The U.S. Centers for Disease Control and Prevention (CDC) is refusing to release updated information on reported cases of myocarditis and pericarditis following COVID-19 vaccination.
COVID-19 vaccines can cause the inflammatory conditions, the CDC has confirmed previously.
The agency has regularly conveyed the number of post-vaccination myocarditis and pericarditis cases to the Vaccine Adverse Event Reporting System (VAERS), which it helps manage, as it has consulted with its advisers on updates to the vaccines.
But during a meeting on Sept. 12, the CDC did not mention VAERS data.
Asked for the information, a CDC spokesman pointed to a CDC study that covers data only through Oct. 23, 2022.
That study identified nine reports of myocarditis or pericarditis following vaccination with one of the bivalent COVID-19 vaccines, which were introduced in September 2022. Seven of the reports were verified by medical review.
Asked for more current data, the spokesman acknowledged the agency has it but is not making it public.
"When appropriate, the updated safety data will be published," the spokesman told The Epoch Times in an email.
He did not answer when asked why the meeting was not an appropriate time.
"The CDC has acknowledged that heart inflammation is a complication of mRNA COVID-19 shots and, yet, the only published data released by CDC officials about that complication is a seven week study that ended on Oct. 23, 2022. Where is more specific myocarditis/pericarditis data related to bivalent COVID shots for the past 10 months?" Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email.
The mRNA shots are made by Pfizer and Moderna. Novavax's updated shot, which uses different technology, has not yet been authorized by the U.S. Food and Drug Administration (FDA).
"I am tired of the CDC and FDA deciding what information the public needs and doesn’t need. This is precisely the information that parents need to have especially when there are still schools and activities mandating these shots. This is evil playing out right before our eyes," Kim Witczak, a drug safety advocate who runs the nonprofit Woodymatters, told The Epoch Times in an email.
She added, "The CDC’s response of 'when appropriate, the updated safety data will be published' is unacceptable and they wonder why there is vaccine hesitancy and lack of trust in public health officials."
Presentation
During the recent meeting, CDC officials and their partners presented data on the bivalent shots to their advisory panel, the Advisory Committee on Immunization Practices. The advisers were considering which groups should be recommended to get one of the new COVID-19 vaccines, which were cleared by regulators with scant clinical trial data.
Dr. Nicola Klein, a Kaiser Permanente doctor who works closely with the CDC, gave a presentation (pdf) on COVID-19 vaccine safety. She presented data from the Vaccine Safety Datalink, a monitoring system that covers a much smaller population than VAERS.
Dr. Klein said that two cases of myocarditis after bivalent vaccination were detected in the Vaccine Safety Datalink (VSD) through March 11. It's not clear why more current data were not presented. Dr. Klein did not respond to a request for comment. The cases did not trigger a safety signal among adults, Dr. Klein said.
The presented data were widely cited by doctors quoted in news outlets, including Dr. Andrew Pavia, who told a briefing that there did not appear to be a "detectable risk" of the bivalent shots causing myocarditis.
"What I was conveying is that in the era of the bivalent vaccine, the number of cases has fallen to where it no longer is giving a signal that is detectable," Dr. Pavia, chief of the University of Utah's Division of Pediatric Infectious Diseases, told The Epoch Times in an email. In response to how he could say that with the missing VAERS data, he said "the strongest data are from the controlled studies like the VSD where you have built in controls."
Through Sept. 8, 98 cases of myocarditis, pericarditis, or myopericarditis were reported to VAERS following bivalent vaccination, according to a search of the system by The Epoch Times.
While anybody can lodge a report with VAERS, research has shown most reports are entered by health care providers. People who submit false information can face prosecution.
Five reports were for people aged 6 to 17 years while another 13 were for people aged 18 to 29.
When presenting to the panel, CDC official Megan Wallace said, "There are limited data to inform the myocarditis risk following an updated mRNA dose." She did not mention the cases reported to VAERS but alleged the benefits of the vaccines outweigh the risks, even for young, healthy males. The Vaccine Safety Datalink, she acknowledged, did have a "relatively lower sample size" of recipients.
Panel members were taken by the data. Dr. Oliver Brooks said "Feel good about the fact that in the bivalent we saw no signal from myocarditis," he said after the presentation. "Very important." Dr. Brooks, chief medical officer at Watts Healthcare Corporation, did not respond to an inquiry.
Dr. Pablo Sanchez, the only member to recommend against a widespread recommendation, said the risk of myocarditis was a reason.
"I think we really need to level with our patients and say what is known and unknown, rather than make a complete recommendation," he said, "especially for some groups that there are limited data."
The labels for the new vaccines say they can cause myocarditis.
"Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination," the labels state. While some people have recovered, others have not. The labels also say, "Information is not yet available about potential long-term sequelae."
