FDA approves Covid boosters for new age category
The US Food and Drug Administration (FDA) has expanded Pfizer/BioNTech Covid booster use to teenagers and cut the time between the primary vaccination and the boosting dose for them from six to five months.
According to the guidance, updated on Monday, “protective health benefits” against coronavirus and its consequences “outweigh the potential risks.” Prior to coming to this conclusion, the FDA analyzed “real-world data” from Israel where boosters for this age category were approved at the end of November.
According to the American Academy of Pediatrics, Covid numbers among US children are “extremely high and increasing” with just over half of 12-17 olds being fully vaccinated.
Besides the new recommendations for 12-17 years olds, the FDA has also approved a third ‘primary series’ dose for 5-11-year-old children who have undergone a solid organ transplantation or were considered “to have an equivalent level of immunocompromise.”
The decisions have been taken amid a new wave of Covid infections caused by the Omicron variant of coronavirus.
“… 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,” the head of the FDA’s Center for Biologics Evaluation and Research Peter Marks said.
On December 31 the US broke another world record for number of Covid cases, with more than 647,000 registered in a single day.