Covid-19 vaccine update: Serum Institute of India expects approval in the next few days

By: |
December 31, 2020 8:15 AM

Adar Poonwalla had on Monday said the approval in India was expected to be received almost simultaneously or within days of the UK regulator approving the vaccine.

It has already manufactured and built up a stock of around 50 million doses at its Pune facility.It has already manufactured and built up a stock of around 50 million doses at its Pune facility.

Cyrus Poonawalla, the chairman of Serum Institute of India (SII), said on Wednesday 17 million doses of the Covid-19 vaccine were ready to be shipped out and that the company was awaiting the government’s approval. Poonawalla said a purchase agreement was yet to be signed and that an approval was expected in the next couple of days. SII has an agreement with AstraZeneca to manufacture and supply the Covid-19 vaccine in India and low income countries.

It has already manufactured and built up a stock of around 50 million doses at its Pune facility.

The Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech. Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech was perused and analysed by the SEC.

The analysis of the additional data and information is going on. SEC will convene again on January 1.

Adar Poonwalla had on Monday said the approval in India was expected to be received almost simultaneously or within days of the UK regulator approving the vaccine. SII had applied for emergency use authorisation on December 7. The company had also subsequently presented additional data sought by the regulators, Poonawalla said.

Health minister Harsh Vardhan had indicated at a SII event on Monday the wait for the vaccine was going to end soon and that the country would see the vaccine launch in January 2021. The Covid-19 vaccine has been developed in record time and demonstrated India’s capability to make vaccines for India and the world and now it was only a matter of few weeks, the health minister said.

The Indian government has indicated that 30 crore people would be vaccinated in the first phase. Frontline health workers, senior citizens and those suffering with co-morbidities would be the first to get the vaccine.

Pascal Soriot, CEO, AstraZeneca, tweeted on Wednesday, they are working with the UK government and the first vaccinations will begin early in the New Year. Soriot said millions of people in the UK who will get access to this new vaccine, which has shown to be effective, well-tolerated, simple to administer and supplied by AstraZeneca at no profit.

AstraZeneca said it is working with its global partners to continue building manufacturing capacity of up to 3 billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8° Celsius) for at least six months and administered within existing healthcare settings.

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