Pune’s Serum Institute to Manufacture COVID-19 Vaccine
Till now, the COVID-19 pandemic has caused over 2.97 million infections across the world and over 27,000 confirmed cases in India. The clock is ticking by and the medical sphere has been trying to control this epidemic in every possible way. In the very recent times, the vaccination for coronavirus has been in talks.
Pune based vaccine maker Serum Institute of India (SII) has partnered with the University of Oxford in the UK for the COVID-19 vaccine trial.
University of Oxford researchers have begun the testing of COVID-19 vaccine in human volunteers in Oxford. The vaccine is based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein, and has been produced in Oxford.
“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 6 months, following which, we hope to scale up production to 10 million doses per month,” said Adar Poonawalla, CEO of Serum Institute India (SII), Pune.
SII is co-ordinating with the Indian Council of Medical Research (ICMR) to go ahead with the vaccine trials in India.
Adar delivered a long statement regarding the whereabouts of this particular vaccine. "Normally vaccine development is a long process, but the regulatory approvals in India have been very carefully changed in the current scenario, for the COVID-19 vaccine development. The University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford. If these trials are successful in the UK, we will start a trial in India. After we get positive results in these trials in India, then the COVID-19 vaccine will be made available by Oct-Nov. This is also dependent on the fact that we will have to start producing the vaccine at our personal cost by next month. We hope to build up 40 million doses by Sept-Oct in the hope that if the trials work, then we have the product ready. Typically, one first waits for the trials to get over, and then start the manufacturing process, but that would be a longer wait. So yes, we are starting the manufacturing process early with 4-5 million doses. This way, we shall be able to have a decent amount ready by October," reveals Adar Poonawalla.
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.
Regarding the initiation of the necessary trials, he said that the trials have to be carried out with the requisite safety and assured efficacy and that they will be starting the trials in India for this vaccine hopefully over the next 2-3 weeks’ time.
The 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.
Regarding the licensing of this vaccine if manufactured successfully, earlier the company had said that it will not patent any COVID-19 vaccine which it develops. Commenting on this, Adar makes it clear that, “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.”
Nature of the Vaccine
This vaccine is created by reducing the virulence - or removing the harmful properties - of a pathogen but keeping it alive. (They cause no or very mild disease because the pathogen is weakened under laboratory conditions.)
"We are planning a set of animal trials (on mice and primates) of this vaccine in April. By September, we should be able to begin human trials," as told by Adar Poonawalla.
A genetically engineered chimpanzee virus would form the basis for the new vaccine. Human clinical trials have already began in Oxford. If all goes well, scientists hope to make at least a million doses by September.
Pricing
As for the pricing of these vaccines, Adar Poonawalla said that it is expected to be substantially lower than the global one as in the case of other vaccines like MMR (measles, mumps, and rubella), which are available at over 10 times the India price in countries like UK.
There has been seen a silver lining after all these months of anticipation. The scientists are wrestling through these tough times to pioneer a possible solution to control this pandemic. Let us pray and hope the manufacturing of these potential vaccines are soon commercially viable and is made available as soon as possible to the billions of people across the globe.
