The FDA has approved a second round of the Moderna Inc (NASDAQ: MRNA) or Pfizer Inc (NYSE:PFE), and BioNTech SE (NASDAQ:BNTX) COVID-19 vaccines for older people and certain immunocompromised individuals.
The agency said the new boosters would be administered at least four months after the previous dose.
The FDA also authorized the second booster dose of the vaccines for younger people with compromised immune systems - those aged 12 and older for the Pfizer/BioNTech shot and 18 and older for Moderna's.
The authorization comes as some scientists have raised concerns about the highly contagious and newly predominant BA.2 omicron subvariant, which has driven new spikes in COVID-19 cases in other countries.
"Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals," top FDA official Dr. Peter Marks said in a statement.
The FDA said it had looked at data from a relatively small, ongoing clinical trial in Israel to help make its decision. In addition, safety data from more than 700,000 people who received second boosters in Israel revealed no new concerns, the agency said.
Price Action: PFE shares are down 0.71% at $52.90, BNTX stock is up 3.33% at $171.86, and MRNA 2.81% at $177.94 during the market session on the last check Tuesday.
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