Top health officials were aware of and actively took steps to “delay warning the public” for months in 2021 about the potential risks of patients suffering from heart-related complications as a result of 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 COVID-19 vaccine, but waited until late June of 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 and 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.
On Feb. 28, 2021, an Israeli Ministry of Health official attempted to contact the CDC and Food and Drug Administration 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…incomplete data make it challenging to assess causation.” US health officials also began requesting 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.”
Around this time, there had been well over 158 cases 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 over 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 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, for example expressed concerns that “myocarditis and pericarditis have not actually signaled.”
Another officials raised concerns that the HAN was necessary because “messages have not been trickling from the vaccine programs to providers at large.”
Johnson’s interim report featured internal communications between health officials, Pfizer and Moderna, briefing them on their deliberations.
Instead of issuing the HAN warning, the CDC put out a notice May 28, 2021, on its website 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 obtained by Johnson’s investigation described myocarditis from 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 to not issue the HAN,” Johnson’s report noted.
By this point, VAERS reports 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 other similar complications.
Internal deliberations over myocarditis and other adverse vaccine effects came against the backdrop of a global pandemic that had uppended the country. Officials raced to boost vaccination to curtail COVID-19-related deaths and hospital overflows.
The vaccines were developed within a record-breaking speed of under a year.
Recently, under the Trump administration, the FDA has moved to tighten requirements for administering booster shots.
Johnson is the chair of the Senate Permanent Subcommittee on Investigations and has led a variety of different investigations into the government’s response to the COVID-19 pandemic.
The interim report his team released Wednesday is just one of several different COVID-19-related topics being probed and comes ahead of his committee’s first hearing of the year to discuss the issue of how health officials handled the myocarditis concerns.
In addition to dropping the report, Johnson’s panel also released 2,400 pages from a trove of documents that his team uncovered via subpoenas and other methods over the past five years.
“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 belong to the American people.”
