National trials of a Covid-19 vaccine delivery system at a vaccination center in Delhi, India.
Photographer: T. Narayan / Bloomberg
Photographer: T. Narayan / Bloomberg
O Serum Institute of India Ltd., which is producing the coronavirus vaccine developed by AstraZeneca Plc and the University of Oxford expect the Indian government to sign a formal supply and pricing agreement a few days after the injection is approved for emergency use.
Officials in New Delhi “indicated orally” that the first 100 million vaccines will be purchased and cost 200 rupees ($ 2.74) and a deal is expected to be struck “in the next day or two,” said Serum CEO Adar Poonawalla, in an interview on Sunday. “They will probably take another 200 million after that and then we will probably end up selling to the private market,” which can be approved in “two or three months” at 1,000 rupees per vaccine, he said.
India’s General Drug Controller VG Somani, at a briefing earlier on Sunday, confirmed the restricted approval of the Astra-Oxford shot. The move came just days after the UK regulator released the vaccine and is the first step in inoculating some 1.3 billion citizens in the country that is home to the world’s second largest Covid-19 outbreak.
“They just want to make sure they have enough products for the most vulnerable and needy to start,” said Poonawalla. “We are expecting two things: how much they want and where they want it. As soon as they give us this guidance within 7 to 10 days we commit, we will implement it. “
Serum, which is the world’s largest manufacturer of vaccines by volume, has an agreement with AstraZeneca to produce at least one billion doses. The company has already grossed 70 million, said Poonawalla, adding that an initial production target of 100 million by December had to be reduced due to delay in approvals.
“In fact, I stopped production because of regulatory delays and uncertainty, not knowing how much to pack,” he said. “You give the production a useful life when you decide to pack it and I have nowhere to store it – we are building a new warehouse, which will take another year and a half, even though we started building it in March. “
Poonawalla also hopes to start supplying the vaccine to Covax, the agency supported by the World Health Organization that is buying vaccines for poor countries in early March. The serum would likely send 20 million starting doses before increasing to about 50 million in one month, he said.
The Indian regulator also gave restricted approval to Covaxin’s Bharat Biotech International Ltd. – which was partially funded by the government of India and has not yet completed the vital phase three tests. Somani said that Covaxin has received authorization for India, which has 10.3 million confirmed infections, to have more vaccination options in case mutant strains arise.
Effectiveness, Faith
Bharat Biotech said last month that it had already produced about 10 million doses before the mid-2021 launch. The company says its inactivated candidate vaccine that uses a dead version of the virus has at least 60% efficacy rates, although it has not yet released data publicly and is awaiting review. in an international health journal.
While the initiative to give limited approval for the Bharat Biotech vaccine was hailed as a “giant leap for innovation and new product development in India” by the company’s managing director, Krishna Ella, in a statement on Sunday, approval regulatory body faced criticism.
“Approval was premature and could be dangerous,” said Shashi Tharoor, a prominent opposition lawmaker, on Twitter. “Its use must be avoided until the complete tests are finished. Meanwhile, India can start with the AstraZeneca vaccine. “
Poonawalla declined to comment on Bharat Biotech’s approval of Covaxin, but said that only AstraZeneca vaccines, Moderna Inc. and Pfizer Inc. had “effectiveness and proof – anything else is faith,” he said. “Let time tell you if it works and then we can comment on how good or bad they are.”
Pfizer is also awaiting Indian approval for its vaccine. His need for ultra-cold storage makes him an unlikely candidate for widespread use across India. Bharat and Serum vaccines can be stored at refrigerator temperature, making them more suitable for the country’s irregular health infrastructure.
(Updates with comments from Serum’s CEO in the second paragraph, details of Bharat Biotech’s approval in the eighth.)