COVID
FDA Blew Off Scheduled Meetings With COVID Vaccine Injury Victims, Emails Show
Private emails obtained by Children’s Health Defense via a FOIA request reveal more evidence that government officials knew of, and were concerned about COVID-19 vaccine adverse events, but that they eventually stopped corresponding with vaccine injury victims.
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.”
Vaccine injury victims felt ‘very betrayed’
But while some people injured by the vaccines received replies and advice from NIH scientists, the latest documents showed that many others received no such replies. Some sent desperate emails to NIH scientists asking for help or an update.
For instance, in a Jan. 14, 2022, email (pages 234-235) to Nath, a vaccine-injured person praised Nath for his previous work helping the vaccine-injured, but then noted that he and other NIH scientists subsequently abandoned them. The email stated, in part:
“Dr. Safavi left a vaccine injured chat last September, something strange was going on. The active engagement from the spring and summer was replaced with distance and vague responses, then nothing. But then some people get telehealth visits, and vague responses … and others are told ‘there is no research’ and that’s it for them.
“I am sure you would understand now why the hundreds+ who were turned down for any assistance are now extremely upset after waiting for so long … many feel very betrayed. They have been waiting and waiting, all while suffering every single day. … The conversation isn’t happening. They are dying.”
Marks and other FDA officials appear to have met with vaccine-injured individuals a few months prior, according to an Aug. 18, 2021, email sent to Nath (page 283). In that email, the vaccine-injured person wrote:
“Our ‘injured’ MDs and I are meeting with peter marks and paul Richards [sic] at the FDA Monday morning. I have discussed this with Janet Woodcock and Paul for the last few weeks.
“Hopeful they will be willing to help us ‘nobodies’ in our quest to get medical help for people, or any sort of acknowledgement so people are able to begin dialogue with their home physicians.”
Some victims said Marks blew off scheduled meetings with them.
Dr. Danice Hertz, a retired gastroenterologist from California injured by the Pfizer-BioNTech COVID-19 shot she received in December 2020, previously told The Defender that she and a group of vaccine-injured individuals secured a Zoom meeting with Marks in early 2021 — which he then skipped.
Previously released documents from CHD’s lawsuit against the NIH contained emails showing that Marks and Woodcock were aware of reports about COVID-19 vaccine injuries in early 2021, including emails from injured people throughout 2021 and 2022 seeking help regarding their injuries.
Previously released documents also revealed that Dr. Anthony Fauci received such emails during the same period.
Other documents indicate that, as early as January 2022, NIH researchers were aware of at least 850 peer-reviewed case reports and/or research articles about COVID-19 vaccine reactions.
In one email (name and agency redacted), NIH researchers were told the federal government was “saddled” with the “mess” of dealing with those injured by the COVID-19 vaccines, due to the liability shield enjoyed by vaccine manufacturers.
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Marks, FDA still publicly claim COVID shots are safe and effective
Marks continues to promote the COVID-19 vaccines as safe and effective and downplay the extent and severity of vaccine-related adverse events.
Last month, he advised the public to get newly updated formulations of the COVID-19 shots, stating the new vaccines “meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.” He said vaccination “continues to be the cornerstone of COVID-19 prevention.”
In a subsequent interview with NPR though, Marks hedged on the question of how effective the new vaccines are.
“The vaccine is not intended to be perfect,” Marks said. “It’s not going to absolutely prevent COVID-19. … But if we can prevent people from getting serious cases that end them up in emergency rooms, hospitals or worse — dead — that’s what we’re trying to do with these vaccines.”
During congressional testimony in February, Marks said, “There was a signal for myocarditis or pericarditis only after the primary vaccination series with the Pfizer mRNA vaccine in those 12 to 17 years of age, and that now that signal is not being seen more recently.”
Marks also claimed that numerous false reports are submitted to the Vaccine Adverse Event Reporting System (VAERS), though other experts have disputed this assertion.
However, Marks also acknowledged that the FDA was overwhelmed with adverse event reports after the COVID-19 vaccines became available, stating that “the avalanche of reports was tremendous.”
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