Comirnaty (Pfizer-BioNTech) mRNA COVID-19 vaccine is FDA-licensed for use in ages 5 years through 64 years with at least one underlying condition that puts them at risk for severe COVID-19 infection and individuals 65 years and older
mNexspike (Moderna) is FDA-licensed for use in ages 12 through 64 years with at least one underlying condition that puts them at risk for severe COVID-19 infection and individuals 65 years and older
Nuvaxovid (Sanofi-Novavax) is FDA-licensed for use in ages 12 through 64 years with at least one underlying condition that puts them at risk for severe COVID-19 infection and individuals 65 years and older
Spikevax (Moderna) mRNA COVID-19 vaccine is FDA-licensed for use in ages 6 months through 64 years with at least one underlying condition that puts them at risk for severe COVID-19 infection and individuals 65 years and older
Although the FDA licenses are limited in the age group younger than 65 years to those with underlying conditions that put them at risk for severe COVID-19 infection, the ACIP has recommended use based on individual decision-making (i.e., shared clinical decision-making) for all people age 6 months and older. This means that it is acceptable standard of care to offer COVID-19 vaccination to people in this age group without a high-risk condition when vaccination is desired.
Last reviewed:
November 16, 2025
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 2025–2026 formula are expected to be consistent with the previous formulations of the product.
Last reviewed:
November 16, 2025
The 2025–2026 formula Nuvaxovid (Sanofi-Novavax) vaccine is an option for any person age 12 years or older who is due for a 2025–2026 updated vaccination. Below are listed the 2025–26 season dosing schedules (if using Nuvaxovid for all doses) for different ages and health conditions:
- Age 12 through 64 years, not moderately or severely immunocompromised: one 2025–2026 formula dose, at least 8 weeks after most recent dose from a previous season
- Age 65 years and older, not moderately or severely immunocompromised: two 2025–2026 formula doses 6 months apart (minimum interval 2 months)
- Age 12 years or older, moderately or severely immunocompromised:
- Previously unvaccinated: give 2 doses at least 3 weeks apart as an initial series, followed by a third dose about 6 months after dose 2 (minimum interval 2 months)
- Previously completed an initial series of any COVID-19 vaccine (2 doses of Novavax protein subunit vaccine or 3 doses of an mRNA vaccine): give first 2025–2026 formula dose at least 8 weeks after most recent COVID-19 vaccine from the previous season, then give a second dose about 6 months later (minimum interval, 2 months)
See Immunize.org’s standing orders template for administration of 2025–2026 formula adjuvanted protein subunit vaccine to individuals age 12 years and older for details: www.immunize.org/wp-content/uploads/catg.d/p3141.pdf.
Last reviewed:
November 16, 2025
