Pfizer withdrew its emergency approval offer for its coronavirus vaccine in India, citing additional information needed by 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 Standards 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 order at this point,” said Pfizer in a statement shared with The Hill.
The company added that “it will continue to engage with the authority and resubmit its application 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 seeking the necessary pathway for emergency use authorization that would allow the availability of this vaccine for any future implantation.”
According to Reuters, Pfizer was the first company to apply for emergency use authorization for its coronavirus vaccine in India at the end of last year, although the country’s drug regulatory agency refused to approve the inoculation until a small local trial is carried out to measure the safety and efficacy of the vaccine for the Indians.
India has already approved COVID-19 vaccines from two other companies that applied for emergency clearance after Pfizer— the Oxford-AstraZeneca vaccine being used worldwide and a vaccine developed in India by a company called Bharat Biotech in partnership with the Indian Medical Research Council.
India last month started a mass vaccination 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 health and frontline professionals and 270 million people over the age of 50 or with an underlying medical condition that put them at greater risk for COVID-19 complications.