The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children as young as 5 years old (Pfizer) or 6 years old (Moderna). The bivalent Pfizer vaccine had previously been authorized for use in persons ≥12 years old and the bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for...

On June 25, 2021, the FDA added a warning to the Fact Sheets for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) about an increased risk of myocarditis and pericarditis following administration of the vaccines.

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18 years old (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent (see Table 1).

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.

The FDA has expanded its Emergency Use Authorization (EUA) for the COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to permit use of the bivalent formulation (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children 6 months to 4 years old who completed the primary series with 3 doses of the monovalent formulation ≥2 months previously. The Pfizer bivalent vaccine had previously been authorized for use as a booster dose in persons ≥5 years old and as a third primary dose in children 6 months to 4 years old. Booster...

According to the Centers for Disease Control (CDC), as of April 24 there have been 844 confirmed cases of measles in the US in 2025; 11% of cases have resulted in hospitalization and 3 patients have died. The majority of cases (96%) have been in unvaccinated persons or in those whose vaccination history was unknown

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.

The FDA has licensed mNEXSPIKE (Moderna), an mRNA vaccine, for prevention of COVID-19 in adults ≥65 years old and in persons 12-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19. Spikevax, the original Moderna mRNA COVID-19 vaccine, remains in production2; it is licensed for use in persons ≥12 years old and is available under an Emergency Use Authorization (EUA) for children 6 months to 11 years old.