As the new Omicron variant leads to record high cases of COVID-19, the Food and Drug Administration (FDA) has approved COVID-19 boosters for children between the ages of 12 and 15 for emergency authorized use based on “real-world” data from Israel.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” Acting FDA Commissioner Janet Woodcock said. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”
According to the FDA, “the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.”
The FDA “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 vaccine at least 5 months following completion of the primary two-dose vaccination series.”
The FDA claimed that “there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.”
However, as noted by Dr. Ramin Farzaneh-Far, M.D., the emergency approval was based “solely on the basis of ‘real world’ (hopelessly confounded) data from [Israel].”
“No clinical trials cited, or conducted presumably,” Farzaneh-Far added. “In fact the word “trial” doesn’t even appear in the @US_FDA press release.”
https://twitter.com/rfsquared/status/1478015176733560835?s=20
Dr. Vinay Prasad, M.D. M.P.H, also criticized the FDA for making the decision with “literally no safety or efficacy data.”
“The FDA EUA for boosting 12 to 15 year olds does not report ANY evidence of efficacy,” Prasad wrote on Twitter. “Just says they do not yet have reports of myocarditis after 6k shots, which is not surprising if rate for D3 myocard is less than D2 (almost surely it is due to interval)”
“Deciding to boost millions of kids with 0 efficacy data with no idea the risk benefit is favorable is something I never thought I would see from FDA,” Prasad added. “Some of these kids who will receive boosters will do so right after an Omicron infection. There is literally no safety or efficacy data to guide that, and none are presented in the insert”
Deciding to boost millions of kids with 0 efficacy data with no idea the risk benefit is favorable is something I never thought I would see from FDA
Would not have happened if Gruber/ Krause still worked therehttps://t.co/4IxCXZw9r4
— Vinay Prasad MD MPH (@VPrasadMDMPH) January 3, 2022
