Press Release: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years
2022年5月18日 - 12:04AM
Dow Jones News
Coronavirus (COVID-19) Update: FDA Expands Eligibility for
Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through
11 Years
Today, the U.S. Food and Drug Administration amended the
emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19
Vaccine, authorizing the use of a single booster dose for
administration to individuals 5 through 11 years of age at least
five months after completion of a primary series with the
Pfizer-BioNTech COVID-19 Vaccine.
"While it has largely been the case that COVID-19 tends to be
less severe in children than adults, the omicron wave has seen more
kids getting sick with the disease and being hospitalized, and
children may also experience longer term effects, even following
initially mild disease," said FDA Commissioner Robert M. Califf,
M.D. "The FDA is authorizing the use of a single booster dose of
the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11
years of age to provide continued protection against COVID-19.
Vaccination continues to be the most effective way to prevent
COVID-19 and its severe consequences, and it is safe. If your child
is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not
yet received their primary series, getting them vaccinated can help
protect them from the potentially severe consequences that can
occur, such as hospitalization and death."
On Jan. 3, the FDA authorized the use of a single booster dose
of the Pfizer-BioNTech COVID-19 Vaccine for administration to
individuals 12 through 15 years of age after completion of primary
vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today's
action expands the use of a single booster dose of the vaccine for
administration to individuals 5 through 11 years age at least five
months after completion of a primary series of the Pfizer-BioNTech
COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech
COVID-19 Vaccine for use in individuals 5 years of age and older
and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in
individuals 16 years of age and older.
"The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to
prevent the most severe consequences of COVID-19 in individuals 5
years of age and older," said Peter Marks, M.D., Ph.D., director of
the FDA's Center for Biologics Evaluation and Research. "Since
authorizing the vaccine for children down to 5 years of age in
October 2021, emerging data suggest that vaccine effectiveness
against COVID-19 wanes after the second dose of the vaccine in all
authorized populations. The FDA has determined that the known and
potential benefits of a single booster dose of the Pfizer-BioNTech
COVID-19 Vaccine for children 5 through 11 years of age at least
five months after completing a primary series outweigh its known
and potential risks and that a booster dose can help provide
continued protection against COVID-19 in this and older age
groups."
Data Supporting Effectiveness
The EUA for a single booster dose of the Pfizer-BioNTech
COVID-19 Vaccine for children 5 through 11 years of age is based on
FDA's analysis of immune response data in a subset of children from
the ongoing randomized placebo-controlled trial that supported the
October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine
primary series in this age group. Antibody responses were evaluated
in 67 study participants who received a booster dose 7 to 9 months
after completing a two-dose primary series of the Pfizer-BioNTech
COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus
one month after the booster dose was increased compared to before
the booster dose.
FDA Evaluation of Safety
The safety of a single booster dose of the Pfizer-BioNTech
COVID-19 Vaccine in this age group was assessed in approximately
400 children who received a booster dose at least five months
(range 5 to 9 months) after completing a two-dose primary series.
The most commonly reported side effects were pain, redness and
swelling at the injection site, as well as fatigue, headache,
muscle or joint pain and chills and fever.
The FDA did not hold a meeting of its Vaccines and Related
Biological Products Advisory Committee on today's action, as the
agency previously convened the committee for extensive discussions
regarding the use of booster doses of COVID-19 vaccines and, after
review of Pfizer's EUA request, the FDA concluded that the request
did not raise questions that would benefit from additional
discussion by committee members. The FDA will make available on its
website relevant documents regarding today's authorization.
The amendment to the EUA was granted to Pfizer Inc.
Related Information
Pfizer-BioNTech COVID-19 Vaccine
COVID-19 Vaccines
Emergency Use Authorization for Vaccines Explained
###
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
(END) Dow Jones Newswires
May 17, 2022 10:49 ET (14:49 GMT)
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