Top federal health officials actively took steps to “delay warning the public” for months in 2021 about the potential risks of heart-related complications from receiving mRNA COVID-19 vaccines, a scathing interim report from Sen. Ron Johnson’s office alleges.
Starting in February 2021, federal health agencies had been alerted to “large reports of myocarditis” in young people who received the Pfizer vaccine, but waited until late June that year to adjust the vaccine labels to make that side effect known.
“Even though CDC and FDA officials were well aware of the risk of myocarditis following COVID-19 vaccination, the Biden administration opted to withhold issuing a formal warning to the public for months about the safety concerns, jeopardizing the health of young Americans,” the 54-page interim report said.
Myocarditis is an inflammatory condition of the heart muscle, while pericarditis entails inflammation of the lining sac around the heart. Myopericarditis is a combination of the two ailments.
Most patients who suffer from those side effects eventually experience “resolution of symptoms,” according to the Centers for Disease Control and Prevention (CDC).
During the time it took health officials to adjust the labels, doctors who warned about the potential risks of myocarditis among those who took the vaccine were subject to censorship, suppression or accusations of peddling misinformation.
Dr. Tracy Beth Hoeg, who consulted for Florida’s Department of Health as an epidemiologist at the time, had one of her tweets labeled “misleading” for making an observation about the risks of myocarditis that showed up in vaccine studies around June of 2021.
“Tasking nonexperts to adjudicate tweets on complex topics like myocarditis and mask efficacy data was destined for a significant error rate,” independent journalist David Zweig, who helped report on the Twitter Files, later reflected.
Even after health officials adjusted the labels, individuals who raised concerns about myocarditis were targeted. Philadelphia cardiology clinic owner Anish Koka’s Twitter account was suspended in September 2022 for ostensibly linking to a review of post-vaccine myocarditis. The account was later reinstated after Koka agreed to delete the tweet.
Johnson claimed that around the time of internal CDC deliberations over myocarditis, his office received “a growing number of letters” from doctors and other health care professionals who “experienced suppression and censoring of this information they [were] experiencing.”
His report explained that some available data raised concerns about myocarditis in early 2021, but top health brass really began examining the matter after Feb. 28, 2021 when an Israeli Ministry of Health official attempted to contact the CDC and Food and Drug Administration (FDA) about 40 cases of myocarditis and other heart-related ailments in young people from the Pfizer vaccine.
At the time, Israel had a much higher vaccination rate than the US, the report noted.
About 10 days later, an FDA official drafted a response noting that “limitations of passive surveillance … [and] incomplete data make it challenging to assess causation.”
US health officials requested more data from the Israelis.
By mid-April, a Defense Department contractor involved with the Pentagon’s work on immunization delivered a presentation to the COVID-19 Vaccine Safety Technical (VaST) working group that concluded “there is a high likelihood that cardiac symptoms following COVID-19 vaccination represent a hypersensitivity eosinophilic myocarditis.”
By this time, there had been more than 158 cases of myocarditis, pericarditis, or myopericarditis reported on the Vaccine Adverse Event Reporting System (VAERS).
The following month, the COVID-19 vaccine was approved for adolescents, and members of VaST “felt that information about reports of myocarditis should be communicated to providers.”
Top health officials also began deliberating on releasing a draft National Health Alert Network (HAN) warning about myocarditis and pericarditis side effects from the vaccine.
“The pros and cons of an official HAN are what the main discussions are right now,” CDC official Dr. Sara Oliver wrote to Moderna on May 25, 2021. “I think it’s likely to be a HAN since that is the CDC’s primary method of communications to clinicians and public health departments, but people don’t want to appear alarmist either.”
About a day later, then-FDA commissioner Dr. Janet Woodcock wrote in an email to then-CDC director Rochelle Walensky that the FDA was opposed to blasting out the warning as drafted.
Other top health officials raised objections as well. Then-director of the Center for Biologics Evaluation and Research, Peter Marks, expressed concerns that “myocarditis and pericarditis have not actually signaled.”
Another official raised concerns that the HAN was necessary because “messages have not been trickling from the vaccine programs to providers at large.”
Instead of issuing the HAN warning, the CDC put out a notice on its website on May 28, 2021, that there had been “increased cases of myocarditis and pericarditis” reported in the US following mRNA COVID-19 vaccination from Pfizer and Moderna, but continued to recommend immunization for those ages 12 and up.
Internal Biden administration talking points from this time period described myocarditis from the COVID-19 vaccine as “rare” and had been circulated to top health brass.
“It is unclear, though, whether these talking points, which minimized the risk and harm of myocarditis, had any effect on the decision not to issue the HAN,” Johnson’s report noted.
By this point, the number of VAERS reports had spiked to 752 cases.
Then, on June 25, 2021, the FDA updated the labels on the Pfizer and Moderna vaccines to note the risk of myocarditis and similar complications.
The report was made public one day after the FDA announced it was moving to tighten requirements for administering booster shots.
Johnson (R-Wis.) is the chair of the Senate Permanent Subcommittee on Investigations and has led multiple investigations into the government’s response to the COVID-19 pandemic.
“The full extent of the Biden administration’s failure to immediately warn the public about all COVID-19 vaccine adverse events must be completely exposed,” his report concluded.
“The American people fund the federal health departments and agencies with their hard-earned tax dollars. The information developed by these departments and agencies belongs to the American people.”
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