Do You Need A COVID-19 Booster Dose? Pfizer-BioNTech Submit Initial Data To Support Idea

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  • Pfizer Inc PFE and BioNTech SE BNTX have submitted Phase 1 data to the FDA to support the evaluation of their COVID-19 booster dose for future licensure. 
  • The data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks.
  • Phase 1 data, part of the companies' Phase 1/2/3 trial program, evaluated a third dose's safety, tolerability, and immunogenicity from the Phase 1 trial of the two-dose series. 
  • Related content: Do mRNA COVID-19 Vaccines Cause Skin Or Kidney Disorders?
  • Participants received a 30-µg booster dose 8 to 9 months after receiving the second dose. Results from the group showed that the third dose elicited significantly higher neutralizing antibodies against the initial virus and variants.
  • Phase 3 results evaluating the third dose are expected shortly.
  • Last week, FDA authorized a third mRNA COVID-19 vaccine booster shot to immunocompromised individuals. The CDC panel also voted in favor of the recommendation.
  • Price Action: PFE shares are up 0.98% at $48.96, while BNTX stock dropped 9.21% at $342.94 during the market session on the last check Monday.
  • Photo by x3 from Pixabay
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Posted In: BiotechNewsHealth CareFDAMoversTrading IdeasGeneralBriefsCOVID-19 CoronavirusCOVID-19 VaccinePhase 1 Trial
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