2 min read.Updated: 20 Nov 2020, 06:03 AM ISTLeroy Leo
Poonawalla says Serum Institute plans to apply for an emergency use authorization from Drug Controller General of India V.G. Somani for the vaccine next month, and get the regulatory green light in January
Serum Institute may sell Covishield, the covid-19 vaccine being developed by Oxford University, for around ₹500-600 per dose in the private market, more than twice the $3 (around ₹220) per shot it will cost the government, chief executive officer Adar Poonawalla said on Thursday.
“Of course, the government of India will be getting it at a far lower price, probably around $3-4 because they’ll be buying huge volumes of hundreds of millions of doses," Poonawala said at the Hindustan Times Leadership Summit.
“So they’ll get access to the price, which is similar to what Covax has got, which is $3, and the general public probably have to pay around ₹500-600." Covax is a World Health Organization-backed facility created to ensure equitable global access to covid-19 vaccines.
The world’s largest vaccine maker by volume is in a pact with the co-developer of the vaccine, British firm AstraZeneca Plc for producing about 1 billion doses as well as their distribution and sale in India and other low- and middle-income countries.
Poonawalla said the company plans to apply for an emergency use authorization from Drug Controller General of India V.G. Somani for the vaccine next month, and get the regulatory green light in January.
The process, however, is contingent on robust efficacy data from AstraZeneca’s trials in the UK, whose results are expected by the end of this month.
“We’re basing the assumption on emergency licensure based on the positive UK results. So these are the caveats. If we get a good UK result by the end of November or early December, we can apply for an emergency licensure use. So you have the vaccine for the vulnerable populations by January or February. And then by March or April, for the general public," Poonawalla said, adding that if any of these milestones get delayed, then Serum’s own plans will be behind schedule.
If things go according to the plan, the company plans to have around 300-400 million shots of the two-dose vaccine ready by March or April, he said.
The company is currently expanding its capacity for manufacturing the vaccine to around 100 million doses from around 50-60 million doses now.
“At the moment, we’re at a 50-60 million capacity on a monthly basis as an output; by February, we will have gone to 100 million doses per month. Right now I’ve dedicated two facilities (for Covishield production) and will dedicate another two facilities by January (or) February," he said, adding that the doubling of monthly output is for both India and Covax.
The company is in talks with Nepal and some African countries but has not signed a bilateral pact for vaccine supply with any country other than Bangladesh.
For Africa, Poonawalla said he expects Covax to handle a significant proportion of the doses.
Serum Institute does not plan to sign pacts with other countries currently because it may not be able to provide vaccines, especially since India’s billion-plus population will be the company’s primary concern, he said.
Going forward, the company has plans to mass-produce a vaccine developed by US-based Novavax and three other candidates.
It plans to launch one of those vaccines every three to four months, with Novavax’s candidate expected by April or May, he said.
Pune-based Serum Institute has also signed pacts with the Bill and Melinda Gates Foundation and Gavi, the Vaccine Alliance, for the manufacturing and delivery of as many as 200 million doses of covid-19 vaccines from Oxford and Novavax.