‘Time to Ground the Plane’: FDA Advisers Recommend JN.1 COVID Vaccines Despite Growing Evidence of Cancer Risks
In a unanimous 16-0 vote, the U.S. Food and Drug Administration’s vaccine advisory committee today recommended a monovalent JN.1-lineage for the 2024-2025 COVID-19 vaccine formula. Critics countered that the vaccines’ risks outweigh the benefits.
In a unanimous 16-0 vote, the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee today recommended a monovalent JN.1-lineage vaccine composition for 2024-2025 Formula for COVID-19 vaccines.
The JN.1 variant has been most dominant this year, Reuters reported.
Last year, the agency’s committee recommended COVID-19 vaccines targeting XBB.1.5, a subvariant of Omicron that dominated the U.S. from November 2021 to 2022.
The committee today also discussed which specific strains within the JN.1-lineage group — such as subvariants KP.2 and KP.3 — the vaccines should target. The FDA said it will later issue an official recommendation to manufacturers about what subvariants it wants to target within the JN.1-lineage group.
David Wiseman, Ph.D., a bioscience researcher, told the committee that in recommending continued COVID-19 vaccination, the FDA may be putting the U.S. public’s health at risk. “Based on the totality of evidence, it is reasonable to believe that the product [COVID-19 vaccines] may be unsafe,” he said.
Wiseman, who spoke during the meeting’s public comment time, recently testified before the Texas Senate about the recent uptick in cancers in the U.S.
Cancer trends during the COVID-19 vaccination era are “widely recognized,” Wiseman said, yet Pfizer failed to test its COVID-19 vaccines for cancer effects.
Wiseman also cited evidence obtained by Health Canada showing Pfizer chose not to disclose to regulatory authorities SV40 sequences that may be linked to cancer.
“As guardians of public trust, where is FDA’s censure of Pfizer?” he asked.
Wiseman also pointed out that the FDA in February testified before a U.S. House of Representatives committee that its officials “have not detected any increase in cancers with the COVID-19 vaccines” — yet the CDC had already generated numerous possible safety signals.
“FDA must investigate cancer signals,” he said.
He referenced the comment by Pfizer’s former head of vaccine R&D, Kathrin Jansen, when describing Pfizer’s development of the COVID-19 vaccines. “We flew the aeroplane while we were still building it,” she said.
“It’s time to ground the plane,” Wiseman said.
The FDA committee’s decision to recommend an updated COVID-19 vaccine also drew criticism from Dr. Mary Tally Bowden, who was suspended from Houston Methodist Hospital during the COVID-19 pandemic for treating COVID-19 patients with ivermectin.
“The FDA needs to pull the COVID shots off the market immediately,” she told The Defender. “Any other product with the types of reactions we have seen would have been pulled off the market a long time ago.”
Bowden was one of three doctors who sued the FDA to stop the agency from giving unlawful medical advice about the off-label use of ivermectin to treat or prevent COVID-19.
The FDA in March settled the suit, agreeing to remove its “You are not a horse” posts discouraging ivermectin use from Facebook, Twitter (now X) and LinkedIn.
COVID hospitalizations at all-time low
Before today’s vote, the FDA’s vaccine advisory committee heard presentations from top researchers at the Centers for Disease Control and Prevention (CDC) and representatives of Pfizer/BioNTech, Moderna and Novavax.
Natalie Thornberg, Ph.D. — the CDC’s lead microbiologist for its respiratory virus immunology division — presented data on current COVID-19 infection levels in the U.S.
One of her slides showed current hospitalizations from COVID-19 are the lowest they have ever been.
She also shared data showing that positive COVID-19 tests and deaths from COVID-19 are also at an all-time low.
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No mention of COVID vaccine injury reports
Thornberg did not mention the 1,637,441reports of injury following a COVID-19 vaccination filed in the Vaccine Adverse Event Reporting System (VAERS) between Dec. 14, 2020, and April 26, 2024.
VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
More than 61,000 of those reports involved children ages 6-17. More than 9,700 involved kids 5 and under.
Thornberg shared the results of a study that showed JN.1 elicited the same severity of symptoms as XBB.
During the public hearing part of the meeting, some commenters urged the FDA to make COVID-19 shots available in early, rather than late, fall.
Amy Harth, Ph.D., said she was concerned about getting a COVID-19 infection and asked the FDA to allow non-immunocompromised adults such as herself to get COVID-19 vaccines twice a year, rather than once a year.
Karl Jablonowski, Ph.D., who attended the meeting, noted that Harth pondered aloud why the agency would only authorize adults to receive one shot a year if they are truly safe.
“Are these shots not as safe as you claim?” she asked.
Jablonowski, a member of the Children’s Health Defense science department, pointed out that Harth “blatantly asked” if COVID-19 vaccines have an “unstated risk.”
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