Pharma

Moderna Covid/flu combo vaccine is moving forward for FDA approval

Combination vaccines can be more convenient and therefore reduce burdens on health systems and pharmacies.
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Francis Scialabba

· less than 3 min read

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Moderna is making Covid and flu shots a two-for-one combo.

The Massachusetts-based biotech company announced that a Phase 3 trial of its combination Covid-19 and influenza vaccine, mRNA-1083, had a stronger immune response than the individual shots for both viruses.

“Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies,” Moderna CEO Stéphane Bancel said in a press release. They could also “offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses,” he said.

mRNA-1083 is made up of Moderna’s vaccine candidate for seasonal influenza as well as its next-generation Covid vaccine candidate, and the individual vaccines both previously had positive Phase 3 clinical trial results, according to the biotech.

Moderna did not confirm when it exactly plans to file for FDA approval, but wrote in an email to Healthcare Brew it is working with regulators on next steps based on the data. Successful Phase 3 trials are typically when a drug is moved forward for approval.

Competitors Pfizer and Novavax are also developing combination vaccines against flu and Covid-19, but Moderna is the first company to achieve positive Phase 3 trial results, according to the release.

Moderna’s Covid vaccine has been a financial boon to the company, bringing in over $18 billion in 2022 and $6.7 billion in 2023. Its Covid vaccine is one of only three FDA-approved products out of the company, including the RSV vaccine that was approved on May 31 (but has not yet hit the market).

Moderna is also developing a combination vaccine against flu and RSV, and another against flu, RSV, and Covid, according to the company.

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.