ST. PETERSBURG, Fla. — Incorrect and misleading is how the heads of the Centers for Disease Control and Prevention and the Food and Drug Administration characterized recent warnings issued by Florida’s top doc about the safety of COVID-19 vaccines.
In a letter sent to the two federal agencies in February, Florida Surgeon General Dr. Joseph Ladapo said increased VAERS reports indicated an increase in risk associated with the COVID-19 vaccines.
VAERS is the Vaccine Adverse Event Reporting System, a database managed by the CDC and the FDA. A disclaimer on the VAERS website warns submissions “may include incomplete, inaccurate, coincidental and unverified information.”
In a response addressed to Ladapo on March 10, FDA Commissioner Robert Califf and CDC Director Rochelle Walensky wrote, “focusing on adverse events in the absence of causal association and without the perspective of countervailing benefits is a great disservice to both individuals and public health.”
Califf and Walensky said reports of adverse events to VAERS following vaccination do not mean the vaccine caused the event, adding that the Emergency Use Authorizations for the COVID-19 vaccines require providers to report certain adverse events through VAERS.
“So more reports should be expected,” they said.
Ladapo called for more research into short- and long-term side effects in his February letter, which the FDA and CDC said has been happening.
“FDA and CDC physicians are continuously screening and analyzing VAERS data for possible safety concerns,” Califf and Walensky said, pointing to an increase in reports of cardiovascular events which lead to further analysis.
“Despite increased reports of these events, when the concern was examined in detail by cardiovascular experts, the risk of stroke and heart attack was actually lower in people who had been vaccinated, not higher,” they said.
In addition to VAERS, the FDA and CDC also utilize other active surveillance systems to monitor the safety of COVID-19 vaccines, including the FDA’s Sentinel BEST system and the CDC’s Vaccine Safety Datalink and a text-based monitoring system.
More than 13 billion doses of COVID-19 vaccines have been given globally, including hundreds of millions of doses of mRNA vaccines. According to the CDC, nearly 42 million COVID-19 vaccine doses have been administered in Florida.
Last year, under Ladapo’s direction, Florida became the first state to recommend against the COVID vaccine for “healthy” kids, despite studies cited by the state concluding vaccines are safe and effective.
The state has also recommended against the vaccine for some men due to cardiac complications, according to their analysis, but scientists said it lacks evidence.