Serum Institute gets nod for Oxford vaccine trials
India’s drug controller on Monday gave approval to Pune-based vaccine manufacturer Serum Institute of India (SII) for conducting phase II and III clinical trials on the vaccine against the coronavirus disease (Covid-19) developed by Oxford University and AstraZeneca, according to the Union health ministry.
The trials are likely to begin within the week, according to people aware of the matter.
This would make the Oxford-AstraZeneca vaccine – called Covishield – the first one to enter phase II and III trials in India. Phase I human trials have started on two indigenously developed vaccines — Bharat Biotech International Ltd’s Covaxin and Zydus Cadila’s ZyCoV-D — to assess their safety.
The company has already bet big on the vaccine working — investing up to $450 million in mass-producing the vaccine.
SII declined to comment on the regulatory approval for it to conduct the trials.
Four other vaccine candidates being supported by the Department of Biotechnology (DBT) under the science ministry are in advanced stages of pre-clinical trials and are likely to enter human trials in another four to six weeks.
Confirming the development, a senior official in the Central Drugs Standard Control Organisation (CDSCO) said: “The subject expert committee that went through the data and protocol submitted for the trial was satisfied with the results, and based on their opinion the drugs controller permitted its trial in India.”
It was always understood that India’s drug regulator would approve the clinical trials once Oxford University, once, on July 20, Oxford University published research that showed that the initial trial results of the vaccine candidate were promising.The vaccine candidate is safe and induced an immune reaction against Sars-CoV-2, the virus that causes the coronavirus disease, and protects healthy people from infection, it said in the journal The Lancet.
Dr G C Khilnani, former head of the department of pulmonology at All India Institute of Medical Sciences, said: “The Oxford vaccine is one of the most promising candidates so far and India being one of the largest vaccine manufacturers, this is a welcome move. A vaccine is needed and fast. We are nowhere close to controlling the infection. Now, the numbers have started going up in the tier-2 and tier-3 cities and every day we are seeing an increasing number of cases....There is a resurgence of cases in many places that had controlled the spread. So, we need a vaccine that is safe, effective and provides long-lasting immunity to go back to normal.”
The study whose results were published in The Lancet were conducted on 1,077 healthy adults aged 18-55 years with no history of Covid-19 in five UK hospitals between April 23 and May 21. The data that was published covered the first 56 days of the trials that are ongoing.
“By now, we have vaccinated about 10,000 people in the UK phase 3 trial at 19 sites, soon 4,000 people in Brazil and in a couple of weeks in South Africa will also be given the candidate vaccine. And most importantly, a trial in the United States will start in the next few weeks with 30,000 people. This is going to be over 50,000 people by the time we finish,” said Prof. Adrian Hill at a symposium organised by the Indian Council of Medical Research on Thursday. He is the director of Oxford’s Jenner Institute that is collaborating with the British-Swedish biopharmaceutical company AstraZeneca.
The vaccine is made from a weakened version of a common cold adenovirus taken from chimpanzees and genetically modified so that it cannot infect humans. To develop the vaccine, researchers added genetic material to the adenovirus from the Sars-CoV-2 virus’ surface protein, spike glycoprotein (S), which helps the virus to bind to ACE2 receptor to enter human cells and cause an infection.
“This was one of the first vaccine candidates to enter phase III trials in late May. And one of the reasons it was possible was because it is a type of vaccine that we already know a lot about. Over 60,000 people have already been vaccinated with investigational adenoviral vaccines. We were able to go ahead quickly because of that safety database on the vaccine platform,” said Prof. Hill.
Serum Institute of India, the world’s largest vaccine manufacturer by volume, is one of the nine global manufacturers of the Oxford-AstraZeneca vaccine.
“We do not know when we will get the results – depending on the instance of the disease at various places , it can be next month or it can be six months. This is a lot of uncertainty for our manufacturers. And, we have taken a risk collectively to engage manufacturers in nine countries,” Prof. Hill said.
The company plans to start human clinical trials in India with about 5,000 participants. “One billion doses of the AstraZeneca-Oxford vaccine will be produced over the next one year. The vaccines will be for India and middle-and-low-income countries across the world,” Adar Poonawalla, chief executive officer, SII, had earlier said.
Dr Vinod Paul, who chairs one of the National Task Forces on Covid-19 management in India, said: “India is one of the vaccine hubs globally, and wherever the Covid vaccine is developed we will take lead in its manufacturing. Vaccine is the ultimate solution to prevent Covid transmission even though India has managed to control the outbreak very well so far.”
To ensure that Phase III trials can start on vaccines that are in advanced preclinical or in early clinical stages, the department of biotechnology has already created five trial sites across the country and is working on preparing six more. Each of the trial sites will provide access to cohorts of 50,000 to 100,000 people . The sites are INCLEN Trust International, Haryana; KEM Vadu, Pune; Christian Medical College, Vellore; Society for Health Allied Research Education (SHARE), Hyderabad; and National Institute of Epidemiology, Tirunelveli..
“At this moment, I am unsure whether these trial sites are part of the approval for SII. However, the sites are ready for SII or any other company to start Phase III trials immediately. This will, of course, be the first Phase III trial to happen in India. The other two indigenously developed vaccines – one by Zydus Cadila that is supported by DBT – are in Phase I and II. This would ideally take between 45 days to two months and a while for data analysis. Depending on the data, they will begin their Phase III trials soon after,” said Dr Renu Swarup, secretary, DBT.
The other two are undergoing merged phase 1 and II trials.