Serum Institute risks making Covid vaccine before trial at new $100 mn unit

Oxford University, which is developing the potential vaccine in collaboration with AstraZeneca, has already announced the start of a Phase II/III trial of AZD1222 in about 10,000 adult volunteers.
Serum Institute of India (SII), which has entered into a partnership with British drugmaker AstraZeneca to supply one billion doses of University of Oxford's potentizal Covid-19 vaccines to low and middle-income countries, is ready with the vaccine facility and will start making a few million doses even before the clinical trials get over, a top company executive said on Friday.

“Oxford vaccines will be made and packaged here in India. We are spending more than $100 million for this facility,” said Adar Poonawalla, CEO, Serum Institute of India.

AstraZeneca has reached a licensing agreement with SII to supply a billion doses of the potential Covid-19 vaccine, with a commitment to provide 400 million before the end of 2020. Hence, if all goes according to plan, India could have its first set of Covid-19 vaccines by the end of the year. AstraZeneca’s executive director and chief executive officer Pascal Soriot has said that the company will make no profit from the drug during the time of pandemic.

Poonawalla clarified that until the trials are completed successfully for safety and efficacy, vaccines will not be distributed either in India or anywhere else in the world. “Having said that we will start making a few millions of doses and stockpiling it at personal risk,” he added.

Oxford University, which is developing the potential vaccine in collaboration with AstraZeneca, has already announced the start of a Phase II/III trial of AZD1222 in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries. The British drugmaker last month also secured over $1 billion in funding from the US to develop the vaccine.

Meanwhile, the Indian government has been very supportive to bring the vaccine here, Poonawalla claimed. “The Indian government and its various departments like DBT, ICMR, CDSCO have been very helpful in regulatory approvals. They have also been funding certain clinical trials for the recombinant BCG vaccine and potentially the Covid-19 vaccine,” he told Business Standard. India has also pledged $15 million to global vaccine alliance Gavi.


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