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Moderna CEO Accuses FDA of Blocking Vaccine Review

  //food-wine.news-articles.net/content/2026/02/11 .. -ceo-accuses-fda-of-blocking-vaccine-review.html
  Published in Food and Wine on Wednesday, February 11th 2026 at 2:07 GMT by AFP
      Locales: N/A, Massachusetts, UNITED STATES

Berlin, Germany - February 11th, 2026 - Moderna CEO Stephane Bancel has publicly accused the U.S. Food and Drug Administration (FDA) of effectively blocking the review of data for its updated COVID-19 vaccine, potentially jeopardizing the availability of crucial fall booster shots for Americans. Bancel's unusually direct criticism, voiced during a conference call with financial analysts on Wednesday, signals escalating tension between a leading vaccine manufacturer and the key U.S. regulatory body.

According to Bancel, Moderna submitted comprehensive data on its newly formulated vaccine - designed to target current, evolving COVID-19 variants - several months ago. Despite this submission, the FDA has not initiated a formal review, leading to what Bancel described as a "standstill." This delay is particularly concerning as it threatens to disrupt preparations for the upcoming fall vaccination season, a critical period for bolstering immunity against the virus, especially given the ongoing evolution of SARS-CoV-2.

"We have been waiting for quite some time, and we believe that the FDA is effectively refusing to review the data," Bancel stated, a remarkably candid admission considering the traditionally cautious relationship between pharmaceutical companies and regulatory agencies. The FDA has yet to issue an official response to these allegations.

The situation highlights a growing undercurrent of frustration within the pharmaceutical industry regarding the speed of drug and vaccine approvals in the United States. While the FDA's rigorous standards are essential for ensuring public safety, critics argue that the current process has become increasingly protracted, hindering the timely delivery of vital medical interventions. This has been a simmering issue since the rapid development and rollout of COVID-19 vaccines, where initial speed gave way to a more cautious, and some argue, excessively deliberate approach.

Looking Beyond U.S. Approval

Faced with this regulatory impasse, Moderna is now actively pursuing alternative strategies to ensure its updated vaccine reaches those who need it. Bancel revealed the company is exploring direct engagement with the Centers for Disease Control and Prevention (CDC), hoping to leverage their expertise and potentially expedite the review process. More significantly, Moderna is considering seeking regulatory authorization in other countries before the U.S., a move that would be highly unusual and underscores the severity of the situation.

"We are looking at other options here, and this includes, if necessary, seeking authorization in other countries first," Bancel confirmed. This implies that Moderna believes it has a stronger path to approval outside of the U.S., potentially in regions with more streamlined regulatory processes. The European Medicines Agency (EMA), the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), and regulatory bodies in countries like Canada and Australia are likely candidates for initial submissions.

Implications for Public Health and Vaccine Strategy

The potential delay in approving updated COVID-19 vaccines has significant implications for public health. While COVID-19 is no longer considered the global emergency it once was, the virus continues to circulate and evolve. New variants, like the recent lineage stemming from Omicron, demonstrate the virus's ability to evade existing immunity, necessitating updated vaccines to maintain protection against severe illness, hospitalization, and death.

The current vaccine strategy relies heavily on annual booster shots, similar to the flu vaccine, to address evolving viral strains. A delay in availability could leave vulnerable populations - including the elderly, immunocompromised individuals, and those with underlying health conditions - at increased risk during the fall and winter months, when respiratory viruses typically surge.

Industry-Wide Concerns and Regulatory Scrutiny

Moderna's public rebuke of the FDA could spark broader scrutiny of the agency's review processes and potentially lead to calls for reform. Some analysts suggest the FDA is facing increased pressure to balance the need for rapid approval with a heightened emphasis on long-term safety monitoring, particularly in light of rare adverse events associated with earlier COVID-19 vaccines.

Furthermore, the situation raises questions about the FDA's resource allocation and its ability to keep pace with the rapid advancements in vaccine technology. The agency has been grappling with a backlog of applications in recent years, and some observers believe it may be understaffed and lacking the necessary expertise to efficiently evaluate complex vaccine formulations. The coming weeks will be critical in determining whether the FDA can resolve this impasse and ensure Americans have access to the updated COVID-19 vaccines they may need this fall.