Pfizer, Serum Seeking Covid Vaccine Approval in India, Says PTI
(Bloomberg) -- Two leading coronavirus vaccine developers -- Pfizer Inc. and AstraZeneca Plc -- have applied for emergency use authorization in India, according to the Press Trust of India, raising the likelihood that mass inoculation efforts could begin within weeks in the country of 1.3 billion people.
Pfizer India has applied to India’s drug regulator for permission to import its experimental mRNA vaccine for sale and distribution without the requirement for local clinical trials, said PTI, citing an unidentified official.
Meanwhile, Serum Institute of India Ltd., AstraZeneca’s India vaccine partner, has applied for emergency use authorization using data from Phase III trials that were conducted locally, as well as in Brazil and the U.K., said PTI citing unnamed officials.
The applications mean that a mass vaccine effort could be shortly underway in India, which has the world’s second-largest outbreak after the U.S. and faces significant challenges in distributing inoculation shots across its vast territory. Pfizer’s shot requires deep-freeze storage and transportation, which rules it out for much of the country’s sprawling hinterland. But its extraordinary efficacy of over 90% means that the nation’s well-to-do elite will likely clamor for access.
AstraZeneca’s vaccine will make a bigger difference to the country’s epidemic, as Serum has committed to produce at least one billion doses, half of which will stay in the South Asian nation. The world’s largest vaccine maker will have 100 million doses ready by this month for the local inoculation drive, said Chief Executive Officer Adar Poonawalla in a November interview.
The application for emergency authorization in India is one of the first globally for AstraZeneca’s vaccine, which has the most supply deals around the world but recently lost ground after a manufacturing discrepancy muddied results from its final stage trials.
Pfizer and its partner BioNTech SE have already received emergency authorization in the U.K. for their shot and are on track to get U.S. and European approval this month.
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