Novavax could make 100 million monthly doses of COVID-19 vaccine by October
Medicines & Vaccines 14/06/2021 •
A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas.

Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine.

This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company.

Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company.

The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors.

“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. 

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”

Efficacy of Over 90%

NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease.

“NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated.

Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). 

Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group.

Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. 

Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days.

Ready to File by Third Quarter

Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements.

According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing.

Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. 

“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said.

There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”.

CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology.

CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval.

“A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated.

 

 

Image Credits: Matt Feldman, Novavax.

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