AZN AstraZeneca PLC

By Eric Bellman 

NEW DELHI -- The companies behind two of the most promising Covid-19 vaccine candidates, AstraZeneca PLC and Pfizer Inc., have asked India for emergency-use authorization to start using their vaccines in the South Asian nation, which has been one of the worst hit by the pandemic.

Both Pfizer and Serum Institute of India -- which is manufacturing AstraZeneca's vaccine for developing countries -- have applied for the authorization, which would allow their vaccines to circumvent a long trial and application process, said an official at the Drugs Controller General of India.

"This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support," Adar Poonawalla, chief executive officer and owner of SII, said in a Tweet Monday.

If either gets authorization, it could be an important jump start for the global manufacturing process as India is one of the world's biggest vaccine manufacturers. The emergency authorization would give its companies the ability and confidence to ramp up production.

Serum Institute already has more than 40 million doses of the AstraZeneca vaccine made and could have more than 100 million by the end of the year, said a company spokesman.

The emergency authorization could release an initial wave of vaccine from the stock that is already made. In theory it can happen in as little as a week, but with the AstraZeneca vaccine, Indian regulators may want to wait until it gets authorizations in the U.K., said T. Jacob John, a retired professor of virology at the Christian Medical College in the southern city of Vellore.

"There is no harm in rushing a drug, but it can't be rushed before it is registered" in the country in which it was developed, he said. "You can't rush when somebody else has to do it."

The U.K. asked its medicines regulator to review AstraZeneca's vaccine, which it has developed with the University of Oxford, for emergency-use authorization, last month. Pfizer's vaccine has already been authorized by U.K. regulators, and approval of its application for authorization to the U.S. Food and Drug Administration is awaited.

Policy makers and regulators around the world are trying to get vaccines to people as soon as they can and have been easing the regular restrictions for bringing a new drug to market.

The regulatory race has been intensified by recent publication of positive clinical data for three different vaccine candidates. Two shots -- one from Pfizer Inc. and Germany's BioNTech SE, and another from Moderna Inc. -- showed to be more than 90% effective at preventing symptomatic Covid-19 in large-scale human trials.

Meanwhile, last month AstraZeneca said its vaccine registered as much as 90% effective, but only among a small subset of subjects who received a lower first dose of the two-shot regimen. In the other group of trial subjects given two full doses, the vaccine showed 62% efficacy.

India needs the vaccine more than almost any other country. It has had more than 9.5 million confirmed coronavirus cases -- second only to the U.S. -- and 140,000 deaths. Its economy has been hit far more than most major economies as the pandemic has squeezed consumer confidence and spending and pushed millions of people back below the poverty line.

--Vibhuti Agarwal contributed to this article.

(END) Dow Jones Newswires

December 07, 2020 08:59 ET (13:59 GMT)

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