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FDA News Release
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”
What you need to know:
Boosters are now authorized for people 12 years of age and older
Today’s action expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include its use in individuals as young as 12 years of age.
Booster interval updated to five months for people 12 years of age and older
The FDA is also authorizing the use of a single booster dose five months after completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 Vaccine.
A third primary series dose for certain immunocompromised children ages 5 through 11
Children 5 through 11 years of age who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination series. Thus, a third primary series dose has now been authorized for this group. This will now allow these children to receive the maximum potential benefit from vaccination.
“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”
The fact sheets for recipients and caregivers and for healthcare providers contain information about the potential side effects, as well as the risks of myocarditis and pericarditis. The FDA and the U.S. Centers for Disease Control and Prevention have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.
The most commonly reported side effects by individuals who received a booster dose or an additional dose as part of a primary series were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the second dose of a two-dose primary series.
The FDA will publicly post documents regarding the agency’s decision on its website following authorization.
The amendment to the EUA was granted to Pfizer Inc.
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.