Novavax’s COVID-19 vaccine may face severe uptake challenges in the US

Novavax has further demonstrated excellent results from its pivotal PREVENT-19 vaccine trial. Despite this positive data, it will likely see very little uptake in the US, says GlobalData, a leading data and analytics company.

Nancy Jaser, PharmD/MBA, Pharma Analyst at GlobalData, comments: “Novavax’s PREVENT-19 trial enrolled close to 30,000 participants across 119 sites in the US and Mexico*. However, vaccination rates are decreasing in the US while mRNA vaccine supplies remain plentiful. It is likely that a large amount of the first doses will go to other countries that have a more urgent need for vaccines. The use of NVX-CoV2373 outside of the US can serve as a great alternative to adenovirus vector-based vaccines due to its easier storage requirements and higher efficacy levels.”

Results show that NVX-CoV2373 was 93% effective against the predominant SARS-CoV-2 variants in the US and Mexico trial population including B.1.1.7 (Alpha). 54 out of the 77 subjects who contracted COVID-19 were sequenced in this trial, which is a high percentage relative to many other vaccine trials. Two cases were found to be caused by variant B.1.351 (Beta), 35 by Alpha, while the others are undisclosed. No sequenced case was determined to be associated with Delta.** This limits the efficacy data against variants, as it only applies to strains circulating through the PREVENT-19 trial population. This is important to keep in mind, since the vaccine will be used globally upon approval.

Jaser continues: “Earlier this year, a Phase 2b trial in South Africa showed 48% efficacy against Beta while a Phase 3 trial in the UK indicated 86% efficacy for Alpha*. Besides this, the vaccine is safe and has a 90% overall efficacy rate along with a 100% rate of protection against moderate and severe infections*. Further, Novavax is testing other versions of this vaccine in an effort to increase efficacy against all variants of concern. Protection against all variant strains of SARS-CoV-2 is a key factor to control the pandemic globally and to finally see a decrease in new cases and deaths. While the US may not see much uptake, this vaccine is a much-needed weapon to end the pandemic battle on a global level.

“The company plans to file for regulatory approvals in the third quarter of this year and it expects to be able to manufacture 100 million doses per month by that time. Novavax currently has deals with the Serum Institute of India and GAVI, a COVAX partner, to supply it with hundreds of millions of doses. The US pre-ordered 100 million doses of Novavax’s vaccine through Operation Warp Speed; a large number of these doses will likely be distributed to countries with a greater need for supply**.”

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