The companies said the vaccine generated an immune response in the
5-to-11 year olds in their Phase II/III clinical trial that matched
what they had previously observed in 16-to-25 year olds. The safety
profile was also generally comparable to the older age group, they
said.
"Since July, pediatric cases of COVID-19 have risen by about 240
percent in the U.S. – underscoring the public health need for
vaccination," Pfizer Chief Executive Albert Bourla said in a news
release.
"These trial results provide a strong foundation for seeking
authorization of our vaccine for children 5 to 11 years old, and we
plan to submit them to the FDA and other regulators with urgency."
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Top U.S. health officials believe regulators could make a decision
https://www.reuters.com/business/
healthcare-pharmaceuticals/exclusive-us-decision-pfizer-covid-19-shot-kids-age-5-11-could-come-october-2021-09-10
on whether the shot is safe and effective in younger children within
three weeks of the companies submitting a request for authorization,
two sources told Reuters earlier this month.
COVID-19 hospitalizations and deaths have surged in the United
States in recent months due to the highly contagious Delta variant.
Pediatric cases are also up, particularly as children under 12 are
all unvaccinated, but there is no indication that, beyond being more
transmissive, the Delta virus is more dangerous in kids.
A rapid authorization could help mitigate a potential surge of cases
in the fall, especially with schools already open nationwide.
The companies' vaccine, called Comirnaty, is already authorized for
use in children as young as 12 in many countries, including the
United States. The vaccine was originally authorized for emerenecy
use in people 16 or older in the United States in December 2020 and
received full U.S. approval in that age group last month.
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 The 5-to-11 year olds were
given two shots of a 10-microgram dose of the
vaccine, one-third the dose size that has been
given to people 12 and older. The companies
expect data on how well the vaccine works in
children 2-to-5 years of age and children 6
months-to-2 years of age as soon as the fourth
quarter of this year. Unlike the
larger clinical trial the drugmakers previously conducted in adults,
the 2,268 participant pediatric trial was not primarily designed to
measure the vaccine's efficacy by comparing the number of COVID-19
cases in vaccine recipients to those who received a placebo.
Instead, the trial compares the amount of neutralizing antibodies
induced by the vaccine in the children to the response of older
recipients in the adult trial.
A Pfizer spokesperson said the companies may later disclose vaccine
efficacy from the trial but there had not been enough cases of
COVID-19 yet among the participants to make that determination.
The vaccine was around 95 percent effective in the adult clinical
trial, but Pfizer has said that immunity wanes some months after the
second dose. U.S. regulators are expected to authorize a third,
booster dose of the vaccine for older and high-risk Americans early
this week.
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The companies said the vaccine was well-tolerated, with side effects
generally comparable to those observed in participants 16 to 25
years of age.
Both the Pfizer and Moderna vaccines have been linked by regulators
to rare cases of heart inflammation in adolescents and young adults,
particularly young men. Pfizer said they did not see any instances
of heart inflammation in the trial participants.
(Reporting by Michael Erman; Editing by Edmund Klamann)
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