THE LATEST

FDA backs Pfizer COVID-19 boosters for seniors, high-risk

Sep 22, 2021, 7:59 PM | Updated: 8:46 pm

A dose of the Pfizer vaccine. (AP file photo)...

A dose of the Pfizer vaccine. (AP file photo)

(AP file photo)

The U.S. moved a step closer Wednesday to offering booster doses of Pfizer’s COVID-19 vaccine to senior citizens and others at high risk from the virus as the Food and Drug Administration signed off on the targeted use of the extra shots.

The FDA authorized booster doses for Americans who are 65 and older, younger people with underlying health conditions and those in jobs that put them at high-risk for COVID-19. The ruling represents a drastically scaled back version of the Biden administration’s sweeping plan to give third doses to nearly all American adults to shore up their protection amid the spread of the highly contagious delta variant.

However, more regulatory hurdles lie ahead before the dispensing of boosters can begin.

Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when. And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence.

The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.

The FDA decision Wednesday was expected after the agency’s own panel of advisers last week overwhelmingly rejected the Biden plan. The panel instead recommended boosters only for those most vulnerable to severe cases of COVID-19.

The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC convenes its own experts.

The CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes.

Ultimately the committee must decide who is considered at high enough risk for an extra dose. Data provided by Pfizer and the Israeli government suggests a strong case for boosters in people 65 and older, but there is less evidence that extra shots provide much benefit for younger people with underlying health conditions.

Several CDC advisers agreed boosters are also important for keeping health care workers on the job.

“We don’t have enough health care workers to take care of the unvaccinated,” said Dr. Helen Talbot of Vanderbilt University. “They just keep coming.”

The CDC has already said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

The World Health Organization and other global health advocates are opposed to wealthy nations dispensing a third round of shots when poor countries don’t have enough vaccine for their first doses. And many independent scientists say that the vaccines continue to perform well against the worst effects of COVID-19 and that their ability to curb the overall trajectory of the epidemic is uncertain.

U.S. regulators will decide at a later date on boosters for people who have received the Moderna or Johnson & Johnson vaccines. If Pfizer boosters are authorized this week, U.S. regulators indicated the shots would not be recommended for people who got a different brand of vaccine initially.

The across-the-board rollout of boosters proposed by the White House was supposed to have begun this week. Some questioned whether President Joe Biden had gotten ahead of the science by announcing his plans before government regulators had reached any conclusions.

Despite the resistance in recent days, some top U.S. health officials said they expect boosters to eventually win broader approval in the coming weeks or months. Dr. Anthony Fauci said over the weekend that “this is not the end of the story.”

Other administration officials noted that the FDA decision covers tens of millions of Americans and that seniors and other high-risk groups would have been the first to get boosters even if extra shots had been authorized for the entire population. Seniors were in the first group of Americans eligible for vaccination last December.

The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking.

The U.S. is dispensing around 760,000 vaccinations per day on average, down from a high of 3.4 million a day in mid-April. About 180 million Americans are fully vaccinated, or 64% of those who are eligible.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

The Latest

FILE - Travelers walk through Seattle-Tacoma International Airport on Friday, April 1, 2022 in Seat...

Associated Press

Florida judge voids US mask mandate for planes, other travel

ST. PETERSBURG, Fla. (AP) — A federal judge in Florida struck down a national mask mandate on airplanes and mass transit Monday, and airlines and airports swiftly began repealing their requirements that passengers wear face coverings. The judge’s decision freed airlines, airports and mass transit systems to make their own decisions about mask requirements, resulting […]

2 years ago

FILE - Elon Musk, Tesla CEO, attends the opening of the Tesla factory Berlin Brandenburg in Gruenhe...

Associated Press

Elon Musk wants to buy Twitter, make it ‘maximally trusted’

In 10 days, Tesla CEO Elon Musk has gone from popular Twitter contributor and critic to the company’s largest individual shareholder to a would-be owner of the social platform — a whirlwind of activity that could change the service dramatically given the sometimes whimsical billionaire’s self-identification as a free-speech absolutist. Twitter revealed in a securities […]

2 years ago

This image provided by New York Police Department on Wednesday, April 13, 2022, shows suspected sub...

Associated Press

Brooklyn subway suspect tipped off police to his location

NEW YORK (AP) — The man accused of shooting 10 people on a Brooklyn subway train was arrested Wednesday and charged with a federal terrorism offense after the suspect called police to come get him, law enforcement officials said. Frank R. James, 62, was taken into custody about 30 hours after the violence on a […]

2 years ago

This photo provided by Will B Wylde,  a person is aided outside a subway car in the Brooklyn boroug...

Associated Press

Police focus on van renter in Brooklyn subway shooting probe

NEW YORK (AP) — A gunman wearing a gas mask set off smoke grenades and fired a barrage of bullets inside a rush-hour subway train in Brooklyn, wounding at least 10 people Tuesday, authorities said. Police were trying to track down the renter of a van possibly connected to the violence. Chief of Detectives James […]

2 years ago

President Joe Biden holds hands with Supreme Court nominee Judge Ketanji Brown Jackson as they watc...

Associated Press

Jackson confirmed as first Black female high court justice

WASHINGTON (AP) — The Senate confirmed Ketanji Brown Jackson to the Supreme Court on Thursday, shattering a historic barrier by securing her place as the first Black female justice and giving President Joe Biden a bipartisan endorsement for his promised effort to diversify the high court. Cheers rang out in the Senate chamber as Jackson, […]

2 years ago

President Joe Biden speaks to the media at Fort Lesley J. McNair, Monday, April 4, 2022, as he retu...

Associated Press

Biden: Putin should face war crimes trial for Bucha killings

WASHINGTON (AP) — President Joe Biden on Monday called for Vladimir Putin to be tried for war crimes and said he’ll seek more sanctions against Russia after what he described as “outrageous” atrocities around Kyiv. One of the president’s top advisers said the Russians had exacted a horrible toll before making a “pell-mell” retreat from […]

2 years ago

FDA backs Pfizer COVID-19 boosters for seniors, high-risk