The vaccine advisory committee for the Centers for Disease Control and Prevention will participate in an emergency meeting next week after hundreds of young Americans developed heart inflammation following their second dose of the Pfizer and Moderna COVID-19 jabs.
As of May 31, the CDC has received 275 preliminary reports of myocarditis and pericarditis in fully-vaccinated 16 to 24-year-olds — a number that’s higher than what scientists expected to see, the CDC said Thursday.
“We clearly have an imbalance there,” Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said in a presentation to an FDA advisory committee.
Across all age groups, a total of 488 Pfizer recipients and 301 Moderna recipients reported the condition — and the majority were male.
Just under 80 percent of the cases were in men, the CDC said.
The median age of patients who experienced the inflammation after a second vaccine dose was 24, according to the CDC’s data.
Reports of the affliction — which is marked by an inflammation of the heart muscle or the lining surrounding it — have been largely mild, however, some have been more serious and led to hospitalizations, the agency said.
There have been a total of 475 reported cases of heart inflammation in vaccinated Americans aged 30 and under. Most of the patients who were hospitalized made a full recovery from their symptoms, however, 41 people had ongoing symptoms.
As of May 31, 15 patients were still in the hospital, three of whom were in intensive care, the CDC said.
It’s still not clear if the vaccine is causing the inflammation but the June 18 meeting will seek to address the condition and figure out how it should be handled moving forward.
Dr. Shimabukuro cautioned against drawing conclusions because the reports are preliminary.
“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,” Shimabukuro said, according to CBS News.
While people as old as 94 have reported the condition, 52.5 percent of cases have been found in patients between the ages of 12 and 24 — a demographic that represents just 8.8 percent of total vaccinations.
The data came on the same day Moderna requested emergency use authorization to give their jab to kids between the ages of 12 and 17.
Now, the disproportionate impact on young Americans has some doctors concerned.
“Before we start vaccinating millions of adolescents and children, it’s so important to find out what the consequences are,” Dr. Cody Meissner, a member of the advisory committee, said at a panel discussion later Thursday, adding he is “worried” about the heart issue, NBC News reported.
He questioned if the condition will lead to scarring of the muscular tissue or arrhythmia.
“I think that’s unlikely but we don’t know that,” said Meissner, a professor of pediatrics at Tufts University School of Medicine.
Dr. Marion Gruber, director of the FDA’s vaccine office, said risk-benefit considerations to determine emergency use authorizations of the jab will need to take the inflammation cases into consideration, CBS News reported.
“Risk-benefit consideration will likely be different, not only compared to those for adults, but also they may be different for younger versus older pediatric groups,” Gruber said.
Dr. Scott Gottlieb, the former commissioner of the FDA, told CNBC Friday the condition needs to be thoroughly investigated.
“The question is what could be the connection between the vaccine and these observations? Is the vaccine creating some kind of inflammatory state that is then leading to this inflammation? And if so, what is the approach going to be?,” he said.
At this point, Gottleib said he believes the “risk benefit still favors vaccination,” however, questions could arise about decreasing the dosage for younger Americans.
“But if, in fact, you find a link between the vaccine and these cases of heart inflammation in younger patients, it could open questions like do you formulate the vaccine at a lower dose, which is already being done for much younger patients,” he told the program.
“So you want to get to the bottom of this so you can try to come up with an approach that mitigates this potential risk.”
Dr. Yvonne A. Maldonado, the chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said Thursday the new data has not led to any “recommended change to vaccination of adolescents 12 and older.”
When cases first started surfacing in late May, the AAP said it’s important for doctors to recognize the symptoms so they can be quickly addressed.
“We look forward to seeing more data about these cases so we can better understand if they are related to the vaccine or if they are coincidental,” Maldonado said in a May 24 news release.
“Meanwhile, it’s important for pediatricians and other clinicians to report any health concerns that arise after vaccination to VAERS (the Vaccine Adverse Event Reporting System) so we can systematically track and analyze them, and determine if they signal a real concern.”
The American Heart Association made similar remarks and said they “strongly urge” those 12 and up to still get the jab.
“We remain confident that the benefits of vaccination far exceed the very small, rare risks. The risks of vaccination are also far smaller than the risks of COVID-19 infection itself, including its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including myocarditis,” the AHA said.
“The recommendation for vaccination specifically includes people with cardiovascular risk factors such as high blood pressure, obesity and type 2 diabetes, those with heart disease, and heart attack and stroke survivors, because they are at much greater risk of an adverse outcome from the COVID-19 virus than they are from the vaccine.”
The AHA is yet to release any updated comments on guidance following the new data.
About 130 million people in the United States have received both doses of one of the mRNA vaccines.
With Post wires