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Pune-based Serum Institute of India seeks regulator’s nod to produce Oxford Vaccine for Covid-19

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As the coronavirus vaccine being developed by Oxford university and AstraZeneca enters the third phase of the trials, Serum Institute of India (SII) is geared up to procure a licence from the Indian regulator to start clinical trials in the country in a week’s time.

Serum Institute of India, the largest vaccine manufacturer in the world, and a partner in the Oxford vaccine project has already been chosen by AstraZeneca to manufacture the vaccine once it is ready. “The trials have shown promising results and we are extremely happy about it. As soon as they grant us permission, we will begin with the trials for the vaccine in India,” said Serum Institute’s CEO Adar Poonawalla. “In addition, we will soon start manufacturing the vaccine in large volumes.”

The Pune-based Serum Institute of India has been mandated to produce at least a billion doses of the vaccine and the production may start before the final nod as the volume is too large and required urgently in view of no other vaccine showing promising results as Oxford-AstraZeneca vaccine owing to its o serious side effects and elicited antibody and T-cell immune responses.

WHO Cautious

The trial results published in The Lancet medical journal, showed that it was tested on 1,077 healthy adults aged 18-55 years with no history of COVID-19. The World Health Organisation (WHO) has welcomed progress made in developing vaccines but warned there was still much work to be done. While the Oxford vaccine undergoes final stage trial in Brazil, other vaccines are making inroads in different stages of trial.

Apart from Oxford vaccine, India has already started Covaxin, indigenously developed vaccine for COVID-19, developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology, has been given the nod for human clinical trials from the Drugs Controller General of India.

As per the deal, Serum Institute of India is hoping to produce the first 400 million doses before the end of 2020.

AstraZeneca UK to produce vaccine after tie-up with Oxford University

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AstraZeneca Plc agreed to make an experimental coronavirus vaccine developed by Oxford University researchers as the race for vaccine heats up. In India, the Serum Institute, the world’s largest maker of vaccines by volume, has already started producing millions of doses of the Oxford University shot and it remains to be seen whether market share will be entered at a later stage depending on the availability of the vaccine.

Astra has a capacity to produce 100 million doses by the end of the year, said the company, which is gearing up for a tough competition with a dozen other competitors across the world. UK-based AstraZeneca announced partnership with the University of Oxford on Thursday to help develop, produce and distribute a potential COVID-19 vaccine as a solution to the deadly disease.

UK Business Secretary Alok Sharma welcomed the tie-up as a vital step while a team of British scientists last week administered first vaccine doses to volunteers. “Our hope is that, by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation,” AstraZeneca Chief Executive Pascal Soriot said.

The vaccine “ChAdOx1 nCoV-19” is being developed by the Jenner Institute and Oxford Vaccine Group. The AstraZeneca-Oxford partnership is looking to provide vaccine inside the UK by the end of the year. Cambridge-based AstraZeneca is also testing two other treatments for coronavirus that has so far infected over 3 million people and killed more than 215,000 worldwide.

The shares of the company rose 2% on London’s FTSE by 9:30 am Friday, outpacing rival GSK. Apart from AstraZeneca. GSK and Sanofi are the other major players working on their own vaccine. Other major drugmakers testing possible COVID-19 vaccines include Pfizer, Moderna, Johnson & Johnson and Novavax. Nearly, 100 vaccines are in the pipeline at various stages of initial trials around the world and scientists say it may take another year for the right vaccine to emerge successfully.

The Indian vaccine being developed by the Serum Institute is a recombinant viral vector vaccine using a weakened version of the common-cold virus spiked with proteins from the novel coronavirus to trigger a response from the body’s immune system.