AstraZeneca said it will immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval.Even as AstraZeneca on Monday announced interim results of clinical trials for the Covid-19 vaccine saying it was 70% effective on average, Serum Institute of India (SII) indicated it could supply doses of the vaccine for emergency and limited use by December end following regulatory nod.
SII has already manufactured 40 million doses and expects to go up to 100 million by January 2021. By July, it could supply 400 million doses, it added. ED and CEO Adar Poonawalla told a news channel SII hopes to win an India approval for emergency use by 2020 end. The maximum retail price for the private market, Poonawalla said, would be Rs 1,000 a dose while the government would be buying it at `250. “We are at the finishing line,” he tweeted.
AstraZeneca said the trials for the vaccine, being developed with the University of Oxford, had revealed it was 70% effective on average. It showed 90% efficacy in one dosing regimen when the vaccine was given as a half dose, followed by a full dose at least a month later, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart, AstraZeneca said in a statement.
Other drug majors who have announced promising results of clinical trials for an anti-Covid 19 vaccine include Pfizer and Moderna. SII is partnering with AstraZeneca to manufacture the Covid-19 vaccine in India. Poonawalla said that based on the results of the trials, SII would approach the Indian regulatory authorities for permission to use the vaccine for emergency use. SII is conducting Phase III trials in India for this vaccine and has administered the first dosage to a majority of those participating in the trials with a second dosage expected in December 2020.
Unlike the Covid-19 vaccines of Pfizer and Moderna, the AstraZeneca vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius) for at least six months and administered within existing healthcare settings. As such, it is considered to be better for India and other developing as well as low-income countries.
AstraZeneca said it will immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The company will seek an emergency use listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.
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