Pfizer COVID booster shot for 12 to 15-year-olds backed by USFDA

"In particular, the Omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines," he said.

The FDA said it had reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the Pfizer-BioNTech vaccine at least 5 months following completion of the primary two-dose vaccination series.

There were no new cases of a rare type of heart inflammation reported to-date in these individuals, the FDA said.

The agency said authorizing the shot at 5 months instead of 6 months may provide better protection sooner against the Omicron variant.

Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 shot greatly improves an individual's antibody response to be able to counter the Omicron variant, the health regulator said .

Two shots of the mRNA vaccine, which the Pfizer shot is based on, are about 35% effective against infection from the Omicron variant but a booster dose restores effectiveness to 75%, according to the U.S. Centers for Disease Control and Prevention, based on data from South Africa and the United Kingdom.

Also Read: First: Beximco Pharma launches generic version of Pfizer Paxlovid for COVID treatment