Novavax phase 3 interim data expected early 2021

Biotech News: Following Prime Minister Scott Morrison’s announcement last month on Australia’s agreement with Novavax to secure 40 million doses of its COVID-19 vaccine candidate NVX-CoV2373, the vaccine program is now entering its phase 3 clinical 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 C. 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.”

Dr Kylie Quinn, RMIT Vice-Chancellor’s Research Fellow at RMIT University, recently said “The inclusion of the Novavax vaccine is particularly notable for vaccine delivery to older individuals. A similar vaccine for influenza is being tested by Novavax in a Phase III clinical trial specifically in older individuals. The trial is still ongoing but initial results showed that the Novavax vaccine generated larger immune responses in older people as compared to the standard flu vaccine.”

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 generalizable across global populations.

Paul Griffin, Director of Infectious Diseases at Mater Health Services, Associate Professor of Medicine at the University of Queensland, said “The Novavax vaccine is based on advanced technology that is different from the other vaccines we have been hearing about mostly. It is a protein-based vaccine targeting the spike protein of the SARS-CoV-2 virus which is the protein the virus uses to get into cells to infect them. 

“The vaccine also contains Novavax’s patented adjuvant, Matrix-M, which has a track record of safely enhancing immune responses when added to their vaccines.,” he added.

United Kingdom (U.K.) pivotal Phase 3 trial update

Novavax completed enrolment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment 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 U.K., European Union and other countries. More than 25 percent of enrollees 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 2b trial update

The Phase 2b 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 U.K., 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.

U.S./Mexico pivotal Phase 3 trial update

Novavax expects its pivotal Phase 3 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 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

Unlike the AstraZeneca/Oxford University and the CSL/UQ vaccines which will be manufactured locally by CSL, the Novavax vaccine will be produced in FUJIFILM Diosynth Biotechnologies in the U.S.