FDA Backs Pfizer Boosters for Seniors  09/23 06:17

   

   (AP) -- 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 
extra shots.

   The FDA authorized booster doses for Americans who are 65 and older, younger 
adults 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.

   FDA acting commissioner Dr. Janet Woodcock said in a statement that the FDA 
authorization would allow for boosters in health care workers, teachers, 
grocery workers and those in homeless 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 keep the public informed," Woodcock said.

   Under the FDA authorization, vaccinated Americans are eligible for a third 
dose six months after receiving their second Pfizer shot. That's different than 
the Biden proposal announced in August, which called for boosters after eight 
months.

   "Today's FDA decision is a major step forward in our effort to provide 
Americans with additional protection from COVID-19," White House press 
secretary Jen Psaki tweeted Wednesday night. "We have been preparing for weeks 
to administer booster shots to eligible Americans and are ready to do so 
following CDC's final recommendation later this week."

   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 Keipp 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. They indicated the Pfizer 
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.