Overview of COVID-19 Vaccines and Vaccination

Introduction

These clinical considerations provide guidance to healthcare professionals and public health officials on use of COVID-19 vaccines. They are informed by:

• Recommendations of the Advisory Committee on Immunization Practices (ACIP) and CDC
• COVID-19 vaccine approval by the U.S. Food and Drug Administration (FDA)
• General Best Practices for Immunization

Types of COVID-19 vaccines

Two types of 2025–2026 COVID-19 vaccines are recommended for use in the United States:

• mRNA vaccines
  • Moderna COVID-19 Vaccines: Spikevax (approved for ages 6 months and older) and mNexspike (approved for ages 12 years and older). These vaccines are hereafter referred to collectively as Moderna COVID-19 Vaccine unless the specific vaccine name is relevant.
  • Pfizer-BioNTech COVID-19 Vaccine: Comirnaty (approved for ages 5 years and older). This vaccine is hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine. There is currently no FDA-approved or FDA-authorized Pfizer-BioNTech COVID-19 vaccine for ages 6 months–4 years.
• Protein subunit vaccine
  • Novavax COVID-19 Vaccine: Nuvaxovid (approved for ages 12 years and older). This vaccine is hereafter referred to as Novavax COVID-19 Vaccine.

There is no preferential recommendation for the use of any one COVID-19 vaccine over another when more than one recommended and age-appropriate vaccine is available.

The 2024–2025 Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines should not be used.

COVID-19 vaccine composition

The 2025–2026 formulations for COVID-19 vaccines in the United States are based on the Omicron JN.1-lineage of SARS-CoV-2, as follows:

• Moderna and Pfizer-BioNTech: LP.8.1 strain
• Novavax: JN.1 strain

COVID-19 vaccine-specific package inserts and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures.

Overview of recommendations for the use of COVID-19 vaccines

Groups recommended for vaccination

COVID-19 vaccination is recommended for the prevention of COVID-19 disease and its complications as follows:

• Adults ages 65 years and older: Vaccination based on individual-based decision-making (also known as shared clinical decision-making)
• People ages 6 months–64 years: Vaccination based on individual-based decision-making (also known as shared clinical decision-making)—with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.

In addition to the CDC list of risk factors for severe COVID-19, the Moderna (Spikevax) package insert states that prematurity (birth at <37 weeks gestational age) has been associated with COVID-19-related hospitalizations in children ages 6–23 months.

Additionally, some people may be at increased risk for SARS-CoV-2 infection including healthcare workers and residents and employees in long-term care facilities and other residential congregate settings.

The vaccination schedules for the 2025–2026 COVID-19 vaccines vary based on vaccination history, age group, and immune status. Detailed schedules, including age-appropriate vaccines, dosages, and intervals between doses for the 2025–2026 COVID-19 vaccines can be found in Table 1; a modified schedule for people who are moderately or severely immunocompromised can be found in Table 2. Because there is no current FDA-approved or FDA-authorized Pfizer-BioNTech COVID-19 Vaccine for children ages 6 months–4 years, the 2025–2026 COVID-19 vaccination schedule has been modified to ensure children previously vaccinated with Pfizer-BioNTech COVID-19 Vaccine receive a 2025–2026 COVID-19 vaccine dose(s) with Moderna (Spikevax) COVID-19 Vaccine.

Self-attestation of COVID-19 risk factors

People can self-attest to factors that increase their risk for severe COVID-19 during the individual-based decision-making process and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.

Vaccine dosage and administration

General Best Practices for Immunization apply to COVID-19 vaccination unless otherwise noted. People should receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination and follow the recommended dosing intervals (Table 1 and Table 2).

COVID-19 vaccine doses should be administered by the intramuscular route.