Bangalore:
The Serum Institute of India, the world’s largest vaccine producer, said Thursday that it has manufactured 40 million doses of AstraZeneca’s potential COVID-19 vaccine and will soon begin producing Novavax’s rival vaccine as both seek approval. regulatory.
While there are no approved COVID-19 vaccines yet and trials are still underway to show they are safe and effective, major drug manufacturers have received funding to start production early to speed deliveries as the pandemic has killed more. than 1.2 million people worldwide.
AstraZeneca said last week that it was withholding deliveries of its COVID-19 candidate vaccine while awaiting data from late-stage clinical trials, which were delayed due to a summer drop in coronavirus infections in the UK.
Serum declined to comment on whether the 40 million doses of the AstraZeneca vaccine were destined for global supply or just India.
For the Novavax vaccine production, Serum said that it has received most of the vaccine from the American company and will soon fill them up and end up in vials.
Novavax, which is testing its vaccine in a late-stage study in the UK, last month postponed the start of its US trial by about a month due to delays in expanding the manufacturing process.
Serum said it had enrolled 1,600 participants in India for the AstraZeneca candidate late-stage trials, and also plans to seek regulatory approval to conduct late-stage trials for the Novavax vaccine.
The AstraZeneca vaccine, jointly 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 seek “early availability” of the injection in India.
The ICMR, a federal government body, had funded the clinical trial site fees for the AstraZeneca vaccine, Serum said. The company and ICMR are conducting phase 2/3 clinical trials of the vaccine at 15 centers in India.
The news came as coronavirus infections in India, the world’s second-worst-hit country, hit 8.68 million on Thursday and the death toll rose to more than 128,000.
India also has at least two homegrown COVID-19 vaccine candidates in development, while Dr Reddy’s Labs is conducting an in-country trial for Russia’s candidate vaccine.
Earlier this week, Pfizer and its partner BioNTech said their vaccine candidate had been shown to be more than 90% effective based on initial test results. Pfizer said it was committed to advancing its commitment to the Indian government to supply its potential vaccine in the country.
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