FDA Gives Green Signal To Second Omicron-Adapted Booster Shots For People At High Risk

 

• On Tuesday, the FDA amended the emergency use authorizations (EUAs) of Moderna Inc 
  MRNA-0.93%+ Free Alerts
   and Pfizer Inc 
  PFE-1.54%+ Free Alerts
  , and BioNTech SE's 
  BNTX-1.25%+ Free Alerts
   COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule. 
• This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations. 
• The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the U.S.
• Those 65 and older can get a second dose of the updated versions of Pfizer-BioNTech's and Moderna's Covid booster at least four months after their last dose, the FDA said in a statement. 
• According to the agency, most immunocompromised people can get an additional dose at least two months after their last dose.
• Most unvaccinated individuals may receive a single dose of a bivalent vaccine rather than multiple doses of the original monovalent mRNA vaccines, FDA said.
• Unvaccinated children six months through 5 years can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine. 
• Children five years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine. 
• The booster shots were reformulated last August to target the BA.4 and BA.5 omicron subvariants in addition to the original strain of the virus.

https://www.benzinga.com/general/biotech/23/04/31858107/fda-gives-green-signal-to-second-omicron-adapted-booster-shots-for-people-at-high-risk-from-covid