Novavax Begins Phase 2 For COVID-19/Influenza Combination And Stand-Alone Flu Shots

by Joy Lin
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Novavax has begun the Phase 2 trial for its COVID-19-Influenza Combination (CIC) and influenza stand-alone vaccine candidates. The dose-confirming trial will test how safe and effective the vaccines are in different formulations in adults aged 50 and 80. 

“We’re encouraged by the initiation of this trial given the positive results shared earlier this year from our Phase 1/2 trial, the first of its kind to evaluate a combined COVID-19 and influenza vaccine,” said Novavax CEO Stanley C. Erck.

“We believe that like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID.”

Initial data from the trial will roll in mid-year 2023 and will inform the course of Phase 3 trials for both vaccines, the company said.

Related Article: Novavax Offers Up $125 Million Of Stock For COVID-19 Vaccine Launch

Using COVID-19 And Flu Antigens To Stimulate Immune Response

Novavax’s CIC, NVX-CoV2373-NanoFlu, is a recombinant protein-based vaccine designed to give protection against COVID-19 and flu. The shot contains antigens derived from the original coronavirus spike protein and four wild-type hemagglutinin (rHA) proteins from the influenza virus. The CIC is formulated with Novavax’s saponin-based Matrix-M adjuvant which boosts the immune response. 

In a Phase 1/2 trial that enrolled 642 adults aged 50 to 70, the CIC elicited a strong immune response similar to standalone flu and COVID-19 shots. Furthermore, modeling showed that the combined formulation could reduce the total amount of antigens used by up to 50%, which could boost production and delivery.  

The Phase 2 trial will be conducted in two parts and is expected to enroll approximately 2,300 participants across Australia and New Zealand. 

Besides the CIC and NanoFlu, Novavax is investigating an Omicron-specific vaccine (NVX-CoV2515) and a bivalent Omicron/original strain-based vaccine. 

Novavax’s original COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), has received authorizations from the US FDA, the European Commission, and the WHO. It is also being evaluated for additional indications and populations such as adolescents and as a booster. 

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