

Health officials are also still collecting data to see if the Johnson & Johnson COVID-19 vaccine would also require a booster.

RELATED: J&J COVID-19 booster 94% effective 2 months after 1st shot, company says

On Tuesday, Johnson & Johnson said that a booster of its one-shot coronavirus vaccine provides a stronger immune response months after people receive the first dose. J&J said in a statement that an extra dose — given either two months or six months after the initial shot — revved up protection. The results haven’t yet been published or vetted by other scientists.

Examined a different way, the company said when people got a second J&J shot two months after the first, levels of virus-fighting antibodies rose four to six times higher. But giving a booster dose six months after the first J&J shot yielded a 12-fold increase.

J&J said it has provided the data to regulators including the FDA, the European Medicines Agency and others to inform decisions about boosters.

The Associated Press and FOX News contributed to this report. This story was reported from Los Angeles.