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FDA approves 1st mRNA flu shot, from Moderna
United States🏛️ PoliticsCenter17 days ago

FDA approves 1st mRNA flu shot, from Moderna

The U.S. Food and Drug Administration (FDA) has approved the first mRNA-based flu shot, mFlusiva, developed by Moderna. The vaccine received conditional approval for adults aged 50 to 65 and those 65 and older, contingent on further trials in the older demographic. Clinical trials showed mFlusiva to be approximately 27% more effective than traditional flu shots. Scientists highlight the advantages of mRNA technology, which allows for quicker production and adaptation to new viral strains. Despite these benefits, the approval process faced delays due to skepticism around mRNA technology, particularly from Health and Human Services Secretary Robert F. Kennedy Jr., who has opposed such vaccines. The FDA initially rejected Moderna's application but later reversed its stance after reviewing additional data. The vaccine's safety profile includes mild to moderate side effects, and Moderna has already secured EU approval for a combined flu and COVID-19 mRNA vaccine.

The U.S. Food and Drug Administration has approved the first messenger RNA-based flu vaccine, marking a pivotal moment in public health and vaccine development. The vaccine, named mFLUSIVA, developed by Moderna, was cleared for use in adults aged 50 and older. The approval came after the FDA initially rejected the application in February, citing concerns over the trial’s comparator standards. However, the agency reversed its stance following further discussions with Moderna and adjustments to the regulatory approach. The approval process unfolded over several months, beginning with Moderna’s submission of its application for mFLUSIVA in early 2026. The FDA initially declined to review the application due to discrepancies in the clinical trial design. Specifically, the agency pointed out that the trial did not use the preferred comparator for adults aged 65 and older, namely, a high-dose or adjuvanted flu vaccine, which is commonly recommended for that demographic. Moderna responded by revising its application, adjusting the trial design to account for age-specific comparisons and submitting a new proposal. After further deliberation, the FDA agreed to proceed with the evaluation. Under the final approval, mFLUSIVA will be available for adults aged 50 to 64 with standard approval, while adults aged 65 and older will receive accelerated approval. This conditional approval requires Moderna to conduct an additional post-marketing study involving approximately 40,000 participants in the older age group over two flu seasons. The study aims to evaluate the vaccine’s long-term efficacy and compare its performance against currently recommended alternatives for seniors. The approval of mFLUSIVA follows a broader context of increased scrutiny of mRNA technology within the U.S. government. Health and Human Services Secretary Robert F. Kennedy Jr., known for his skepticism toward mRNA vaccines, has publicly questioned their safety and effectiveness. His criticisms led to the cancellation of nearly $500 million in federal mRNA vaccine research contracts, redirecting funds toward traditional vaccine platforms. Additionally, Kennedy oversaw the replacement of members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices with individuals aligned with his views on vaccine safety. These actions created a challenging environment for companies like Moderna, which have been pushing for wider adoption of mRNA technology. Despite the political pressure, Moderna persisted with its trials and ultimately secured FDA approval. The company argues that mRNA vaccines offer distinct advantages, particularly in terms of manufacturing speed and adaptability. Unlike traditional flu vaccines, which require months of preparation and are often based on outdated strain predictions, mRNA vaccines can be rapidly updated to match circulating strains, potentially improving their effectiveness. The approval of mFLUSIVA also highlights the growing global interest in mRNA technology. The vaccine has already been accepted for regulatory review in the European Union, Canada, and Australia, with plans to submit applications to additional countries. This international momentum underscores the potential of mRNA vaccines to revolutionize not only flu prevention but also responses to other infectious diseases. As the vaccine moves toward availability for the 2026–27 flu season, questions remain about its real-world impact. While preliminary trials suggest mFLUSIVA is more effective than current flu vaccines, especially in older adults, the lack of formal endorsement by the CDC’s Advisory Committee on Immunization Practices means that widespread use may face hurdles. Private insurers typically cover only ACIP-approved vaccines, and federal distribution programs rely heavily on the committee’s recommendations. Without official backing, the vaccine’s accessibility and affordability could be limited, despite its technical merits. For now, the approval represents a significant step forward for mRNA technology in the fight against influenza. With its unique advantages and the support of regulatory bodies worldwide, mFLUSIVA stands as a testament to the evolving landscape of vaccine science and public health strategy.

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CBS News (US) logoCBS News (US)IndependentCenterFactual 98Objective 8518 days ago
FDA approves Moderna's mRNA flu vaccine after initial pushback

The U.S. Food and Drug Administration (FDA) has approved Moderna's new mRNA-based flu vaccine, mFLUSIVA, for adults aged 50 and older. This marks the first mRNA flu vaccine to gain FDA approval. The approval followed a period of regulatory pushback, including an initial refusal to consider Moderna's application due to concerns over the clinical trial design. The FDA later reversed its decision after discussions with Moderna led to revisions in the application. The vaccine demonstrated higher efficacy compared to standard flu shots in trials involving adults aged 50 and older, prompting Moderna to adjust its submission to include additional studies and targeted approvals for different age groups. Moderna anticipates the vaccine will be available for the 2026-27 flu season.

