The U.S. Food and Drug Administration said earlier this
month it would look to complete its data review for this age group as quickly
as possible, likely in a matter of weeks rather than months. That could mean an
authorization of the shot for children by the end of October, sources have told
Reuters.
The companies, however, have yet to start the official process
for authorization, which could slow the decision. According to the Wall Street
Journal, the FDA may not make its decision until sometime between Halloween and
Thanksgiving, citing a person familiar with the matter.
A Pfizer spokesperson said the company expects to start and
complete its application very soon.
A decision on the vaccine's use in younger children is
eagerly awaited by millions of Americans as coronavirus infections have soared
in children to the highest point in early September, according to data from the
American Academy of Pediatrics.
The vaccine, which is already authorized for 12 to 15-year-
olds and fully approved for ages 16 and up, induced a strong immune response in
the target age group in a 2,268-participant clinical trial, the companies said
on Sept. 20.
The Pfizer-BioNTech vaccine was authorized for the 12-15 age
group roughly a month after the companies filed for authorization. If the same
timeline is followed for this application, younger children could start
receiving their shots as soon as late October.
A rapid authorization could help mitigate a potential surge
of cases this fall, with schools already open nationwide.
While kids are less susceptible to severe COVID-19, they can
spread the virus to others, including vulnerable populations that are more at
risk of severe illness.
The companies said they plan to submit the data to the
European Medicines Agency and other regulatory authorities. They also plan to
submit data from the full late-stage trial for scientific peer-reviewed
publication.
The FDA was not immediately available to comment.
Data from the companies' trial showed the two-shot vaccine
generated an immune response in children that matched what was previously
observed in 16-to-25 year olds. The safety profile was also comparable to the
older age group, Pfizer said.
The drugmakers are also testing the vaccine in children aged
2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth
quarter.
Moderna's COVID-19 vaccine is not yet authorized for use in
adolescents in the United States, while it has gained authorization for that
age group in Europe.
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 no instances of heart inflammation were
seen in the trial participants. - Reuters