Florida Surgeon General Hits Back at FDA, CDC Over COVID-19 Vaccine Safety
Florida Surgeon General Hits Back at FDA, CDC Over COVID-19 Vaccine Safety

By Zachary Stieber

U.S. officials are gaslighting the public about COVID-19 vaccine safety, a top Florida public health official says, as he urged the officials to investigate concerns with the shots.

“Your ongoing decision to ignore many of the risks associated with mRNA COVID-19 vaccines, alongside your efforts to manipulate the public into thinking they are harmless, have resulted in deep distrust in the American health care system,” Dr. Joseph Ladapo, Florida’s surgeon general, wrote in a new letter to Drs. Robert Califf and Rochelle Walensky.

The Pfizer and Moderna COVID-19 vaccines utilize messenger RNA, or mRNA, technology.

Ladapo raised the alarm in an alert in February, noting that the number of reported adverse events following a COVID-19 vaccination had spiked well above the increase in overall vaccine administration during the pandemic. He told Califf, the head of the U.S. Food and Drug Administration (FDA), and Walensky, the head of the U.S. Centers for Disease Control and Prevention (CDC), that they should acknowledge serious side effects and stop claiming the vaccines are safe and effective. Among his citations: a study that found the mRNA vaccines were linked to an excess risk of some serious adverse events.

Walensky and Califf responded by claiming that more reports of adverse events were expected because vaccine companies and health care workers were required to report certain ones due to the vaccines being under emergency authorization.

They also noted that just because a person suffered a problem after vaccination, the problem was not necessarily caused by the vaccine.

“Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event,” they said.

Walensky and Califf also said that virtually every person should get a primary series of a vaccine and a bivalent booster.

“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” the officials said.

They largely cited non-peer-reviewed studies published by the CDC’s quasi-journal, including a study that found a bivalent booster provided a boost of just 50 percent or less protection against symptomatic infection.

The FDA authorized the Moderna and Pfizer bivalent vaccines as boosters without clinical trial data, and the CDC recommended them to most Americans. The FDA has since replaced the old Moderna and Pfizer vaccines with the bivalents even though no efficacy estimates from trials have been published. The CDC now says that unvaccinated people should get a single dose of one of the vaccines, down from at least three doses, and that certain populations should get an additional shot.

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky in Washington on Feb. 8, 2023. (Drew Angerer/Getty Images)

Ignored Studies

In their response, Walensky and Califf decried “misinformation about COVID-19 vaccine safety” that they said, “has caused some Americans to avoid getting the vaccines they need to be up to date.” They did not address studies that have reached concerning conclusions, including one that found an increase in acute cardiac events following mRNA COVID-19 vaccination.

Ladapo in the new missive said that the officials were ignoring scientific evidence indicating a poor safety profile, including data from the CDC’s v-safe system, which showed that many vaccinated people were unable to conduct normal activities after being vaccinated.

reanalysis of Moderna and Pfizer trial data, meanwhile, found vaccinated people were actually at higher risk of some serious adverse events such as coagulation disorder, or blood clotting problems. The overall risk was one in 550, researchers said.

“As you are aware, this is extraordinarily high for a vaccine. In comparison, the risk of serious adverse events after influenza vaccination is much lower,” Ladapo wrote. “For you to claim that serious adverse events such as these are ‘rare’ when Pfizer and Moderna’s clinical trial data indicate they are not, is a startling exercise in disinformation.”

Ladapo said U.S. officials appear poised to promote new vaccines to Americans without properly weighing data on risks and benefits and urged them to publicly release data and answer pressing questions, including their interpretations of a Thailand study that found a high incidence of heart injury in young boys after mRNA vaccination and a Swiss study that found a high incidence of heart injury in adults following receipt of an mRNA booster.

He also said officials should explain why they left out certain adverse events that were forecasted to potentially be caused by the vaccines off of surveys the CDC sent to vaccinated people.

“Your organizations are the main entities promoting vaccine hesitancy—Florida promotes the truth. It is our duty to provide all information within our power to individuals so they can make their own informed health care decisions,” Ladapo said. “A lack of transparency only harms Americans’ faith in science. I, Floridians, and people around the world await your response.”

The CDC and FDA did not respond to requests for comment.

Food and Drug Administration Commissioner Robert Califf speaks to members of Congress in Washington on June 16, 2022. (Joe Raedle/Getty Images)

V-Safe Update

It’s not clear who made the decision to leave the adverse events, including myocarditis, a condition now known to be caused by the mRNA vaccines, off of the surveys sent to v-safe participants. A Freedom of Information Act request seeking all communications and other documents related to the decision turned up no documents, the CDC told The Epoch Times on May 11.

V-safe is a new program started by the CDC during the pandemic that relies on users reporting issues through smartphones.

The agency is not allowing anyone else to sign up for v-safe as of May 19, it said in a recent update. After May 19, people who already signed up will not be able to add additional doses to their account.

Participants can still log information pertaining to their health until June 30. After that date, participants will no longer have access to their account.

“At this point in the program, very little new data are being reported to the v-safe system. V-safe was developed specifically for COVID-19 vaccines and has been an essential component of the pandemic vaccine safety monitoring systems that have successfully and comprehensively characterized the safety of the COVID-19 vaccines used in the United States,” the CDC says on its website.

The agency is developing a new version of the system, “which will allow users to share their post-vaccination experiences with new vaccines.”

The CDC had refused to release raw v-safe data until forced by a judge in a case brought by the Informed Consent Action Network, represented by lawyers including Aaron Siri.

Siri questioned the decision to end the monitoring.

“To date, v-safe is the only unfiltered vaccine safety data that is available to the public, despite the fact that the agency has required multiple legal actions to obtain it, and if CDC ends the v-safe program or changes it in a way that significantly affects this transparency, that would be alarming,” Siri told The Epoch Times via email. “It is already unclear why participants will lose access to their own entries after June 30. It will be interesting to see what the new version of v-safe entails and whether or not users are still invited to complete free-text fields where they can share any information they choose with CDC.”


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