The multinational pharmaceutical Pfizer company approached the Indian regulator with a request similar to the one in the United Kingdom
The company has applied to the Controller General of Drugs of India (DCGI) for an EUA on its vaccine, according to a source from the Ministry of Health by BusinessLine.
Similarly, it is not yet clear how long the process will take, as a committee will review whether "bridging studies" will be required to assess how the vaccine works in the Indian population.
Pfizer has consistently argued that its vaccine has the potential to be part of the COVID-19 solution in India and globally. To address this new problem, it wants to collaborate with the government to make the vaccine available in the country.
The problem, however, is in its storage and distribution, as the next generation mRNA vaccine will need temperatures of (minus) 70 ° C.
In response to a query about the US filing in India, a Pfizer spokesperson said:
Pfizer is dedicated to ensuring the availability of this vaccine for use by governments around the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with the respective government authorities and after authorization or regulatory approval.