Allegations have surfaced that Moderna and the Food and Drug Administration (FDA) withheld critical information during their approval process for Moderna's bivalent Covid booster.
Last December, advisors who authorized the new Covid vaccine declared that they were not presented with trial evidence showing that the booster may be less effective at fighting Covid than its predecessor.
Despite the extremely limited nature of their initial trial results, advisors have voiced vehement disapproval that its absence from panel discussions suggests a troubling lack of transparency.
In an astounding cost of $5billion, US taxpayers have footed the bill for a new booster to fight mutated variants – and it was no small expense.
Before being given the green light, both the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are required to assemble their advisory councils. Afterwards, a panel of independent examiners must listen to testimonials from each team prior to voting on whether or not they should approve its authorization.
Stanford, the University of Pennsylvania and Harvard's independent advisors – among them being renowned infectious disease experts and vaccinologists – have all expressed their concerns regarding the scarcity of information shared with them during conversations about approving bivalent booster shots.
Last June and September, both the FDA and CDC advisory panels were presented with an abundance of data that undeniably showed the new bivalent vaccine to be far more efficient than its predecessor.
To assess the effectiveness of omicron vaccine compared to its predecessor, scientists performed laboratory experiments on patients who had received both vaccines. After that, they exposed samples of their blood to omicron and observed how successful it was at generating antibodies against Covid-19 in comparison with those vaccinated using the earlier shot.
Even with the exclusion of data from the study that focused on actual Covid-19 infections, this research was still successful in demonstrating its efficacy.
The concealed figures exposed that 3.2% of those who acquired the latest bivalent vaccine were infected, in comparison to merely 1.9% among those who had been administered with the previous booster dose – revealing an evident dominance for the upgraded version.
When presenting to a panel in June, Dr. Stephen Hoge neglected to share data indicating the bivalent booster was less effective than its predecessor shot – an omission that likely influenced their decision-making process.
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After consulting with a total of 35 advisors, the CDC and FDA found that six would have kept their opinion constant even after receiving added information.
The study was hampered by a lack of research participants and an absence of the double-blind technique, which ensures neither doctors nor patients are aware who will receive what vaccine.
Despite this, the advisors insist that it should have been made known to them under any circumstance.
Dr. Eric Rubin, a highly-regarded immunology and infectious disease expert as well as a respected member of the FDA's vaccine advisory committee, made it unmistakably clear to CNN that their team was more than capable: “We know exactly how to interpret these results – we are not naïve children.”
At last year's booster shot meetings, Moderna revealed their vaccine breakthroughs.
It appears there is an ongoing dispute between Moderna and FDA representatives about whose responsibility it was to include the data in these vital conversations.
Just before the FDA's June meeting, Moderna spokesman Christopher Ridley informed CNN that, in accordance with a request for an update on their ongoing study, they had provided the agency with infection data.
Just before the panel meeting on June 25th, the study was released in a preprint format for public consumption.
Despite Michael Felberbaum, a spokesperson for the FDA, claiming that they only acquired the pre-print barely before their advisory committee meeting; making it impossible to review and incorporate into their conference paperwork.
When the study reached the FDA, Dr. Stephen Hoge – President of Moderna – shared its key contents with an advisory panel at the organization.
In his presentation to the committee at the end of June, Dr. Hoge's CNN reviews and transcripts demonstrated how the bivalent booster was evidently better in creating antibodies – a fact that he mentioned repeatedly.
Unfortunately, the study's data demonstrating how inadequately this booster performed in comparison to its predecessor when attempting to protect against Covid infection was conveniently excluded.
Dr. Jacqueline Miller, a senior executive at Moderna, is accused of exhibiting selectively chosen information during her presentation to CDC advisors in September.
At a recent panel discussion, Dr. Miller was questioned about cases of Covid in those who had received the original vaccine versus the booster; however, instead of revealing complete results from hundreds of study participants – which showed that the bivalent booster demonstrated more successful prevention rates than its predecessor – he only highlighted disease incidence rates between people with and without evidence of prior infection. Additionally, it was not mentioned that for those without previous exposure to Covid-19, the initial vaccination proved significantly better at keeping them safe from contracting it in comparison to its successor.
Shortly after the panel's approval, the US government placed orders with Pfizer and Moderna for their bivalent booster shots – an agreement worth a combined $4.94billion; Pfizer receiving $3.2billion whereas Moderna obtaining $1.74billion from this deal.
A former FDA scientist declared to CNN that there was no valid explanation for omitting the study from meeting material, even if it was a limited timeframe.
Dr. Philip Krause, formerly in charge of the vaccine division at the agency, voiced concerns about the lack of critical data presented during both meetings; he argued that this failure to provide all necessary information “raises doubts about whether or not [the] review process is able to give an open and thorough assessment.”
Dr. Krause was deeply concerned about restoring the public's lost faith in the FDA's capability to evaluate data objectively and make shrewd decisions without bias. It was paramount that Americans would not question or doubt their trustworthiness anymore.
As masking requirements have been continually revised, along with reports of the CDC and FDA changing Covid guidance at the behest of politics, trust in government health agencies has decreased significantly throughout this pandemic.
Despite being available to the public since late August, uptake of the bivalent booster has been surprisingly low in comparison with that of the first two vaccine doses. According to CDC records, only 15.4 percent of Americans have received it – a far cry from nearly 70% who got their original set of vaccinations.
Surprisingly, even in the demographic most vulnerable to serious illness – those aged 65 and above – less than 40% have opted for the vaccine.
The US continues to face immense vaccine hesitancy, particularly regarding the mRNA Covid jab. Vaccine skeptics are worried about a lack of clarity around the development and authorization procedure for vaccines – fears that will likely be exacerbated by recent claims made even by FDA advisors themselves.
Following six months since the FDA advisory meeting, Moderna has yet to publish results from another randomized Phase 3 trial which examined infection rates between participants who received the new booster versus those given the existing shot. This study was conducted on a total of 3,000 individuals.