BENGALURU (Reuters) – Serum Institute of India, the world’s largest vaccine producer, said on Thursday it had manufactured 40 million doses of AstraZeneca’s potential COVID-19 vaccine and would soon start manufacturing rival Novavax vaccine, as they both seek regulatory approval.
While no COVID-19 vaccine has yet been approved and trials are still underway to prove they are safe and effective, major drugmakers have been funded to start production early to speed up shipments, because the pandemic has killed more than 1.2 million people worldwide.
AstraZeneca AZN.L said last week it was withholding shipments of its COVID-19 vaccine candidate pending data from advanced clinical trials, which have been delayed due to a summer drop in coronavirus infections in the UK.
Serum declined to say whether the 40 million doses of the AstraZeneca vaccine were intended for global supply or just India.
For the production of Novavax NVAX.O vaccine, Serum said he received most of the vaccine from the US company and will soon be filling and finishing them in vials.
Novavax, which is testing its vaccine in an advanced-stage study in the UK, delayed the start of its US trial by about a month last month due to delays in ramping up the manufacturing process.
Serum said it has recruited 1,600 participants in India for the advanced stage trials of AstraZeneca’s candidate, and also plans to seek regulatory approval to conduct advanced stage trials for the Novavax vaccine.
The AstraZeneca vaccine, co-developed by the University of Oxford, is the most advanced in human testing in India, Serum said, adding that the company and the Indian Council for Medical Research (ICMR) will continue the “Early availability” of vaccine in India.
The ICMR, a federal government agency, had funded the cost of a clinical trial site for the AstraZeneca vaccine, Serum said. The company and the ICMR are currently conducting phase 2/3 clinical trials of shooting in 15 centers across India.
The news came as coronavirus infections in India, the second-worst-affected country in the world, reached 8.68 million on Thursday and the death toll rose to more than 128,000.
India also has at least two COVID-19 vaccine candidates in development, while local drug maker Dr Reddy’s Labs REDY.NS is currently conducting an in-country trial for Russia’s vaccine candidate.
Earlier this week, Pfizer PFE.N and its partner BioNTech 22UAy.DE reported that their vaccine candidate was more than 90% effective based on the results of the initial trials. Pfizer said it was determined to advance its engagement with the Indian government to deliver its potential vaccine to the country.