Pfizer-BioNTech COVID-19 Vaccine (2024–2025 Formula), brand name Comirnaty, is FDA-licensed for a single dose in recipients age 12 years and older.
Moderna COVID-19 Vaccine (2024–2025 Formula), brand name Spikevax, is licensed for use in recipients age 12 years and older.
Novavax COVID-19 Vaccine (2024–2025 Formula) is authorized for emergency use as a 2-dose primary series or a single dose in previously vaccinated individuals age 12 years and older.
Last reviewed:
August 31, 2024
Clinical trial results for the original monovalent Pfizer-BioNTech COVID-19 Vaccine (administered as a two-dose primary series) demonstrated that among vaccine recipients age 12–15 years, side effects during the 7 days after vaccination were commonly reported (90.9% of vaccine recipients reported a local reaction and 90.7% reported a systemic reaction). Most reactions were mild to moderate. Pain at the injection site was the most common local reaction. One in 10 reported a side effect that interfered with daily activities. Side effects usually resolved after 1–2 days. Systemic side effects (e.g., fever, fatigue, headache, muscle pain) were more commonly reported after the second dose than after the first dose. No specific safety concerns were identified among adolescent vaccine recipients.
The safety and side effects of the 2024–2025 formula approved in August 2024 are expected to be consistent with the previous formulations of the product.
Last reviewed:
August 31, 2024
Yes. The 2024–2025 formula Novavax vaccine is an option for any person age 12 years or older who is unvaccinated or was previously vaccinated with any COVID-19 vaccine and is due for a 2024–2025 updated vaccination. Any person age 12 years or older who has never had a dose of any COVID-19 vaccine should receive two doses of Novavax vaccine, administered 3 to 8 weeks apart, as a primary series.
Adults age 65 years or older who are not immunocompromised and who did not require a 2-dose primary series with the current 2024–2025 Formula are NOT recommended to receive any additional doses of the current 2024–2025 Formula at this time.
Novavax recipients with moderate to severe immunocompromise being vaccinated for the first time may receive a third dose at least 2 months following the second dose in their primary series and may receive subsequent additional doses at the discretion of their healthcare provider, in consideration of their individual circumstances.
Additional details from FDA are available: www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted.
Last reviewed:
August 31, 2024
