Moderna's mRNA flu vaccine mFLUSIVA received FDA approval for adults over 50, marking the first mRNA-based flu shot. However, uncertainty remains due to the CDC advisory panel being defunct amid litigation, affecting coverage recommendations.
<p>Despite significant drama from Trump officials this year, the Food and Drug Administration has for the first time approved a flu vaccine that uses mRNA technology.</p>
<p>On Thursday, vaccine maker <a href="https://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNA">Moderna announced</a> that its flu shot, mRNA-1010, aka mFLUSIVA, had earned approval for use in all adults ages 50 and up. The approval announcement follows a <a href="https://arstechnica.com/health/2026/06/fda-advisors-unanimously-vote-to-approve-modernas-mrna-after-agency-drama/">unanimous vote by FDA advisors in June to approve the vaccine</a>. That vote was based on its superior efficacy to existing seasonal flu shots and a good safety record demonstrated in trials that included nearly 44,000 people. After that vote, the FDA set a goal of August 5 for a decision on the vaccine's fate.</p>
<p>While the unanimous support from FDA advisors boded well for Moderna's shot, the overall path to approval was treacherous and uncertain, even until the end. For one thing, current Health Secretary Robert F. Kennedy Jr. is a well-established anti-vaccine advocate who has worked diligently in his time in office to thwart vaccinations. One of his first acts as health secretary was <a href="https://www.nytimes.com/2026/06/25/us/politics/kennedy-cdc-emails.html">canceling a federal campaign to encourage people to get flu shots</a> in the midst of a bad flu season—despite the fact that the Centers for Disease Control and Prevention had already paid for the campaign and the flu season was killing relatively high numbers of children.</p><p><a href="https://arstechnica.com/health/2026/08/modernas-mrna-flu-shot-earns-fda-approval-after-rollercoaster-review/">Read full article</a></p>
<p><a href="https://arstechnica.com/health/2026/08/modernas-mrna-flu-shot-earns-fda-approval-after-rollercoaster-review/#comments">Comments</a></p>
# Moderna's mRNA flu shot earns FDA approval after rollercoaster review
Source: [https://arstechnica.com/health/2026/08/modernas-mrna-flu-shot-earns-fda-approval-after-rollercoaster-review/](https://arstechnica.com/health/2026/08/modernas-mrna-flu-shot-earns-fda-approval-after-rollercoaster-review/)
## Remaining uncertainty
At the FDA advisory committee’s June meeting, experts expressed optimism about an mRNA\-based flu vaccine\. The platform—the same used in the company’s COVID\-19 vaccines—is agile, easily allowing tweaks and updates to vaccine design, and it offers swifter vaccine production at scale compared to existing flu vaccines\. Traditional flu vaccines are grown in fertilized chicken eggs, a process that requires six to eight months, compared to mRNA vaccines’ one to two months\.
Moderna CEO Stéphane Bancel celebrated the approval in a statement Thursday, saying it “demonstrates the continued strength and versatility of our mRNA platform\.”
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” he said\. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation\.”
Despite the approval, the vaccine still faces some uncertainty\. The CDC advisory panel that makes recommendations for federal vaccine policy is effectively defunct\. In March, a federal judge ruled that most of the anti\-vaccine allies Kennedy had installed onto the advisory panel were unqualified\. The judge thus[ordered a temporary injunction reversing their appointments](https://arstechnica.com/health/2026/03/judge-temporarily-blocks-rfk-jr-s-changes-to-cdc-vaccine-recommendations/)and undoing many of Kennedy’s changes to federal vaccine recommendations\. The Trump administration is currently appealing the judge’s ruling\. But amid the litigation, the CDC’s panel—the Advisory Committee on Immunization Practices—has not met\.
Without an ACIP recommendation on mFLUSIVA’s clinical use for the quickly approaching flu season, doctors will face uncertainty about which adults over age 50 should be recommended to use the vaccine\. It’s also unclear if mFLUSIVA will be covered by federal vaccine programs or private insurance companies, which are required to cover ACIP\-recommended vaccines\.
Moderna said it expects to have mFLUSIVA available for the 2026–2027 flu season\. But[The Wall Street Journal reported](https://www.wsj.com/health/pharma/fda-approves-first-mrna-flu-vaccine-in-win-for-moderna-after-arduous-process-039156b6)that Wall Street is not expecting meaningful sales until the 2027–2028 season\.
FDA advisors voted unanimously to approve Moderna's seasonal mRNA flu vaccine, mRNA-1010, after initial rejection by a Trump appointee. The vaccine showed 27% better efficacy than standard flu shot and stronger immune response than high-dose vaccine in older adults.
Moderna announced FDA approval of mFLUSIVA (mRNA-1010), a seasonal influenza vaccine for adults 50 and older, following unanimous advisory committee recommendations.
A global review led by UBC researchers confirms that mRNA vaccines are safe and highly effective against COVID-19, and have potential applications for influenza, RSV, cancer, and autoimmune disorders, addressing misconceptions and supporting evidence-based decisions.
Moderna and Merck announced positive Phase 3 results for their personalized cancer vaccine, which reduced melanoma recurrence, causing Moderna stock to surge by over 110%.
Moderna and Merck's Phase 3 trial of an mRNA cancer vaccine, personalized using AI algorithms, shows promising results for melanoma treatment, with Elon Musk praising mRNA's potential despite past controversies.