Moderna and the Food and Drug Association (FDA) have been accused of withholding data during the approval process for the pharmaceutical giant’s bivalent Covid booster.
Vaccination consultants who signed off on the updated shot late last year claim they were not shown any trial data to suggest the booster was actually less effective at preventing Covid than the older vaccine it was meant to replace.
While the early study results had significant limitations, “disappointed” and “disgruntled advisors” say the omission of panel discussions shows a striking lack of transparency.
US taxpayers ended up paying almost $5 billion for the new booster, which was supposed to improve immunity to new variants.
The infection data, which was not shared with the advisors although it came from a limited sample size, suggested that the new bivalent booster shot was actually LESS effective than the original vaccine at preventing new strains of Covid-19. 3.2 percent of study participants given the new Vax caught the virus, compared to just 1.9 percent of those given the old vaccine
For new vaccines to be approved, both the FDA and the Centers for Disease Control and Prevention (CDC) must convene their advisory panels and make presentations to an advisory panel. This panel of objective reviewers then votes on whether or not to recommend its approval.
It is these independent consultants – including infectious disease experts and vaccinators from Stanford, the University of Pennsylvania and Harvard – who are now raising concerns about the incomplete information they are being shown during the bivalent booster vaccine approval interviews.
At both an FDA meeting in June and a CDC advisory panel in September, experts were shown reams of information suggesting the new bivalent vaccine was more effective than its predecessor.
These results were based on lab tests in which blood from bivalent vaccinees was exposed to Omicron and then compared to samples from people vaccinated with the older vaccine to estimate how well each elicited antibodies to fight Covid.
However, other data from the same study was not presented to the panels looking at actual infections – who did and did not contract Covid-19.
The withheld data showed that 3.2 percent of study participants who received the updated bivalent vaccine became infected – compared to just 1.9 percent of those who received the original booster.
dr Stephen Hoge, Moderna’s president, did not discuss results suggesting the new bivalent booster was less effective than the original injection during his presentation to the panel in June
Six out of 35 advisors to the CDC and FDA say restricting the data would not have changed their vote.
These limitations included the small number of study participants and the lack of a double-blind procedure, which ensures that neither the doctor nor the participants know which vaccine is being given to whom.
But the consultants argue they should have been shown anyway.
dr Eric Rubin, an immunology and infectious disease specialist and a member of the FDA’s Vaccine Advisory Committee, told CNN: “[We’re] no children’s group. We know how to interpret these results.’
During last year’s booster vaccination meetings, executives at vaccine maker Moderna also made similar presentations.
Moderna and FDA spokespersons appear to be at odds over exactly who is responsible for the omission of the data during these crucial discussions.
In an email to CNN, Moderna spokesman Christopher Ridley said the company shared the infection data with the FDA ahead of the agency’s board meeting in June after being asked for an update on the ongoing study.
The study was publicly posted online as a preprint on June 25, three days before the panel meeting.
However, FDA spokesman Michael Felberbaum claims that the FDA received the preprint less than a day before the advisory committee meeting — which he says is too late to review and include in the agency’s meeting papers.
Regardless of when exactly the study was sent to or received from the FDA, certain contents of it were personally reviewed by Moderna’s President, Dr. Stephen Hoge, shown to her Advisory Board.
According to videos and transcripts viewed by CNN, Dr. Hoge, during his presentation to the committee in late June, relied solely on the data demonstrating the purported superiority of the bivalent booster in eliciting antibodies.
However, data from the same study suggesting the booster’s poor performance in preventing Covid infection compared to its predecessor has been conveniently left unmentioned.
dr Jacqueline Miller, Moderna’s senior vice president, is accused of showing similarly curated footage during her presentation to CDC advisers in September.
Even when asked explicitly by a panel member about Covid cases among those who received the original vaccine versus the booster, Dr. Miller an allegedly incomplete answer.
dr Miller cited disease incidence rates in both people with and without evidence of prior infection – which cast the bivalent booster shot in a much more positive light – and failed to mention those of the hundreds of study participants who did not previously receive Covid, the original vaccine had been significantly more effective in preventing infection.
The US government agreed to buy Pfizer and Moderna’s bivalent booster shortly after the panel voted to approve it – resulting in a $3.2 billion deal for Pfizer and $1.74 billion led for Moderna
A former FDA scientist told CNN there was no excuse for excluding the study from the meeting footage, no matter how short the timeline.
dr Philip Krause, who once helped head the agency’s vaccines division, said the failure to present such important data at both meetings “raises questions about the ability of the process to allow for a full and transparent review of the data.”
dr Krause’s primary concern was to regain the public’s loss of trust in the FDA.
The key, he indicated, was that Americans’ confidence in the FDA’s ability to objectively review data and make informed decisions was not diminished.
Flip-flop guidelines on mask-wearing, as well as whistleblower allegations that both the CDC and FDA changed Covid guidelines under political pressure, have both helped slow public confidence in state health officials during the pandemic fades.
The bivalent booster vaccine, which has been available to all Americans over the age of 12 since late August, has seen remarkably low uptake compared to the first two doses of the vaccine.
According to CDC data, only 15.4 percent of the US population received the bivalent booster shot — compared to the nearly 70 percent who received the original shot.
Even in the most vulnerable age group – 65 years and older – only 38 percent have since opted for the new vaccine.
Vaccination hesitancy, particularly with regard to mRNA Covid vaccination, remains widespread in the United States.
These Vax skeptics are concerned about a lack of transparency surrounding the vaccine development and approval process — fears that are likely only fueled further by these recent claims from FDA advisers themselves.
Six months after the FDA advisory meeting, Moderna has yet to release data from another randomized phase 3 study of 3,000 participants that will compare infections in participants who received the new booster vaccine versus those who received the old vaccine.