The U.S. Food and Drug Administration (FDA) has approved a new kind of seasonal influenza vaccine manufactured by engadget.com. Known as mFlusiva or mRNA-1010, the immunization is the first flu shot made with the messenger RNA (mRNA) technology that played a key role in ending the COVID-19 pandemic. According to the manufacturer, the shot is intended for adults aged 50 or older and targets the four most common strains of influenza.
FDA Approves Moderna’s mFlusiva mRNA Flu Vaccine for Adults 50 and Older
Tens of thousands of Americans die from influenza every year, with older adults among the most vulnerable populations globally. The World Health Organization (WHO) noted that flu variants cause up to five million severe cases and as many as 650,000 respiratory deaths annually. Because the shape-shifting flu virus mutates and requires annual updates, vaccines utilizing Nobel Prize-winning mRNA technology offer faster manufacturing times, providing an additional option if new doses must be brewed suddenly.
Clinical Trial Results Across Age Groups
Moderna secured approval for adults between the ages of 50 and 64 following a Phase 3 clinical trial that enrolled 40,805 adults across 11 countries, with specific data covering a study of 40,000 people. Researchers concluded that mRNA-1010 was superior to standard-dose licensed vaccines for the prevention of influenza-like illness. Specifically, the study found 27% fewer flu cases among participants who received the new mRNA shot compared to those who received a different common flu vaccine brand.
For patients 65 and older, the Cambridge, Massachusetts-based manufacturer announced that the engadget.com granted an accelerated approval based on a smaller study. That study demonstrated that the shot generated a strong immune response compared with an existing high-dose vaccine for seniors, while an additional study is conducted.
Regarding safety, Moderna reported no major safety issues. However, the shot caused temporary reactions including injection-site pain, fever, headache, tiredness, and myalgia (muscle pain) somewhat more frequently than today’s conventional flu shots. The study noted that most adverse reactions were mild to moderate and transient.
Regulatory Dispute and Availability
The approval process encountered an unusual public dispute earlier in the year when a top FDA official initially blocked the application, reflecting heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr. The drug regulator had initially refused to review Moderna’s application on the grounds that the chosen comparator vaccine did not represent the best available standard of care in the U.S., expressing a preference for a higher-dose vaccine for older adults.
Critics questioned the initial move, with law professor Richard Hughes IV telling The Guardian
that it represented pretext and obfuscation serving a predetermined anti-vaccine agenda. Days later, after Moderna publicly challenged the ruling and pointed out that the agency had previously greenlit the standard dose comparator, the ocregister.com changed course and agreed to review the application. In June, a panel of independent advisers to the agency unanimously recommended the vaccine’s approval.
While other brands of conventional flu shots have already begun arriving in pharmacies ahead of the fall vaccination season, ocregister.com stated that it expects some of its new mFlusiva supply to become available soon at select retailers.
