The Centers for Disease Control and Prevention (CDC) on Thursday night approved the reformulated COVID-19 shots that target the latest Omicron subvariants for the fall, CNBC reported.
The agency’s independent committee on vaccines had voted 13 to 1 earlier on Thursday in favor of the shots after reviewing the available safety and effectiveness data over an almost seven-hour-long meeting.
CDC Director Dr. Rochelle Walensky signed off on the shots a few hours later, clearing the way for pharmacies to soon start administering the shots.
Pfizer’s Omicron boosters were cleared for people ages 12 and older, while Moderna’s updated shots were authorized for people ages 18 and older.
The eligible age groups can receive the boosters at least two months after completing their primary series or their most recent booster with the old shots, according to CNBC.
The CDC approval came a day after the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer COVID-19 vaccines to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Pfizer last week announced it had submitted an application to the FDA for an updated COVID-19 vaccine targeting the Omicron subvariant.
In January, Pfizer and BioNTech began enrollment for a clinical trial to test the safety and immune response of their Omicron-specific COVID-19 vaccine.
Pfizer CEO Albert Bourla said last November that three doses of the original Pfizer vaccine would remain effective even against the Omicron variant of the coronavirus, but added that a new vaccine specifically made to combat the new strain could be ready in 100 days.
Walensky said on Thursday her decision followed “a comprehensive scientific evaluation and robust scientific discussion.”
“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to receive it,” she said in a statement quoted by CNBC.
Pfizer plans to ask the Food and Drug Administration to also authorize the new boosters for children ages 5 to 11 years old in early October, company executives told the committee Thursday.