The Food and Drug Administration on Monday amended the emergency use authorization for the Pfizer-BioNTech coronavirus vaccine to expand eligibility for booster doses to individuals ages 12 to 15.
The agency said it also would shorten the time between the completion of primary vaccination of the Pfizer vaccine and a booster dose from six months to five months.
Additionally, the FDA said it would allow for a third dose for certain immunocompromised children ages 5 through 11.
“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,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”
The FDA said its decision was based on real-world data from Israel, including safety data from more than 6,300 individuals ages 12 through 15 who received a booster dose of the vaccine at least five months following completion of the primary two-dose vaccination series.
The FDA said 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.
No new safety concerns have emerged from a population of over 4.1 million individuals 16 years of age and older in Israel who received a booster dose at least five months following completion of the primary vaccination series, the agency said.
Additionally, they said peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant.
“Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant,” the FDA noted.