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FDA OKs COVID-19 Boosters     10/21 07:12

   U.S. regulators on Wednesday signed off on extending COVID-19 boosters to 
Americans who got the Moderna or Johnson & Johnson vaccine and said anyone 
eligible for an extra dose can get a brand different from the one they received 
initially.

   WASHINGTON (AP) -- U.S. regulators on Wednesday signed off on extending 
COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine 
and said anyone eligible for an extra dose can get a brand different from the 
one they received initially.

   The Food and Drug Administration's decisions mark a big step toward 
expanding the U.S. booster campaign, which began with extra doses of the Pfizer 
vaccine last month. But before more people roll up their sleeves, the Centers 
for Disease Control and Prevention will consult an expert panel Thursday before 
finalizing official recommendations for who should get boosters and when.

   The latest moves would expand by tens of millions the number of Americans 
eligible for boosters and formally allow "mixing and matching" of shots -- 
making it simpler to get another dose, especially for people who had a side 
effect from one brand but still want the proven protection of vaccination.

   Specifically, the FDA authorized a third Moderna shot for seniors and others 
at high risk from COVID-19 because of their health problems, jobs or living 
conditions --- six months after their last shot. One big change: Moderna's 
booster will be half the dose that's used for the first two shots, based on 
company data showing that was plenty to rev up immunity again.

   For J&J's single-shot vaccine, the FDA said all U.S. recipients, no matter 
their age, could get a second dose at least two months following their initial 
vaccination.

   The FDA rulings differ because the vaccines are made differently, with 
different dosing schedules --- and the J&J vaccine has consistently shown a 
lower level of effectiveness than either of the two-shot Moderna and Pfizer 
vaccines.

   As for mixing and matching, the FDA said it's OK to use any brand for the 
booster regardless of which vaccination people got first. The 
interchangeability of the shots is expected to speed the booster campaign, 
particularly in nursing homes and other institutional settings where residents 
have received different shots over time.

   FDA officials said they wanted to make the booster guidance as flexible as 
possible, given that many people don't remember which brand of vaccine they 
received.

   "Being able to interchange these vaccines is a good thing --- it's like what 
we do with flu vaccines," FDA's Dr. Peter Marks told reporters Wednesday 
evening. "Most people don't know what brand of flu vaccine they received."

   Still, he added that many people will decide to get a booster from the same 
company as their initial vaccination.

   The agency's mix-and-match decision was based on preliminary results from a 
government study of different booster combinations that showed an extra dose of 
any type revs up levels of virus-fighting antibodies. That study also showed 
recipients of the single-dose J&J vaccination had a far bigger response if they 
got a full-strength Moderna booster or a Pfizer booster rather than a second 
J&J shot. The study didn't test the half-dose Moderna booster.

   Health authorities stress that the priority still is getting first shots to 
about 65 million eligible Americans who remain unvaccinated. But the booster 
campaign is meant to shore up protection against the virus amid signs that 
vaccine effectiveness is waning against mild infections, even though all three 
brands continue to protect against hospitalization and death.

   "Today the currently available data suggest waning immunity in some 
populations of fully vaccinated people," said FDA's acting commissioner Dr. 
Janet Woodcock. "The availability of these authorized boosters is important for 
continued protection against COVID-19 disease."

   The Moderna booster decision essentially matches FDA's ruling that high-risk 
groups are eligible for the Pfizer vaccine, which is made with the same 
technology.

   FDA recommended that everyone who'd gotten the single-shot J&J vaccine get a 
booster since it has consistently shown lower protection than its two-shot 
rivals. And several independent FDA advisers who backed the booster decision 
suggested J&J's vaccine should have originally been designed to require two 
doses.

   Experts continue to debate the rationale of the booster campaign. Some warn 
that the U.S. government hasn't clearly articulated the goals of boosters given 
that the shots continue to head off the worst effects of COVID-19, and wonder 
if the aim is to tamp down on virus spread by curbing, at least temporarily, 
milder infections.

   FDA regulators said they would move quickly to expand boosters to lower age 
groups, such as people in their 40s and 50s, if warranted.

   "We are watching this very closely and will take action as appropriate to 
make sure that the maximum protection is provided to the population," said 
Marks, the FDA's top vaccine official.

   In August, the Biden administration announced plans for an across-the-board 
booster campaign aimed at all U.S. adults, but outside experts have repeatedly 
argued against such a sweeping effort.

   On Thursday an influential panel convened by the CDC is expected to offer 
more specifics on who should get boosters and when. Their recommendations are 
subject to approval by the CDC director.

   The vast majority of the nearly 190 million Americans who are fully 
vaccinated against COVID-19 have received the Pfizer or Moderna options, while 
about 15 million have received the J&J vaccine.

 
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