50mn doses ready as DCGI approves Serum’s Covishield
Pune-based Serum India Institute’s (SII) gamble to start producing vaccine shots at its Manjri-based facility eight months before when the efficacy of Covishield vaccine was not established,has finally paid off as they got the approval from Drugs Controller General of India (DCGI) on Sunday.
Minutes after DCGI issued a statement, approving Covishield and Bharat Biotech’s Covaxin for restricted emergency use, SII said it is ready to roll out the vaccines in India.
Adar Poonawalla, chief executive officer of SII, tweeted, “Happy new year, everyone! All the risks Serum institute took with stockpiling the vaccine, have finally paid off. Covishield, India’s first Covid-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”
Director DCGI VG Somani said on Sunday, “The subject expert committee of central DCGI met on January 1 and 2 and made recommendations based on the proposal for approval of restricted use in emergency situations of Serum institute’s Covishield vaccine. It has approved the use with adequate safety and restricted used in emergency situation. The committee included experts from various medical fields.”
As of date, the institute has over 50 million doses ready and the vaccine manufacturer has set a target of producing 500 million doses by July 2021. In his earlier interaction with media, Poonawalla had stated that most proportion of the vaccine would be set aside for the Indian market, as per the institute’s deal with Melinda Gates foundation, which has also invested in the project, the vaccine would also be supplied to the Covax countries, including African nations.
Umesh Shaligram, director of research and development at SII, at a webinar on Thursday however claimed that the vaccine producer has stockpile of 75 million doses.
It was in early May when Pune-headquartered SII received an original vaccine seed from the UK and started production of Covishield, the Oxford-developed vaccine which was yet to get even preliminary approvals by Indian and UK authorities. To produce vaccine at a mass level considering the urgency of its requirement, SII expanded its capacity at its Manjri plant in Pune. According to SII, the manufacturer has assembly lines to crank out 500 doses per minute.
This even as India was yet to face the first severe wave of Covid-19. This huge risk has now reaped huge benefits for the institute as DCGI approved the vaccine on Sunday. The emergency use authorisation will now allow the vaccine to be administered on a mass scale.
When the institute had begun the mass production with its own investment and had called it a huge risk as the vaccine candidate was yet to get any approval even from the government in the UK where the vaccine was being produced, Poonawalla said, “it’s a gamble, he is willing to play” . The institute had invested about a $100 million in this project.
Over the eight months, the vaccine production went on smoothly even as it met with a controversy when a volunteer from Chennai alleged that he faced neurological damage due to the vaccine.