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FDA rejects experts' petition to relabel COVID vax as federal research confirms poor performance

False statements by Walensky, Fauci, Biden do not show "commonly held belief" that vaccines stop infectious and transmission, agency says.

Published: April 30, 2023 11:13pm

Updated: May 1, 2023 1:04pm

CDC Director Rochelle Walensky, former White House COVID adviser Anthony Fauci and especially President Biden repeatedly and falsely told Americans throughout 2021 that COVID-19 vaccines will protect them from infection and transmission.

Despite this trail of official misinformation, the Food and Drug Administration has rejected a "petition for administrative action" from prominent medical researchers to order vaccine manufacturers to set the public record straight through revised labeling requirements on trial design, results and adverse events.

The agency's rationale for inaction appears to undermine its own repeated warnings against treating COVID with ivermectin, an antiviral with a long safety record that few if any Americans are confirmed to have used unsafely in the COVID context.

COVID vaccine labels will remain largely unchanged, even as ongoing research provides further evidence of the poor performance of the two-strain bivalents, whose uptake has plateaued at 1 in 6 Americans, against evolving Omicron subvariants. 

A new study funded by the National Institutes of Health and coauthored by National Institute of Allergy and Infectious Diseases researchers found that Omicron-Wuhan boosters, approved based on mouse data, performed far better against "wildtype" and old Omicron subvariants in 18-49 year-olds who took the original monovalent booster, 77% of whom had prior infection.

For both BA.1 and BA.4/5 subvariants combined with the original strain, bivalents produced the fewest neutralizing antibodies for "currently circulating" strains: 8-22 times and 13-35 times lower against BQ.1.1 and XBB.1 than against BA.1 and D614G, and 4-12 times and 8-22 times lower than against BA.4/BA.5 and D614G.

The results "highlight ongoing concern that the breadth of antibody response from current updated vaccines is not optimal for the pace of virus evolution," they wrote in the journal Clinical Infectious Diseases, published by the Infectious Diseases Society of America. 

The new findings echo a CDC study that found bivalent boosters have less than 50% absolute effectiveness against symptomatic infection for every vaccinated adult age group compared to the unvaccinated. Earlier independent studies first sounded the alarm about bivalents' lack of improvement over monovalents.

The Coalition Advocating for Adequately Labeled Medicines filed the FDA petition in January, asking for several new labeling requirements for licensed and emergency use vaccines made by Pfizer and Moderna. 

Led by University of Maryland pharmacologist Linda Wastila, the coalition includes Marty Makary of Johns Hopkins, Vinay Prasad of the University of California San Francisco, UCLA's Patrick Whelan and Wastila's UMD colleague Peter Doshi, senior editor of the British Medical Journal, as well as Kim Witczak, consumer representative on the FDA's advisory committee for new drugs.

Labels should include language "clarifying" that phase III trials were neither "designed to determine" nor showed "substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death," reflecting the FDA's repeatedly stated uncertainty.

The petition cites false statements on infection and transmission by federal officials as well as arbitrary herd immunity thresholds invoked by Pfizer, Moderna and the FDA to induce vaccination. Walensky did it again in April by telling lawmakers vaccines stopped "wild-type" virus, an assertion the CDC contradicted when she said it in March 2021.

Pfizer's label should note the FDA authorized a new formulation with a different "buffer" without clinical studies, and that its phase III trials showed waning efficacy two months after the second dose and that data haven't been reported for pregnant women since their study ended in July.

The coalition wants myriad adverse events added to the label, including multisystem inflammatory syndrome in children, sudden cardiac death, decreased sperm concentration and "detection of vaccine mRNA in breastmilk," as well as "frequency data for clinical and subclinical myocarditis," perhaps the best known serious adverse event, which is associated mostly with young men.

The FDA granted one request — to revise Pfizer's bivalent label with updated clinical data — while denying the others as not required by regulation or necessary for "safe and effective use."

In its April 19 response letter, which came a day before Walensky's false statement to Congress about infection and transmission, the agency pointed to "countervailing statements" by Fauci and Walensky that acknowledged the trial design and transmission by vaccinated people with high viral loads. 

The petition has not shown a "commonly held belief" or "widespread misconception" in the public that "clinical trials provided substantial evidence of efficacy" against transmission, a condition not required for approval, the agency said. It noted the phrase on the current label is "active immunization to prevent ... disease."

The FDA did not show a "commonly held belief" that Americans would confuse animal and human dosages of ivermectin, however, before conflating the two in a series of public service announcements that often included references to horses.

The buffer switch in Pfizer's vaccine was an irrelevant "manufacturing change," while its failure to report trial data on pregnant women "may not bear on the safety of a drug," such as if a trial sponsor has trouble enrolling subjects, the response says. Waning efficacy after dose two is already covered by the fact sheet, which says protection duration is "currently unknown."

The FDA spends several pages answering the proposed adverse-event additions but ultimately finds the coalition has not shown "there is some basis to believe there is a causal relationship," concluding that updated labeling information would thus not be "useful to healthcare practitioners."

Wastila blasted the agency's response in comments to TrialSiteNews

"FDA, CDC, NIH, the White House, the media aggressively promote these products as preventing infection and transmission," she said, leading Americans to "get vaccinated and boosted to protect grandma, to travel safely, and to get back to normal ... Misinformation of the highest degree." 

The timing of the response is "curious" because the FDA has revoked the monovalent mRNA vaccines' authorization, leaving only emergency-use-authorized bivalents, she said, asking: "And where is the emergency?"

The FDA's newly stated disclaimer that prevention of infection and transmission is optional "is a weak defense against the widely accepted public notion that vaccines prevent transmission," a claim still made by the CDC, consumer representative Witczak wrote in an email.

She pointed to the CDC's COVID vaccine safety page, last updated Dec. 22, which says the therapeutics are "effective" in "limiting the spread" of SARS-CoV-2.

"As real world data started to emerged that disproved the efficacy, the FDA should have come clean with the public. Instead they remained quiet and the products were mandated in many settings based on CDC recommendations," especially universities and medical systems, Witczak said.

The FDA did not respond to Just the News queries about its "commonly held belief" rationale for rejecting updated labels in light of its conflation of animal and human dosages of ivermectin.

Its stated justification for the ivermectin warnings was "multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock," but it has apparently not specified how many or whether it confirmed them.

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