Skip to content

Modern Vaccine Combing Protection Against Flu and Covid Excels - Political Obstacles Could Jeopardize Its Success

Vaccine study hints at equivalent or superior defense against influenza and COVID-19 with a blended approach, opposed to existing inoculations.

Modern Vaccine Combating Both Flu and Covid-19 Shows Promise, but Political Hurdles Threaten Its...
Modern Vaccine Combating Both Flu and Covid-19 Shows Promise, but Political Hurdles Threaten Its Success

Modern Vaccine Combing Protection Against Flu and Covid Excels - Political Obstacles Could Jeopardize Its Success

Moderna's innovative combination vaccine, mRNA-1083, which targets both influenza and COVID-19, is currently not approved by the Food and Drug Administration (FDA). The company voluntarily withdrew its biologics license application (BLA) for mRNA-1083 in May 2025, following a request from the FDA for additional flu vaccine efficacy data[1][2][3][4][5].

The request for further data comes as regulatory barriers remain, influenced by the novelty and safety concerns surrounding mRNA technology voiced within some health agencies[1][3]. Moderna is now preparing to resubmit the application, following positive Phase III efficacy results from its standalone flu vaccine candidate, mRNA-1010, which outperformed an existing flu vaccine by over 26% in adults aged 50 and above[1][2][3][4].

In the Phase III trial, participants were given either mRNA-1083 (plus a placebo) or two already approved flu and COVID-19 vaccines. On average, the response was higher to flu strains among those given mRNA-1083[6]. However, it's important to note that no mRNA-based flu vaccine is currently approved.

The FDA's new rule, which mandates placebo-controlled trials for vaccines that can be compared to existing vaccines, such as the mRNA-1083 vaccine, might jeopardize the timeline for the approval of the mRNA-1083 vaccine[7]. The new process requires all new vaccines to undergo placebo-controlled trials to receive approval.

The experimental vaccine, mRNA-1083, was found to be safe and well-tolerated in the trial. The immune response to circulating flu and COVID-19 strains was at least as strong in mRNA-1083 participants as in those given the separate vaccines[6]. The study results were published in JAMA on Wednesday.

Despite the promising results, there is some skepticism within U.S. health authorities about mRNA vaccine technology safety, cited by individuals such as Health Secretary Robert F. Kennedy Jr. and CDC advisory committee member Robert Malone[1]. The FDA recently granted approval for Moderna’s COVID-19 vaccines only for restricted populations (e.g., adults 65+ or children at increased risk), reflecting cautious regulatory oversight and the novelty of mRNA vaccine technology for flu applications[3].

The Department of Health and Human Services recently mandated an overhaul of the vaccine approval process, which could potentially delay the availability of upcoming seasonal vaccines, including current COVID-19 shots. Moderna expects the mRNA-1083 vaccine to be approved no sooner than 2026[8].

It's worth noting that RFK Jr. has a history of supporting the anti-vaccination movement and has wrongly declared the mRNA COVID-19 vaccine as the "deadliest vaccine ever made."

[1] https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-withdraws-us-application-for-combination-flu-covid-19-vaccine-2025-05-12/ [2] https://www.statnews.com/2025/05/12/moderna-withdraws-us-application-for-combination-flu-covid-19-vaccine/ [3] https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-modernas-covid-19-vaccine-adults-65-years-older [4] https://www.modernatx.com/news/moderna-announces-positive-topline-results-for-mRNA-1010-its-mRNA-based-influenza-vaccine-candidate-in-phase-3-trial [5] https://www.modernatx.com/news/moderna-announces-withdrawal-of-biologics-license-application-for-mRNA-1083-its-mRNA-based-combination-flu-and-covid-19-vaccine-candidate [6] https://jamanetwork.com/journals/jama/fullarticle/2786872 [7] https://www.fda.gov/media/154299/download [8] https://www.modernatx.com/news/moderna-announces-withdrawal-of-biologics-license-application-for-mRNA-1083-its-mRNA-based-combination-flu-and-covid-19-vaccine-candidate

  1. The science community is closely watching the resubmission process of Moderna's mRNA-1083 vaccine, as it aims to provide simultaneous protection against both influenza and COVID-19.
  2. The future of mRNA-1083 hinges on whether Moderna can address concerns about the vaccine's efficacy data, as requested by the Food and Drug Administration (FDA) in 2025.
  3. As the debate over mRNA vaccine safety continues, U.S. health authorities, such as Health Secretary Robert F. Kennedy Jr., have expressed concerns, which may affect the regulatory oversight and approval of mRNA-based vaccines like mRNA-1083.
  4. Technology companies like Moderna are navigating the changing landscape of vaccine approval, with the Department of Health and Human Services mandating a new process that could potentially delay the availability of upcoming seasonal vaccines, including mRNA-1083.
  5. The publication of the experimental mRNA-1083 study results in JAMA revealed that the vaccine was safe, well-tolerated, and showed a strong immune response to both circulating flu and COVID-19 strains, adding another layer to the ongoing discourse on the future of health-and-wellness policy-and-legislation involving mRNA technology within the general news sphere.

Read also:

    Latest