Indian firm ready to begin producing possible vaccine

Pune-based Serum Institute of India (SII) said on Sunday it will likely begin the production of a coronavirus disease (Covid-19) vaccine developed by Oxford University in the next two-three weeks and hopes to bring it to the market by October if human clinical trials of the same are successful.

The company has partnered with Oxford University as one of the seven global institutions manufacturing the vaccine.

“SII will be manufacturing the vaccine in anticipation of clinical trials succeeding by September-October in the UK… Following that, SII has undertaken the decision to initiate the manufacture at their own risk. The decision has been solely taken to have a jump-start on manufacturing, to have enough doses available, if the clinical trials work,” said Adar Poonawalla, chief executive officer of the Indian vaccine major, said in a statement.

The vaccines will be manufactured at the company’s facility in Pune as building a new facility for Covid-19 vaccines would have taken around two-three years, he added.

The human safety trial of the vaccine began in Oxford on Thursday, with the first two of the 800 healthy volunteers recruited for the study being injected with ChAdOx1 nCoV-19. This is the sixth coronavirus vaccine to enter the first phase of clinical trials, raising hopes of an antidote against the virus that continues to ravage the world.

If the trials are a success, scientists hope to have one million doses ready by September, and to dramatically scale up manufacturing after that.

“Our team has been working closely with Dr Hill ( professor Adrian Hill) from Oxford University, and we are expecting to initiate production of the vaccine in two-three weeks and produce five million doses per month for the first 6 months, following which, we hope to scale up production to 10 million doses per month,” Poonawalla said, according to PTI.

The company plans to initiate the trials in India for the vaccine with necessary regulatory approvals, which are underway presently, the news agency reported.

“Keeping the current situation in mind, we have funded this endeavor at a personal capacity and hopefully will be able to enlist the support of other partners to further scale-up the vaccine production,” Poonawalla said.

The trial will study whether the new vaccine is safe and can generate strong immune responses against Sars-Cov-2, the virus that causes Covid-19, and protect healthy people from infection.

The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified to make it impossible for it to infect humans.

To develop the vaccine, researchers added genetic material to ChAdOx1 from the Sars-CoV-2 virus’s surface protein, spike glycoprotein (S), which helps the virus to bind to Ace2 receptors to enter human cells and cause an infection.

Regulatory authorities are working with SII to ensure smooth procedural functioning. “We are in touch with the Department of Biotechnology (DBT) and ICMR (Indian Council of Medical Research),” Poonawalla said.

The company earlier said it will not patent any Covid-19 vaccine which it develops. Asked about that stand, 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 it, 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.