Novavax Releases Promising Data from Descriptive Trial for COVID/Flu Combination and Stand-Alone Flu Vaccines
Both investigational vaccines induced strong immunity across all antigens and researchers reported no new safety signals, supporting phase 3 development.
Novavax today reported early phase 3 data showing that its COVID-19–influenza combination vaccine (CIC) and stand-alone trivalent influenza vaccine (tNIV) generated strong immune responses and were well tolerated in adults aged 65 years and older.
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In this initial cohort of approximately 2,000 participants, both candidates induced neutralizing antibody levels against influenza strains H1N1, H3N2, and B, and SARS-CoV-2, with responses ranging from 2.4- to 5.7-fold above baseline. Immunogenicity appeared comparable to licensed vaccines Fluzone HD and Nuvaxovid. Safety profiles were also similar, with more than 98% of solicited adverse events rated as mild or moderate.
While the study was not powered for statistical comparisons, these descriptive data will inform a registrational phase 3 program and ongoing partnering discussions, according to the statement.
The preliminary phase 3 findings build on data from an earlier phase 2 study in which the company's CIC, its stand-alone influenza, and high-dose COVID-19 vaccine candidates all produced strong immune responses and showed acceptable safety profiles in adults aged 50 to 80 years.
The stand-alone flu vaccine outperformed the inactivated adjuvanted trivalent vaccine Fluad (Sequiris) and the inactivated influenza trivalent vaccine high dose Fluzone HD (Sanofi) in hemagglutination inhibition (HAI) responses, with titers 31% to 56% higher for all strains and up to 89% higher for A strains. The CIC vaccine achieved antibody levels comparable to Novavax’s prototype COVID-19 vaccine and flu responses in line with authorized comparators. The high-dose COVID-19 candidate elicited IgG and neutralizing responses approximately 30% higher than the prototype vaccine, while maintaining a similar safety and reactogenicity profile.
No serious adverse events related to the vaccines were observed. These findings supported continued development and informed the design of the phase 3 trial reported today.
