What are the recommendations for COVID-19 booster doses?

From the Guidelines

COVID-19 booster doses are currently recommended for everyone aged 5 years and older, with specific recommendations varying by age and health status, as outlined in the most recent guidelines from the Advisory Committee on Immunization Practices 1.

Key Recommendations

• For most adults and adolescents, a single dose of the updated mRNA vaccine (Pfizer-BioNTech or Moderna) is recommended at least 2 months after their last COVID-19 vaccine dose.
• Older adults (65+) and immunocompromised individuals may benefit from more frequent boosters, typically every 4-6 months, due to their higher risk of severe disease.
• Children ages 5-11 should receive age-appropriate formulations.

Rationale

The boosters are designed to target circulating variants, particularly Omicron subvariants, providing broader protection than the original vaccines. Boosters are important because immunity from vaccination or prior infection wanes over time, and the virus continues to evolve.

Side Effects and Considerations

Side effects are generally mild and similar to those of previous doses, including arm soreness, fatigue, and headache lasting 1-2 days. People should consult their healthcare provider about timing, especially if they've recently had COVID-19, as it's generally advised to wait 3 months after infection before receiving a booster 1.

From the FDA Drug Label

The safety of a Moderna COVID-19 Vaccine booster dose in individuals who completed primary vaccination with another authorized or approved COVID-19 vaccine (heterologous booster dose) is inferred from the safety of a Moderna COVID-19 Vaccine booster dose administered following completion of a Moderna COVID-19 Vaccine primary series (homologous booster dose) In an independently conducted study (Gili Regev-Yochay, Tal Gonen, Mayan Gilboa, et al. 2022 DOI: 10. 1056/NEJMc2202542), Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a 2-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. Study 5 (NCT04927065), a Phase 2/3 open-label study conducted in the United States, evaluated the immunogenicity, safety, and reactogenicity of a booster dose of the bivalent vaccine (Original and Omicron BA. 1) compared to a booster dose of Moderna COVID-19 Vaccine

The recommendations for COVID-19 booster doses are as follows:

• A booster dose of Moderna COVID-19 Vaccine can be administered to individuals who have completed primary vaccination with another authorized or approved COVID-19 vaccine.
• The safety of the booster dose is inferred from the safety of the homologous booster dose and data from independent clinical trials.
• A second booster dose of Moderna COVID-19 Vaccine can be administered to individuals 18 years of age and older who have received a 2-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior.
• The bivalent vaccine (Original and Omicron BA.1) can be administered as a second booster dose to participants 18 years of age and older who have previously received a primary series and a first booster dose with Moderna COVID-19 Vaccine at least 3 months prior 2.

From the Research

COVID-19 Booster Dose Recommendations

The recommendations for COVID-19 booster doses vary based on age, immunocompromised status, and other factors.

• The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose 3.
• For adults aged ≥50 years, a second mRNA booster dose is authorized ≥4 months after receipt of a first booster dose 4.
• Immunocompromised persons aged ≥12 years are recommended to complete a 3-dose primary mRNA COVID-19 vaccination series followed by a first booster dose ≥3 months after dose 3 and a second booster dose ≥4 months after dose 4 5.

Booster Dose Safety and Effectiveness

Studies have shown that booster doses are safe and effective in preventing COVID-19-associated hospitalization and critical illness.

• Local and systemic reactions are commonly reported after booster doses, but serious adverse events are rare 3, 4, 5.
• Bivalent mRNA booster doses have been shown to provide additional protection against COVID-19-associated emergency department and urgent care visits and hospitalizations compared to monovalent vaccine doses 6.
• Heterologous booster doses (using a different vaccine than the primary series) have been shown to be effective in preventing COVID-19, including severe disease and death 7.

Special Considerations

Certain populations may require special consideration when it comes to COVID-19 booster doses.

• Immunocompromised individuals may require additional doses or a different vaccination schedule 5.
• Adults aged ≥50 years may be eligible for a second booster dose ≥4 months after receipt of a first booster dose 4.
• Children aged 5-11 years are eligible for a bivalent Pfizer-BioNTech booster dose ≥2 months after completion of a primary series or monovalent booster vaccination 3.