SII Spearheads Efforts For Vaccine To Fight COVID-19 Ser

Serum Institute of India (SII), the world’s largest vaccine manufacturer by number of doses produced and sold globally, has been working on the BCG vaccine, which is primarily used against tuberculosis and given to newborns, to be used in human clinical trials soon, to test its efficacy in improving overall immunity against COVID-19. SII has received a go-ahead from the Drug Controller General of India (DCGI) to start human clinical trials. Some sites have been identified, where 6,000-7,000 participants will undergo the trials.

“The new and improved recombinant one (VPM 1002)…will be used in the clinical trial. Many believe that countries where the BCG vaccine has been given, have fewer COVID-19 fatalities and lesser severity of cases. Hence, testing the BCG vaccine’s ability in improving overall immunity is crucial before we prescribe and recommend the same. A clinical trial will be launched soon and it should be over within two months,” said Adar Poonawalla, CEO of SII – the largest manufacturer of vaccines against polio and diphtheria, adding, “…we cannot arrive at any conclusion before the clinical study is over, nor do we want to make any claims.”

This is set to be the largest human trials yet in the country against the new coronavirus. The trials, approved by the DCGI), is set to start within a week at 40 hospitals. Pune’s Bharati hospital, KEM hospital and Symbiosis hospital are among the selected facilities starting the tests.
Researchers say the vaccine will be initially given to two groups — healthcare workers and family contacts of patients with COVID-19. Swab samples will be taken from all of them to check if they are negative for the disease before the BCG shots are given. Dr. Sanjay Lalwani, Medical Director of Bharati Hospital, Pune, has said that there would be stimulation of the immunological system, which may help prevent the person from getting complications related to the disease.

Meanwhile, the global hunt for a vaccine has scientists and top pharmaceutical companies working in collaboration to find a cure. Good news comes in from University of Oxford’s Jenner Institute, which has devised a super-fast vaccine against the novel coronavirus and promises the delivery of one million doses of the vaccine by September 2020.

As per Oxford’s Professor, vaccinologist Adrian Hill, “The team is confident about the trials. We didn’t want to reach a stage in September when trials were finished, but they didn’t have a vaccine. We have started at-risk manufacturing this vaccine – not on a small scale but with a network of seven manufacturers in different places across the world.” They have three manufacturing partners in the UK, two in Europe, one China and one in India. The Indian manufacturing partner is Pune’s Serum Institute of India (SII). 

Dr. Umesh Shaligram, SII’s R&D Director, has been closely working with Dr Adrian Hill. “In two weeks’ time, we should be able to produce five million doses a month and then scale that up to 10 million a month after about six months. We have already started getting the regulatory approvals in place, and I must thank the Indian Regulatory Authorities in helping us a lot in this,” informed Adar Poonawalla, in a recent TV interview. The Poonawallas are self-funding this initiative. “We are funding this internally. We will hopefully get some partners to help us along the way,” he said. SII, had earlier, successfully partnered with the Oxford University scientists for a malaria vaccine in the past. 

Last week, SII announced that it would not patent the vaccine it is developing for COVID-19, which is expected by 2021. “When the vaccine is developed, … whosoever makes and develops the vaccine will need multiple partners to manufacture the vaccine. I hope that whichever company develops the vaccine will not hide behind patents and makes it available even on royalties or some commercial understanding to as many manufacturers across the world to make billions of dosages very quickly. I can speak for my company, SII. We are not going to patent this product and we will make it available to as many people as we can to manufacture this drug because we don’t want to make money from and commercialise something beyond a sustainable level in such a public health epidemic… we are able to do this because we are a private limited company and that is part of why we didn’t list, because we are not accountable to shareholders,” Adar Poonawalla remarked during an online conference on the theme of ‘Combating COVID-19: Biotech To The Rescue’, organised by the Department of Biotechnology and Bennett University. 

In an exclusive interview with IANS, Adar Poonawalla shared that SII has associated with US-based biotechnology firm, Codagenix and developed a virus-vaccine candidate which is closest to the novel coronavirus, with human trials of the vaccine are expected to commence by September-October. 

Speaking on the Covid-19 trajectory in India and the effectivity of the lockdown, he said, “Through the nationwide lockdown and rampant health advisories spread across the length and breadth of the country, we have done a commendable job in containing the spread of the virus. However, the trajectory needs to slow down further. The next few months are extremely crucial for our country… requiring all of us to practice social distancing as that is the most efficient intervention available presently. Breaking the chain of transmission holds the priority as it gives a chance to the more vulnerable population a chance at survival and reduces the pressure on the hospitals. We need to use this time in strengthening our health-care infrastructure to combat the Covid-19 pandemic.” 

Sharing his views on developing ‘Herd Immunity’ against the Covid-19, he said, “Herd Immunity is when most of the population develops immunity against the disease, by way of vaccination or immunization caused by acquiring the disease and developing anti-bodies via exposures in the past. In order for it to be implemented, we need to have an efficacious vaccine available for mass use. Since the data for relapse is insignificant at the moment, we cannot be dependent on developing ‘Herd Immunity’ at this stage.”

As regards the strategy to combat Covid-19, Adar suggests, “Ideally, we should focus on strict and compulsory implementation of social distancing norms even after the lockdown is lifted. The next key step should be to re-establish the economy. Additionally, we need to focus our attention on building a robust and viable testing system along with the necessary equipment, while also enabling fast-tracking of processing and approvals for quick distribution of necessary medical supplies, especially vaccines and other medications… I would also send this message to the government that please do not have multiple lockdowns after we open up in May-June, because we will just cripple the economy and step on people’s livelihoods beyond a point, that we won’t be able to comeback.” 

The Community feels a sense of pride and gratitude in the earnest and noble efforts put in by SII under the stalwart leadership of the Poonawallas. Here’s wishing all the committed scientists, most of whom are working around the clock to find a vaccine, the very best of luck in this life-saving endeavour! Godspeed!

 

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