Bid to get green light for vaccine drive in India
TWO leading coronavirus vaccine developers – Pfizer Inc. and AstraZeneca Plc – have applied for emergency use authorisation in India, according to a Press Trust of India (PTI) report, 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 the report, citing an unidentified official.
Meanwhile, Serum Institute of India, AstraZeneca’s India vaccine partner, has reportedly applied for emergency use authorisation using data from phase 3 trials that were conducted locally, as well as in Brazil and the UK.
The applications mean that a mass vaccine effort could soon be under way in India, which has the world’s second-largest outbreak after the US and faces significant challenges in distributing inoculation shots across its vast territory. Pfizer’s shot requires deep-freeze storage and transport, which rules it out for much of the country’s remote areas. But its extraordinary efficacy of over 90% means that the nation’s wellto-do elite will probably clamour for access.
AstraZeneca’s vaccine will make a bigger difference to the country’s epidemic, as Serum has committed to produce at least 1 billion doses, half of which will stay in India. The world’s largest vaccine maker was set to have 100 million doses ready by this month for the local inoculation drive, chief executive Adar Poonawalla said last month.
The application for emergency authorisation 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 authorisation in the UK for their shot and are on track to get US and European approval this month.