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(Adds comments from FDA news conference)
By Ankur Banerjee and Michael Erman
Oct 20 (Reuters) - The U.S. Food and Drug Administration on
Wednesday authorized booster doses of the COVID-19 vaccines from
Moderna Inc and Johnson & Johnson, and said
Americans can choose a different shot from their original
inoculation as a booster.
That means all three vaccines authorized in the United
States can also be given as boosters to some groups.
"The availability of these authorized boosters is important
for continued protection against COVID-19 disease," acting FDA
Commissioner Janet Woodcock said in a statement. She noted that
data suggests vaccine effectiveness may wane over time in some
fully vaccinated people.
The decision paves the way for millions in the United States
to get the additional protection as the highly contagious Delta
variant of the virus causes breakthrough infections among some
who are fully vaccinated.
The agency previously authorized boosters of the Pfizer Inc
COVID-19 vaccine developed with German partner BioNTech
SE at least six months after the first round
of shots to increase protection for people aged 65 and older,
those at risk of severe disease and those who are exposed to the
virus through their work.
Last week, an advisory panel to the FDA voted to recommend a
third round of shots of the Moderna vaccine for the same groups.
Moderna's booster is half the strength of the shots administered
for the company's initial series of inoculations.
The panel also recommended a second shot of the J&J vaccine
for all recipients of the one-dose inoculation at least two
months after receiving their first.
FDA officials suggested last week they were considering
lowering the recommended age for booster shots of the
Pfizer/BioNTech vaccine to as young as 40, based on data from
Israel, where Pfizer booster shots have already been
administered broadly.
They did not lower the age range for the shots on Wednesday,
but said they were assessing the benefits and risks of broader
use of boosters and plan to update the public in the coming
weeks.
"There is evidence that suggests potentially that lowering
the age of those eligible for boosters may make sense in the
future," FDA official Peter Marks told a news conference. "It's
something we're looking at closely."
'MIXING AND MATCHING'
The FDA and U.S. Centers for Disease Control and Prevention
(CDC) were under pressure to authorize the additional shots
after the White House announced plans in August for a widespread
booster campaign.
The advisory panel meeting included a presentation of data
on mixing vaccines from a U.S. National Institutes of Health
study in which 458 participants received some combination of
Pfizer/BioNTech, Moderna and J&J shots.
The data showed that people who initially got J&J's COVID-19
vaccine had a stronger immune response when boosted with either
the Pfizer or Moderna shot, and that "mixing and matching"
booster shots of different types was safe in adults.
Still, FDA officials said the data was not yet clear on
whether any shot combination should be preferred.
"Because we don't have those data right now, I think we just
have to be noncommittal about what is the best," Marks said.
Many countries including the UK have backed mix-and-match
strategies for the widely used AstraZeneca Plc vaccine,
which is not authorized in the United States but is based on
similar viral vector technology as J&J's vaccine.
Reuters reported in June that infectious disease experts
were weighing the need for booster shots of either the Pfizer or
Moderna vaccine after the J&J shot.
A CDC advisory committee on Thursday will make its
recommendations about which groups of people should get the
Moderna and J&J boosters, which the agency's director will use
to inform her final decision.
About 11.2 million people have so far received a booster
dose, according to data from the CDC https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
(Reporting by Ankur Banerjee in Bengaluru and Michael Erman in
New Jersey; Editing by Bill Berkrot and Peter Cooney)
