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May 13, 2024 Agency Capture COVID News

COVID

‘Do Your Job. We Beg of You’: FDA Officials Knew of COVID Vaccine Injuries in Early 2021 But Took No Action

FDA officials Dr. Janet Woodcock 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 but continued to promote them as “safe and effective,” according to documents obtained by Children’s Health Defense.

"fda" letters with broken covid vaccine bottle

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.

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.”

FDA, CDC pushed boosters despite knowledge of injuries

Emails Marks and Woodcock received at least as early as February 2021 from people injured by the vaccines indicate they were aware of the adverse events — even though that year, Woodcock publicly defended the vaccines.

In September 2021, Woodcock and Dr. Rochelle Walensky, the Centers for Disease Control and Prevention’s top official, signed a joint statement saying that COVID-19 vaccine protection was waning and that boosters are “needed to maximize vaccine-induced protection and prolong its durability.”

That month, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster shot to be administered to people 65 and older — and all adults at “high risk” of illness.

The FDA granted the EUA even though Pfizer didn’t test its booster in at-risk populations. Pfizer conducted only one Phase 1 study involving 12 people ages 65 and older.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations,” Woodcock said in a statement at the time.

And Marks said in a statement, “The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision.”

Yet, in a Feb. 21, 2021, email exchange (pages 133-134), someone injured by a COVID-19 vaccine informed Marks about their severe adverse reaction post-vaccination.

“I am a [redacted] who suffered a terrible reaction 30 minutes after receiving the first dose of the Pfizer Covid vaccine,” the email read. “I am still very symptomatic [redacted] out with severe paresthesias, chest tightness, tremor, dizziness, headaches.”

The email, initially sent to Dr. Alkis Togias, branch chief of Allergy, Asthma, and Airway Biology at the National Institute of Allergy and Infectious Diseases, also stated:

“I have subsequently been contacted by five other women who have had very similar neurological reactions to mine and are all quite ill weeks after receiving their vaccines. They have had similar difficulty in getting appropriate medical care as the medical community knows nothing about these reactions.

“They too have reported their reactions to the drug companies, the regulatory governmental agencies, and there has been no response or documentation of their reactions.

“It is apparent that these neurological reactions are not unheard of. Why are they not being addressed? Why are our reports being ignored?”

In a response that day, Togias said he forwarded the email to “colleagues at the FDA.” Later that day, Marks responded, “So sorry to hear of your symptoms. We take all adverse event reports seriously. I have asked our pharmacovigilance team to follow up with you. We certainly hope that you feel better soon.”

No further communications between Marks and the author of this email appear in the current or previous tranches of documents connected to this FOIA request.

‘Do your job. We beg of you.’

In a June 29, 2021, email (page 138) sent to Woodcock, another vaccine injury victim wrote, “I need to know what has happened to me. I have had severe burning paresthesias from head to toe since I received the Pfizer Covid vaccine [redacted]. I am in severe pain and incapacitated. I take medications seven times a day that do nothing.”

The email also stated:

“I have never heard of an illness like this. It is unbearable. I am barely surviving … There are 1000’s of others like me. No one in this country knows what has happened to us. We have reached out to every expert across the country, including the CDC [Centers for Disease Control and Prevention] and the NIH. …

“It is ridiculous and criminal that no one is talking about these reactions or trying to help us. It is time that we get the help that we need. Please. Stop gaslighting us and help us. We are innocent Americans who took the vaccine willingly with no informed consent and our lives have been taken from us.

“You have abandoned us. Please. It is your duty to acknowledge and help us. We are tired of writing these letters to you and pleading for help. Do your job and help us. We beg of you.”

Another email thread between Woodcock and a vaccine injury victim — spanning between Oct. 25, 2021, and June 2, 2022, (pages 15-25), initially also addressed to Marks and other federal public health officials — came from someone who sustained injuries after receiving the Johnson & Johnson (Janssen) COVID-19 vaccine.

In the initial Oct. 25, 2021, email (page 22), the person wrote that he/she “was vaccinated with Janssen/J&J on [redacted] to protect others and to model civic duty, to model it was safe and effective, and to lead through action. … I was determined to help do my part to stop and counter misinformation, disinformation, and hesitancy.”

