In a Feb. 15 hearing by the Select Subcommittee on the Coronavirus Pandemic, U.S. health officials side-stepped a question when asked whether the U.S. Food and Drug Administration (FDA) is actively conducting extended safety surveillance on those who received early COVID-19 vaccines.
Rep. Nicole Malliotakis (R-N.Y.) asked Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, whether the FDA is conducting active surveillance and if there are any specific health markers they’re studying that may signal trends requiring further inquiry.
“Every time we go through and do the safety surveillance, we start back, and it goes back to 2020. In some cases where we’re looking for certain things, we might use a different window, but indeed, we have to look from the beginning of the period of surveillance. I can turn it over to Dr. Jernigan because he can speak for CDC [Centers for Disease Control and Prevention] in that regard,” Dr. Marks said.
“So with regard to myocarditis, we certainly have been monitoring the issue with various different data systems. I think the most recent data really demonstrates that you’re about eight times less likely to get myocarditis if you’re vaccinated compared to those that are unvaccinated,” Dr. Daniel Jernigan, director of the National Center for Emerging and Zoonotic Infectious Diseases at the CDC responded.
Rep. Malliotakis told Jernigan she wanted to know about “everything,” not just myocarditis.
Dr. Jerrigan asked her to repeat the question, and she asked again whether the FDA was conducting extended safety surveillance on early recipients of COVID-19 vaccines.
“Most of the reports that we get of adverse events are in the few weeks following the vaccination,” Jernigan said. In terms of monitoring these over time, Jernigan said the agency has “vaccine effectiveness” systems in place at the CDC.
Neither Jernigan nor Marks referenced any active surveillance initiatives being undertaken by their agencies to monitor people who received the original COVID-19 vaccines for long-term health effects.
“There is no system in place for long-term vaccine safety surveillance in this country,” Ms. Liz Willner, founder of OpenVAERS, told The Epoch Times.
“The FDA and CDC do not actively search for safety signals. They did not find the myocarditis or the thrombosis with thrombocytopenia syndrome that led to the withdrawal of the J&J COVID vaccine—those signals were discovered by the European Medicines Agency. The Vaccine Safety Datalink has never corroborated any vaccine safety signals, including myocarditis, because you cannot find what you are not looking for,” she added.
According to the CDC, the Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system co-managed by the FDA and CDC that relies on individuals to send reports of their experiences to the agencies. It is not designed to determine whether a vaccine caused a health condition. The Vaccine Safety Datalink uses electronic health data from participating sites to monitor and assess the safety of vaccines and is not available to the public.
At one point during the hearing, Dr. Marks was asked whether COVID-19 vaccines have resulted in an increase in cancers and whether “turbo cancers” are real.
“I’m a hematologist oncologist that’s board certified. I don’t know what a turbo cancer is. It was a term that was used first in a paper in mouse experiments describing an inflammatory response,” Dr. Marks said. “We have not detected any increase in cancers with the COVID-19 vaccines.”
The inquiry was part of a long line of questioning to examine the government’s post-marketing surveillance of COVID-19 vaccine safety and the process for adjudication claims for compensation.
FDA Director Dr. Peter Marks said they tried to be prepared for reports that may come into VAERS but received a “tremendous” avalanche of adverse event reports after COVID-19 vaccines were released.
