FDA issue Pfizer vaccine emergency clearance for children, and delay Moderna
pharmafile | November 1, 2021 | News story | Sales and Marketing |
The FDA has informed Moderna that it needs more time to review the company’s COVID vaccine in children aged 12 and older, in order to evaluate a rare heart risk from the jab. They have issued emergency clearance for the use of the Pfizer BioNTech vaccine in children aged 5 to 11 in the US.
The FDA indicated that for children aged 5 to 11, the Pfizer vaccine should be administered in two doses, three weeks apart. According to the FDA, this age group should receive a “lower dose” of 10 micrograms, in comparison to the 30 micrograms used in those aged 12 and older. After this approval, the CDC will study whether to authorise immunisation for this age group.
The FDA is meanwhile analysing emerging data on the risk of myocarditis, an inflammation of the heart muscle and a rare cardiac side effect of the Moderna jab. Moderna have stated in a news release that the FDA has indicated it will take until at least January to complete this review for the application of the jab in 12 to 17-year olds.
Moderna stated that it is “fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.” The company further stated that it plans to delay its request for emergency use authorisation for the COVID vaccine in children aged 6 to 11, until the extended review is completed for those aged 12 and older.
According to the FDA, COVID cases among children aged 5 to 11 accounted for 39% of infections in people under the age of 18 in the US.