Data Supports Administering Cell-Based Influenza Vaccine in Children
New Jersey-based Seqirus-US announced Phase 3 clinical data demonstrating that the company's cell-based quadrivalent seasonal influenza vaccine (QIVc) was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months through <4 years of age during the U.S. 2019/20 influenza season.
This Phase 3 clinical study was designed to support an application currently under review with the U.S. FDA for an expanded age indication for people six months of age and above for QIVc, marketed as FLUCELVAX® QUADRIVALENT in the USA.
QIVc (FlucelVax) utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing. Cell-based influenza vaccines are designed to produce an exact match to those selected by the World Health Organization each year.
"As COVID-19 mitigation tactics like social distancing relax, influenza vaccination remains of critical importance," said Jonathan Edelman, M.D., VP of Clinical Development at Seqirus and study author.
Several factors can impact seasonal influenza vaccine effectiveness, including vaccine recipient characteristics such as age and health or a mismatch between circulating strains and the influenza strains contained within the seasonal influenza vaccine. Traditional egg-based vaccine production can cause the strain to mutate, leading to an antigenic mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine, says Seqirus.
In the U.S., Seqirus operates a state-of-the-art cell-based manufacturing facility in Holly Springs, North Carolina, purpose-built in partnership with the US Biomedical Advanced Research and Development Authority.