Moderna doses 1st participant in phase 3 clinical trial of combo flu, COVID vaccine

(NEW YORK) — Moderna announced Tuesday it has dosed its first participant in a phase III clinical trial of a combination influenza and COVID-19 vaccine.

This phase will evaluate the safety and efficacy of the combo vaccine compared to flu and COVID vaccines that are administered separately in two groups, one involving 4,000 adults aged 65 and older and another involving 4,000 adults between ages 50 and 64.

In earlier Phase I/II clinical trials, data showed that the vaccine candidate achieved antibody levels similar or greater to the licensed standalone influenza vaccine and to Moderna’s COVID vaccine.

In a press release, the biopharmaceutical company said the combination vaccine has “the potential to efficiently reduce the overall burden of acute viral respiratory disease” by giving simultaneous protection against flu and COVID in a single dose.

Moderna said this could benefit the public health by increasing vaccine coverage rates for both viruses due to the convenience and easy administration of getting two shots at once.

The company previously announced that it is aiming for regulatory approval for the combination vaccine in 2025.

Moderna did not immediately reply to ABC News’ request for comment.

“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies,” Moderna CEO Stéphane Bancel said earlier this month in a statement when phase I/II clinical trial data was released. “Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems.”

Moderna estimated between 50 and 100 million COVID vaccine doses will be administered this fall and that, with time, the COVID market will approach the influenza market in the U.S.

Currently, between 500 million and 600 million flu shot doses are administered around the world with 150 million occurring in the U.S., according to Moderna.

Earlier this month, Moderna also said the rates of adverse reactions were not serious and similar to those experienced by the study participants who received the COVID vaccine by itself.

Moderna is not the only company that has been investigating a flu-COVID combination vaccine.

Pfizer-BioNTech announced in November 2022 that it had begun phase I clinical trials and, a month later, announced it had been given Fast Track designation by the U.S. Food and Drug Administration to help expedite the development and review of new drugs.

Pfizer previously told investors during an earnings call in January 2023 that a successful COVID-flu combination vaccine could help increase the percentage of Americans who receive a COVID vaccine.

Novavax also announced it is currently in the process of phase I/II clinical trials. In May 2023, the company said data showed there was a robust immune response among study participants.

Public health officials encourage anyone 6 months and older to get their annual flu and COVID-19 shots to minimize the risk for severe illness.

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