Nationwide trials of a Covid-19 delivery system at a vaccination center in Delhi, India.
Photographer: T. Narayan / Bloomberg
Photographer: T. Narayan / Bloomberg
The Serum Institute of India Ltd., which manufactures the coronavirus vaccine developed by AstraZeneca Plc and the University of Oxford, expect the Indian government to sign a formal offer and price agreement within days of the shot being approved for emergency use.
New Delhi officials have ‘verbally’ indicated that the first 100 million vaccines will be bought and priced at 200 rupees ($ 2.74), and an agreement must be signed in the next one or two days, ‘said Serum’s executive. chief, Adar Poonawalla, said in an interview on Sunday. ‘They will probably take another 200 million, and then we’ll probably sell to the private market,’ which can be approved at ‘1 or three months’ at 1,000 rupees per vaccine.
India Drug Control General VG Somani confirmed the limited approval of the Astra-Oxford shot during an information session earlier on Sunday. The move came days after the British regulator approved the vaccine and is the first step to vaccinate about 1.3 billion citizens in the country where the second largest Covid-19 outbreak in the world exists.
“They just want to make sure they have enough products for their most vulnerable and needy to begin with,” Poonawalla said. ‘We are waiting for two things: how much they want and where they want it. Once they give us the direction within 7 to 10 days, we will implement it. ”
Serum, which is the largest vaccine producer in the world, has an agreement with AstraZeneca to produce at least one billion doses. The company has already earned 70 million, Poonawalla said, adding that an initial production target of Due to a backlog in approvals, 100 million had to be scaled back by December.
“I actually stopped production due to the delays due to the regulations and uncertainty, not knowing how much to pack,” he said. ‘You set a shelf life on the production if you decide to pack it and I have nowhere to store it. We are building new warehouses, which will take another year and a half, although we started building them in March. ”
Poonawalla also expects to start delivering the vaccine to Covax, the body backed by the World Health Organization that buys shots for poor countries, in early March. Serum will probably send 20 million doses within a month before being scaled up to about 50 million, he said.
India’s regulator also granted limited approval to Covaxin from Bharat Biotech International Ltd. – which is partly funded by the Indian government and has not yet completed the important phase three trials. Somani said Covaxin had gotten the nod so India, which has 10.3 million confirmed infections, had more vaccination options should mutant strains emerge.
Efficiency, faith
Bharat Biotech said last month that it had already produced about 10 million doses before an expected launch by mid-2021. The firm says its inactivated vaccine candidate using a dead version of the virus has an efficacy rate of at least 60%, but that it does not yet have the disclosure of information and awaits a peer review in an international health magazine.
While the move to give limited approval for the Bharat Biotech vaccine, in a statement on Sunday by Krishna Ella, a joint managing director of Krishna Ella, the regulatory nod was criticized.
“Approval was premature and could be dangerous,” Shashi Tharoor, a prominent opposition lawmaker, said on Twitter. ‘Its use should be avoided until complete trials are over. India, meanwhile, could launch the AstraZeneca vaccine. ”
Poonawalla declined to comment on the approval of Bharat Biotech’s Covaxin, but said only the AstraZeneca vaccines, Moderna Inc. and Pfizer Inc. has ‘efficiency and proof – anything else is faith’, he said. “Let time know if it works, and then we can comment on how good or bad they are.”
Pfizer is also still awaiting India’s approval for its vaccine. The need to make ultra-cold storage makes it an unlikely candidate for widespread use in India. Both Bharat and Serum vaccines can be stored at refrigerator temperature, making them more suitable for the country’s poor health infrastructure.
(Updates with Serum CEO’s comments from the second paragraph, details on the approval of Bharat Biotech from eighth.)