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Moderna and officials at the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) withheld data on Moderna’s bivalent boosters from the agencies’ vaccine advisory committees last year when they met to discuss whether the shot should be authorized, CNN reported Wednesday.

Advisors said they were “disappointed” and “angry” that Moderna and government scientists had evidence they didn’t share showing that the bivalent boosters may have been less effective at preventing COVID-19 than the original shots.

Both advisory committees voted to recommend the shots.

Panel members interviewed by CNN said the data would not have changed their recommendation. However, they were upset by the “lack of transparency.”

“I was angry to find out that there was data that was relevant to our decision that I didn’t get to see,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory panel, who voted against authorizing the bivalent boosters. “Angry because they should trust us to make the decision based on all the data.”

“These agencies, whether it’s the FDA or CDC, can’t make that decision for us. That’s the point of having an independent advisory committee,” he added.

Offit authored an article published Wednesday in the New England Journal of Medicine (NEJM) criticizing the bivalent boosters and concluding:

“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later.”

Two studies published this week in the NEJM suggested the bivalent boosters offer no extra protection against the virus, according to U.S. News & World Report.

Previous studies by researchers at Harvard and Columbia and an analysis of CDC data by experts at Children’s Health Defense also showed the new boosters were not significantly more effective than the original vaccines.

U.S. taxpayers spent nearly $5 billion on boosters, which the federal government purchases and makes available at no cost to consumers, contributing to the combined $93.2 billion in profits that Pfizer and Moderna are projected to make from the vaccines in 2022.

Former FDA official: ‘no excuse’ for excluding the data

CNN exposed the latest in a series of questions experts have raised concerning different aspects of the booster approval process.

Scientists expressed concerns last year that the clinical data from human subjects was gathered from boosters designed to treat the first version of Omicron, known as BA.1.

But when other variants became dominant, Pfizer and Moderna reformulated the booster to target the BA.5 variant. They did not have time to complete new trials on humans with the reformulated doses for their targeted fall booster rollout — so the vaccines were tested only in mice, CNBC reported.

Moreover, the FDA and CDC approved the boosters based on older data — some of which was withheld, as CNN detailed — from a previous version of the bivalent booster.

The FDA and CDC met in June and September 2022 respectively. According to CNN, at the June meeting, the FDA and Moderna presented data on the vaccines to the committee, including immunogenicity data showing how well each vaccine produced antibodies against a previous Omicron strain of COVID-19.

The data indicated that the bivalent vaccine “worked better” than the original vaccine.

Pfizer also presented data to the committee indicating its two COVID-19 vaccine boosters targeting Omicron showed a higher immune response than its existing COVID-19 vaccine, although it was not mentioned in yesterday’s CNN report.

The withheld data examined the rate of actual infections post-vaccination. Neither Moderna’s president Stephen Hoge nor the FDA’s Dr. Jerry Weir mentioned the data in their presentations.

A 22-page FDA briefing document given to the advisors did not mention this infection data either.

The infection data demonstrated that 1.9% of study participants who received the original booster became infected with COVID-19 and 3.2% of those who received the bivalent booster became infected.

The “serious limitations” of this study, according to CNN, were that it was small, not double-blind and not peer-reviewed at the time.

The data was posted online prior to meetings as a preprint.

The FDA said the agency did not include the data in its presentation because officials received it shortly before the meeting and “generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.”

CNN interviewed six advisors from the two panels who all expressed frustration at not being shown the study.

“It’s not a group of children,” said Dr. Eric Rubin, a member of the FDA vaccine advisory committee. “We understand how to interpret these results.”

Dr. Philip Krause, deputy director of the FDA’s Office of Vaccine Research and Review until his October 2021 resignation, said:

“I don’t think there’s any excuse for excluding it [the infection data] …

“The FDA’s objective review of the data is what is providing the great, great value to the American people, because this way they know that somebody who doesn’t have a stake in the outcome has looked at the deepest possible level at these data.”

In interviews, the advisors said they should have access to all available data to make their decision. They said because the meetings are livestreamed, other regulatory agencies around the world use and rely on that data, as does the general public.

At the close of the June 28 meeting, the FDA advisors voted 19-2 to recommend the bivalent booster. Offit and Dr. Henry Bernstein, a professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell, voted against recommending the shots.

On Aug. 31, 2022, the FDA authorized the bivalent boosters. They included the Moderna infection data in their written decision.

CDC ‘aware’ of data but also didn’t mention it

In the September 2022 CDC advisory council meeting, CDC scientists and Moderna’s Dr. Jacqueline Miller also excluded Moderna’s infection data from their presentations.

Kristen Nordlund, a CDC spokeswoman, acknowledged the “CDC was aware” of the data but indicated they excluded it because of its limitations.

The data would later be published in the NEJM.

The CDC advisors voted 13-1 in favor of recommending the bivalent booster for Americans in fall 2022. Dr. Pablo Sanchez, a professor of pediatrics at the Ohio State University College of Medicine, voted in opposition.

CDC Director Dr. Rochelle Walensky signed off on the recommendation later that day, and the vaccines were made available to the public. They are the only boosters available once someone has had their primary series of a COVID-19 vaccine.

