At what age is the COVID-19 (Coronavirus Disease 2019) vaccine, such as Pfizer-BioNTech (mRNA vaccine) or Moderna (mRNA vaccine), offered to patients?

From the Guidelines

The COVID-19 vaccine is currently offered to individuals 6 months of age and older, as recommended by the Advisory Committee on Immunization Practices (ACIP) in 2024 1.

Key Recommendations

• The vaccine is recommended for all eligible age groups because it significantly reduces the risk of severe COVID-19 disease, hospitalization, and death.
• For children 6 months to 4 years, a three-dose primary series of the Pfizer-BioNTech vaccine at a lower dose is recommended, while those 5-11 years receive a two-dose primary series at a pediatric dose.
• Individuals 12 years and older receive the standard adult dosing of the Pfizer-BioNTech or Moderna vaccine.
• The mRNA technology in these vaccines teaches cells to produce a harmless piece of the virus spike protein, triggering an immune response that creates antibodies to protect against future infection.

Age-Specific Guidance

• Children 6 months to 4 years: three-dose primary series of Pfizer-BioNTech vaccine at a lower dose 1.
• Children 5-11 years: two-dose primary series of Pfizer-BioNTech vaccine at a pediatric dose 1.
• Individuals 12 years and older: standard adult dosing of Pfizer-BioNTech or Moderna vaccine 1.

Immunocompromised Individuals

• Persons who are moderately or severely immunocompromised should receive at least 1 dose of 2024-2025 COVID-19 vaccine, with additional doses recommended depending on vaccination history 1.

Side Effects and Safety

• Side effects are generally mild and may include pain at the injection site, fatigue, headache, and muscle pain, which typically resolve within a few days.
• The vaccines have been shown to be safe and effective in reducing the risk of severe COVID-19 disease, hospitalization, and death 1.

From the FDA Drug Label

The effectiveness of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age is based on: • effectiveness of the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) in individuals 6 months of age and older, and • immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older Study C4591007 (Study 3) is a Phase 1/2/3 multicenter, randomized, dose finding, open-label (Phase 1) and multinational, saline placebo-controlled, observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 4,695 participants 5 through 11 years of age, of whom 3,109 participants received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 1,538 participants received placebo in Phase 2/3 Study 3 also enrolled 1,776 participants 6 through 23 months of age, of whom 1,178 participants were in the Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA) group and 598 participants in the placebo group; and also enrolled 2,750 participants 2 through 4 years of age, of whom 1,835 participants were in the Pfizer-BioNTech COVID-19 Vaccine group and 915 participants in the placebo group in Phase 2/3

The COVID-19 vaccine, such as Pfizer-BioNTech, is offered to patients 6 months of age and older.

• The vaccine is administered as a primary series to participants 6 months through 11 years of age.
• The vaccine is also administered as a primary series to participants 12 years of age and older.
• Booster doses are administered to participants 5 years of age and older, with specific age groups receiving different formulations of the vaccine, such as the bivalent vaccine. Key points about the age groups for vaccination include:
• 6 months through 23 months: enrolled in Study 3, with 1,178 participants receiving the vaccine and 598 participants receiving placebo.
• 2 through 4 years: enrolled in Study 3, with 1,835 participants receiving the vaccine and 915 participants receiving placebo.
• 5 through 11 years: enrolled in Study 3, with 3,109 participants receiving the vaccine and 1,538 participants receiving placebo.
• 12 years of age and older: enrolled in Study 2, with approximately 44,000 participants randomized to receive the vaccine or placebo. 2 2

From the Research

COVID-19 Vaccine Eligibility by Age

The COVID-19 vaccine is offered to patients of various ages, depending on the vaccine type and the patient's health status.

• Children aged 6 months-5 years are eligible for the Moderna COVID-19 vaccine, administered as 2 doses (25 µg each), 4 weeks apart 3.
• Children aged 6 months-4 years are eligible for the Pfizer-BioNTech COVID-19 vaccine, administered as 3 doses (3 µg each), at intervals of 3 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3 3.
• Children aged 6 months-5 years who have completed a primary series are also eligible for a bivalent mRNA booster dose ≥2 months after completion of the primary series 4, 5.
• Children aged 5-11 years are eligible for a bivalent Pfizer-BioNTech or Moderna booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose 5.
• Adults aged ≥18 years are eligible for the Moderna COVID-19 vaccine, administered as a primary series of 2 intramuscular doses (100 μg each) 4 weeks apart, with an 8-week interval considered optimal for some adolescents and adults 6.

Vaccine Effectiveness and Safety

Studies have shown that the COVID-19 vaccines are effective in preventing symptomatic SARS-CoV-2 infection and COVID-19-associated emergency department and urgent care encounters among children aged 6 months-5 years 4, 7.

• The effectiveness of 2 monovalent Moderna doses against symptomatic infection was 60% (95% CI = 49% to 68%) 2 weeks-2 months after receipt of the second dose 7.
• The effectiveness of 3 monovalent Pfizer-BioNTech doses against symptomatic infection was 31% (95% CI = 7% to 49%) 2 weeks-4 months after receipt of the third dose 7.
• The safety of bivalent mRNA booster doses among children aged 5-11 years has been characterized, with local and systemic reactions commonly reported, but serious adverse events are rare 5.