Pfizer has withdrawn its candidacy for emergency approval of its coronavirus vaccine in India, citing additional information needed for the country’s drug regulator, the pharmaceutical company confirmed to The Hill.
The decision, first reported by Reuters on Friday, came after a Wednesday meeting with Central Drug Control Organization of India.
“Based on the deliberations of 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 work with the authority and resubmit its 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 to the Government in India and to following the necessary path for emergency use authorization to allow the availability of this vaccine for to any future deployment “
According to Reuters, Pfizer was the first company to apply for emergency use authorization for its coronavirus vaccine in India late last year, although the regulatory agency of the country’s drug has refused to approve inoculation until a small local trial is conducted to measure safety and efficacy. of the vaccine for the Indians.
India has already approved COVID-19 vaccines from two other companies that 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 collaboration with the Indian Council of Medical Research.
India started last month in mass vaccine deployment campaign, which aims to vaccinate 300 million people in a country with a population of more than 1.3 billion people.
The first round of vaccinations targeted 30 million front-line health workers and 270 million people over the age of 50 or with an underlying medical condition that puts them at increased risk for COVID-19 complications.