The Centers for Disease Control and Prevention announced Thursday that it is holding an “emergency meeting” next week to discuss the higher-than-expected reports of heart inflammation following doses of the experimental mRNA-based Pfizer and Moderna COVID-19 vaccines.
“The CDC has identified 226 reports that might meet the agency’s ‘working case definition’ of myocarditis and pericarditis following the shots,” CBS News reported. According to the CDC, “the vast majority” of young people have recovered from the disease, “but 41 have ongoing symptoms, 15 are still hospitalized, and 3 are in the intensive care unit.”
The actual number of heart inflammation cases, which have occurred in previously healthy young people, could be much higher than those that have been reported, independent reporter and vaccine skeptic Ales Berenson noted on Twitter.
1/ @cdcgov has now analyzed the VAERS data on #Covid vaccine myocarditis in teens and young adults. It is terrible.
Based only on received reports – and remember, most side effects go unreported even when they are serious – the rate is as high as 40 times the background rate… pic.twitter.com/GhlUtgrRjT
— Alex Berenson (@AlexBerenson) June 10, 2021
The “emergency meeting” is scheduled for next Friday, and will discuss the benefit-risk of using COVID-19 mRNA vaccines in adolescents and young adults.
“It’s a bit of an apples-to-oranges comparison because, again, these are preliminary reports. Not all these will turn out to be true myocarditis or pericarditis reports,” cautioned Dr. Tom Shimabukuro, a CDC vaccine safety official.
Shimabukuro said their findings were mostly “consistent” with reports of rare cases of heart inflammation that had been studied in Israel and reported from the U.S. Department of Defense earlier this year.
The CDC is working on more data and analysis on the reports ahead of the emergency meeting of its own advisers next week, he said, and also planned to analyze the risk of heart inflammation posed by catching COVID-19.
The new details about myocarditis and pericarditis emerged first in presentations to a panel of independent advisers for the Food and Drug Administration, who are meeting Thursday to discuss how the regulator should approach emergency use authorization for using COVID-19 vaccines in younger children.
After earning an emergency use authorization for its COVID-19 vaccine in Americans as young as 12 last month, Pfizer announced this week it had decided on doses to use in a clinical trial in children as young as 6 months old and hoped to submit data by October. Moderna said Thursday that it too had requested the FDA’s permission to give its mRNA vaccine to adolescents.
While Pfizer has said they expect to wrap up trials for children as young as 2 by September, FDA officials have previously cautioned that authorizing vaccines for these age groups could take longer — “mid to late fall” at the earliest — citing the additional follow-up data needed for children after they receive the shots.
“We recognize that some adverse reactions, for example myocarditis or pericarditis as discussed earlier today, may be too infrequent to detect in a safety database of typical size for pre-licensure clinical trials,” said Dr. Doran Fink, a top official in the FDA’s vaccine office.
Meanwhile, even as reports of heart inflammation in previously healthy young people mount, the FDA is working on “school-focused strategies” so the vaccines can reach more adolescents.
PARENTS: the #covid vaccine fanatics are coming for your kids at school. They aren’t even hiding it. “School-focused strategies” start next month.
And they as much as tell schools not to ask for parental consent unless required: these are “routine immunizations,” @cdcgov says. pic.twitter.com/KEsHfvuLVh
— Alex Berenson (@AlexBerenson) June 10, 2021
Germany’s vaccine advisory committee, known as STIKO, meanwhile, announced Thursday that it is not currently recommending the use of the Pfizer coronavirus vaccine for those aged 12-17 without pre-existing conditions, Reuters reported.
STIKO said in a statement that only children and adolescents with pre-existing conditions that raise their risk of a serious case of coronavirus should be given the vaccine.