Senior Biden Food and Drug Administration (FDA) officials spent weeks casting doubt on reports of cardiac risks associated with the rollout of the COVID-19 vaccines to young adults and teenagers in the spring of 2021, according to a Senate report released Wednesday.
Among the officials named in the report is former FDA Center for Biologics Evaluation and Research Director Peter Marks — responsible for dubbing the mRNA COVID-19 vaccine development push “Operation Warp Speed”— who resigned from his post in March in opposition to what he described as Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s “unprecedented assault on scientific truth,” particularly on vaccines.
But a new interim report by the Senate Homeland Security and Governmental Affairs’ Select Permanent Subcommittee on Investigations — which draws on 2,473 subpoenaed documents — raises questions about Marks’ own judgement on the COVID-19 vaccine and the judgement of other Biden administration officials.
The report chronicles how early warning signs for myocarditis and pericarditis — inflammation of the heart muscle or heart lining — were first communicated to the Centers for Disease Control and Prevention (CDC) by February 2021. Yet Marks and longtime FDA official Janet Woodcock raised doubts about the need to disseminate a formal warning in May 2021, the Senate committee’s report alleges.
The doubts of the FDA officials in May 2021 apparently prompted the CDC to “walk back” planned language for its website about the need to restrict exercise after myocarditis or pericarditis, according to the Senate report.
“The Biden administration’s decision to downplay the COVID-19 vaccine health risks and delay warning the public about cardiac-related adverse events associated with the mRNA vaccines jeopardized the public’s health,” the report alleges.
HHS turned over the documents in response to a January subpoena issued by Wisconsin Sen. Ron Johnson, finally responding to yearslong requests that were either ignored or barely answered under the Biden presidency.
Marks and Woodcock could not be reached for comment.
In a hearing Wednesday about the report, Democratic Sen. Richard Blumenthal refuted the idea there had been a “coverup” of the risk of myocarditis or pericarditis by pointing to a May 14, 2021, communication from CDC’s National Center for Immunization and Respiratory Diseases to CDC grantees asking them to report any evidence of cardiac side effects.
FDA recently ordered the drugmakers to expand the population covered by myocarditis and pericarditis warnings from males 18 to 24 years old for Moderna’s vaccine and 12 to 17 years old for Pfizer’s vaccine, to males ages 16 to 25 for both products, CBS reported Wednesday, citing letters posted to the FDA website.
Timeline
As early as Feb. 28, 2021, the Israeli Ministry of Health reached out to CDC to request a point of contact to discuss reports of myocarditis in young people receiving the COVID-19 vaccine, the report shows.
“The Israeli National Focal Point is noticing a large number of reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine,” an email obtained by the committee reads.
The ministry had seen about 40 cases mostly in people from 16 to 30 years old, a separate CDC email indicates, according to the committee’s report.
By April 21, 2021, a cardiovascular immunologist working with the U.S. Defense Health Agency warned public health officials about an association between myocarditis and the COVID-19 vaccines, documents obtained by the committee show.
The immunologist, Renata Engler, also warned that V-safe, a surveillance program to monitor the safety of COVID-19 vaccines that the CDC rolled out in December 2020, may not fully capture the prevalence of this side effect, the Senate report states.
Users of the V-safe app were asked if they experienced 10 symptoms ranging from muscle aches to nausea, but were not asked about symptoms that could signal a cardiac problem like chest pain, palpitations or shortness of breath, according to the Engler’s presentation, which was obtained by the committee.
“If you do not ask, you will not see it, but does that mean it does not exist?” her presentation reads, according to the committee’s report.
Engler did not respond to a request for comment.
By mid-May, momentum for a warning to be issued was building within CDC, the report shows: On May 14, 2021, CDC received notice that the European Medicines Agency had asked the pharmaceutical companies Pfizer and Moderna for more information about the risk of myocarditis and pericarditis. On May 17, 2021, the CDC’s advisers on the issue, the COVID-19 Vaccine Safety Technical Work Group, stated that members “felt that information about reports of myocarditis should be communicated to providers.”
By May 23, 2021, the Senate report shows, the CDC had drafted a formal notice to clinicians about myocarditis and pericarditis risk in young people through the Health Action Network or “HAN” with an expected release of May 25, 2021.
But on May 26, 2021, Woodcock alerted CDC Director Rochelle Walensky that “FDA does not concur with the issuance of the myocarditis HAN as written,” according to an email obtained by the committee.
The HAN was nixed the same day, other emails obtained by the committee indicate.
Walensky did not respond to a request for comment.
The CDC pivoted to less formal communication of the possible side effect through “clinical considerations” posted to its website, the report states.
But Marks raised doubts about even that less formal action being necessary, according to another email obtained by the committee.
“I need to ask for your patience with me,” Marks wrote on May 26, 2021. “We still have concerns here if myocarditis and pericarditis have not actually signaled.”
“Can you help me understand why we are doing this when pediatricians and others in the community already seem to be aware?” he continued.
The next day, internal emails obtained by the committee show that CDC official Demetre Daskalakis pared back the planned language for the CDC website about myocarditis.
“One language change around management and then we can move it forward,” Daskalakis wrote in the email. “They want to walk back this sentence: ‘Due to concerns for sudden cardiac events while the heart recovers, consider restricting patients with myocarditis from rigorous activity like competitive sports for at least 3 months until cleared by a healthcare professional.’”
Daskalakis did not respond to a request for comment.
On May 28, 2021, CDC posted its planned “clinical considerations” on its website about myocarditis and pericarditis, which did not contain the sentence about the risk of exercise and sports, the report states.
Another month would elapse before the FDA moved to change patient and provider fact sheets on the Pfizer and Moderna vaccines to include information about the risk of myocarditis and pericarditis on June 25, 2021.
“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,” the committee’s report concludes.
Editor’s note: This article has been updated to include remarks from Sen. Richard Blumenthal at a Wednesday hearing on the report.
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