The recent developments in the Covid-19 vaccine policy, made by Robert F. Kennedy Jr, Health and Human Services secretary, are clearly sending us regressing rather than progressing, according to Moderna CEO Stéphane Bancel. His remarks came during the WIRED Health summit held on Tuesday. Moderna, a leading manufacturer of mRNA-based Covid-19 vaccines, has been subject to new restrictions with the FDA’s approval of their updated version of their shot. Unlike the previous recommendation for everyone above 6 months, the vaccines are now only for individuals at high risk of serious disease, marking an unclear and confounding shift.
Despite having set a solid list of beneficiaries, the vaccines now seem to exclude healthy individuals. Bancel rightly points out the stumbling blocks rose by the new measure, highlighting how it could potentially affect high-risk individuals within families who need the protection. Recollecting the earlier times when anyone could merely walk into a pharmacy and get a shot, the current predicament requires a prescription in several states due to the FDA’s alterations. A critical look at the situation certainly raises questions about the sensibility of the changes.
In a perplexing move earlier in May, Kennedy prematurely terminated a $590 million contract with Moderna related to the development of an mRNA-based bird flu vaccine candidate. Bird flu has been persistently plaguing wild birds and causing outbreaks in poultry and US dairy cows since March 2024, distressingly affecting industries. Occasionally, farm workers contracted the disease, hence posing a potential pandemic threat if it eventually spreads from person to person. Surprisingly, however, Kennedy cut short what could have been a potentially promising solution.
Adding to the series of unexpected decisions, Kennedy disclosed that HHS would henceforth not recommend mRNA Covid-19 vaccines for non-risk groups including healthy children and pregnant women. June saw the FDA imposing new labels on mRNA vaccines, displaying information on the rare risks of myocarditis and pericarditis. These are side effects noticeably observed in young men post-vaccine administration. The series of actions against mRNA vaccines raise reasonable doubts about the administration’s approach towards the pandemic.
The onslaught on mRNA vaccines continued with August witnessing a ‘coordinated wind-down’ of mRNA vaccine research. This move by HHS culminated in the cancellation of 22 related contracts and investments worth almost $500 million. Interestingly, the body decided to switch its focus to the older ‘whole-virus’ vaccines, a move that seems to undermine the undeniable potential of mRNA vaccines in today’s health crises.
In defiance of the backlash from the administration against mRNA vaccines, Bancel positively notes an ‘encouraging dialog’ with the FDA. Bordering on the absurd, it’s an odd fact that the body overseeing the nation’s health is facing such criticism from the CEO of a major vaccine manufacturer. It should trigger some reflection on the decisions governing the nation’s public health and whether or not they’re driving us in the right direction.
Things look not so bleak for Moderna as it received an expanded approval for its respiratory syncytial virus (RSV) vaccine to include adults aged 18 to 59 at an increased risk. The approval comes after the vaccine was initially approved for adults aged over 60 years in May 2024. Amidst the unreasonable scrutiny and the discouraging climate resulted from the administration’s decisions, this approval can be seen as a ray of hope, even though it speaks nothing about the justified criticism on the administration’s decisions.
During the early parts of the year, there were pronounced concerns about getting these approvals. Bancel readily admits these worries without shying away from expressing his team’s apprehensions. The fear of these no-longer-unfounded worries is a grim marker of the less than satisfactory conditions imposed by the administration.
Despite the overarching crackdown on mRNA research, the unexplainable line of attack does not seem to extend to the cancer space. Moderna is forging ahead with the development of numerous mRNA therapies against cancer, including personalized cancer vaccines. This can be seen as a defiant move towards harnessing the power of this breakthrough technology against the deadly disease.
Currently, Moderna has 45 cancer-related programs in the pipeline under various stages of research and testing. They reasonably expect to receive around 10 FDA approvals in the coming three years. It’s a testament to their commitment to utilizing the same technology that was effective for infectious diseases like Covid-19, which in retrospect painted promising results.
In view of baseless accusations that the Covid vaccines have not undergone thorough testing, Bancel put forth a clear rebuttal. He vehemently observes that there has never been a vaccine that was studied for efficacy and safety to this degree in vaccination history. The efficacy and safety have been validated through real-world studies involving literally millions of people.
Bancel’s statement underlines the rigorous scrutiny the vaccines have faced, challenging any ungrounded criticisms hinting at lack of proper testing. The fact that it was backed by countless studies reflecting on vaccines’ efficacy and safety speaks loudly of the unwavering commitment of companies like Moderna.
Despite the encouraging scientific data supporting the vaccines’ safety, efficacy, and benefits, the administration’s approach doesn’t seem to align. The relentless backlash against mRNA vaccines from the administration, as reflected in their decisions and actions, presents a stark contrast to the positive reviews and therapies championed by Moderna and other similar companies.
These incidents raise a significant, albeit uncomfortable question about the administration’s attitude towards science and advancement in health technology. Unsurprisingly, they also have the power to stir up public doubts and provoke second-thoughts about health decisions.
At the end of the day, scientific advancements should outweigh politics and unsupported biases. It is disheartening to see entities vested with the responsibility of national health take steps that incite doubts about these revolutionary vaccines rather than doing the opposite.
One hopes that the administration will adopt a more science-friendly approach, placing national health and safety at the forefront of their decisions. Meanwhile, the likes of Moderna continue to champion scientific advancements, plowing forward amidst challenges, striving to break new grounds in vaccine research and development.
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