FDA grants full approval to Moderna’s COVID-19 vaccine; but the ‘FDA approved’ Spikevax vaccine is not available to people in the US and has not been tested for Omicron
On Monday, the US Food and Drug Administration (FDA) announced that it granted full approval to Moderna’s COVID-19 vaccine, Spikevax, for use in people ages 18 and older. Spikevax had been given emergency authorization for the same age group in December 2020.
This is the second COVID-19 vaccine to receive full approval following Pfizer’s approval vaccine in August 2021. Just like the Pfizer “approval” episode, this vaccine will not be able for anyone for an indefinite period of time. And according to the FDA, the shot was approved without being tested for Omicron, which accounts for 99.9% of current U.S. COVID cases.
In a widely-celebrated press release on Monday, the FDA said:
“Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.”
However, the FDA also noted (page 3) in the small print of its approval letter that Spikevax and Moderna’s emergency use authorization shots are “legally distinct” products, adding that there are “certain differences that do not impact safety or effectiveness.” The same disclaimer was made when the FDA approved Pfizer’s Comirnaty, which has never seen the light of day in the United States.
“9 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.”
Moreover, the FDA said that Spikevax will not be available for an indefinite period of time. The FDA stated:
“Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”
Phil Kerpen noted the similarities between Pfizer and Moderna’s approval. “Same old song,” Kerpen tweeted.
— Phil Kerpen (@kerpen) January 31, 2022
Below is the entire press release.LOA with Moderna approval final