Despite public statements by government officials affirming the safety and efficacy of COVID-19 vaccines in early 2022, documents obtained by Children’s Health Defense (CHD) reveal that, at that time, public health officials were increasingly concerned about vaccine-related adverse events.
The 300 pages of documents released on Aug. 22 contain private correspondence from 2021 and early 2022 between U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials, and emails from vaccine-injured individuals to NIH scientists.
CHD requested the documents via a Freedom of Information Act (FOIA) request in 2022. In April 2023, CHD sued the NIH to obtain the records after the agency failed to respond. In an October 2023 settlement, the NIH agreed to produce 7,500 pages of documents at a rate of 300 pages per month.
Last month’s tranche of documents showed that in late 2021 and early 2022, FDA and NIH officials privately expressed concerns about the growing rate of adverse events related to the COVID-19 vaccines — concerns that reached high-level FDA officials.
A Jan. 24, 2022, email (pages 239-240) to Dr. Janet Woodcock, the FDA’s principal deputy commissioner of food and drugs, and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, alerted them to the existence of “scientific data” regarding adverse events.
The email, titled “Impromptu Meetup” and sent by an individual whose name is redacted, stated:
“We are in [Washington] DC the remainder of today and tomorrow. Some of our epidemiologists happen to be in town as well and would like to have the opportunity to review with you the scientific data they have.
“Also checking in to see what progress has been made with our researchers?”
In a reply later that day, Woodcock said, “We are evaluating the data and analyses that have been done on adverse events after vaccination, particularly neurologic AE’s” (adverse events).
However, she added that the FDA was “not having in person meetings” at that time but stated that “something could be set up for a discussion between the scientists but it would need to be scheduled to ensure the right people attend.” She did not clarify who the “right people” would be.
On the same day, Marks also responded to the email, stating that the FDA has “connected with” NIH researcher Dr. Avindra Nath — who was studying vaccine-related adverse events — and was “also working through contacting other physicians as well.”
Marks added that he “sent a note to our pharmacovigilance group to see if they can free up time today or tomorrow” but said that “setting up a virtual meeting at some point in the near future when there is more time to plan participants and the agenda may make sense.”
There is no indication as to whether this meeting ultimately took place.
The emails followed just months after another NIH scientist, Farinaz Safavi, M.D., Ph.D., of the NIH Division of Neuroimmunology and Neurovirology, appeared to acknowledge the potential dangers of COVID-19 boosters.
In a Sept. 30, 2021, email (page 129), Safavi told a vaccine-injured individual, “We do not have any data to suggest for or against booster shot [sic] but the consensus among our team is not to take if patient develop [sic] significant neurological complications post vaccine.”
The individual emailed Safavi earlier that day asking whether it was advisable to receive the then-new COVID-19 booster, despite saying that “nothing has really changed” regarding their symptoms.“I think my ears are still off, but I have gotten used to it.”
The injured person previously contacted Safavi earlier in 2021 complaining about injuries sustained following vaccination — describing in a March 26, 2021, email (page 136), “severe paresthesias in my face and scalp and tongue and chest band tightness,” and “severe muscle spasms in my scalp and jaw and even my gums and teeth hurt.”
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