Pfizer has withdrawn its bid for urgent approval of its coronavirus vaccine in India, citing additional information that the country’s drug regulator needs, the pharmaceutical company confirmed to The Hill.
The decision, first reported by Reuters Friday after Wednesday came a meeting with India’s Central Drugs Standard Control Organization.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application 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 approval request 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 government use in India and to follow the required path for authorization for emergency use, enabling the availability of this vaccine for future applications. is going to be.”
According to Reuters, Pfizer was the first company to apply for an emergency use permit for its coronavirus vaccine in India late last year, although the country’s drug regulator has denied the vaccination until a small local trial has been conducted to verify safety and efficacy. measure. of the vaccine for Indians.
India has already approved COVID-19 vaccines from two other companies that applied for an emergency permit after Pfizer: the Oxford-AstraZeneca vaccine in use around the world and a vaccine developed in India by a company called Bharat Biotech in partnership with the Indian Council for Medical Research.
India started one last month massive roll-out campaign for vaccination, which aims to vaccinate 300 million people in a country of more than 1.3 billion inhabitants.
The first round of vaccinations targeted 30 million health care providers and frontline workers and 270 million people who are either over 50 or have an underlying medical condition that puts them at higher risk for complications from COVID-19.