Serum Institute of India that is conducting clinical trials for the Oxford University-AstraZeneca coronavirus vaccine is likely to start trials for the Novavax COVID-19 vaccine. This development comes after drug regulator Drugs Controller General of India (DCGI) allowed SII to resume its trials for the Oxford vaccine in India. The trial was put on hold following an adverse event in a participant.
Adar Poonawalla-helmed Serum Institute had partnered with Novavax in August for the production of its coronavirus vaccine. The US drug developer said on Tuesday that it is planning to double its COVID vaccine manufacturing capacity to 2 billion doses annually. As part of the expanded agreement, Serum would manufacture the antigen component of the candidate NVX CoV2373.
The Novavax-Serum Institute trials will be led by ICMR-National AIDS Research Institute, Pune. According to a report in The Economic Times, the trials are set to start in October.
Pune-based Serum would have exclusive rights for the Novavax vaccine in India during the term of the deal and non-exclusive rights during the 'pandemic period'. This will apply in all countries, except upper-middle or high-income countries, as designated by WHO.
Novavax had said that its coronavirus vaccine produced high levels of antibodies against coronavirus, as realised from the small, early-stage clinical trial conducted by them.
Stanley C Erck, President of Novavax said that they are committed to equitable global delivery of the COVID-19 vaccine. "With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents," said Erck.
He added that they are working with "extraordinary urgency" to develop the vaccine which is now in Phase 2 of clinical trials. Erck said they hope to start Phase 3 efficacy trials around the world in the coming weeks.