India’s drug controller on Monday gave approval to Pune-based vaccine manufacturer Serum Institute of India (SII) for conducting phase II and III clinical trials on the vaccine against the coronavirus disease (Covid-19) developed by Oxford University and AstraZeneca, according to the Union health ministry. The trials are likely to begin next week. Phase I human trials have started on two indigeniously developed vaccines Bharat Biotech International Ltd’s Covaxin and Zydus Cadila’s ZyCoV-D to assess their safety. The development comes after an expert committee on Friday recommended that SII be allowed to conduct these trials after it studied a revised proposal submitted by the Pune-headquartered firm.
It needs mention here that the Pune-based firm has a tie-up with Swedish-British firm AstraZeneca, which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low- and middle-income countries. According to reports, the SII plans to conduct its phase II/III trials on around 1,600 participants.Among the amendments that SII had made to its protocol, it expanded the number of trial sites it is looking at around 20 facilities across India, said a senior government official.
Serum Institute of India (SII) last Monday said that the distribution of Covid-19 vaccine vials in India will be through a government network rather than private entities. The firm, known to be the largest vaccine manufacturer by volume across the world, said everyone will get the dose.There are more than 150 vaccine candidates undergoing clinical trials, with human trials of more than two dozen of these underway. However, the University of Oxford’s vaccine candidate is seen as the front runner.