HQ Team
June 12, 2025: Novavax Inc.’s investigational vaccine that protects against both Covid-19 and seasonal flu in a single shot has generated a “strong immune response” during end-stage trials, the company stated.
The single shot, called Covid-19-Influenza Combination (CIC), could make it easier and more convenient for people, especially older adults, to stay protected against both viruses with fewer injections.
The CIC vaccine targets both Covid-19 and flu at once, which no current vaccine on the market does. This could simplify vaccination campaigns, especially during flu season when Covid-19 is still circulating.
The trials also demonstrated a positive response to standalone influenza vaccines. The vaccines produced immune responses similar to Novavax’s existing Covid-19 shot Nuvaxovid and Sanofi’s flu shot Fluzone HD.
‘Robust immune response’
The study, which involved about 2,000 participants, 65 years or older, tested the safety and immune response of the Covid-19-influenza combination and standalone flu vaccines compared, respectively.
Nuvaxovid is already authorised in many countries and uses a protein-based technology, different from mRNA vaccines like Pfizer or Moderna. Some people prefer protein-based vaccines due to perceived safety or fewer side effects.
Fluzone HD is a high-dose flu vaccine designed for older adults.
“Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated,” said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax.
Mild or moderate severity
“This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners,” she said.
Both stand-alone flu and CIC vaccine candidates were well tolerated, with reactogenicity comparable to that of authorised comparators.
More than 98% of adverse events were mild or moderate in severity, according to a company statement.
The study was not designed to show statistically significant results. The data will be used for a future late-stage study, which can be submitted for regulatory approval, according to the statement.
Partners
“This cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (Covid-19) to inform a future registrational Phase 3 program.”
These early results will guide larger, more definitive late-stage trials to confirm effectiveness and safety. Positive data also help Novavax collaborate with partners and regulators to bring these vaccines to market, according to the statement.
Last year, Novavax signed a $1.2 billion licensing pact with Sanofi to commercialise and further develop its Covid-19 vaccine, Nuvaxovid.
