Moderna gets EU approval for mRNA combination Covid-flu shot

• EU approves Moderna's flu-Covid shot for adults 50+
• It's the first single-dose vaccine for both flu and Covid
• Moderna's shot showed higher immune response in late-stage trials

Did our AI summary help?

European regulators have approved Moderna Inc.’s novel combination flu and Covid shot, handing a victory to the embattled vaccine maker that’s faced heavy resistance to its new immunizations in the US.

The European Medicines Agency’s human medicines committee recommended authorizing the shot, which uses messenger RNA technology, for adults 50 and older. It’s the first approved vaccine to protect against both respiratory diseases in a single dose.

The European regulators’ decision is a much-needed win for the company, which generated enormous sales during the pandemic with its breakthrough Covid shot developed using mRNA technology. But Moderna has struggled since then with slowing demand for that vaccine and with launching new products.

Under the leadership of Health Secretary Robert F. Kennedy Jr., a vaccine skeptic, US officials have only made things harder for the company, narrowing the population of people who are eligible for Covid vaccines, creating confusion over how to get them and raising questions over their safety.

Earlier this month, the US Food and Drug Administration refused to review Moderna’s standalone flu vaccine, saying its studies didn’t compare the shot to the “best-available standard of care.” Moderna pushed back, saying the FDA previously approved the design of its studies and the agency had become so unpredictable that it threatened US leadership in developing new medicines. A week later, the agency reversed course and agreed to review the company’s flu shot after the two sides agreed to a revised approach.

Moderna’s combination Covid-flu vaccine has also faced a rocky path with regulators. Last May, the company withdrew its application for approval with the FDA, saying the agency wanted to see more data from a trial of its standalone flu shot. The company says it’s awaiting more guidance from the FDA before resubmitting the application.

Older generations of vaccines used inactivated or weakened version of a virus or a piece of it to spur immunity, while mRNA temporarily turns the body’s cells into tiny vaccine-making factories.

Some critics, including members of a key Centers for Disease Control and Prevention advisory panel, have advanced theories that mRNA vaccines persist throughout the body for months, leading to dangerous side effects. Yet years of evidence dispute this claim. Strands of mRNA have a very short half-life, and don’t typically remain in the body for more than 24 hours.

Despite early promise that mRNA technology could eventually be used to treat cancer, last year Kennedy terminated contracts worth almost $500 million to develop vaccines using the technology.

Combination shots are a key part of Moderna’s strategy to grow beyond its Covid vaccine. The company believes it can increase vaccine use by appealing to people who are hesitant to get two shots at once and don’t want to return to get vaccinated multiple times.

Pfizer Inc. and its partner, BioNTech SE, have also been developing a Covid-flu combination shot, but have faced setbacks in clinical trials.

In a late-stage clinical trial, Moderna compared people who got its combination vaccine with those who got a competitor’s flu shot and Moderna’s Covid vaccine separately during the same visit. Moderna’s combination shot generated higher immune responses against both viruses than licensed flu and Covid vaccines in adults 50 years and older.