COVID Toddler Vax Clears Major Hurdle
An advisory committee recommended that the FDA give emergency use authorization (EUA) to both Moderna and Pfizer/BioNTech’s mRNA COVID-19 vaccines for infants, toddlers, and preschool kids. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 in favor of expanded access to each vaccine, in another unanimous decision that the benefits of the vaccines […]
FDA Panel Unanimously Backs Moderna’s COVID Vax for Kids and Teens
A committee of independent vaccine experts recommended that the FDA grant an emergency use authorization (EUA) for the two-dose Moderna COVID-19 vaccine for kids ages 6 to 17 years. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0, agreeing unanimously that the benefits of vaccination outweigh the risks in two age groups: kids […]
Prior Authorization Back in the Spotlight on Capitol Hill
WASHINGTON — Prior authorization, that oft-maligned process of getting insurer approval prior to performing a procedure or prescribing a drug, is in the spotlight once again, on several fronts. On Capitol Hill, the issue began to bubble up in late April, when the Department of Health and Human Services (HHS) Office of Inspector General (OIG) […]
FDA Panel Backs Pfizer Booster for Select Groups
An FDA advisory panel recommended emergency use authorization (EUA) of a booster dose of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for individuals 65 and older, and those judged to be at high risk of severe COVID-19. On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 18-0 that the known and potential benefits […]
Monoclonal Antibody Cocktail Authorized for Post-COVID Exposure
FDA expanded the emergency use authorization (EUA) for the monoclonal antibody cocktail casirivimab and imdevimab, to include post-exposure prophylaxis (PEP) among certain people exposed to COVID-19, manufacturer Regeneron announced on Friday. Casirivimab-imdevimab (REGEN-COV) is the first monoclonal antibody treatment that can be used either as a treatment for COVID-19 or after exposure but prior to […]