Novavax a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has released an update on its COVID-19 vaccine. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with the company’s proprietary Matrix‑M.
“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, 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.”
Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonised and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalisable across global populations.
UK pivotal Phase III trial update
Novavax completed enrolment of 15,000 participants in a pivotal Phase III clinical trial being conducted in the UK to determine efficacy and safety of NVX-CoV2373. The U. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrolment of volunteers.
Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the UK, European Union and other countries. More than 25% of participants in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.
South Africa Phase IIb trial update
The Phase IIb trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.
This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the UK, availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.
US/Mexico pivotal Phase III trial update
Novavax expects its pivotal Phase III clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.
Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase III has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the US and Australia are expected to be unblinded in Q1 and will be targeted for publication.
Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.
Novavax was awarded $1.6 billion in funding from the US government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the US and Mexico pivotal Phase III trial and manufacturing scale-up.
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