Bias read (Center): The article presents a factual account of the FDA's approval process for Moderna's flu vaccine, highlighting both the regulatory hurdles and the scientific basis for the approval. While there is mention of political figures like Health and Human Services Secretary Robert F. Kennedy Jr., who has been

Why factuality (98): The article accurately reports the FDA's approval of Moderna's mRNA flu vaccine, mFlusiva, and provides specific details about the approval conditions, including the age groups and the requirement for a post-marketing study. It also references the initial rejection and subsequent revision of the app

Why objectivity (85): The article maintains a neutral tone overall but includes a quote from Robert F. Kennedy Jr., which could subtly imply a contrast between his views and the FDA's decision.

NBC News logoNBC NewsIndependentCenterFactual 98Objective 8518 days ago
FDA approves 1st mRNA flu shot, from Moderna

The U.S. Food and Drug Administration (FDA) has approved the first mRNA-based flu shot, mFlusiva, developed by Moderna. The vaccine received conditional approval for adults aged 50 to 65 and those 65 and older, contingent on further trials in the older demographic. Clinical trials showed mFlusiva to be approximately 27% more effective than traditional flu shots. Scientists highlight the advantages of mRNA technology, which allows for quicker production and adaptation to new viral strains. Despite these benefits, the approval process faced delays due to skepticism around mRNA technology, particularly from Health and Human Services Secretary Robert F. Kennedy Jr., who has opposed such vaccines. The FDA initially rejected Moderna's application but later reversed its stance after reviewing additional data. The vaccine's safety profile includes mild to moderate side effects, and Moderna has already secured EU approval for a combined flu and COVID-19 mRNA vaccine.

Bias read (Center): While the article discusses the approval of an mRNA flu vaccine and mentions opposition to mRNA technology from a political figure, it presents both sides of the issue. It provides balanced information about the scientific merits of mRNA vaccines, the regulatory process, and the controversy around a

Why factuality (98): The article accurately reports the FDA's approval of Moderna's mRNA flu vaccine, mFlusiva, and provides specific details about the approval conditions, including the age groups and the requirement for a post-marketing study. It also references the initial rejection and subsequent revision of the app

Why objectivity (85): The article maintains a neutral tone overall but includes a quote from Robert F. Kennedy Jr., which could subtly imply a contrast between his views and the FDA's decision.

The Washington Times logoThe Washington TimesParty-alignedConservativeFactual 98Objective 8017 days ago
FDA approves first mRNA flu vaccine after reversing its own rejection

The U.S. Food and Drug Administration (FDA) has approved Moderna's first mRNA-based seasonal flu vaccine, mFLUSIVA, for individuals aged 50 and older, after initially rejecting it in February due to concerns about trial comparator standards. Moderna revised its application following discussions with regulators, leading to conditional approval for adults 65 and older, which requires a post-marketing study over two flu seasons. This decision follows broader skepticism within the Trump administration regarding mRNA technology, with Health and Human Services Secretary Robert F. Kennedy Jr. criticizing its safety and efficacy. The administration has also taken steps to reduce federal support for mRNA vaccines, including canceling $500 million in research contracts and replacing CDC advisory committee members with vaccine skeptics. Former FDA vaccine chief Vinay Prasad left the agency amid controversy surrounding its vaccine approvals.

Bias read (Conservative): The article frames the FDA's approval of the mRNA flu vaccine within the context of broader skepticism towards mRNA technology, particularly from Trump administration officials. It highlights criticism of mRNA vaccines by figures like Robert F. Kennedy Jr., and describes actions taken by the Trump-P

Why factuality (98): The article accurately reports the FDA's approval of Moderna's mRNA flu vaccine, mFLUSIVA, and provides specific details about the approval conditions, including the age groups and the requirement for a post-marketing study. It also references the initial rejection and subsequent revision of the app

Why objectivity (80): The article maintains a relatively neutral tone but includes quotes from Moderna and mentions Robert F. Kennedy Jr.'s criticisms, which could be seen as slightly favoring the narrative of overcoming vaccine skepticism.

Quartz logoQuartzIndependentCenterFactual 95Objective 8517 days ago
FDA approved Moderna's mRNA flu vaccine after initially refusing to review it

The FDA has approved Moderna's mRNA-based flu vaccine, named mFlusiva, making it the first such vaccine to receive regulatory approval globally. This marks a significant development in vaccine technology, as mRNA vaccines have previously been used for other diseases like COVID-19 but not yet for influenza. The approval comes after initial reluctance from the FDA to review the vaccine, indicating a shift in regulatory stance. Moderna's vaccine uses messenger RNA to instruct cells to produce proteins that trigger an immune response against the flu virus. This approval could lead to new approaches in flu vaccination strategies and potentially improve global health outcomes by offering a more adaptable and rapid response to flu strains.

