Similar to the agency’s licensing last year of Pfizer’s Comirnaty vaccine, the approval raised a number of legal questions related to mandates and product availability.
Spikevax is a two-dose primary series, approved also for administration as part of a heterologous (“mix and match”) single booster dose for individuals who previously completed their original series of vaccinations with the Pfizer or Johnson & Johnson COVID vaccines.
According to the FDA, Spikevax “has the same formulation as the [Emergency Use Authorization (EUA)] Moderna COVID-19 Vaccine and … can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.”
However, in its approval letter, the FDA said Spikevax is “legally distinct” from the Moderna EUA vaccine:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”