FDA expands use of Pfizer-BioNTech COVID-19 vaccine

Today, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:

• Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
• Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
• Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“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 to 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.

• The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.
• The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.
• These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases.
• The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.