Bias read (Center): The article reports on a scientific and medical advancement without taking a political stance or showing bias toward any particular ideology. It focuses on the technical aspects of the vaccine and the regulatory process rather than political implications.

Why factuality (95): The article accurately states that the FDA approved Moderna's mRNA flu vaccine, mFlusiva, and mentions it is the first of its kind globally. However, it lacks specific details about the approval conditions such as the age groups and the requirement for a post-marketing study.

Why objectivity (85): The article presents the information neutrally but includes a brief mention of the 'initially refusing to review it,' which slightly implies a change in stance without providing detailed context on the reasons behind the reversal.

STAT News logoSTAT NewsIndependentCenterFactual 90Objective 7518 days ago
FDA approves Moderna’s mRNA flu vaccine, the first to use the technology

The U.S. Food and Drug Administration (FDA) approved Moderna’s mRNA-based influenza vaccine, marking the first such vaccine to receive approval. The approval came after a reversal of an initial rejection by FDA official Vinay Prasad, who had previously issued a 'refusal-to-file' notice due to concerns about the vaccine’s comparator trials. The vaccine, named mFlusiva, is intended for adults aged 50 to 64 with standard approval and for those 65 and older with accelerated approval, accompanied by a post-licensure trial. Moderna highlights the vaccine’s potential advantages, including faster production compared to traditional egg- or cell-based methods, which could improve strain targeting and aid pandemic preparedness.

Bias read (Center): The article presents a factual account of the FDA’s approval process and the technical aspects of the vaccine without overtly favoring any political ideology. While the development of mRNA vaccines is tied to broader public health and scientific innovation discussions, the piece does not take a pole

Why factuality (90): The article accurately describes the FDA's approval of Moderna's mRNA flu vaccine and highlights its significance. However, it lacks specific details about the approval conditions and the initial rejection by the FDA.

Why objectivity (75): The article has a more opinionated tone, especially in the opening paragraph, and frames the approval within the context of vaccine skepticism, which may influence the reader's perception.

NPR News logoNPR NewsIndependentCenterFactual 85Objective 8022 days ago
FDA weighs a new kind of flu shot based on technology RFK Jr. has questioned

The FDA is considering approval for Moderna's mRNA-based flu vaccine, which represents a novel approach to influenza prevention. This decision could mark a significant shift in vaccine development within the biotechnology sector. The potential approval highlights ongoing advancements in mRNA technology, though it has drawn scrutiny from various stakeholders including figures like Robert F. Kennedy Jr., who have raised questions about such innovations. The outcome of this decision may influence future vaccine strategies and public health policies.

Bias read (Center): The article presents information about a regulatory decision without overtly favoring any particular political stance. It focuses on the technical aspects of the vaccine and its implications for the biotech industry, rather than taking a clear ideological position. While there is mention of RFK Jr.'

Why factuality (85): The article accurately describes the FDA's consideration of Moderna's mRNA-based flu shot and its potential impact on the biotech industry. However, it lacks specific details about the approval status and conditions.

Why objectivity (80): The article maintains a neutral tone but focuses on the broader implications of the FDA's decision, which may slightly shift focus away from the specifics of the approval.

NPR News logoNPR NewsIndependentCenterFactual 50Objective 7018 days ago
U.S. missile stockpiles dwindle. And, FDA weighs approval of flu shots with mRNA tech

The U.S. Army's missile stockpile is decreasing and may take several years to replenish, raising concerns about national defense capabilities. Meanwhile, the Food and Drug Administration is evaluating the approval of a new flu vaccine that uses mRNA technology, which has been previously used in COVID-19 vaccines. The dual focus highlights ongoing challenges in military readiness and advancements in medical science. The article presents these two separate developments without further elaboration on their implications.

Bias read (Center): The article reports on two distinct issues, military supply and FDA regulatory decision, with balanced presentation. There is no overt ideological framing, emphasis on specific political agendas, or biased language. It simply informs on current developments without leaning toward any particular side.

Why factuality (50): The article is unrelated to the main topic of the FDA approving Moderna's mRNA flu vaccine. It discusses U.S. missile stockpiles and the FDA's consideration of a flu vaccine, but it does not provide any specific information about the approval of Moderna's vaccine.

Why objectivity (70): The article is neutral in tone but is largely irrelevant to the main topic. It mentions the FDA considering a new type of flu shot but does not provide detailed information or context about the approval process or the vaccine itself.

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