Pfizer has dropped its bid for emergency approval of its coronavirus vaccine in India, citing additional information needed by the country’s drug regulator, pharmaceutical company The Hill has confirmed.
The decision, first reported by Reuters Friday came after a meeting Wednesday with India’s Central Drug Control Organization.
“Based on the deliberations at the meeting and our understanding of the additional information the regulator may need, the company has decided to withdraw its request at this time,” Pfizer said in a statement shared with The Hill.
The company added that “it will continue to interact with the authority and resubmit the request for approval with additional information as it becomes available in the near future.”
The statement went on to say: “Pfizer remains committed to making its vaccine available for use by the Government in India and to follow the necessary path to authorize emergency use to allow the availability of this vaccine for any future implementation.”
According to Reuters, Pfizer was the first company to apply for emergency use of its coronavirus vaccine in India late last year, although the country’s drug regulatory agency refused to approve the inoculation until a small local study was conducted. measure the safety and efficacy of the vaccine for Indians.
India has already approved COVID-19 vaccines from two other companies that have applied for emergency authorization after Pfizer – the Oxford-AstraZeneca vaccine is used worldwide and a vaccine developed in India by a company called Bharat Biotech in partnership with Indian Medical Research Council.
India last month started a massive vaccination campaign, which aims to vaccinate 300 million people in a country with a population of over 1.3 billion people.
The first round of vaccinations targeted 30 million healthcare and front-line workers and 270 million people over the age of 50 or who have a medical condition that puts them at higher risk for complications. COVID-19.