India Readies Sites For Phase-3 Trials Of Oxford COVID Vaccine
India has readied five sites for the final stage of human trials of the Oxford-AstraZeneca COVID-19 vaccine.
The government has readied five sites across the country for the third and last stage of human trials of the AstraZeneca-Oxford COVID vaccine, Secretary of Department of Biotechnology (DBT) Renu Swarup said on Monday, 27 July.
Speaking to news agency PTI, she said, “The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials.”
For a vaccine to be administered to people of the country, it is important to have data from within India.
“DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important because if the vaccine has to be successful and if it has to be given to the Indian population, we need to have the data within the country. For that, a Phase 3 trial has been proposed. Five sites are ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies.”Renu Swarup
Oxford University's vaccine, called AZD1222, is being manufactured by pharmaceutical major AstraZeneca and the UK government has ordered 100 million doses ahead of time. Here in India, Serum Institute in Pune (SII) has tied up with the University of Oxford to produce the vaccine on a mass scale.
SII CEO Adar Poonawalla, CEO, Serum Institute of India has sought approval from the Indian regulator to carry out human trials in India.
“The trials have shown promising results and we are extremely happy about it. We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes.”Adar Poonawalla
They've said that they can manufacture and produce millions of doses in a short span of time.
Preliminary Data from Phase 1/2 Trials of Oxford Vaccine
In ‘promising’ results, the University of Oxford's coronavirus vaccine was found to be safe and capable of triggering an immune response, as FIT had earlier reported. The long-awaited Phase 1 human trial involving 1,077 people results were published on 20 July inThe Lancet. The vaccine boosted T cell and antibody immunity and produced strong responses on both accounts, the study found, with T cell immunity peaking after two weeks and then dropping slightly by day 56. Antibody immunity, on the other hand, peaked after four weeks and remained high by day 56, indicating that it may well last for even longer.
The study showed 90% of people developed neutralising antibodies after one dose. Ten people required two doses to produce neutralising antibodies.
While exciting, larger trial results will have to be examined before we can say the vaccine is safe and provides protection.
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