Three days after a U.S. Food and Drug Administration advisory panel voted against Pfizer’s application for a COVID-19 booster shot for people over 16, the drug giant announced clinical trials show its vaccine is safe and effective for children aged 5 to 11.
The company said it will submit its data to the FDA as soon as possible, reported the Washington Times, which noted the trial must be completed and the results submitted later this year.
As WND reported Friday, with the Biden administration set to roll out its COVID-19 vaccination booster plan this week, the FDA panel concluded that, among many concerns, there is insufficient data to judge the Pfizer vaccine’s risks to younger groups. The members highlighted the possible increased risk for heart inflammation, or myocarditis, particularly among males ages 16-17.
In July, Dr. Marty Makary argued in a Wall Street Journal editorial that the evidence behind the CDC’s push to vaccinate children is flimsy, arguing the agency overcounts COVID hospitalizations and deaths, and won’t consider whether or not one shot is sufficient for many people.
Makary, a professor at Johns Hopkins University, noted that at the time, the CDC had counted 335 children under 18 who had died with a COVID-19 diagnosis code in their record. The current figure is 439.
“Yet the CDC, which has 21,000 employees, hasn’t researched each death to find out whether Covid caused it or if it involved a pre-existing medical condition,” he wrote.
Without such information, the CDC Advisory Committee on Immunization Practices decided in May that the benefits of two-dose vaccination outweigh the risks for children 12 to 15.
“I’ve written hundreds of peer-reviewed medical studies, and I can think of no journal editor who would accept the claim that 335 deaths resulted from a virus without data to indicate if the virus was incidental or causal, and without an analysis of relevant risk factors such as obesity,” Makary wrote.
Fauci’s claim ‘a total fabrication’
In a lecture earlier this month hosted by the London School of Hygiene and Tropical Medicine, Dr. Anthony Fauci insisted children should be administered a COVID-19 vaccine.
The top White House coronavirus adviser claimed “we have lost more children from SARS-CoV-2 than we ever lose for influenza — and we vaccinate children against influenza.”
Kyle Lamb, a data specialist for Florida Republican Gov. Ron DeSantis, presented the evidence that Fauci’s claim “is a total fabrication.”
In the 2017-18 flu season alone, he pointed out on Twitter, the CDC estimates 643 pediatric deaths. Yet after more than 19 months of COVID-19, there have been a total of 439 deaths.
See the data presented by Lamb:
So far, there have been 439 deaths of children ages 0-17 *with* COVID-19 since the start of the pandemic. Remember, this is over 20 months — the first of many important qualifiers.
— Kyle Lamb (@kylamb8) September 18, 2021
Further, studies — including one by Stanford researchers on children and a recent one by Harvard and Tufts scholars on VA patients, have concluded COVID-19 hospitalizations have been overcounted, leading to overestimates of the severity of the disease.
‘We are eager to extend the protection’
On Monday, Pfizer CEO Albert Bourla argued that over the past nine months, “hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine.”
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” he said.
Pfizer hopes later this year to report the results of its studies in two other cohorts, ages 2 to 5 and 6 months to 2.