US FDA backs Pfizer’s COVID-19 booster shot for 12- to 15-year-olds

The agency
also authorized a third shot for children aged 5 through 11 years who are

regulatory decisions come as schools reopen in much of the country, and as
COVID-19 cases surge due to the Omicron variant of the virus, with health
authorities warning that its high transmissibility could overwhelm many health

The US Centres
for Disease Control and Prevention is expected to weigh in on the changes this
week, according to the New York Times. The CDC was not immediately available
for comment.

on the FDA’s assessment of currently available data, a booster dose of the
currently authorized vaccines may help provide better protection against both
the Delta and omicron variants,” said Peter Marks, director of the FDA’s
Centre for Biologics Evaluation and Research.

The US
government has been urging vaccinated Americans to get boosters and for the
unvaccinated, who are at much higher risk of severe COVID-19 and death, to be

So far, 62%
percent of the eligible US population is considered fully vaccinated with a
third of them also having received a booster dose.

In making
its decision, the FDA said it reviewed real-world data from Israel, including
safety data from more than 6,300 individuals aged 12 through 15 years who received
a booster dose of the Pfizer-BioNTech vaccine at least 5 months following
completion of the primary two-dose vaccination series.

There were
no new cases of a rare type of heart inflammation reported to-date in these
individuals, the FDA said.

tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines
generate low immune responses against omicron, while the addition of a booster
appears to restore protection against the highly-mutated variant.

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Two shots of
the mRNA vaccine are about 35% effective against infection from the omicron
variant, but a booster dose restores effectiveness to 75 percent, according to
the CDC, based on data from South Africa and the United Kingdom.

The FDA said
authorizing the shot at 5 months instead of 6 may provide better protection
sooner against Omicron.

Dr Eric
Topol, director of the Scripps Research Translational Institute in La Jolla,
California, said a third shot is essential to protect against omicron for
severe disease.

“A good
thing here is also the change on the timing of the booster to five months
instead of six. That’s a big step for this country, which has been resistant to
the data,” he added.

including the United Kingdom and Israel have narrowed their window for boosters
from six months to three or four following the second shot to try to fight the
spread of the easily transmitted Omicron variant.

Adalja, a senior scholar at the Johns Hopkins Institute for Health Security,
said he does not believe a boosters is necessary for most people since two
doses of the vaccine have been effective at preventing hospitalizations and
severe disease in all but older people.

“When I
work at the hospital, I don’t see patients there because they lack a booster, I
see patients because they lack first and second doses,” Adalja said.

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