Indian trial of AstraZeneca’s COVID-19 vaccine continues, yet to face any issue: Serum Institute


The UK-based paharma company paused the human clinical trials of the pandemic drug after reportedly developed side effect

Pune-based Serum Institute of India (SII) on Wednesday made it clear that it is continuing with the trials of AstraZeneca's COVID-19 vaccine candidate in India.

The statement of SII came after the UK-based AstraZeneca announced that the late-stage studies of the COVID-19 vaccine candidate developed by the Oxford University are on temporary hold after a participant in Britain had an adverse reaction to it.

“We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all,” SII informed in a tweet on Wednesday.

SII has entered into a tie-up with AstraZeneca to manufacture and supply 1 billion doses of the COVID-19 vaccine. It is conducting clinical trials of the potential vaccine in India.

The Drug Controller General of India had granted permission to SII last month to conduct Phase-II and -III human clinical trials of the coronavirus vaccine candidate developed by Oxford University and AstraZeneca.

Recently, the company had clarified that the Phase III trials of the coronavirus vaccine was underway and it would inform officially about the availability of the drug.

On Monday, SSI announced that it entered into a new landmark partnership with Gavi, The Vaccine Alliance and the Bill and Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs).

The pact will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the Gavi COVAX AMC mechanism as early as the first half of 2021, is said.

The Bill and Melinda Gates Foundation, via its Strategic Investment Fund, will provide at risk funding of $150 million to Gavi, which will be used to support the SII to manufacture the potential vaccine candidates

The vaccines will be priced at maximum $3 per dose and made available to the 92 countries included in Gavi’s COVAX Advance Market Commitment (AMC).

Image credit: Sakal Times

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