01/7Oxford Coronavirus vaccine: Serum Institute to begin trials this week; all you need to know
Oxford University's prime vaccine candidate, ADZ-1222, made in collaboration with British-Swedish pharmaceutical giant AstraZeneca is one of the top contenders in the vaccine development race. The vaccine, which is currently undergoing critical stage trials will also be holding mid and late scale trials in India, which is currently the third-worst affection nation by COVID-19, with over 2.7 million infection cases.
02/7Phase II and III trials to be conducted pan India
Private vaccine maker, Serum Institute of India, which is spearheading trials and production of the Oxford vaccine will be starting the trials this week at selected research centres across the country.
The start of Oxford vaccine trials in the country will make the group the first one to start late scale trials in India. Currently, two other vaccines, which have been produced locally- Covaxin and ZyCOV-D are in nascent stages of testing.
03/7Serum Institute working on producing a low-cost vaccine
The news comes after an expert panel of authorities met with representative leading vaccine makers from the country to devise a framework around vaccine distribution in the country, going forward. The trials will be conducted in 10 centres at first, following which authorities plan to set up more centres across the country's length and breadth.
Pune-based SII, owned by conglomerate Adar Poonawalla, which has promised to produce over a hundred million doses of the vaccine is already in the middle of ramping up production facilities. The vaccine company is also in talks with private firms and philanthropists to raise funds for the same. Serum Institute will also be receiving close to $150 million 'at-risk' funding from Bill and Melinda Gates Foundation to develop a low-cost, readily available doses for populations at large which will be routed through GAVI.
04/7How will the trials be conducted?
According to reports, the testing will be done as per randomized controlled trials at centres pain India. Around 1600 volunteers have been recruited for the same.
As per now, only healthy volunteers, who do not have any history of contracting COVID-19 in the past 8-9 months have been selected to be dosed. All volunteers are aged between 20 and 50 years old. The trials, much like other outsourced trials will not involve young children or older people right now, since it won't be a safe option. Simultaneous trials will be held in countries like the USA and Brazil.
05/7Purpose of the trials
The focus of conducting trials in India is to see whether it can elicit a good immune response in the body, does not cause side-effects and delivers a safe response, just as what was seen in early phase studies. The analysis would be done 58 days after the dosing so as to test safety and immunogenicity response.
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06/7Dosing schedule
As per reports, the volunteers will be provided vaccine dosage, spaced two weeks apart. Positive data received from early-stage Oxford trials suggested that the strongest immunization was observed in patients who received a double dose of the experimental vaccine. The trials, which will be conducted over the next few months will be wrapped up by late November or December, post which, the results will have concurred with the global trial data.
07/7Pricing of the vaccine
Serum Institute of India plans to reserve at least 50% of the vaccine doses for the Indian population if the vaccine is approved for use. The vaccine will be sold under the means of 'pandemic pricing' and capped affordably so that all sections of the population would have easy access to it. There are also reports which suggest that early doses of the vaccine could be made available for as little as Rs. 250-300 per jab, making it one of the cheapest vaccines under the offering.
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