▼ Summary
– Moderna’s CEO criticized recent FDA changes that restrict Covid-19 vaccines to high-risk individuals, calling it a “step backward.”
– The FDA now limits Covid vaccines to those 65 and older or with health issues, whereas they were previously recommended for anyone 6 months or older.
– HHS Secretary Robert F. Kennedy, Jr. has terminated contracts and shifted funding away from mRNA vaccines, including canceling a $590 million bird flu vaccine deal.
– Despite policy changes, Moderna received approvals for updated Covid shots and expanded use of its RSV vaccine, and remains optimistic about FDA dialogue.
– Moderna is advancing mRNA cancer therapies, with 45 programs in development and expectations for multiple FDA approvals in the coming years.
During a recent industry summit, Moderna’s chief executive Stéphane Bancel voiced strong disagreement with recent federal health policy shifts, calling them a setback for public health. His comments came in response to changes implemented by Health and Human Services Secretary Robert F. Kennedy, Jr., which narrowed eligibility for COVID-19 vaccination. Bancel argued that the new restrictions create unnecessary confusion and barriers for families seeking protection.
Under the revised guidelines, COVID-19 vaccines are now recommended only for individuals aged 65 and older or those with specific health risks. Previously, the shots were available to anyone six months or older. Bancel emphasized that this change complicates efforts to protect vulnerable household members, since many states now require a prescription for vaccination. He described the policy as a “step backward” that could reduce vaccine access just as updated formulations receive approval.
Kennedy, who assumed the role of HHS secretary earlier this year, has taken a notably critical stance toward mRNA vaccines. In May, his department terminated a $590 million agreement with Moderna aimed at developing an mRNA-based bird flu vaccine. That contract had been approved during the final days of the Biden administration. Kennedy has also moved to halt recommendations for mRNA COVID-19 vaccines among healthy children and pregnant women, citing safety concerns.
Further aligning with this position, the FDA recently mandated new labeling for mRNA vaccines to include warnings about rare cardiac side effects such as myocarditis and pericarditis, which have been observed primarily in young males. In August, HHS canceled nearly $500 million in mRNA-related contracts and research investments as part of what it termed a “coordinated wind-down.” Kennedy has publicly questioned the effectiveness of mRNA vaccines against respiratory infections, though experts widely contest this view.
Despite these challenges, Bancel expressed optimism about Moderna’s ongoing dialogue with regulatory bodies. The company secured approval this year for an updated COVID-19 vaccine, albeit with usage limitations, as well as expanded authorization for its RSV vaccine to include younger at-risk adults. Bancel acknowledged that many within the company had been concerned about receiving these approvals given the political climate.
Moderna continues to advance its mRNA research in other areas, particularly oncology. The firm currently has 45 cancer-related programs in development and anticipates up to ten new FDA approvals within the next three years. Bancel highlighted that the same mRNA technology used in COVID-19 vaccines is now being applied to create personalized cancer vaccines.
Addressing persistent criticism about vaccine testing, Bancel firmly stated that COVID-19 vaccines are among the most thoroughly studied medical products in history. He pointed to real-world data involving millions of people, underscoring both the safety and efficacy of mRNA vaccines. Despite political and public skepticism, he remains confident in the science supporting their use.
(Source: Wired)