Novavax, Inc. today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.
“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,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “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.”
The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.
The study employed descriptive endpoints, assessing safety and the immunological responses of different CIC vaccine formulations. A Design of Experiments (DOE) modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.
Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. These data support advancement to a Phase 2 confirmation trial, expected to begin by the end of 2022.
Data from the trial were presented at the World Vaccine Congress (WVC) in Washington, DC.
Influenza Program Update
At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint. These results have previously been published in The Lancet.
Authorization in the U.S.
Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or approved for use in the U.S. by the U.S. Food and Drug Administration.
Important Safety Information for NVX-CoV2373
• NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
• Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
• Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
• Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
• NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
• The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
• Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
• The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
• Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
• The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.