‘It shook my faith’: New report reveals Moderna failed to share damning data about its new booster with federal immunization advisers

Federal immunization advisers have expressed outrage that government scientists and pharmaceutical company Moderna failed to share damning data on its new booster shot during discussions over whether to foist it on the public.

according to a CNN report Infection data released Wednesday, conveniently withheld from both the U.S. Food and Drug Administration and Centers for Disease Control and Prevention immunization advisors last summer, “suggested the possibility that the updated booster shot might not be more effective at preventing it.” of Covid-19 infections than the original recordings.”

The data examining the impact of the booster dose on actual infections showed that “1.9% of study participants who received the original booster vaccine became infected,” while “those who received the updated bivalent vaccine – the one from which the Scientists hoped it would work better – a higher percentage, 3.2%, became infected.”

The FDA finally approved the Moderna bivalent vaccine on August 31. The agency reportedly only released the previously omitted infection data on September 13.

The Imperial Family Foundation reported that by December the US had purchased nearly 171 million doses of the bivalent booster for approximately $4.9 billion.

The CDC specified that as of January 4, over 48.2 million people aged 5 and over had received a bivalent booster dose. Approximately 33.6 million doses of Moderna’s updated booster were delivered and 17.5 million doses administered.

What is the background?

Twenty-one advisers to the Vaccines and Related Biological Products Advisory Committee met in the summer of 2022 to review the effectiveness and deployment of Moderna’s proposed new booster vaccine. Among the panellists were infectious disease experts and vaccinators from various prestigious universities.

CNN noted that there was a sense of urgency behind those talks, as it reportedly emerged quickly Immunity to the original COVID-19 vaccine decreased and that the first booster series had shown to be less effective against the Omicron strain.

Impressed by the apparent need to launch a new booster, on June 28, panelists listened to a presentation by Moderna President Stephen Hoge detailing the findings in a then-brand new version preprint study which his company had financed.

The study, which was neither peer-reviewed nor published in a medical journal, praised the bivalent booster and suggested it was “superior” in producing antibodies directed against the omicron variant.

Hoge reportedly neglected to mention the part of the to learn It states: “In participants with no previous SARS-CoV-2 infection, 11 of 339 participants (3.2%) experienced infections [new bivalent booster group] and in 5 of 266 participants (1.9%) in the [original booster group] Group after the booster.”

This infection data was based on an analysis of hundreds of patients, 16 of whom became infected. The study was neither randomized nor double-blind.

The consultants received a 22-page FDA briefing document that these infection dates were also omitted, CNN reported.

modern, profit oriented to push his new booster was apparently not the only one who left this data out.

dr Jerry Weir, director of the Viral Products Division in the FDA’s Office of Vaccines Research and Review, also made a presentation to the consultants and also neglected to mention these infection dates.

Not understanding that there was data showing that more bivalent-boosted subjects became infected than those without the booster, FDA advisers voted 19-2 to recommend its approval.

The FDA approved the booster shortly thereafter, and the U.S. government eventually purchased over $1.74 billion worth of cans from Moderna alone.

CNN noted that several months after FDA advisers met, Moderna still hasn’t released data from a randomized phase 3 trial that compared infections in people who received the original vaccine versus those who received the new one received booster vaccination.

Missed a second chance for transparency

Fourteen CDC advisors reportedly met on Sept. 1, the day after the FDA approved Moderna’s bivalent booster. Their job: to determine whether the agency should recommend a new syringe to Americans.

Once again, scientists gave lectures, and again the infection data did not emerge.

Along with the scientists, Jacqueline Miller, senior vice president at Moderna, made a presentation for the CDC advisors. As in the company president’s previous presentation to FDA immunization advisors, Miller also omitted the note that more bivalent-boosted subjects became infected than those who received only the original vaccine.

Kristen Nordlund, a spokeswoman for the CDC, suggested the agency was aware of the data, which it downplayed, claiming the study was not “designed to evaluate the vaccine’s effectiveness.”

A non-voting member of the advisory committee suggested that Nordlund’s rationale for allegedly ignoring the data was “very weak”.

dr William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, told CNN, “The data is limited, but it’s informative, and I think one would have expected a full presentation to include it.”

The CDC advisors, who disputed what Schaffner might otherwise have called a “full presentation,” ultimately voted 13-1 in favor of recommending the refresher.

Later that day CDC Director Rochelle P. Walensky endorsed the recommendations of the CDC Advisory Committee on Immunization Practices for the use of updated COVID-19 boosters from Pfizer-BioNTech for individuals 12 and older and Moderna for individuals 18 and older.

“The updated COVID-19 boosters are formulated to better protect against the last circulating COVID-19 variant. They can help restore protection that has waned since the previous vaccination and are designed to provide broader protection against newer variants,” Walensky said in a statement. “This recommendation followed extensive scientific evaluation and informed scientific discussion.”

setback

dr Paul Offit, a member of the FDA Advisory Committee, told CNN that the revelation that this data was withheld from CDC and FDA vaccine advisors ahead of approval and recommendation decisions “shook my faith. It shook my faith in those decisions.”

“I was upset to find out that there was data relevant to our decision that I couldn’t see. Upset because they should trust us to make the decision based on all the data,” Offit said

“Decisions that are made for the public must be made on the basis of all available information – not just some information, but all information,” he added. “These agencies, whether FDA or CDC, cannot make that decision for us. That is the point of an independent advisory committee.”

dr Arnold Monto, acting chair of the FDA Advisory Group, said, “There should always be full transparency. … This data should not be discarded. They’re early, but they indicate that we need to look at them and see what value they have.”

CDC vaccine advisor Dr. Pablo Sanchez noted that the data “should have been presented to the consultants before they made their decision.”

dr Philip Krause, former associate director of the FDA’s Office of Vaccine Research and Review, stressed that there was no excuse for excluding the data.

“The company’s failure to provide this information on the [FDA advisers meeting] and the omission of discussion of the data at this meeting raises questions about the ability of the process to allow for a full and transparent review of the data,” Krause said.

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