COVID-Flu Combination Vaccine Performs Well in Clinical Trial, Moderna Says

Pharmaceutical company says the combo shot, if approved, ‘could improve compliance.’

Moderna's headquarters in Cambridge, Mass., on May 8, 2020. Maddie Meyer/Getty Images

A combination vaccine that targets both COVID-19 and influenza did well in a phase 3 clinical trial, Moderna said on June 10.

Participants who received the combination shot had at least the same level of immune response as comparison cohorts, according to the Massachusetts-based pharmaceutical company, which produced one of the most widely used COVID-19 vaccines in the world.

The trial compared the immune responses in adults aged 50 and older who received the combination vaccine with the responses in adults in the same age range who received an influenza vaccine and Moderna’s COVID-19 shot. Adults aged 65 and older in the comparison group received an enhanced flu vaccine.

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The responses in trial participants who received one dose of the combination shot “were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators,” Moderna said in a statement.

The results from the phase 3, randomized, partial blind trial have not been peer reviewed or published for public review.

Moderna said it planned to present the data at an unnamed upcoming medical conference and submit it for publication in a journal.

Moderna, Pfizer, and Novavax, which currently make the three COVID-19 vaccines available in the United States, have been moving toward combination vaccines in the hope they will boost flagging vaccination numbers as fewer people opt to take influenza and COVID-19 shots.

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

The results are the first from a phase 3 trial to be announced for a combination shot.

Mr. Bancel told news outlets that Moderna is eyeing having its vaccine on the market in the fall of 2025.

The trial enrolled about 8,000 adults and is still going on. Investigators measured immune responses and recorded adverse events among participants.

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The combination vaccine “showed an acceptable tolerability and safety profile,” according to Moderna.

It said that more than half of the adverse events that participants were asked to record were grade one or two in severity and were “consistent with the licensed vaccines used in the trial.” The most common solicited adverse reactions included fatigue and headache.

Moderna’s COVID-19 vaccine can cause serious problems like heart inflammation, with some cases resulting in death.

The company did not respond to a request for comment for more details on the adverse events recorded in the trial.

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The effectiveness of both the influenza and COVID-19 vaccines is typically subpar, according to data from the U.S. Centers for Disease Control and Prevention (CDC) and elsewhere.

Influenza vaccines have been under 50 percent effective in 12 of the past 20 years, according to studies from the agency and other institutions.

The COVID-19 vaccines provide poor protection against infection and quickly degrading shielding against hospitalization, according to CDC data presented this month.

Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, questioned the need for COVID-flu vaccines in light of the data. He also pointed to Moderna’s trial.

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“The trial for this combination product involved a plausible but useless outcome, ‘eliciting a higher immune response than the licensed comparator vaccines used in the trial,’” Dr. Risch told The Epoch Times in an email. “That says nothing empirical about reducing infection risk.”

FDA Directs Manufacturers

The U.S. Food and Drug Administration (FDA), meanwhile, has directed Moderna, Pfizer, and Novavax to develop updated COVID-19 vaccines in light of their waning effectiveness.

The agency told the manufacturers to target the JN.1 variant in the updated shots, which are expected to be available starting in the fall.

The new vaccines will “more closely match currently circulating SARS-CoV-2 viruses,” the FDA said in a statement.

Advisers to the agency previously recommended the FDA direct the manufacturers to target JN.1, in part because of concerns that Novavax, which produces a protein-based vaccine, would not be able to shift to a shot targeting KP.2, a JN.1 sublineage.

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Moderna said on Jun 7 it has already filed an application for its updated shot, based on the new directive. Novavax said on June 10 that it is ready to deliver its updated shots in September, pending authorization. Pfizer officials said during a recent meeting that they would be prepared to meet demand from the United States and other countries.

The currently available COVID-19 vaccines were just authorized in the fall of 2023 to try to combat lower effectiveness against newer variants.

Just 23 percent of American adults, and 14 percent of children, have received one of those shots, according to survey data from the CDC. About 48.5 percent of adults, and 54 percent of children, received an influenza vaccine in the past flu season, according to estimates from the agency.

Fewer children received an influenza shot, and fewer adults received a COVID-19 shot, than in prior years. More health care workers are also declining both vaccines.