Pfizer said it doesn’t “currently have data on incidence of infection post bivalent booster. However, we continue to monitor real-world data and collect data from our own studies,” according to a statement provided to CNN from Jerica Pitts, senior director of global media relations.

Offit: ‘I didn’t see the benefits’ 

In an interview with ZDoggMD following the meetings in July, Offit said the FDA advisory panel meeting was unusual and he believed the panel was led to “vote yes” to reformulated boosters without critical data, The Defender reported.

He said:

“I’ve seen nothing like this. I guess the thing that’s most upsetting to me is normally when you get something from the FDA when we have these meetings, you usually get it a few days before you meet. You usually get a couple of hundred pages.

“Here on the other hand, normally you get the EUA [Emergency Use Authorization] submission from the company, which is 85 to 100 pages long, and then you get the FDA’s review of all those data. It’s a very thorough review. Not here though. Here, it was 22 pages from the FDA, which included a half-page on Pfizer’s data and a half-page on Moderna’s data.”

The question vaccine advisors are always asked to consider in the end is whether the benefits outweigh the risks — even if the risks are generally small and sometimes unknown, Offit said. “I didn’t see the benefits.”

Offit said he was surprised that out of 21 voting members, 19 voted “yes” because he “just didn’t see the evidence for that.”

“I think this was something that was desired by the Biden administration,” he added.

In August 2022, U.K. regulators approved Moderna’s bivalent booster, after complaints about a lack of demand for shots.

“We have a big demand problem,” Moderna CEO Stéphane Bancel said in May 2022, during a panel discussion at the World Economic Forum’s meeting in Davos, Switzerland.

Similarly, in the U.S., pharmacies, states and federal agencies have tossed 82.1 million COVID-19 vaccine doses in the trash due to lack of demand, Dr. Joseph Mercola reported.

Writing in The Defender last September, Dr. Meryl Nass, an internist with special interests in vaccine-induced illnesses, explained that the authorization of the bivalent Pfizer and Moderna COVID-19 vaccines without any human trials on the approved version of the booster was historically unprecedented.

This made it particularly concerning and “risky,” according to Drs. Peter McCullough, Meryl Nass and Michelle Perro, that the Pfizer booster was approved for babies as young as 6 months old.

COVID vaccine critics weigh in on CNN report

Commenting on the CNN article, Dr. Robert Malone wrote that CNN “seems to be seeking some sort of shelter from the coming storm of data and public awakening to the shocking reality of what has been done to them by federal genetic vaccine propaganda, coercion, mandates, bungled policies and stacked layers of COVID crisis lies.”

Malone, author of “Lies My Gov’t Told Me: And the Better Future Coming,” also wrote:

“The CNN article provides an amazing summary of so much of what has gone wrong with the regulatory approval and authorization for these mRNA vaccine products originally intended to protect us from infection, replication, and spread, and to enable us all to achieve herd immunity. Remember that, way back when?

“But then we learned that does not happen, and they changed the goalposts to protecting from disease and death. And now not even THAT limited hangout can be defended, except by only citing old data and ignoring current data.”

Igor Chudov, an outspoken critic of COVID-19 vaccines, also commented on CNN’s revelations, writing:

“FDA charlatans approved the Moderna bivalent Covid booster for millions of people based on antibodies in TEN MICE (who all got sick with Covid when challenged with the virus).

“And now, the FDA advisers are ‘angry’ that Moderna did not present real-life data showing that bivalent-boosted people are 68% (3.2/1.9) more likely to get Covid.

“Why did they not get angry several months before?

“The data that was not presented was available in plain sight!”

Massive profits for Pfizer and Moderna 

More than a month before the FDA gave its thumbs up to the entirely new booster formulation, the federal government ordered 105 million doses from Pfizer and more than 65 million doses from Moderna.

The contract with Pfizer was for $3.2 billion and the contract with Moderna was for $1.74 billion.

Moderna made nearly $18 billion in 2021, and reported Monday that it met its 2022 forecasts, generating about $18.4 billion in profits for 2022.

Pfizer made nearly $37 billion in profits in 2021 and projected that it would make approximately $32 billion in 2022, with another $22 billion profit from Paxlovid, their drug to treat COVID-19.

In 2021, Oxfam reported these profits averaged $65,000 per minute.

Both Moderna and Pfizer are considering charging $110 to $130 per dose for their COVID-19 vaccines in the U.S. when they shift from government contracting to commercial distribution.

The price hike would quadruple the price of the vaccine in a move that Sen. Bernie Sanders (I.-Vt.) called out as “outrageous” and “unacceptable corporate greed.”

Sanders, the incoming chairman of the Senate Health Committee, sent a letter to Bancel urging the company to refrain from any price increase.

He said because the government had supported Moderna and the vaccine had been developed in partnership with scientists at the National Institutes of Health, a taxpayer-funded agency, Moderna should not seek such high profits.

“Let’s be clear,” Sanders wrote. “The purpose of the recent taxpayer investment in Moderna was to protect the health and lives of the American people, not to turn a handful of corporate executives and investors into multi-billionaires,” he said.