Moderna requests an EUA for its COVID-19 booster for all adults; the Securities and Exchange Commission (SEC) is investigating claims regarding data for Cassava Sciences’ Alzheimer drug; Florida legislators approved a bill barring private companies from issuing COVID-19 vaccine mandates.
Moderna has asked the FDA for emergency use authorization(EUA)for booster doses of its COVID-19 vaccine for all adults, seeking to expand the number of people who can receive a third dose, according to The Hill. The FDA previously granted an EUA for Moderna’s booster dose to be given at least 6 months after the second dose to people 65 years or older and adults at high risk for severe COVID-19 due to underlying conditions or their living or work environments. The request comes as the FDA is expected to authorize Pfizer’s booster dose for for all adults ahead of a CDC advisory meeting on Friday, November 19. CDC Director Rochelle Walensky, MD, MPH, will have the final say on whether all adults can get a third dose of Pfizer or Moderna’s vaccines.
According to The Wall Street Journal, the Securities and Exchange Commission (SEC) is investigating claims that Cassava Sciences manipulated research results of its experimental Alzheimer drug, simulfilam. Cassava disclosed in a securities filing that it is cooperating with federal investigators but did not name an agency. The National Institutes of Health, which has been providing $20 million in grants to Cassava and its academic collaborators for drug development since 2015, is also investigating the claims. The accusations appeared in a public petition written by 2 physicians to the FDA asking it to suspend Cassava’s clinical trials, saying they doubted Cassava’s research due to some studies using duplicated images from other sources.
Florida Republican legislators approved a bill that would block businesses from issuing COVID-19 vaccine mandates, according to The Associated Press. Under the bill, private companies would be barred from having vaccine mandates unless they allow workers to opt out for medical reasons, religious beliefs, immunity based on previous infection, regular testing, or an agreement to wear protective gear. The bill would also fine businesses that fire a worker without allowing the exemptions, bars schools from issuing vaccine mandates, and allows parents to sue schools with mask requirements.