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Business News/ Companies / News/  Serum Institute produces 40 mn doses of Covishield
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Serum Institute produces 40 mn doses of Covishield

Due to the urgent need for a covid-19 vaccine, manufacturers are taking a risk by producing doses even before the trials are completed and results are deemed successful

Covishield, originally being co-developed by the University of Oxford and UK’s Astrazeneca plc, is the furthest vaccine in human testing in India, with the trial expected to be completed as early as next month (REUTERS)Premium
Covishield, originally being co-developed by the University of Oxford and UK’s Astrazeneca plc, is the furthest vaccine in human testing in India, with the trial expected to be completed as early as next month (REUTERS)

Serum Institute of India (SII) has already produced 40 million doses of its covid-19 vaccine ‘Covishield’ at-risk even as the world’s largest vaccine producer reached one step closer to its launch by completing enrolment of 1,600 participants for its phase 3 trial.

The company has partnered with the Indian Council of Medical Research (ICMR) for the trials. ICMR has funded the clinical trial site fees while Serum Institute has funded other expenses for Covishield.

“Based on the Phase 2/3 trial results, SIIwith the help of ICMR will pursue the early availability of this product for India. SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI (Drug Controller General of India)," the Pune-based company said in a statement.

Due to the urgent need for a covid-19 vaccine during the pandemic, manufacturers are taking a risk by producing doses even before the trials are completed and results are deemed successful. Phase 3 trials, which measure efficacy, are usually the most challenging of the three stages of clinical trials.

Covishield, originally being co-developed by the University of Oxford and UK’s Astrazeneca plc, is the furthest vaccine in human testing in India, with the trial expected to be completed as early as next month. If successful, the government is preparing for inoculation, first of healthcare workers, from as early as January.

AstraZeneca signed a pact with Serum Institute in June for manufacturing a billion doses of the vaccine at its Pune facility, when approved, for India and other low- and middle-income countries. The company has a total manufacturing capacity of 1.5 billion doses per year.

Health secretary Rajesh Bhushan had last month said that the government has estimated about 3 crore, or 30 million, frontline healthcare workers, including 7 million doctors and paramedics.

The stock of Covishield vaccine, given two doses per person, could potentially be enough to inoculate a large number the healthcare workers. This would help the government move on sooner to the next groups on its priority list—other frontline workers, the elderly and the comorbid.

However, a major caveat is the successful completion of not just Serum Institute’s phase 3 trial, but also that of Astrazeneca and Oxford’s massive global phase 3 study. The co-developers are conducting efficacy trials of up to 50,000 participants in UK, Brazil, South Africa, Japan and the US. Results from the late-stage trials are also anticipated by next month, depending on the rate of infection within the communities where the clinical trials are being conducted.

Serum Institute on Thursday announced that it has also collaborated with the ICMR for conducting clinical trial of Covovax, the vaccine candidate developed by US-based Novavax.

Novavax has started its phase 3 trials in South Africa and the UK and will soon commence the study in the US. Covovax, formulated at Serum Institute, will be tested in a phase 3 trial in India and the company and ICMR plan to make an application for the trial to regulatory authorities.

Serum Institute said that it has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. An adjuvant is a compound that is added to a vaccine to boost its immune response to produce more antibodies and provide longer-lasting immunity. This minimizes the dose of vaccine needed.

Like Astrazeneca, Pune-based Serum Institute has also tied-up with Novovax to produce 1 billion doses of the vaccine.

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Published: 12 Nov 2020, 12:12 PM IST
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