Vaccine stocks slumped Monday after an explosive memo from FDA vaccine chief Vinay Prasad surfaced late Friday, signaling the agency is preparing to roll out tough restrictions on new vaccines for children. Prasad described a “profound revelation” linking Covid shots to at least ten deaths in children.
By late morning, Vaccine makers dropped on the memo: Moderna -6%, BioNTech -4.3%, Novavax -4%, Vaxcyte -6.6%.
Wall Street analysts weighed in on the memo, and all agreed it introduces a new regulatory overhang for vaccine stocks.
Here’s what the research desks told clients:
William Blair, Myles R. Minter (rates the MRNA market perform)
- “Our interpretation of the memo is that CBER will focus its efforts on the younger 12- to 24-year-old male population for newly approved Covid-19 vaccines where the myocarditis risk is highest”
- If new regulatory restrictions were to be implemented in the higher myocarditis risk population, analysts see further headwinds toward Moderna’s declining Covid-19 franchise “alongside further negative sentiment that this memo and subsequent actions may generate”
- Analyst says Pfizer, BioNTech, Novavax and Sanofi could also be impacted
- “The memo also indicates several upcoming reforms to the CBER vaccine regulatory pathway, most notably the “demand” for pre- market randomized trials assessing clinical endpoints, not just immunogenicity, for most new vaccine products”
Hellbound and Down 