Kennedy’s tenure as the U.S. health secretary has been marked by controversy and speculation about his intentions regarding vaccines. Kennedy, a longtime critic of vaccines, has wasted no time in using his powers to influence Americans’ thinking about immunizations. His actions have raised concerns among vaccine advocates and public health officials, who fear that his efforts could undermine public confidence in vaccines and harm Americans’ health.
One key issue that has raised eyebrows is the delay in the FDA’s decision on Novavax’s application for full approval of its Covid-19 vaccine. Despite the agency’s professional staff recommending approval, political appointees under new Commissioner Marty Makary paused the decision, citing the need for an additional study. This move, which is highly unusual, has sparked speculation about Kennedy’s influence on the decision-making process. The FDA’s insistence on a new randomized controlled trial to determine the vaccine’s effectiveness has raised questions about the agency’s commitment to evidence-based decision-making.
Another issue that has attracted scrutiny is the FDA’s proposed overhaul of the system for updating Covid vaccines. Makary’s suggestion that the strain change rule, which streamlines the process for updating seasonal vaccines, may no longer apply to Covid vaccines has raised concerns about the potential impact on vaccine development and approval. Critics worry that imposing new requirements on Covid vaccine manufacturers could delay the availability of updated vaccines and undermine efforts to control the pandemic.
The pending decision on Moderna’s next-generation Covid vaccine is also being closely watched. The vaccine, known as mRNA-1283, has shown promising results in clinical trials, with longer-lasting antibodies and comparable effectiveness to the existing vaccine. Moderna is hoping to supply the new vaccine to the U.S. in time for the fall, but the FDA’s decision on its approval will be a key factor in determining the vaccine’s availability.
Overall, Kennedy’s actions as health secretary have sparked concerns about the future of vaccine regulation and policy in the U.S. His apparent willingness to challenge established scientific evidence and introduce new requirements for vaccine approval has raised alarm bells among public health experts. As the debate over vaccines continues to unfold, it remains to be seen how Kennedy’s influence will shape the nation’s approach to immunization and public health. This decision led to Novavax having to throw out millions of doses of its vaccine. This year, the agency has promised to make its decision by the end of May.Â
Experts are already discussing what the strain selection process might look like for the Covid vaccines for the 2025-2026 season. One possibility is that the FDA could choose a strain from the ongoing pandemic, rather than waiting for a new variant to emerge. This would allow the vaccine manufacturers to get a head start on producing doses.Â
There are concerns, however, that selecting a strain too early could result in the vaccines being less effective against emerging variants. This is a delicate balance that the FDA and vaccine manufacturers will have to navigate.Â
As the discussions around Covid vaccines for children and strain selection for the next season continue, it is clear that there are still many challenges ahead in the fight against the pandemic. It will be crucial for all stakeholders to work together to ensure that safe and effective vaccines are available to protect the population. The FDA has made a last-minute decision to allow Novavax to bring its version of the COVID-19 vaccine to the market. This decision comes amidst uncertainty surrounding the involvement of U.S. health agencies in the selection of strains for the upcoming 2025-2026 Northern Hemisphere winter. Experts advising the World Health Organization will recommend which strains the vaccines should target, but with the Trump administration’s withdrawal from the WHO, the role of U.S. health agencies in this process remains uncertain. Additionally, the FDA has not always aligned with the WHO’s recommendations in the past.
The FDA’s expert vaccines panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), has not convened since Kennedy took over as the Secretary of Health and Human Services (HHS). A meeting that would have advised on the composition of flu shots for the next winter season was canceled. There are speculations that VRBPAC might be called to advise on COVID-19 vaccines, but the FDA needs to announce this soon to comply with public notice requirements.
The lack of clarity surrounding the vaccine approval process poses challenges for manufacturers. An official from one of the companies expressed concerns about the uncertainty. The ACIP, the expert panel advising the CDC on vaccines, recently met to recommend new vaccines and alter existing guidance. However, the lack of a CDC director or acting director has delayed the adoption of these recommendations as official policy.
Moderna has requested the FDA to expand the license for its RSV vaccine, mResvia, to include adults aged 18 to 59 with underlying medical conditions. The ACIP has recommended expanding eligibility for RSV vaccination to include high-risk individuals aged 50 to 59. Whether the FDA will meet the deadline for Moderna’s license expansion remains to be seen.
The fate of Moderna’s BARDA contract, worth nearly $600 million, is also under scrutiny. BARDA aims to develop medical countermeasures for potential biological threats. The contract with Moderna involves the production of vaccines for various flu viruses, including H5N1. The rapid production capabilities of mRNA vaccines have raised concerns about the potential termination of funding for the project by the Trump administration.
Overall, the uncertainty surrounding the approval process for COVID-19 vaccines and other medical countermeasures underscores the challenges faced by health agencies and manufacturers in navigating the evolving landscape of public health emergencies. The project in question, which has not seen any public updates in the past two months, has left many wondering about its fate. Will it survive in its current form, or will it be scaled back? Those involved in pandemic planning are closely monitoring the situation, eager for any new developments.
It is important to note that not every decision made by the Trump administration follows a clear pattern. While it may appear that vaccines utilizing mRNA technology are at risk, recent actions suggest otherwise. Just this month, the FDA granted a fast-track designation to a self-amplifying mRNA vaccine targeting H5N1, developed by Arcturus Therapeutics and funded by BARDA. This move has sparked interest and speculation among experts in the field.
The uncertainty surrounding the project underscores the importance of staying informed and vigilant when it comes to pandemic preparedness. With so much at stake, it is crucial to keep a close eye on any updates or changes that may impact public health and safety.
As the situation continues to evolve, it is essential for all stakeholders to remain engaged and proactive in their efforts to combat infectious diseases. By staying informed and working together, we can better prepare for and respond to future health crises.
