Maryland-based Novavax, Inc. announced data from the first co-administration study of a SARS-CoV-2 vaccine candidate [Novavax, NVX-CoV2373] and an approved influenza vaccine.
As part of Novavax's Phase 3 clinical trial of NVX-CoV2373 in the United Kingdom, about half of 431 volunteers also received an approved seasonal influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based, quadrivalent seasonal influenza vaccine].
The sub-study demonstrated that vaccine efficacy appeared to be preserved in those receiving both vaccines compared to those vaccinated with NVX-CoV2373 alone.
Vaccine efficacy in the sub-study was 87.5% (95% CI: -0.2, 98.4), while efficacy in the main study was 89.8% (95% CI: 79.7, 95.5) against SARS-CoV-2.
Local and systemic reactogenicity was largely absent or mild in all groups. A few events, such as pain and tenderness at the injection site and muscle aches, were elevated in those co-vaccinated.
Rates of severe events were low in all groups, and there were no additional early safety concerns associated with co-administration.
"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," stated Professor Paul Heath, FRCPCH, Vaccine Institute, St George's, University of London, and St George's Hospital, London, who is chief investigator of the Novavax United Kingdom trial.
"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," said Health in the press statement issued on June 14, 2021.
Despite the decrease in the immunogenicity with concomitant vaccination, anti-Spike antibody levels were more than 3-fold higher than levels found in the convalescent serum in those who received both vaccines.
"These data could be used to help inform guidance or recommendations on the co-administration of influenza and COVID-19 vaccines, overcoming challenges and contributing towards a new normal to protect at-risk populations from both infections," added Raja Rajaram, M.D., Medical Affairs Lead, EMEA, Seqirus, a co-author of the study.
Novavax, Inc. (NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.