FDA approves updated COVID-19 vaccines for higher-risk Americans, clearing way for shipments

The Food and Drug Administration approved updated COVID-19 vaccines on Thursday for people at higher risk, clearing the way for manufacturers to begin shipping the new formulations to pharmacies and physicians’ offices, according to The Hill.

The updated vaccines include new mRNA formulations from Pfizer-BioNTech and Moderna, the companies said after the agency action, The Hill reported. The FDA also approved an additional COVID-19 vaccine that is not mRNA, from Sanofi, the report said.

The FDA’s approvals focus on updated versions designed to address the current needs of higher-risk populations, The Hill said, rather than broad authorization for the general population in the initial rollout described in the report.

With the agency greenlighting the updated products, the practical effect is that healthcare providers can begin ordering the newly authorized shots for administration in outpatient settings, including pharmacies and doctors’ offices, The Hill reported.

Regulatory authorizations for updated COVID-19 vaccines typically require manufacturers to bring specific product formulations to the FDA for review, a process intended to ensure that vaccine changes are evaluated by the agency before distribution. In this case, the FDA’s approval of both mRNA and non-mRNA options expands the set of formulations available for clinicians and patients within the higher-risk group described by The Hill.

The Hill’s report did not provide additional details on the specific groups included within the FDA’s “higher risk” framing, nor did it list the dosing schedules or product-by-product age indications in the excerpt available for this draft.