- The National Institutes of Health (NIH) has begun a mid-stage study to determine the risk of allergic reactions shortly after receiving COVID-19 vaccines made by Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)/BioNTech SE (NASDAQ: (BNTX)).
- Several allergic reaction incidents, including serious episodes known as anaphylaxis, have been reported in the U.S. after vaccinations of Pfizer/BioNTech and Moderna shots.
- “The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID).
- The NIH Phase 2 study will enroll 3,400 adults ages 18 to 69. Participants will be randomly assigned to receive either a Pfizer–BioNTech vaccine, a Moderna vaccine, a placebo followed by a Pfizer–BioNTech vaccine, or a placebo followed by the Moderna vaccine.
- The trial’s goal is to assess the proportion of participants with a systemic allergic reaction within 90 minutes after injection. Data is expected to be reported later this summer.
- An independent data and safety monitoring board (DSMB) will review blinded and unblinded study data at scheduled review meetings to ensure study participants’ safety.
- price Action: PFE, (BNTX), and MRNA shares are down 0.36% at $35.92, 3.82% at $112.68, and 1.21% at $131.92, respectively, during market trading hours on the last check Wednesday.
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