The Pune-based vaccine manufacturer Serum Institute of India (SII) is expecting the results of the clinical trials of the COVID-19 vaccine candidate Covishield by January.
“We have started manufacturing the product,” the SII’s Executive Director, Suresh Jadhav, said on Saturday, adding that the institute would produce 50 million to 60 million doses of the vaccine candidate developed by AstraZeneca and Oxford University every month from January.
“But, till January, we will also have about 80 to 100 million doses in stock for supply if we get permission for emergency use by the government.”
At a virtual conference on “COVID-19 vaccine — a global perspective” organised by the JSS Research Foundation, Dr. Jadhav said the trials of Covishield were in the final stages in India. While the Phase 3 trials had been completed in some parts of the world, in India, they were in the final stages with the injections scheduled for completion by November-end.
He hoped that the results of the trials would be available by January for submission to the regulator, Drug Controller General of India (DCGI), which had already permitted the SII to start manufacturing the vaccine after the trials entered phase 3.
Covishield is one of the five vaccine candidates with which SII was involved in India. Globally, a total of 321 vaccine candidates are in different stages of development, 50 of them in clinical evaluation phase.
Dr. Jadhav said the world required 16 billion doses of vaccine with each of the 7.2 billion people on the planet requiring two doses each, besides the 1.5 to 2 billion that were likely to go waste.
“It will require years together for several manufacturers to come up with the required quantity,” he said.
Pre-booking problem
He expressed concern over the pre-booking of COVID-19 vaccines by the developed world.
“Most of the developed world has booked more than double the quantity they require from western manufacturers,” he said, adding that about 3.4 billion doses had already been booked by the developed world by giving the manufacturers an advance amount.
Pointing out that such a trend was not witnessed in developing countries, Dr. Jadhav raised questions over equal distribution of the vaccine to all parts of the world.
Expiry date
He sought to highlight the challenge the manufacturers would face when giving an expiry date for the vaccine product. “Unless there is a good stability data for a long period of time for the product, manufacturers cannot determine to what extent the product will remain stable,” he said, adding that availability of stability data was one of the major reasons for vaccines to take a long time for development.