TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.

The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.

Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the...

New 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) that more closely target currently circulating variants have been licensed by the FDA for persons ≥12 years old and made available under FDA Emergency Use Authorizations (EUAs) for use in persons 6 months to 11 years old.1-3 A 2024-2025 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax is expected to become available soon for persons ≥12 years old.

On November 19, the FDA 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 booster dose for all adults ≥18 years old after primary immunization with either the same COVID-19 vaccine or a different one. Booster doses of these vaccines were previously authorized only for select populations (age ≥65 years or persons at high risk for severe COVID-19). The EUA for the adenovirus-based vaccine manufactured by Johnson & Johnson was amended in October 2021...

On April 23, 2021, on advice from the Advisory Committee on Immunization Practices (ACIP), the FDA and CDC recommended that use of the Johnson & Johnson adenovirus-based COVID-19 vaccine resume despite its association with development of thrombosis with thrombocytopenia syndrome (TTS). Administration of the vaccine had been paused on April 13 because of 6 reports of TTS, but after completing a data review that identified a further 9 cases associated with the formulation, the agencies concluded that the benefits of the vaccine outweighed its risks. About 7.98 million doses of the...

View the Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines