Moderna’s flu-Covid combo vaccine elicits ‘strong’ immune response in Phase 1/2 study, company says

Covid-19 antigen home tests indicating a positive result are photographed in New York, April 5. The Biden administration has announced that it is providing $600 million in funding to produce new at-home Covid-19 tests and is restarting a website allowing Americans to again order up to four free tests per household.
(CNN) — In a Phase 1/2 clinical trial, Moderna’s combination vaccine appeared to elicit “strong” immune responses against both influenza and Covid-19 and was found to be safe, the company announced Wednesday.

The investigational vaccine, named mRNA-1083, was developed to offer some protection against both flu and Covid in a single shot, and in Wednesday’s announcement, the company said that it plans to begin a Phase 3 trial of mRNA-1083 among adults 50 and older this year.

The ongoing Phase 1/2 clinical trial involves comparing safety and immunogenicity results from a standard flu shot in adults ages 50 to 64 against results from the combination vaccine in adults ages 65 to 79. For both age groups, mRNA-1083 was also compared against the updated Covid-19 vaccine.

Moderna announced that in the Phase 1/2 study, mRNA-1083 appeared to achieve antibody titers similar to or greater than both the licensed flu shot and the updated Covid-19 vaccine. The two-in-one vaccine also appeared to have a similar safety profile to the Covid-19 vaccine and no new safety concerns were identified.

“With today’s positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.

The combination vaccine would not be available for the current respiratory virus season; separate flu shots and updated Covid-19 vaccines are now recommended and rolling out around the country. Moderna said in its announcement that it is targeting 2025 for potential regulatory approval of the combination vaccine.

“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies. Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems,” Bancel said. “We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”

Moderna isn’t the only company that has been studying a two-in-one combination vaccine against both flu and Covid-19; Pfizer and BioNTech have been working on one, and Novavax, too.

There could be a benefit to having a combination Covid-19 and flu vaccine, Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University, told CNN last year.

“There are logistical benefits: The number of injections that need to be given is reduced; the benefits to the storage facilities that are delivering, administering these vaccines don’t have to store as many vaccines because they’re in a combined form,” she said last year.

But she added that there are some limitations, as well.

“There are a couple of different issues with combinations. You have to make sure that they work together, which doesn’t always happen. Sometimes, the vaccine components can interfere with each other, and you don’t get as good an immune response as you would like,” Chatterjee said. “And then there’s the safety factor. As you add more vaccines together, often you get more reactions, particularly local reactions.”

Another element: Will enough people even take the vaccine? Chatterjee said last year that a combination flu and Covid-19 vaccine might improve that uptake.

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