Novavax expects filing for covid vaccine approval in December1 min read . Updated: 27 Aug 2020, 02:35 PM IST
- Novavax Inc has already entered into a supply and license agreement with the Serum Institute of India for the development and commercialization of its COVID-19 vaccine candidate.
Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday.
Novavax Inc has already entered into a supply and license agreement with the Serum Institute of India for the development and commercialization of its COVID-19 vaccine candidate. The Indian drugmaker will have exclusive rights for the vaccine in India during the term of the deal and non-exclusive rights during the “Pandemic Period" in all countries other than those designated by the World Bank as upper-middle or high-income countries.
The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.
Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50% of the trial's population.
Early-stage data from a small clinical trial of the vaccine has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.
The US government has already announced deals for supplying six Covid-19 vaccines candidates. Those shots are being developed by Johnson & Johnson, Moderna Inc., Pfizer Inc. in partnership with BioNTech SE, the University of Oxford in collaboration with AstraZeneca Plc, Sanofi with GlaxoSmithKline Plc, and Novavax Inc.
(With Agency Inputs)