The regulator of medicines in the country is reluctant to accept the application and to carry out a local survey on the safety and immunogenicity of the vaccine in Indian citizens.
Pfizer’s pharmaceutical company has withdrawn its application for emergency use in India of its vaccine against covid-19, developed with the German company BioNTech, according to the Reuters company this week.
The company took the decision to hold a reunion of the markets with the regulator of medicines in the country. “On the basis of the deliberations in the meeting and our understanding of the additional information that the regulator may require, the company has decided to withdraw its application at this time”, the company announced.
“Pfizer will continue to interact with the authorities and volverá to present his approval proposal with additional information means that it is available in the future “, aggregate.
The pharmaceutical company has applied for the authorization for its vehicle at the end of this year, but the Gobierno Indio has approved two more vaccines, one from AstraZeneca and another developed by Bharat Biotech together with the Indian Research Council.
According to Reutres, the Central Organization for the Control of Medicines in India, it accepts the Pfizer approval request by implementing a local test regarding the safety and immunogenicity of the Indian vaccine.
Indian sanitary authorities generally require additional solutions to determine whether a vaccine is safe and generates an immune response in its citizens, whose genetic composition can be different from that of the people in the Western nations.
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