Red alert: They’re coming for your kids.Experimental jab approved for Emergency Use Authorization despite only 3 months worth of data
The Food and Drug Administration on Friday granted emergency use authorization for Pfizer-BioNTech’s experimental Covid-19 jab to be given to children 5 to 11.
“This is the first Covid-19 vaccine authorized in the United States for younger children,” reports CNN.
In a press release, the FDA declared the vaccine was safe for the age group because it had been “studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study,” — despite studies still ongoing.
“Commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.”
The press release explains that, since there have been numerous cases of myocarditis, or heart inflammation, in vaccinated males aged 12-17, a risk-benefit analysis was used where they weighed possible Covid cases, hospitalizations, and deaths against those that may be caused by the vaccine.
The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age. Therefore, the FDA conducted its own benefit-risk assessment using modelling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.
The approval comes after an FDA vaccine advisory panel on Tuesday recommended the injection for children 5 to 11 despite admitting not knowing the long-term risks.
In fact, one FDA voting member actually stated, “We’re never gonna learn about how safe the vaccine is until we start giving it.”
The FDA briefing document the panel used to come to its conclusion outright admitted it has no available data for myocarditis cases in children 5 to 11, so it assumes it would be at about the same notable myocarditis rate as children 12-15.
“For this analysis, the estimate for ages 12-15 years is applied to ages 5-11 years because vaccine-associated myocarditis/pericarditis data is not available for this age group,” the document admits.
NIH director of clinical innovation, Dr. Michael Kurilla, who was the only abstention in the 17-0 vote, objected to the EUA during Tuesday’s panel citing concerns the vaccine could be given to healthy children who don’t need it.
“I think the idea of doing under an emergency use authorization, two doses for everybody without any flexibility around this, I think is just not going to go over very well and I don’t think it’s going to give the health care community the options and parents the options to choose what’s best for their children,” he said.
Kurilla also provided a list of other reasons for his abstention, including the fact trials, only looked at 3 months’ worth of data.
NIH’s Dr Michael Kurilla was the 1 abstention in FDA advisory panel vote on Pfizer/BioNTech vaccine for kids 5-11. He says in statement explaining his vote that “the basis for my abstention was the specific wording of the question to be voted on and the following considerations:” https://t.co/I9dR4tgekv pic.twitter.com/OQt3Zluwgs— Meg Tirrell (@megtirrell) October 26, 2021
“While there are clearly high-risk groups within the 5-11 age group for which this vaccine would significantly reduce serious disease, I do not expect protection from infection to last more than a few months and this may negatively impact public perception of vaccines,” Kurilla said.
“Taken together, I don’t see the need for ’emergency use’ of this vaccine across the entire age group and would have preferred a more nuanced approach.”
The vaccine rollout will begin after the CDC reviews the FDA’s EUA.
“The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet November 2 to discuss whether to recommend use of the vaccine among US children,” reports CNN. “Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine.”