Pfizer COVID-19 vaccine safe, effective on adolescents in trial,
companies say
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[March 31, 2021]
By Julie Steenhuysen
CHICAGO (Reuters) - Pfizer Inc and BioNTech
SE said on Wednesday their COVID-19 vaccine was safe and effective and
produced robust antibody responses in 12- to 15-year olds, paving the
way for them to seek U.S. emergency use authorization in weeks.
Pfizer hopes that vaccinations of the group could begin before the next
school year, Albert Bourla, Pfizer's chairman and chief executive, said
in a statement.
Pfizer's vaccine is already authorized for use in people starting at age
16. The new study offers the first evidence of how the vaccine will also
work in school-age adolescents.
In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of
COVID-19 in the group that got a placebo shot and none in the group that
got the vaccine, resulting in 100% efficacy in preventing COVID-19, the
companies said in a statement.
The vaccine was well tolerated, with side effects in line with those
seen among those aged 16 to 25 in the adult trial. It did not list the
side effects for the younger group, but the adult trial's side effects
generally were mild to moderate and included injection-site pain,
headaches, fever and fatigue.
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A medical worker fills a syringe with Pfizer-BioNTech vaccine at the
COVID-19 vaccination centre of 'Healthcare Centre' in Nis, Serbia,
March 3, 2021. REUTERS/Marko Djurica
The companies also studied a subset of teens to measure the level of
virus-neutralizing antibodies a month after the second dose and
found it was comparable to study participants aged 16 to 25 in the
pivotal trial in adults.
Bourla said the company planned to seek emergency authorization from
the U.S. Food and Drug Administration "in the coming weeks and to
other regulators around the world, with the hope of starting to
vaccinate this age group before the start of the next school year."
Last week, the companies gave the first vaccine doses in a series of
trials testing the vaccine in younger children, that will eventually
go to those as young as 6 months of age.
(Reporting by Julie Steenhuysen; Editing by Peter Henderson and
Peter Cooney)
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