Moderna says combination flu, COVID shot succeeds in study

Dive Brief:

• Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or older.
• Dubbed mRNA-1083, the shot is made up of Moderna’s second-generation COVID vaccine and a candidate for influenza, which have each been tested on their own in separate trials. The company pit mRNA-1803 against Spikevax, its approved COVID vaccine, and against flu shots from drugmakers Sanofi and GSK.
• Moderna said the data showed a single dose of mRNA-1083 was statistically equivalent, or “non-inferior,” to giving those vaccines together. It plans to present full results at an upcoming medical meeting, and to discuss next steps with regulators.

Dive Insight:

Moderna’s combination vaccine is key to its growth plans, but could also prove important for future vaccination efforts against two viruses that account for a substantial share of the seasonal infectious disease burden.

The company hopes its combination shot could ease the burden on healthcare workers and the public. Combination vaccines, such as the Tdap and MMR shots, can help improve adherence as well as immunization coverage. A shot like mRNA-1083, if approved, could be a more convenient option, especially among older adults who may need several shots each fall.

In Moderna’s study, mRNA-1083 was tested in two groups of 4,000 adults. In one, adults aged 65 years or older were randomly given either Moderna’s candidate, or Spikevax and Sanofi’s Fluzone together. (Fluzone is a high-dose vaccine for influenza.) The second group was made up of adults aged 50 years to 64 years who received with mRNA-1083 or Spikevax alongside GSK’s Fluarix.

MRNA-1083 was judged by trial researchers to be non-inferior the comparator vaccines in both groups, spurring higher antibody responses to the influenza strains H1N1, H3N2 and B/Victoria, as well as to SARS-CoV-2.

Advisers to the Food and Drug Administration in March recommended that flu vaccines this year be updated to include those three strains.

Moderna also tested immune responses against the B/Yamagata strain of influenza. However, that strain is no longer commonly circulating and public health agencies have recommended its removal from updated flu shots.

Moderna said most adverse events in the study were mild in severity and comparable to the profiles of the licensed vaccines used. Common side effects were injection site pain, headache, fatigue and muscle pain.

The company previously forecast its combo shot could arrive on market in the U.S. next year, a timeline that looks possible given the trial findings. Michael Yee, an analyst at Jefferies, wrote in a note to clients that, while the company’s “pipeline is progressing nicely,” Moderna’s near-term focus should be on launching its newly approved RSV vaccine and meeting its 2024 guidance.

Moderna’s RSV shot, dubbed Mresvia, was cleared by the FDA late last month for use in older adults. It’s the third to be approved, following OKs for GSK’s Arexvy and Pfizer’s Abrysvo.