“I was assured, and thankful for living in the United States where symptoms wouldn’t be suppressed, censored, or hidden and dismissed,” the email continued, later stating, “I never expected any of this to happen. I trusted the nurse who told me there were no adverse reactions to J&J, not even anaphylaxis.”

The author of the email noted “two major gaps that may be getting lost,” including “a major gap preventing creating a barrier to mandatory reporting all cases of Multisystem Inflammatory Syndrome [MIS] required in each of the EUA Fact Sheets for Healthcare Providers” and “A gap between research and practice — COVID-19 as a vascular disease — the research exists, but it is not making it to clinicians.”

The emailer also discussed difficulties reporting injuries to the Vaccine Adverse Event Reporting System (VAERS) and to Janssen, writing:

“While I reported to VAERS, my information was incorrect on the forward facing display. When I attempted to correct it based on medical records, it took multiple attempts until I was told it was against policy to update incorrect information.

“While I reported to Janssen, my adverse reaction reports went missing each of the first three case numbers I was provided, while I was seeing reports that there were no adverse reactions reported. … I kept resubmitting, and asking why I was told on three occasions there was no record of me in their system (even with audio-recorded calls).”

“You all are my last line of seeking answers and presenting what is known and what exists — in hope to see a logical explanation and know that once gaps are identified, there can be and will be change,” the author wrote.

During his congressional testimony in February, Marks said public health agencies “encourage[e] safety reporting” of adverse events, “very good safety surveillance mechanisms [were] in place,” the “COVID vaccines are the most closely monitored vaccines that have ever been rolled out in U.S. history” and claimed that numerous “false” reports are submitted to VAERS.

But Marks acknowledged the FDA was unprepared for the “avalanche of reports” of vaccine injuries it received. “We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS,” Marks said.

An Oct. 26, 2021, response from Woodcock (page 21) stated she was “looking through the documentation.” She said, “Let me absorb this information and I will get back to you,” she wrote. In a follow-up sent later that day, she added, “I have been looking into a variety of reports similar to yours. I will get back to you.”

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Yet no further communication appears in this email chain until May 7, 2022, when the injured person followed up with Woodcock (page 16), saying their concerns were “unresolved.”

“It is May 6, 2022 and most medical providers do not know MIS is possible following vaccination,” the individual stated, adding, in part:

“[I] have identified that the time of manufacture of my lot number coincides with the time of known contamination. I have multiple corroborating quantitative and biological data from medical and research tests for myself that show evidence of more than one type of spike protein in my blood, and antibodies to more than one type of spike glycoprotein. …

“… All of my requests for information so far have been dismissed, denied, or absence of response [sic] despite my attempt to obtain the most accurate information …

“I have followed up when NIH stated they had no intention of updating public facing websites to alert doctors of the neurological risks of vaccination. I have multiple sources of evidence now that demonstrate my neurological injury matches the pattern of other neurological vaccine injuries. … My vision injury matches what is seen in Traumatic Brain Injury patients. …

“Because FDA, CDC, NIH stated that the vaccines were safe and effective, I did not receive a diagnosis, rather, I was told by doctor after doctor and specialist after specialist that it was impossible because there are no adverse reactions from Janssen vaccination. Because of that, I did not receive early intervention for neurological injury that could have been addressed earlier. …

“There is still no notification to recipients of Janssen vaccination that there was known contamination. … In addition, my VAERS report is still inaccurate, and CDC has refused to update my report to match medically verified information including my [redacted] ER visits, and neurological injury persisting past a year.”

The individual also accused the FDA of negligence. “Because FDA did not ensure that informed consent consistently occurred, people are still being provided unapproved products and being told they are approved, as I was. This goes entirely against ethical protocols for administering an unapproved product and allowing such practices to continue because the statements are not clear.”

A May 7, 2022, reply from Woodcock stated, “Thank you for writing. You are connected to the right people here at FDA.” But despite additional follow-up emails sent by the injured individual on May 7, 2022, May 18, 2022, and June 2, 2022, no further replies from Woodcock or other public health officials appear to have been sent.

“The heads of these agencies need to be held responsible and disciplined appropriately,” Hertz said. “The dangers of these vaccines need to be made public and those impacted by the vaccines need to be helped and compensated appropriately.”

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