Federal vaccine advisers have expressed their outrage that government scientists and the pharmaceutical company Moderna neglected to share damning data about its new booster shot during discussions about whether it should be foisted upon the public.
According to a CNN report published Wednesday, the infection data that was conveniently withheld from both U.S. Food and Drug Administration and Centers for Disease Control and Prevention vaccine advisers last summer "suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots."
The data, which looked at the booster's impact on actual infections, indicated that "1.9% of the study participants who received the original booster became infected" whereas "those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected."
The FDA ultimately authorized the Moderna bivalent vaccine on Aug. 31. The agency reportedly did not publicize the previously omitted infection data until Sept. 13.
The Kaiser Family Foundation reported that as of December, the U.S. had purchased nearly 171 million doses of the bivalent booster for approximately $4.9 billion.
The CDC indicated that over 48.2 million people ages 5 and older had been given a bivalent booster dose as of Jan. 4. Approximately 33.6 million doses of Moderna's updated booster have been delivered, and 17.5 million doses have been administered.
What is the background?
Twenty-one advisers on the Vaccines and Related Biological Products Advisory Committee convened in summer 2022 to consider the efficacy and deployment of Moderna's proposed new booster shot. Among the panelists were infectious disease experts and vaccinologists from various esteemed universities.
CNN noted there was a sense of urgency behind these talks, as it was fast becoming clear that alleged immunity from the original COVID-19 vaccine was waning and that the first booster series had proven less effective against the Omicron strain.
Impressed by the apparent need to roll out a new booster, the panelists listened to a presentation on June 28 from Moderna President Stephen Hoge detailing the findings in a then-brand-new preprint study that his company had funded.
The study, which had not been peer-reviewed or published in a medical journal, sang the bivalent booster's praises, suggesting that it was "superior" at producing antibodies set to tackle the Omicron variant.
Hoge reportedly failed to mention the part of the study that stated, "In participants with no previous SARS-CoV-2 infection, infections occurred in 11 of 339 participants (3.2%) in the [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 advisers received a 22-page FDA briefing document that similarly omitted this infection data, reported CNN.
Moderna, profit-incentivized to push its new booster, was apparently not alone in leaving out this data.
Dr. Jerry Weir, director of the Division of Viral Products at the FDA's Office of Vaccines Research and Review, similarly gave a presentation to the advisers and similarly neglected to mention this infection data.
Without the understanding that there was a data set showing more bivalent-boosted test subjects got infected than those without the booster, the FDA advisers voted 19-2 to recommend its authorization.
The FDA approved the booster shortly thereafter, and the U.S. government ultimately purchased over $1.74 billion worth of doses from Moderna alone.
CNN noted that several months after the FDA advisers' meeting, Moderna has still not released data from a randomized phase 3 trial comparing infections in persons who received the original shot with those who received the new booster.
A second opportunity for transparency squandered
Fourteen CDC advisers reportedly convened on Sept. 1, the day after the FDA authorized Moderna's bivalent booster. Their job: to determine whether the agency should recommend that Americans get the new shot.
Once again, scientists gave presentations, and once again, the infection data didn't come up.
Like the scientists, Jacqueline Miller, senior vice president at Moderna, gave a presentation to the CDC advisers. As in the company president's previous presentation to the FDA vaccine advisers, Miller similarly omitted the indication that more bivalent-boosted test subjects got infected than those who had only received the original shot.
Kristen Nordlund, a spokesman for the CDC, suggested the agency was aware of the data, which she downplayed, claiming the study had not been "designed to assess vaccine effectiveness."
One non-voting member of the advisory committee suggested Nordlund's rationale for ostensibly ignoring the data was "very weak."
Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, told CNN, "The data are limited, but they are informative, and I think one would have anticipated that a complete presentation would have included them."
The CDC advisers, denied what Schaffner suggested could otherwise have been a "complete presentation," ultimately voted 13-1 in favor of recommending the booster.
Later that day, CDC Director Rochelle P. Walensky endorsed the CDC Advisory Committee on Immunization Practices’ recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.
"The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants," said Walensky in a statement. "This recommendation followed a comprehensive scientific evaluation and robust scientific discussion."
Dr. Paul Offit, a member of the FDA advisory committee, told CNN the revelation that this data was withheld from CDC and FDA vaccine advisers ahead of authorization and recommendation decisions "did shake my faith. It shook my faith in how these decisions were being made."
"I was angry to find out that there was data that was relevant to our decision that I didn’t get to see. Angry because they should trust us to make the decision based on all the data," said Offit
"Decisions that are made for the public have to be made based on all available information – not just some information, but all information," he added. "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."
Dr. Arnold Monto, acting chair of the FDA advisers' group, said, "There should always be full transparency. ... These data should not be dismissed. They are early, but they indicate that we need to look at them and see what their value is."
CDC vaccine adviser Dr. Pablo Sanchez noted that the data "should have been presented to the advisers prior to their decision."
Dr. Philip Krause, the former deputy director of the FDA's Office of Vaccine Research and Review, underscored that there no excuse for excluding the data.
"The company’s failure to present this information at the [FDA advisers meeting] and the omission of discussion about the data at that meeting raises questions about the ability of the process to provide a full and transparent review of the data," said Krause.
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