January 31, 2022
We now have a second fully FDA approved vaccine to fight Covid19.
Moderna received it’s full approval from the FDA this morning for the two-dose primary series for those over the age of 18. The vaccine will be marketed under the name Spikevax.
The FDA clearly states “Spikevax has the same formulation as the EUA Moderna Covid-19 vaccine… Spikevax can be used interchangeably with the EUA Moderna Covid-19 vaccine to provide the Covid-19 vaccination series.”
It’s important to note the use of the Moderna vaccine as a third booster dose and as a third primary dose for certain immunocompromised people is still approved under emergency use authorization by the FDA
I linked the announcement, the letter of authorization for the biologics license application and even the package insert since I know you guys like to see that.
FDA announcement here.
FDA fact sheet here.
FDA approval letter for Biologics License Application for Moderna here.
Package insert here.
