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", reported Hintustan Times. 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 commercialized 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. Meanwhile, medical research body ICMR will soon launch a COVID vaccine website which will provide information related to the COVID-19 vaccine development in India and abroad, with majority of the updates in several regional languages in addition to English, according to Live Mint. Earlier this month, Serum Institute of India had entered into a partnership with Gavi (Global Alliance for Vaccines and Immunization) and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries. The Bill & Melinda Gates Foundation will provide funding of $150 million to Gavi, which will be used to support the Serum Institute to manufacture the potential vaccine candidates. The collaboration will provide upfront capital to Serum Institute to help it increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification. In another development, the Times of India reported that the Pune-based Serum Institute has set a ceiling price of $3 per dose for the proposed COVID-19 vaccine for India and low-and middle-income countries (LMICs). Significantly, the ceiling price is only for vaccines proposed to be distributed to 92 countries under the Covax alliance — co-led by Gavi, Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO), formed to accelerate development of COVID-19 vaccines and ensure their rapid and equitable access. — Agencies
