The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
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Novavax shared positive initial results Wednesday from the Phase I/II clinical study of its proposed combination vaccine for COVID-19.
NVX-CoV2373, a combination of Novavax’s COVID-19 vaccine and its quadrivalent influenza vaccine candidate, demonstrated a tolerability and safety profile consistent with the two vaccines’ profiles as standalone units. The researchers also did not find any serious adverse events directly related to the combo immunization, which they labeled as COVID-Influenza Combination Vaccine (CIC).
Using a modeling-based approach, the researchers were able to fine-tune their dose-selection strategies to make way for possible future developments. NVX-CoV2373 was evaluated using descriptive endpoints linked to immunological responses and safety when different formulations were applied.
Preliminary results showed different formulations led to immune responses not typically seen in standalone COVID-19 and influenza vaccine products. They also found that the combination can possibly cause a 50% reduction in total antigen amount. The scientists compared the CIC with vaccines including flu, H1N1, H3N2, SARS-CoV-2 rS and B-Victoria HA antigens.
“We’re encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19. We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza,” commented Gregory M. Glenn, M.D., president of research and development at Novavax, in a statement.
Novavax is preparing to launch a Phase II confirmation trial by the end of 2022.
Despite this positive outcome, however, U.S. Food and Drug Administration official Dr. Doran Fink said in an interview with reporters that the emergency use authorization (EUA) application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
At a meeting by the Centers for Disease Control and Prevention, he said that NVX-CoV2373 needs to be thoroughly reviewed for its clinical data and its manufacturing processes before a EUA can be issued. Additional data may be required, and the process will need to go through a stringent assessment with the FDA’s advisory committee. Fink did not provide a timeline for the approval.
Novavax is already approved in multiple countries as a primary and a booster shot for people ages 18 years and up, including Europe, Switzerland, India and Japan, where it carries the brand name Nuvaxovid. It is also allowed for adolescents ages 12 to 17 years in the European Union under a conditional marketing authorization. In mid-April, the company licensed and transferred its manufacturing technologies and supplies the Matrix-M adjuvant to its partner, Takeda, to create the vaccine at the latter’s facility in Hikari and distribute it in Japan after that.
