Pune based vaccine manufacturer Serum Institute of India (SII) on Monday said it will apply for a license to start from the Indian drug regulator to start clinical trials of Oxford University’s experimental COVID-19 vaccine in the country within a week.
The move comes after the vaccine, called AZD1222, that is being developed by the pharmaceutical company AstraZeneca and researchers at the University of Oxford had shown positive results in its interim trials.
The vaccine was found to be safe for human use as well as trigger a protective immune response in the participants who were given a dose of it.
“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,” SII Chief Executive Officer Adar Poonawalla said.
“As soon as they grant us permission, we will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes,” he added.
AstraZeneca has partnered with nine companies across the globe and committed to the production of 2 billion doses once the vaccine is ready to be rolled out.
India’s Serum Institute, the largest vaccine manufacturer in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it gets ready.
The results of the interim trials of the experimental COVID-19 vaccine have been published in the medical journal The Lancet.
“We are encouraged by the Phase I/II interim data showing AZD1222 was capable of generating a rapid antibody and T-cell response against SARS-CoV-2,”said MenePangalos, executive vice president of BioPharmaceuticals Research and Development at AstraZeneca.
“While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world,” he added.
The next phase of the trials of the experimental COVID-19 vaccine is currently underway in the UK, Brazil and South Africa and is due to start in the US.