Editor’s note: For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.
The Food and Drug Administration (FDA) has authorized updated COVID-19 vaccines from Moderna and Pfizer-BioNTech.
The mRNA vaccines, which should be available in the coming days, are monovalent vaccines that target the omicron variant KP.2 strain and better match circulating strains.
The Centers for Disease Control and Prevention (CDC) recommends everyone 6 months and older get an updated vaccine as protection from last season’s vaccines has likely waned.
While COVID-19 levels vary by state, wastewater testing by the CDC indicates COVID levels are very high nationally and especially in the West and South.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a press release. “…Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
Dosing varies by age and immunocompromise status.
- Unvaccinated children ages 6 months through 4 years are eligible to receive three doses of Pfizer-BioNTech’s vaccine or two doses of Moderna’s vaccine.
- Children ages 6 months through 4 years who have been vaccinated previously against COVID-19 are eligible to receive one or two doses of the updated vaccines. Timing and number of doses depend on the previous COVID-19 vaccine received.
- Individuals ages 5 years and older are eligible to receive a single dose. If they recently received a dose, they should wait two months before getting an updated vaccine.
- Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years.
The FDA said it expects side effects to be similar to previous versions of the vaccines, which have been administered to hundreds of millions of people in the U.S. The vaccines can be given at the same time as flu vaccines and respiratory syncytial virus immunizations.
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Dr. Marks said.
The Pfizer-BioNTech vaccine for ages 12 years and older will come in a single-dose glass prefilled syringe, while the vaccine for children ages 5-11 years will come in a single-dose vial. For children ages 6 months through 4 years, vaccines will come in vials with three doses each that require dilution. All will come in boxes of 10 syringes or vials. The vaccines are available through Pfizer Prime and wholesalers.
Both vaccines for children under 12 years will be 100% returnable any time before Sept. 15, 2025, once they have expired. For the adolescent/adult vaccine, credit will be issued for returned units up to 30% of doses purchased.
Moderna’s vaccines will come in prefilled syringes available in packs of 10. The vaccines are available through Moderna or wholesalers.
For physician clinics, 100% of pediatric doses and 10% of the adolescent/adult doses can be returned unless contract terms differ. Customers can visit https://modernadirect.com/ or talk to their account representative for more details.
Manufacturers have said they expect an adequate supply of vaccines for the 2024-’25 season.
Novavax also has requested authorization of its protein-based vaccine for people ages 12 years and older that targets the JN.1 strain. That vaccine is under FDA review.
Resources
- Information on Moderna’s updated vaccine for adolescents and adults and for children under 12 years
- Information on Pfizer-BioNTech’s updated vaccine for adolescents and adults and for children under 12 years
- CDC clinical considerations for administering COVID-19 vaccines
- AAP COVID-19 vaccination resources
- AAP COVID-19 dosing guide
- CDC COVID-19 Vaccination Field Guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information for parents on COVID vaccines from HealthyChildren.org
