Novavax is expecting to launch a phase 3 clinical trial of its COVID-19 vaccine NVX-CoV2373 in the US in the coming weeks, and has also announced that it has completed enrolment in its late-stage UK trial.
The US phase 3 trial launch has been delayed by issues surrounding Novavax’s manufacturing plans, in particular with the commercial manufacturing scale-up of its vaccine for the late-stage study.
Novavax is planning to use vaccine material produced at a FUJIFILM Diosynth Biotechnologies plant in North Carolina to support the commercial scale-up required for phase 3 trials in the US and Mexico.
In a statement, the company said that it is working ‘closely’ with the US Food and Drug Administration (FDA) to enable the vaccine produced at this plant to be used within the phase 3 trials.
“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley Erck, president and chief executive officer of Novavax.
“We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide,” he added.
At the same time, Novavax announced that its UK-based phase 3 trial investigating NVX-CoV2373 has competed enrolment of 15,000 participants.
The company is expecting interim data from this trial as early as the first quarter of 2021, but this depends on the overall COVID-19 infection rate in the region.
In addition, Novavax said that over 25% of participants in this trial are over the age of 65, with a ‘large proportion’ of volunteers also having underlying medical conditions.
In August, Novavax signed a deal with the UK government for early access to its COVID-19 vaccine, with the deal including an initial 60 million doses of the vaccine, depending on approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
As Novavax seeks to move NVX-CoV2373 through late-stage testing, a number of COVID-19 vaccine candidates from other drug developers have already been submitted to global health authorities.
This includes Pfizer/BioNTech’s candidate BNT162b2, which scored emergency approval from the MHRA today.
Moderna has also submitted its mRNA-based vaccine to the MHRA under a rolling review process, while AstraZeneca’s Oxford University-partnered vaccine is also currently being assessed in the UK.