The US government has committed a massive $1.6bn in funding to late-stage biotech company Novavax for the accelerated development of its investigational coronavirus vaccine.
The deal is the latest in a string of agreements made by the federal government under its Operation Warp Speed scheme, which was created earlier this year to aid the development and manufacture of promising coronavirus vaccines.
The agreement with Novavax is the largest to date, and under its terms the biotech company will produce 100 million doses of its vaccine by the beginning of 2021, if its proven to be safe and effective in clinical testing.
The money will also go towards completing late-stage clinical development and establishing large-scale manufacturing for Novavax’ experimental candidate, NVX-CoV2373. That includes a pivotal phase 3 trial with up to 30,000 participants set to begin in autumn this year.
The agreement also allows for an add-on agreement with the US government for the additional production and procurement of Novavax’ vaccine to further support Operation Warp Speed’s goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
“Adding Novavax’ candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said US Health and Human Services Secretary Alex Azar.
“The $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people,” he added.
An initial phase 1/2 trial of NVX-CoV2373 began in Australia in May, testing the vaccine in 130 healthy participants between the ages of 18 and 59 years. According to Novavax, preliminary immunogenicity and safety results are expected by the end of the month, and the phase 2 portion to assess immunity, safety and COVID-19 disease reduction is set to begin shortly after that.
The US government has now invested almost $4bn to help pharma and biotech companies develop coronavirus vaccines, although little is known about how exactly Operation Warp Speed is spending the money or how decisions are being made, according to The New York Times.
So far, that funding has gone to six companies, including AstraZeneca, Moderna, Merck, Sanofi and Johnson & Johnson’s Janssen division. These companies are at varying stages of development, and also differ in their experience in bringing a successful product to market.
AstraZeneca, Merck, Sanofi and Janssen all have a wealth of expertise in running large late-stage trials, whereas the relatively young Moderna has allegedly clashed with US government scientists over pivotal trials of its vaccine candidate. Sources familiar with the matter told Reuters that the ‘lack of staff and expertise’ is a main source of that discord, which has caused a delay of the critical human trials.
Novavax, like Moderna, has never brought a product to market, but the promise of their respective technologies has enough potential to warrant a large amount of funding, not only from the US but also from other organisations, including the Coalition for Epidemic Preparedness Innovations (CEPI).