U.S. COVID-19 Vaccine Product Information

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FDA approved and authorized 2024–2025 Moderna and Pfizer-BioNTech COVID-19 vaccines on August 22, 2024. FDA also authorized 2024–2025 Novavax COVID-19 Vaccine on August 30, 2024. CDC is now updating the product information materials below for these vaccines. See Use of COVID-19 Vaccines in the United States for more information, including recommendations for use of these vaccines in people ages 6 months and older.

Information by Brand

Materials for 2024–2025 approved and authorized vaccines coming soon

Pfizer-BioNTech

At-a-Glance
Standing Orders:
- 6 months–4 years of age
- 5 years of age and older
Labels and BUD Guidance

Moderna

At-a-Glance
Standing Orders:
- 6 months–4 years of age
- 5 years of age and older
Labels and BUD Guidance

Novavax

Education for Patients and Parents

Immunization providers should provide a Vaccine Information Statement (VIS) or Emergency Use Authorization (EUA) Factsheet for Recipients to a patient, parent, or legal representative before each dose of COVID-19 vaccine.

Interim COVID-19 Immunization Schedule for Ages 6 months and older

Find guidance for COVID-19 vaccination schedules based on age and medical condition.

Additional Resources

Prevaccination Screening Checklist

CDC is replacing the COVID-19 specific screening questionnaire these resources from Immunize.org that will help providers determine if a contraindication or precaution exists for all routinely recommended vaccines.

Emergency Use Instructions (EUI)

EUIs provide information about emergency use of FDA-approved medical products that may not be included in, or differ in some way, from the information provided in the FDA-approved labeling (package insert). New EUI for Pfizer-BioNTech and Moderna COVID-19 vaccines were issued August 23, 2024.

For Healthcare Providers

For Recipients and Caregivers