FDA slaps damning warnings on COVID-19 vaccines; highlights Biden administration’s safety-risk gloss

Federal health authorities rebuked Florida Surgeon General Dr. Joseph Ladapo for suggesting in 2022 that the benefit of COVID-19 vaccination among healthy young men was outweighed by the risk of heart conditions, myocarditis in particular.

{snip}

“Our goal is not to get into like a fight or a tiff, because public health isn’t served well by this,” said Dr. Peter Marks, then-director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research. “Our goal is to help get to … an acceptance that there are overall benefits of these vaccines, despite the fact that yes, it is true that there could be some side effects.”

‘Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.’

Marks’ former agency has since acknowledged that there is a greater risk of post-vaccination myocarditis than the so-called experts were first willing to publicly admit.

Months after telling both vaccine manufacturers to include new safety information regarding their respective drugs in the stated interest of “radical transparency,” the FDA indicated on June 25 that it required Pfizer and Moderna to note the estimated unadjusted incidence of heart conditions following administration of the 2023-2024 formula of the Comirnaty and Spikevax vaccines, as well as the longitudinal results of a 2024 study concerning cardiac manifestations and outcomes of vaccine-associated myocarditis in American youths.

{snip}

For years, the fact sheets for the mRNA COVID-19 vaccines noted that reports of adverse events demonstrated increased risks of myocarditis and pericarditis, particularly following the second dose, and that the “observed risk is highest in males 12 through 17 years of age.”

Now, the package inserts state that “the observed risk has been highest in males 12 years through 24 years of age” and:

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

The package inserts for both drugs also now state:

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.

{snip}

When discussing the updates, Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, provided a refresher about the effort by the previous administration to downplay the risk of myocarditis.

Prasad, referring to congressional testimony given by Sen. Ron Johnson (R-Wis.) in May, noted that Centers for Disease Control and Prevention and the FDA officials were aware in early 2021 of a safety signal for the heart condition on the basis of Pentagon and Israeli data.

‘The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.’

{snip}

On May 26, 2021, then-acting FDA Commissioner Janet Woodcock told then-CDC Director Rochelle Walensky that the “FDA does not concur with the issuance of the myocarditis HAN as written.”

That day, both agencies reportedly decided to “nix the HAN” alert.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Woodcock stated the following month. “The benefits of COVID-19 vaccination continue to outweigh the risks, given the risk of COVID-19 diseases and related, potentially severe, complications.”

The nixed alert could have made a difference.

{snip}

FDA Commissioner Martin Makary and Prasad noted in a May article in the New England Journal of Medicine that “the FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”

Blaze News reached out to the FDA but did not immediately receive a response.