If human clinical trials are successful, product will be out in the market by October
New Delhi: Indian vaccine major Serum Institute of India said on Sunday that it plans to start production of the COVID-19 vaccine developed by Oxford University in the next two to three weeks.
If human clinical trials of the vacine are successful, the product should be available in the market by October.
However, human clinical trials are a big if. They will take place in the UK.
The Pune-based company has partnered with Oxford University as one of the seven global institutions manufacturing the vaccine.
"Our team has been working closely with Dr Hill from Oxford University, and we are expecting to initiate production of the vaccine in 2-3 weeks and produce 5 million doses per month for the first six months, following which we hope to scale up production to 10 million doses per month," Serum Institute India (SII) CEO Adar Poonawalla said.
SII has collaborated with scientists at Oxford University for a malaria vaccine project in the past and can say with certainty that they are some of the best scientists, he added.
"We expect the (COVID-19) vaccine to be out in the market by September-October, only if the trials are successful with the requisite safety and assured efficacy. We will be starting trials in India for this vaccine hopefully over the next 2-3 weeks' time," Poonawalla said.
SII will begin manufacturing the vaccine in anticipation of clinical trials succeeding by September-October in the UK, he added.
"Following that, we have undertaken the decision to initiate manufacturing at our own risk. The decision has been solely taken to have a jump-start on manufacturing, to have enough doses available, if the clinical trials prove successful," Poonawalla said.
The company plans to initiate the trials in India for the vaccine with necessary regulatory approvals, which are underway presently.
"Keeping the current situation in mind, we have funded this endeavour at a personal capacity and hopefully will be able to enlist the support of other partners to further scale-up vaccine production," Poonawalla said.
The vaccines will be manufactured at the company's facility in Pune. Building a new facility for COVID-19 vaccine would have taken around 2-3 years, he added.
Indian regulatory authorities are working with the company to ensure smooth procedural functioning. "We are in touch with the Department of Biotechnology (DBT) and ICMR," Poonawalla said.
The company had earlier said it will not patent any COVID-19 vaccine which it develops.
Asked about the decision, Poonawalla reiterated, "We will not patent Serum's vaccine for COVID-19 and will make it available for all to produce and sell, not just in India but across the world."
Whosoever makes and develops the vaccine will need multiple partners to manufacture the vaccine, he added.
"I hope that whichever company develops the vaccine does not get it patented and makes it available based on royalties or a commercial understanding to as many manufacturers across the world to make billions of dosages at a fast pace," Poonawalla said.
Death toll due to COVID-19 has crossed 200,000 globally, with the number of infections at over 2.8 million.
In India, the coronavirus has claimed over 800 lives and the number of cases has crossed the 26,000-mark.