Federal vaccine advisors expressed outrage at the failure of government scientists and Moderna to share critical data on the new booster shot in discussions about whether the vaccine should be forced upon the public.
CNN published Wednesday’s report that infection data was withheld from the U.S. Food and Drug Administration and Centers for Disease Control and Prevention vaccine advisors last summer. This “suggested that the updated booster might not have any greater effectiveness in preventing Covid-19” infections, according to CNN.
Data from the study that examined the impact of the booster on actual infections showed that 1.9% of participants in the study who received the original booster were infected, while 3.2% of those who received the updated bivalent vaccine, the one scientists believed would work better, became infected.
The FDA approved the Moderna bivalent vaccine in its final form on August 31. According to reports, the agency did not release previously omitted information until September 13.
According to the Kaiser Family Foundation, nearly 171,000,000 doses of bivalent boosters were purchased by the United States as of December for an estimated $4.9 billion.
As of January 4, the CDC reported that 48.2 Million people aged 5 and over had received a bivalent booster dose. Moderna’s booster has been given in 33.6 million doses, with 17.5 million doses administered.
In the summer of 2022, 21 advisors from the Vaccines and Related Biological Products Advisory Committee met to discuss the effectiveness and deployment of Moderna’s new booster shot. The panelists included vaccinologists and experts in infectious diseases from prestigious universities.
CNN reported that there was an urgency to these talks as it became clear that immunity from the COVID-19 vaccine was rapidly waning, and that booster series 1 had been less effective against the Omicron strain.
The panelists were impressed by the need to roll out a booster and listened to Stephen Hoge, Moderna President, present his findings from a brand-new preprint study he had funded.
Although the study was not peer-reviewed and published in a medical journal it praises the bivalent booster for its ability to produce antibodies that can be used against the Omicron variant.
Hoge apparently did not mention the section of the study that said, “Infected occurred in participants with no prior SARS-CoV-2 infections in 11 of 339 participants (3.2%) in the [new bivalent boost group] and in 5 out of 266 participants (1.9% in the original booster group] after the booster.”
These infection data were based on an analysis of thousands of patients. 16 of them became infected. The study was not double-blind and randomized.
CNN reported that the FDA briefing document, which was 22 pages long, also omitted this information.
Moderna was profit-incentivized by its new booster and apparently, this wasn’t the only one who left out this data.
Dr. Jerry Weir (director of the Division of Viral Products, FDA’s Office of Vaccines Research and Review) also gave a presentation to advisers and neglected to mention the infection data.
The FDA advisors voted 19-2 in favor of its authorization, despite the fact that the data showed more people with the booster than without it.
Soon after, the FDA approved the booster and the U.S. purchased more than $1.74 billion in doses of Moderna.
CNN reported that Moderna still has not released data from the phase 3 randomized trial, which compared infections among people who received the original shot and those who received it with the booster. This was despite having held the FDA advisors’ meeting for several months.
Another chance for transparency was squandered
On Sept. 1, 2014, 14 CDC advisors met to discuss Moderna’s bivalent booster. Their task was to decide whether the agency should recommend Americans receive the new shot.
Scientists gave presentations again and the infection data did not come up.
Jacqueline Miller (senior vice president at Moderna), gave a presentation to CDC advisers. Miller, like the previous presentation by the company president to the FDA vaccine advisors, also omitted the warning that more subjects who received bivalent-boosted shots were infected than those who received the original shot.
Kristen Nordlund was a spokesperson for the CDC. She suggested that the agency knew about the data but she dismissed it, claiming that the study wasn’t “designed to evaluate vaccine effectiveness”.
Nordlund’s reasoning for ostensibly not ignoring data was suggested by a non-voting member of the advisory committee.
CNN’s Dr. William Schaffner, an infectious diseases expert at Vanderbilt University Medical Center, stated that although the data were limited, they were informative and one would have expected that a full presentation would include them.
The CDC advisors denied Schaffner’s suggestion that it could have been a “complete present” and voted 13-1 to recommend the booster.
Later, CDC Director Rochelle P. Wilensky endorsed recommendations of the CDC Advisory Committee on Immunization Practices for updated COVID-19 boosters. Moderna is recommended for those aged 18 and over.
“The new COVID-19 boosters have been updated to provide better protection against the latest COVID-19 variant. They can restore immunity that has diminished since previous vaccinations and is designed to offer greater protection against the newer variants,” Walensky stated in a statement. “This recommendation was based on a thorough scientific evaluation and robust scientific discussions.”
CNN’s Dr. Paul Offit, a member of the FDA advisory committee, said that the revelation that the data had been withheld from the CDC and FDA vaccine advisors before authorization and recommendation decisions were made “did shake my faith.” It shook my faith in the way these decisions were made.”
“I was angry to discover that there was data relevant to our decision that wasn’t available to me. Offit said that she was angry because they shouldn’t trust us to make the right decision based on all data.”
He said, “Decisions made for the public must be based on all information available – not just some but all information.” These agencies, whether they’re the FDA or CDC can’t make that decision.” This is why we need an independent advisory panel.
Dr. Arnold Monto is the acting chair of the FDA Advisors’ Group. He stated, “There should always be full transparency. … These data shouldn’t be ignored. These data are still early in their development, but they suggest that we should look at them and assess their value.
Pablo Sanchez, a CDC vaccine advisor, stated that the data should have been presented to advisers before they made a decision.
Dr. Philip Krause was the FDA’s former deputy director of its Office of Vaccine Research and Review. He stressed that there is no reason to exclude the data.
Krause stated that the failure of the company to present the information at the [FDA advisors meeting] and the absence of discussion about data at that meeting raises doubts about the process’ ability to provide a complete and transparent review of data.
