By Matthew Perron, Lauren Niergaard and Mike Stobe | The Associated Press
The U.S. on Wednesday one step closer to offering a booster dose of Pfizer’s COVID-19 vaccine to senior citizens and others at high risk from the virus, the Food and Drug Administration signed off on Targeted Use of Additional Shots Gone.
The FDA has authorized a booster dose for Americans who are 65 years of age and older, young adults with underlying health conditions, and those in jobs that put them at high risk for COVID-19. The ruling represents a scaled-back version of the Biden administration’s sweeping plan to give nearly all American adults a third dose to shore up their safety amid the spread of the highly contagious Delta variant.
However, there are more regulatory hurdles before the booster can begin to be distributed.
Advisors from the Centers for Disease Control and Prevention opened a two-day meeting Wednesday in which they made their specific recommendations about who should get additional shots and when. And in their first day of discussion, some experts were so puzzled by questions surrounding the booster’s rationale that they suggested deferring the decision for a month in the hope of more evidence.
The uncertainties were yet another reminder that the science surrounding the booster is more complex than in the Biden administration, when the president and his top aides launched their plan at the White House last month.
The FDA’s decision on Wednesday was expected after the agency’s own panel of advisors overwhelmingly rejected the Biden plan last week. The panel instead recommended boosters only for those most vulnerable to severe cases of COVID-19.
FDA Acting Commissioner Dr. Janet Woodcock said in a statement that FDA authorization will allow boosters for health care workers, teachers, grocery workers and homeless in shelters or prisons.
“As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and inform the public,” Woodcock said.
The timing of the FDA’s decision was extremely unusual because the agency usually takes action before the CDC has convened its experts.
CDC panelists listened to a series of presentations on Wednesday outlining the knotty status of the science on the booster. On the one hand, vaccines for COVID-19 continue to provide strong protection against serious illness, hospitalization, and death. On the other hand, there are indications of more low-grade infections between vaccines as immunity is reduced.
Ultimately, the committee will have to decide who is considered to be at high risk for additional doses. Data provided by Pfizer and the Israeli government suggest a strong case for boosters in people 65 and older, but there is little evidence that additional shots provide greater benefit for younger people with underlying health conditions. Huh.
Many CDC advisors agree that boosters are also important for hiring health care workers.
“We don’t have enough health care workers to take care of those without vaccinations,” said Dr Helen Keep Talbot from 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 oppose third rounds of shots from wealthy countries, when poorer countries do not have enough vaccine for their first dose. And several independent scientists say vaccines continue to do well against the worst effects of COVID-19 and their ability to halt the pandemic’s overall trajectory remains uncertain.
US regulators will decide at a later date on boosters for people who have received either Moderna or Johnson & Johnson vaccines. He indicated that the shots would not be recommended for people who had initially received a different brand of vaccine.
The across-the-board rollout of the booster proposed by the White House was due to begin this week. Some questioned whether President Joe Biden had overtaken the science by announcing his plans before government regulators reached any conclusions.
Despite resistance in recent days, some top US health officials said they expect the booster to eventually gain widespread 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’s decision covers millions of Americans and that seniors and other high-risk groups would have been the first to receive the booster, even if additional shots had been authorized for the entire population. The first group of Americans eligible for vaccination last December were seniors.
The US has already authorized a third dose of Pfizer and Moderna vaccines for some people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have in some cases managed to get a booster just by asking.
The US averages about 760,000 vaccinations per day, down from a high of 3.4 million per day in mid-April. About 180 million Americans have been fully vaccinated, or 64% of them eligible.