Novavax COVID-19 vaccine, flu shot coadministration likely ‘viable strategy,’ company says

Maryland-based biotech company Novavax on Monday announced its experimental COVID-19 vaccine remained effective when coadministered with an approved flu shot. Researchers and drug makers are interested in studying coadministration and associated efficacy, or giving multiple vaccines to a person during one visit, to ease logistics and help patients catch up on missed vaccinations, especially amid the pandemic.

The news comes hours after Novavax announced on Monday that its COVID-19 vaccine was found to be over 90% effective overall, and offered 100% protection against moderate and severe disease in a Phase 3 clinical trial. The company said it intends to file for FDA authorization in the third quarter. 

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Preliminary findings from a Phase 3 clinical trial, posted ahead of peer review, involved 431 volunteers in the U.K. enrolled in a coadministration sub-study, in which all participants received an approved flu shot. About half also received the company’s investigational COVID-19 vaccine while the rest were given placebo.

“The study demonstrated that vaccine efficacy appeared to be preserved in those receiving both vaccines compared to those vaccinated with NVX-CoV2373 alone,” the company wrote in a statement posted Monday. “The protection afforded by the candidate vaccine was consistent with the main study at 87.5% (sub study) and 89.8% (main study) respectively.”

“The findings suggest simultaneous vaccination may be a viable immunization strategy,” the company wrote in the release.

Despite the “modest decrease,” antibodies against the spike protein were reported as over three-fold higher than levels found in blood samples of people who received both vaccines.

“As the next influenza season approaches and people still need a primary COVID-19 vaccine series or a booster, separate healthcare visits to cover both COVID-19 and influenza vaccinations will be burdensome,” Dr. Gregory M. Glenn, president of Research and Development, Novavax, said in the release. “As the first clinical study to evaluate safety, immunogenicity, and efficacy of a COVID-19 vaccine when co-administered with a seasonal influenza vaccine, these results demonstrate the promising opportunity for concomitant vaccination, which may improve the uptake of both vaccines.”

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Local side effects were reported as mostly absent or mild, with “a few events” like pain and tenderness at the injection site reported more often among those who were co-vaccinated. The effects usually lasted about two days. The company said the coadministration appeared safe, and the rates of severe events were low.

“This study shows how important it is to assess the safety profile and immune responses when COVID-19 and influenza vaccines are administered at the same time,” Professor Paul Heath, FRCPCH, Vaccine Institute, St George’s, University of London and St George’s Hospital, London, chief investigator of the Novavax United Kingdom trial, said in the release. “The results are reassuring and we are excited by the possibility of concomitant use of these vaccines as an important tool in the fight against both of these important respiratory viruses.”

Fox News’ Alexandria Hein contributed to this report.