- The FDA has expanded the emergency use authorization (EUA) of Pfizer Inc PFE / BioNTech SE’s BNTX bivalent COVID-19 vaccine as a single booster dose in youngsters below 5 years of age.
- The amended authorization is for kids six months by way of 4 years of age who’ve accomplished their preliminary three-dose vaccination with Pfizer’s unique shot.
- Associated: Pfizer/BioNTech Get Prepared For London Courtroom Battle With Moderna Over COVID-19 Vaccine Patents.
- In December, the company authorized Pfizer/BioNTech’s up to date shot as a 3rd dose for teenagers aged six months by way of 4 years who haven’t accomplished their major vaccination collection or are but to obtain the third dose.
- The amended authorization is predicated on information from 60 youngsters from the expanded age group, who accomplished major vaccination with three doses, acquired a booster shot of Pfizer/BioNTech, and confirmed an immune response to each the unique SARS-CoV-2 virus pressure and Omicron BA.4/BA.5.
- Final month, the businesses submitted an FDA supplemental advertising software for approval of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a major collection and booster dose(s) for 12 years and older.
- Value Motion: PFE shares are down 0.38% at $39.75, and BNTX shares are down 0.47% at $129.77 in the course of the premarket session on the final verify Wednesday.
- Photograph through Wikimedia Commons
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