Concerns rise among experts that resistance against vaccines could potentially halt vaccines under FDA review.
Vaccine Anxiety Looms Over Modern, Novavax, and Pfizer's Emerging Vaccines
With worry growing, experts fear that anti-vaccination sentiments within federal and state governments may impede the approval of groundbreaking vaccines. This trepidation leaves these vaccines hanging in limbo, due to potential obstacles like increased scrutiny, political interference, and legislation.
Last week, the FDA's hesitance in approving Novavax's Covid-19 vaccine fuels confusion. Despite being available under emergency use authorization since 2022, the FDA is demanding more data. This delay has sparked curiosity among public health professionals. The FDA's decision on Moderna's next-gen Covid-19 shot, mRNA-1283, is due by May 31, adding to the uncertainty.
Moderna has also filed for FDA approval of its flu+Covid combination vaccine, mRNA-1083. If granted, it will be the first in the US to offer protection against both diseases in a single shot. Moderna plans to make all three vaccines (seasonal flu shots, Covid-19 shots, and combination vaccines) available as they become capable, according to company President, Dr. Rituparna Das.
Moderna unveiled trial data in June, showing that the combo vaccine, mRNA-1083, is safe and elicits stronger immune responses against flu viruses and the coronavirus in adults age 50 and older compared to existing vaccines. The potential for 1083 to streamline vaccination and alleviate pressure on hospitals during the fall and winter seasons is exciting.
Combination vaccines are common in pediatrics; the MMR and DTaP vaccines are examples. Similarly, Pfizer & BioNTech and Novavax are working on influenza and Covid-19 combination vaccines, raising the question: will these new vaccines face the same fate as Novavax's Covid-19 vaccine?
While Novavax's vaccine uses traditional protein-based technology, the combos being developed by Moderna and Pfizer/BioNTech are mRNA vaccines. Misunderstandings and misinformation about mRNA technology have driven legislation aiming to limit or ban the use of these innovative vaccines. Lawmakers in some states, like Montana, have proposed bills to restrict their use.
The growing concern among public health experts revolves around whether anti-vaccination sentiments and bills restricting mRNA technology may block patients from accessing not just a flu+Covid vaccine but any life-changing treatment. Low vaccination rates provide an ideal environment for the spread of contagious diseases.
According to Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials, the environment is conducive to more jurisdictions introducing legislation against mRNA vaccines. "This is a dangerous path," she warns, "It is vital to ensure that vaccines remain accessible to regulate the spread of infectious diseases."
Dr. Peter Hotez, a vaccine specialist, is equally alarmed. The Trump administration's attempts to evaluate mRNA research and technology, along with external pressure to downplay the success of mRNA vaccines, are concerning. The US Department of Health and Human Services has reportedly asked the CDC to study vaccines and autism, despite scientific evidence debunking the link between the two.
Dr. Marks, director of the FDA's Center for Biologics Evaluation and Research, played a crucial role in industrializing mRNA vaccines during the pandemic. However, he was recently forced out of the agency. Additionally, some NIH officials have urged scientists to remove mRNA vaccine references from grant applications, potentially jeopardizing future mRNA research.
Moderna spokesperson Jenna Sexton emphasizes that these legislative efforts to limit mRNA medicines could impede significant research and restrict patient access to groundbreaking treatments. "The hostility toward mRNA technology is a misconception that is frequently cited in support of these restrictive policies," she argues.
If enacted, these measures could hamper crucial research and potentially delay life-changing medical advancements. Given the ongoing concerns, scientists and doctors should collaborate to educate the public and policymakers about the overall benefits and risks of mRNA medicine.
- Health concerns extend beyond just Novavax's Covid-19 vaccine, as the approval of Moderna's flu+Covid combination vaccine, mRNA-1083, in 2025 and the Covid-19 vaccines developed by Pfizer-BioNTech may face similar challenges due to anti-vaccination sentiments and legislation aimed at restricting mRNA technology.
- As experts express worry over potential obstacles that may impede the approval of groundbreaking vaccines, the potential impact is not just limited to vaccines; it could also block patients from accessing life-changing treatments, including vaccines that combat both flu and Covid-19.
- Misunderstandings and misinformation about mRNA technology have driven legislation aiming to limit or ban the use of these innovative vaccines, such as bills proposed in Montana and other states, which could potentially delay or hamper crucial research and the development of life-changing medical advancements in the future.
