This is the first COVID-19 vaccine to be authorized in the United
States for ages 12 to 15. Vaccinating younger ages is considered an
important step for getting children back into schools safely. U.S.
President Joe Biden has asked states to make the vaccine available
to younger adolescents immediately.
Biden issued a statement hailing the authorization as "a promising
development in our fight against the virus."
"If you are a parent who wants to protect your child, or a teenager
who is interested in getting vaccinated, today’s decision is a step
closer to that goal," he said.
The vaccine has been available under an emergency use authorization
to people as young as 16 in the United States. The vaccine makers
said they had started seeking full approval for the immunization in
people 16 and older last week.
Peter Marks, director of the U.S. Food and Drug Administration's
Center for Biologics Evaluation and Research, told reporters that
states will likely be able to begin vaccinating 12- to 15-year-olds
after an advisory committee of the U.S. Centers for Disease Control
and Prevention considers the expansion on Wednesday.
Most children with COVID-19 only develop mild symptoms or no
symptoms at all. However, children are not without risk of becoming
seriously ill, and they can still spread the virus. There have been
outbreaks traced to sporting events and other activities for
children in this age range.
'A GODSEND'
Dr. William Gruber, a top vaccine scientist at Pfizer, said the
authorization of the vaccine for young teens would help the United
States expand its immune population and protect an age group that
has not been completely spared from severe disease.
"I hear from pediatricians and people out in the community, what a
godsend this is going to be for the adolescent population who have
been restricted in terms of sports activities, drama club and the
other sorts of things that naturally we want them to engage in,"
Gruber said.
Vaccines are crucial to ending the pandemic. But many health
officials are concerned that vaccine hesitancy in some adults will
be even more pronounced when it comes to their children.
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Parents may question the risks
versus benefits, given the unknowns about the
vaccines' long-term impact on children's
development and the low numbers of young kids
who have been hit hard by COVID-19.
The companies said in March that they found the
vaccine produced robust antibody responses and
was safe and effective in 12- to 15-year olds in
a clinical trial.
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 and none among those who
received the vaccine, resulting in 100% efficacy
in preventing the illness, the companies said at
the time.
Around 46% of people in the United States have
received at least one shot of a COVID-19
vaccine, according to data from the U.S. Centers
for Disease Control and Prevention (CDC).
But the pace of U.S. vaccinations has slowed
significantly since peaking at a seven-day
average of more than 3.3 million doses a day in
mid-April. That average had fallen by more than
a third to around 2.1 million shots a day as of
May 4, according to CDC data.
Pfizer's vaccine is the only one authorized for
16- and 17- year-olds in the United States.
Nearly 2 million people in that age group have
received at least one shot, according to CDC
data. Many states only opened to non-high risk
individuals in that age group in early April.
Widely vaccinating 12- to 18-year olds could
allow U.S. schools and summer camps to relax
masking and social distancing measures suggested
by the CDC.
Pfizer has said it expects to have safety and
efficacy data on the vaccine for children ages 2
to 11 in September, when it plans to ask for
that age group to be included in the emergency
authorization.
(Reporting by Michael Erman; Editing by Caroline
Humer, Bill Berkrot, Leslie Adler and Cynthia
Osterman)
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