Executives at Novavax have said the company’s manufacturing capacity can meet the demand in the US for a COVID-19 vaccine in 2021.
At the peak, Novavax expects demand in the US to hit as many as 500 million to 600 million doses per year. The company plans to start producing its vaccine candidate NVX-CoV2372 on a large scale at the beginning half of 2021, and expects to manufacture over two billion doses of the vaccine annually if it proves effective in late-stage trials.
Last week, Novavax posted positive results from a phase 1 trial of NVX-CoV2373, in which the candidate was evaluated at two dose levels – 5µg and 25µg – with and without an adjuvant in 131 healthy adults between the ages of 18 and 59 years.
In the early study, the vaccine produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, following a single dose. Participants also demonstrated higher levels of antibodies after two doses compared to the levels seen in recovered COVID-19 patients.
The addition of Novavax’s Matrix-M adjuvant also boosted the effect of the vaccine, the company said. The vaccine was generally well-tolerated, with only some participants experiencing local symptoms and systemic events, including headache, fatigue and muscle pain.
Novavax received $1.6bn in funding from the US government’s Operation Warp Speed in July to accelerate the development of its investigational coronavirus vaccine.
Under the terms of the agreement, Novavax will produce 100 million doses of its vaccine by the beginning of 2021 if it continues to prove to be safe and effective in clinical testing.
The funding will also be used to complete late-stage clinical development and establish large-scale manufacturing for Novavax’s vaccine candidate.
Although Novavax is still awaiting a US Food and Drug Administration (FDA) review of the early study data, the company expects to begin a phase 3 trial of NVX-CoV2373 by autumn, which will evaluate the vaccine in up to 30,000 participants.
Novavax has already launched the phase 2 portion of the vaccine trial at a number of sites in multiple countries, which will evaluate if NVX-CoV2372 can prevent SARS-CoV-2 infection or reduce the severity of COVID-19 in a larger pool of participants.