The Serum Institute of India (SII) has claimed that it has started the manufacturing process of a potential coronavirus vaccine which was developed by the University of Oxford. According to Suresh Jadhav who is the Executive Director of SII, the company has decided to manufacture about two-three million doses of the vaccine by August end. He said that SII will ensure that the manufacturing of vaccines meets the stipulated commercial scale-batch for phase 3 trial.
He said, “Based on the safety and immunogenicity data of the phase-3 trial carried out in India, we will trigger the production of the vaccines even before the results are formally available”. He said that the SII expects the phase 3 trial will take four months for the study to complete.
Preliminary results of the Phase 1/2 trial published in the medical journal – The Lancet has shown that Oxford COVID-19 vaccine ChAdOx1 nCoV-19 builds and enhances the strength of the human immune responses to the COVID-19 virus without any early safety concerns.
According to the researchers, the vaccine generated a T-cell (white blood cell) response within 14 days of vaccination and an antibody response within 28 days. T cells have the ability and function to attack the SARS-CoV-2 virus infected cells which are responsible for causing COVID-19 disease.
SII has signed an agreement with British biopharmaceutical company AstraZeneca under which it will have to extensively manufacture about 1 billion doses of the Oxford vaccine for India as well as for the Gavi countries.
The CEO of SII, Adar Poonawalla had said that around 4,000-5,000 people in Pune and Mumbai will be used for the phase 3 trials of the vaccine which is scheduled to prolong to a two months period in cities with many hotspots. The trials will look for the efficacy of the vaccine dubbed Covishield in India. While the phase 3 trials have already commenced in overseas countries like the UK, South Africa and Brazil.
He added that the company plans to manufacture around 300-400 million doses of the vaccine by the year-end. If initial and licensure trials are found to be successful, ChAdOx1 nCoV-19 will be available for less than Rs 1,000 per dose in the Indian market.
According to the report, Serum Institute is also planning to collaborate with other developers in order to manufacture additional coronavirus vaccines developed by other institutes, apart from the one created by Oxford University.