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

Florida Surgeon General Dr. Joseph Ladapo in Tampa, Fla., on Oct. 15, 2022. York Du/The Epoch Times

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

“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 Dr. Robert Califf, commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).

The Pfizer and Moderna COVID-19 vaccines use 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 COVID-19 pandemic. He told Califf and Walensky that they should acknowledge serious side effects and stop claiming that the vaccines are safe and effective. Among his citations is a study that found that 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 events because of the emergency use authorization of the vaccines.

They also noted that problems suffered after vaccination aren’t 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 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 that a bivalent booster provided a boost of just 50 percent or less in 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 states 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 dose.

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 didn’t address studies that have reached concerning conclusions, including one that found an increase in acute cardiac events following mRNA COVID-19 vaccination.

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

A reanalysis of Moderna and Pfizer trial data found that vaccinated people were actually at higher risk of some serious adverse events, such as coagulation disorder, or blood clotting problems. The overall risk was 1 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.”

He 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.

Ladapo 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 that 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,” he 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 didn’t respond to requests by The Epoch Times for comment.

Food and Drug Administration Commissioner Dr. Robert Califf speaks to members of Congress 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 isn’t allowing anyone else to sign up for v-safe as of May 19, it stated in a recent update. After May 19, people who already signed up won’t be able to add additional doses to their accounts.

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

“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’s website reads.

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 a group of lawyers that included 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 in an 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.”