Serum Institute of India (SSI), which has entered a manufacturing partnership with AstraZeneca to produce Oxford University’s Covid-19 vaccine candidate, has issued a clarification, denying reports that the shot may be launched in 73 days as “completely false and conjectural”.
The Pune-based company’s clarification said that the government has granted it permission to only manufacture Covishield and stockpile it for future use, according to news agency ANI. It has also said, according to ANI, that Covishield will be commercialised once trials are proven successful and requisite regulatory approvals are in place.
The world’s largest vaccine manufacturer said it will confirm its availability officially only once the vaccine is proven immunogenic and efficacious, ANI reported.
Serum Institute has registered for Phase II and III clinical trials on Covishield with the Clinical Trials Registry of India (CTRI). The trials will be conducted on 1,600 healthy participants across India.
It has struck a production and clinical trials deal with AstraZeneca for the AZD1222 vaccine, which has till now been tested in the most number of people among the close to 200 options across the world. The company had entered into a partnership with Gavi, The Vaccine Alliance and the Bill & Melinda Gates Foundation, to speed up the manufacture and delivery of up to 100 million doses of Covid-19 vaccines for India and sevetal low- and middle-income countries.
India’s drugs controller had given approval to SII for conducting Phase II and III clinical trials of the vaccine candidate in the country on August 3.