On Monday the FDA approved Spikevax, the second licensed COVID-19 vaccine. But Spikevax will be as elusive as Comirnaty. Even though the FDA press release makes it sound like Moderna is simply changing the name of its COVID-19 Vaccine to Spikevax, Moderna COVID-19 Vaccine will continue to be available under EUA just like Pfizer-BioNTech COVID-19 Vaccines. As with Pfizer, FDA has approved a phantom vaccine while using EUA to shield Moderna from product liability. Instead of protecting Americans, the FDA is double-dealing deceptively to benefit a large pharmaceutical company.
FDA issued two letters on January 31, 2022, both addressed to Michelle Olsen of ModernaTX, Inc. The first letter permits the company to market its COVID-19 vaccine under the label SPIKEVAX. FDA took this action without a referral to the Vaccines and Related Biological Products Advisory Committee because Moderna’s Biologics License Application (BLA) “did not raise concerns or controversial issues that would have benefitted from an advisory committee discussion.” Which is not the same as saying the BLA does not raise concerns or controversial issues.
Potential concerns and controversial issues are detailed later in the letter as “Postmarketing Requirements/Commitments.” These include studies to address the effect of the vaccine on children, due in 2024, and studies to determine the risk of myocarditis, due between June 2023 and October 2028. The results of required studies on the effect of the vaccine on pregnancy will not be known until June 2024, but the product can be distributed just as soon as Moderna receives “a notification of release from the Director, Center for Biologics Evaluation and Research.”
The second letter reaffirms the Emergency Use Authorization for Moderna COVID-19 Vaccine. This letter offers flimsy reasons for the persistence of the EUA. For example, the letter states that
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.
Footnote 11
Of course, there would be sufficient approved vaccine if FDA required Moderna to relabel existing inventory as “Spikevax.” This option is not addressed in the letter.
The letter goes on to say that the scope of the license is a subset of the scope of the EUA, and that the EUA must continue so that vaccine is available in unapproved situations. Of course, those situations could be addressed in an EUA that excludes the licensed situations, but that option is not considered in the letter.
Finally, in language that seems to have been boilerplate from the Pfizer-BioNTech EUA, the FDA will allow Moderna COVID-19 vaccine to be administered to individuals 18 years under EUA because “there remains, however, a significant amount of Moderna COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization.” Does that mean that Moderna will stop manufacturing the EUA version of its vaccine and just consume inventory? I doubt it.
According to its package insert, Spikevax is approved for adults 18 years and older as a two dose primary series. However, like Comirnaty and Pfizer-BioNTech Purple, the revised Vaccine Information Fact Sheet about Spikevax and the Moderna COVID-19 Vaccine permits Spikevax to be used interchangeably with Moderna COVID-19 Vaccine.
So now our vaccine chart looks like this:
Within a vaccine landscape that is more complicated than ever, we still do not have a licensed COVID-19 vaccine for Americans.
