Nationwide trials of a Covid-19 vaccine delivery system at a vaccination center in Delhi, India.
Photographer: T. Narayan / Bloomberg
Photographer: T. Narayan / Bloomberg
The Serum Institute of India Ltd., which produces the coronavirus vaccine developed by AstraZeneca Plc and the University of Oxford expect the Indian government to sign a formal supply and pricing agreement within days of the shot being approved for emergency use.
Officials in New Delhi have indicated “orally” that the first 100 million vaccines will be purchased and priced at 200 rupees ($ 2.74) and that a deal should be signed “in the next one or two days,” said Adar Poonawalla. Serum’s Chief Executive Officer in an interview on Sunday. “They will probably take another 200 million after that and then we will probably sell to the private market,” which could be approved in “two or three months” for 1,000 rupees per vaccine, he said.
India’s drug inspector general VG Somani confirmed in a briefing earlier on Sunday the limited approval of the Astra-Oxford shot. The move came just days after the UK regulator approved the vaccine and is the first step to inoculate about 1.3 billion civilians in the country home to the world’s second largest Covid-19 outbreak.
“They just want to make sure they have enough products for their most vulnerable and needy,” said Poonawalla. “We are waiting for two things: how much they want and where they want it. Once they give us that direction, we have committed to rolling it out in 7-10 days. “
Serum, which is the world’s largest vaccine producer by volume, has an agreement with AstraZeneca to produce at least one billion doses. The company has already made 70 million, Poonawalla said, adding that an initial production target of 100 million in December had to be scaled back due to a delay in approvals.
“I actually stopped production because of the regulatory delays and uncertainty because I don’t know how much to pack,” he said. “You assign a shelf life to the production when you decide to package it and I have nowhere to store it – we are building new warehouses, which will take another year and a half even though we started building it in March. “
Poonawalla also expects to begin supplying the vaccine to Covax, the World Health Organization-backed agency that buys shots for poor countries, in early March. Serum would likely send an initial 20 million doses before scaling up to about 50 million within a month, he said.
The India regulator also gave limited approval to Covaxin from Bharat Biotech International Ltd. – which is partially funded by the Indian government and has yet to complete those crucial phase three trials. Somani said Covaxin got the nod, so India, which has 10.3 million confirmed infections, had more vaccination options in case mutant strains emerge.
Efficacy, faith
Bharat Biotech said last month that it had already roughly produced 10 million doses pending an expected rollout by mid-2021. The company says its inactivated vaccine candidate using a dead version of the virus has at least 60% efficacy, although it has yet to disclose data and is pending a peer review in an international health diary.
While the move to give limited approval for Bharat Biotech’s vaccine was hailed as a “giant leap for innovation and new product development in India” by the company’s joint president, Krishna Ella, in a statement on Sunday, it received a regulatory nod criticism.
“Approval was premature and could be dangerous,” Shashi Tharoor, a prominent opposition lawmaker, said on Twitter. “Its use should be avoided until the full trials are over. India may in the meantime start using the AstraZeneca vaccine. “
Poonawalla declined to comment on Covaxin’s approval from Bharat Biotech, saying only AstraZeneca’s vaccines, Moderna Inc. and Pfizer Inc. had “effectiveness and evidence – everything else is faith,” he said. “Show time if it works, and then we can indicate how good or bad they are.”
Pfizer is also still awaiting Indian approval for its vaccine. The need for ultra-cold storage makes it an unlikely candidate for widespread use across India. Both Bharat and Serum vaccines can be stored at refrigerator temperature, making them more suitable for the country’s patchy health infrastructure.
(Updates with comments from the CEO of Serum from the second paragraph, details on the approval of Bharat Biotech from the eighth.)