Without Citing Clinical Trials, FDA Approves Emergency Use Of COVID-19 Boosters For Children 12 And Up

The Food and Drug Administration (FDA) announced that COVID-19 boosters for children between the ages of 12 and 15 have been approved for emergency authorized use based on “real-world” data from Israel. The announcement came on Monday morning and was criticized by some medical doctors for not citing clinical trials in their approval process.

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.”

Based on 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, Dr. Ramin Farzaneh-Far, M.D., said that 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 observed. “In fact the word “trial” doesn’t even appear in the ⁦@US_FDA ⁩ press release.”

Adolescent ⁦@pfizer⁩ booster receives EUA solely on the basis of “real world” (hopelessly confounded) data from 🇮🇱
No clinical trials cited, or conducted presumably. In fact the word “trial” doesn’t even appear in the ⁦@US_FDA⁩ press release. https://t.co/v6fJZbWPfv

— Ramin Farzaneh-Far MD (@rfsquared) January 3, 2022

According to a biography page, Farnzaeh-Far was “Chief Medical Officer of Ra Pharmaceuticals from 2016 until it was acquired by UCB in 2020” and is an “experienced clinical trialist and board-certified cardiologist. He has held academic faculty positions at UCSF and the University of Texas Southwestern Medical Center.” Ramin completed his internal medicine residency at Brigham & Women’s Hospital in Boston and trained in cardiovascular medicine at UCSF.

Dr. Vinay Prasad, M.D. M.P.H, a “hematologist-oncologist and Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco,” also criticized the FDA for making the decision without any proof of efficacy.”

“The FDA EUA for boosting 12 to 15 year olds does not report ANY evidence of efficacy,” Prasad tweeted.

“Deciding to boost millions of kids with [zero] efficacy data with no idea the risk-benefit is favorable is something I never thought I would see from FDA,” he added.

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

“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, M.D., said in a press release.

“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 to in order to effectively fight COVID-19,” he added.

According to STAT News, the Centers for Disease Control and Prevention’s independent panel known as “Advisory Committee on Immunization Practices” is expected to meet this Wednesday to discuss whether the CDC should advise doctors to “urge” the use of the booster shot, or simply let parents known children age 12-15 may receive the dose:

A panel of independent experts that advises the Centers for Disease Control and Prevention on vaccination policy is expected to meet within days — likely Wednesday — to discuss the policy change. It’s possible the ACIP will issue what’s known as a permissive recommendation — saying youths aged 12 to 15 may get a booster if they wish, but stopping short of urging them to do so.

If the committee goes this route, it will likely be because of still outstanding questions about the risk of myocarditis and pericarditis — inflammation of the heart and tissue surrounding the heart, respectively — that may be associated with getting a booster shot for this age group. The ACIP’s recommendation must be approved by CDC Director Rochelle Walensky before it can come into effect.

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