From almost being de-listed by the NASDAQ stock index in 2018 due to poor financial performance, US vaccine firm Novavax has completed a remarkable turnaround. Now the holder of one of the world’s leading COVID-19 vaccine candidates and the recipient of billions of dollars in funding from the US government and various international institutions, Novavax is slated to launch its COVID-19 vaccine globally this year following a massive US and Mexico Phase 3 Trial.

Novavax’s vaccine, created using moth cells harnessed to produce the virus’ spike protein – which the pathogen uses to invade human cells – outshone those of its major competitors on key measures in monkey and early human tests and has continued to perform well in later clinical trials.

Unlike the other recipients of funding from the US government’s Operation Warp Speed program, which aims to rapidly produce at least 300 million COVID-19 vaccine doses, Novavax is a relatively small company. This means that it has missed out on the advantages that come with having the first approved vaccine on the market; however, Novavax’s vaccine may prove to be the most effective of all.

This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa

Professor Shabir Maddi, Vaccines and Infectious Diseases Analytics Research Unit (VIDA), Wits

The candidate stands out particularly for its efficacy against new strains of COVID-19, demonstrating 89.3 percent efficacy in its UK Phase 3 Trial back in January, where over 50 percent of cases were attributable to the now-predominant UK variant. It also demonstrated clinical efficacy in a Phase 2b trial in South Africa, where over 90 percent of sequenced cases were attributable to the prevalent South Africa escape variant.

“This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” said Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. “I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”

In terms of its vaccine’s suitability for global distribution, Novavax also has an edge on some of its competitors given that it is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

These advantages have been recognised by the global organisations charged with sourcing vaccines for low- and middle-income countries. In recent news, the company made an additional commitment to COVAX – the WHO’s distribution network for low- and middle-income countries, in conjunction with CEPI and GAVI – bringing its total commitment to 1.1 billion. Novavax is working with the Serum Institute of India – the world’s largest vaccine maker – to deliver the doses

Novavax Timeline

• • January 2020 – Novavax begins work on a coronavirus vaccine.
  • May 2020 – Novavax launches clinical trials for their vaccine.
  • July 2020 – The US government awards Novavax USD1.6 billion to support the vaccine’s clinical trials and manufacturing.
  • August 2020 – Novavax launches a Phase 2 trial on 2,900 people in South Africa.
  • September 2020 – Novavax launches a Phase 3 trial with up to 15,000 volunteers in the United Kingdom.
  • December 28 2020 – Novavax launches a Phase 3 trial with 30,000 people in the United States. The trial had been delayed because of problems with manufacturing the doses required for the study.
  • 2021 – If its clinical trials succeed, Novavax expects to deliver 100 million doses for use in the United States this year.

Source: New York Times

However, as Meredith Wadman pointed out in Science Magazine back in November 2020, scepticism still abounds around Novavax’s ability to deliver on these massive commitments. Having focused on making vaccines for over 20 years the company has never brought one to market and senior executives have sold off tens of millions of dollars of company stock since its share price skyrocketed in Summer 2020.

Additionally, “Novavax must rely mostly on contract manufacturers to meet its ambitious goal for 2021: producing enough vaccine to give 1 billion people two shots each. If manufacturing problems crop up – and the company last week said manufacturing delays had slowed launch of its late-stage North American trial – competing vaccines may surge ahead,” she noted.

Nevertheless, with results from the company’s 30,000-participant US and Mexico Phase 3 trial expected this year, the story of Novavax’s COVID-19 vaccine and its journey to market seems sure to remain compelling for the foreseeable future.