by Michael Nevradakis, Ph.D., Childrens Health Defense:
U.S. Food and Drug Administration (FDA) officials Dr. Janet Woodcock, 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, knew about COVID-19 vaccine injuries in early 2021, according to documents obtained by Children’s Health Defense (CHD).
The same documents revealed that Dr. Anthony Fauci knew COVID-19 vaccines were causing serious injuries within days of their rollout in December 2020.
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The latest documents show vaccine-injured individuals emailed Woodcock and Marks several times throughout 2021 and 2022 with pleas for help regarding their injuries — when they claimed the vaccines were “safe and effective.”
The 300-page batch of documents released on April 21 contains correspondence between the National Institutes of Health (NIH) and people who contacted the agency about injuries they sustained after receiving a COVID-19 vaccine.
CHD requested the documents via a Freedom of Information Act (FOIA) request in November 2022. On April 12, 2023, CHD sued the NIH to obtain the records after the NIH failed to respond to the FOIA request.
In an October 2023 settlement, the NIH agreed to produce up to 7,500 pages of documents at a rate of 300 pages per month.
Documents contradict FDA officials’ public statements
Between January 2021 and February 2022, Woodcock was the FDA’s acting commissioner. Previously, she led COVID-19 therapeutic development as director of the FDA’s Center for Drug Evaluation and Research. Marks has headed the Center for Biologics Evaluation and Research since 2016.
The documents contradict testimony and public statements Woodcock and Marks made in 2021 — and more recently — about the safety of the COVID-19 vaccines.
Dr. Joel Wallskog, a Wisconsin orthopedic surgeon who stopped practicing medicine after being injured by Moderna’s COVID-19 vaccine, told The Defender that public health officials “clearly privately were aware of these adverse events but continued to publicly communicate the ‘safe and effective’ narrative.”
Dr. Danice Hertz, a retired gastroenterologist from California who was injured by the Pfizer-BioNTech COVID-19 vaccine, frequently communicated by email with officials, including Marks. She told The Defender the documents reflect her own experience.
Hertz said she has amassed 160 pages of emails with Marks and other officials. She sent the first email in December 2020, when she first attempted to alert FDA officials about her injuries. She told The Defender:
“All this time, I have known that they were very aware of our pain and suffering yet chose to ignore us. It is clear from reading these documents that very serious and similar neurological injuries were occurring, yet these individuals continued to promote these vaccines without providing informed consent to the public about their dangers.”
Hertz said that by ignoring the multitude of complaints, FDA officials made it difficult for the vaccine-injured to be acknowledged and to get care for their injuries.
‘Why are our reports being ignored?’
Speaking to The New York Times on May 3, Woodcock said she believed that some of the vaccine-injured did experience injuries that were “serious” and “life-changing” beyond those officially recognized by federal agencies.
“I’m disappointed in myself,” she told the Times. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”
During congressional testimony in February, Marks downplayed the occurrence and frequency of adverse events related to the COVID-19 vaccines.
According to Marks, those adverse events include “some initial discomfort … in the arm” and “fatigue.” He said, “There are rarely more serious side effects,” noting that the FDA “identified myocarditis and rare allergic reactions” but “by putting mitigation strategies in place, both [have] decreased in occurrence.”
But during the hearing, Marks admitted that corners were cut.
“In order to get the vaccines to people in need when thousands of people were dying, we actually allowed the safety to be authorized with just two months of median follow-up, rather than the normal six to 12. But we were confident that that would capture adverse events.”
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