In reversal, US agrees to review new Moderna flu shot

The United States Food and Drug Administration has decided to review a new vaccine for influenza, despite rejecting the application earlier this month. Advertisement World In reversal, US agrees to review new Moderna flu shot The United States Food and Drug Administration has decided to review a new vaccine for influenza, despite rejecting the application earlier this month. A US Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025. (Photo: REUTERS/Dado Ruvic) 19 Feb 2026 12:32AM (Updated: 19 Feb 2026 12:33AM) Bookmark Bookmark Share WhatsApp Telegram Facebook Twitter Email LinkedIn Set CNA as your preferred source on Google Add CNA as a trusted source to help Google better understand and surface our content in search results. Read a summary of this article on FAST. Get bite-sized news via a newcards interface. Give it a try. Click here to return to FAST Tap here to return to FAST FAST NEW YORK: Vaccine manufacturer Moderna said Wednesday (Feb 18) the US Food and Drug Administration walked back its previous position and agreed to review the company's new mRNA-based flu shot.Last week the US firm said the federal vaccine regulator rejected the application for review of the new shot, calling its clinical trial inadequate.But Moderna said that after a "constructive" meeting the FDA had accepted the application for review based on a regulatory pathway focused on older adults.The company's application now seeks full approval for adults 50 to 64 and accelerated approval for adults 65 and older, Moderna said in a statement. It also agreed to conduct an additional study after the shot hits the market.The FDA's rejection had come as the body has called for a reconsideration of approval procedures for certain vaccines, including for influenza - proposed federal policy changes under President Donald Trump that have triggered widespread alarm among public health and medical professionals.The new shot uses mRNA technology, which health chief Robert F. Kennedy Jr, a vocal vaccine sceptic, has criticised. He notably cut off federal research grants that funded mRNA development.That contradicts Trump's position during his first presidential term, when he called mRNA technology a "modern-day miracle." President Donald Trump speaks in the Roosevelt Room of the White House, Sep 22, 2025, in Washington, as Health and Human Services Secretary Robert F. Kennedy Jr. listens. (Photo: AP/Mark Schiefelbein) It was used during the Covid-19 pandemic to swiftly develop an immunisation that global health authorities deemed safe and effective against the fast-spreading illness. It was credited with saving millions of lives.Moderna's new shot had already been accepted for review in the European Union, Canada and Australia.Vinay Prasad, the top US vaccine official, had signed the letter rejecting Moderna's bid for approval, saying the company's clinical trial was not "adequate and well-controlled," and had not tested its experimental shot against the best product on the market.In the large trial Moderna had compared its new vaccine with Fluarix, an approved flu shot from the company GSK.Moderna said the rejection was "inconsistent with previous written communications" with the FDA.In a statement Wednesday Moderna's CEO, Stephane Bancel, said "we appreciate the FDA's engagement" in a "constructive" meeting the company had requested following the rejection."Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."Since Trump retook the White House, both he and health chief Kennedy have come under broad criticism from public health and medical experts for sowing doubt about the safety and efficacy of vaccines widely known to be safe, and upending the paediatric immunisation schedule. Related: Deadly Nipah virus deemed 'limited' by scientists How NUS Medicine is training the next generation of healthcare leaders in Asia Source: AFP/fs Sign up for our newsletters Get our pick of top stories and thought-provoking articles in your inbox Subscribe here Get the CNA app Stay updated with notifications for breaking news and our best stories Download here Get WhatsApp alerts Join our channel for the top reads for the day on your preferred chat app Join here Related Topics United States Moderna FDA Influenza Advertisement Also worth reading Content is loading... Advertisement Expand to read the full story Get bite-sized news via a newcards interface. Give it a try. Click here to return to FAST Tap here to return to FAST FAST