US pharma giant Novavax Inc is already conducting a late-stage clinical trial in the UK for its experimental coronavirus vaccine apart from one in South Africa.
[REPRESENTATIVE IMAGE] (Photo Credits: novavax.reportablenews)
American pharma giant Novavax Inc said on Monday that it has further delayed a US-based late-stage clinical trial for its experimental coronavirus vaccine. The trial is expected to begin in the coming weeks instead of November, Novavax Inc added.
This is the second time Novavax Inc has rescheduled the Phase-3 clinical trial in the US.
Stating that it is working with the US FDA (Food and Drug Administration) to seek approval for its experimental Covid-19 vaccine, Novavax Inc also asserted that it will use vaccine material being produced at a commercial scale in the US and Mexico. This Covid-19 vaccine is being produced at a plant in North Carolina.
A late-stage clinical trial for Novavax Inc’s experimental vaccine is already underway in the UK. As many as 15,000 participants have enrolled in this trial which is expected to churn out interim data as early as the first quarter of 2021.
This morning, we provided an update on clinical development of our #COVID-19 candidate #vaccine, including that we’ve completed enrollment for our pivotal Phase 3 trial in the UK and Phase 2b trial in South Africa. Read our announcement for details. https://t.co/ztcm3U2msz pic.twitter.com/pgeSNbyXwW
— Novavax (@Novavax) November 30, 2020
Data released by the pharma giant revealed that more than 25 per cent of the participants are above the age of 65, most of them with underlying co-morbid medical conditions.
Earlier, Novavax Inc had said that its UK trial could form the basis for global regulatory approvals.
In addition, Novavax Inc is also conducting a Phase 2b trial in South Africa with 4,400 volunteers. According to earlier statements, efficacy data from this clinical trial will also be available in the first quarter of 2021.
American pharma giant Moderna also said on Monday that it will seek Emergency Use Authorisation for its coronavirus vaccine with 94 per cent efficacy from regulators in the US and Europe.
(With inputs from Reuters)