EU regulator backs Moderna’s combined COVID and flu vaccine approval

By Bhanvi Satija

Feb 27 (Reuters) - Europe's medicines regulator recommended approval for Moderna's COVID and flu combination vaccine on Friday, putting it on track to become the first single shot to protect people aged 50 and older against both illnesses.

Currently people need two separate shots to protect them against COVID-19 and influenza and the vaccines are updated regularly to match the viral strains in circulation.

Moderna is banking on the COVID-flu combination shot and also an mRNA-based flu shot to help it return to revenue growth as demand for COVID vaccines has collapsed in the years after the pandemic.

It hopes international markets will drive revenue growth this year, as anti-vaccine activist U.S. Health Secretary Robert F. Kennedy Jr has disrupted the domestic market.

Moderna said its combination shot, mCombriax, could be available in certain EU markets for the 2026-2027 season.

The company expects the shot to be more widely available across the region in 2027, when the market reopens as current EU vaccine contracts expire.

Moderna’s COVID-flu combination vaccine: approval path and market impact

Moderna shares and investor context

MODERNA SHARES HAVE PLUNGED FROM 2021 HIGHS

Shares of the biotech, which were flat in U.S. premarket hours on Friday, have declined by nearly 90% from 2021 highs.

Regulatory status and application timeline

Last year, Moderna withdrew its U.S. application for its COVID-flu combination shot to wait for efficacy data from a late-stage trial of its influenza vaccine.

Earlier this month, the company said it was waiting for guidance from the Food and Drug Administration on refiling the application.

U.S. regulators initially refused to review a separate mRNA-based flu vaccine from the company, then reversed course a week later after Moderna amended its application.

Clinical evidence cited by the EMA

Study design and antibody response results

EMA's recommendation on Friday was based on data from a study of 8,000 participants that showed those who received mCombriax generated more antibodies than those who received separate shots against the viruses.

Comparator vaccines used in the analysis

The study compared mCombriax with a combination of Moderna's COVID-19 shot Spikevax and traditional flu shots from GSK and Sanofi.  

Additional immune response and vaccine composition details

EMA also considered data from a study of a similar mRNA flu vaccine, in which mCombriax triggered an adequate immune response. The shot contains messenger RNA with instructions for making proteins found on some strains of the influenza virus and SARS-CoV-2.

Next steps for EU marketing authorization

EMA's recommendation will be reviewed by the European Commission, which will give the final sign off for marketing in the European Union. It was not clear how long that decision would take.

(Reporting by Sri Hari N S in Bengaluru and Bhanvi Satija in London; Editing by Vijay Kishore, Nivedita Bhattacharjee and Barbara Lewis)