The pharmaceutical company has confirmed to The Hill that Pfizer has removed its bid for emergency approval of its coronavirus vaccine in India.
The decision, first reported by Reuters Friday came after a Wednesday meeting with India’s central drug standard control organization.
“Based on the deliberations during 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 he shared with The Hill .
The company added that it would “continue to enter into discussions with the authorities and resubmit its approval request with additional information as it will be available in the near future.”
The statement added: “Pfizer is still committed to making its vaccine available for use by the Government of India and to following the necessary path of emergency authorization authorizing the availability of this vaccine for future deployment.”
According to Reuters, Pfizer was the first company to apply for an emergency permit for its coronavirus vaccine in India at the end of last year, although the country’s drug regulatory agency did not want to approve the vaccination until a small local test was done on its safety and efficacy. to measure. of the vaccine for Indians.
India has already approved COVID-19 vaccines from two other companies that have applied to Pfizer for emergency approval – the Oxford-AstraZeneca vaccine is used worldwide and a vaccine developed in India by a company called Bharat Biotech in partnership with the Indian Council for Medical Research.
India launched a massive vaccination deployment campaign, which aims to vaccinate 300 million people in a country with more than 1.3 billion inhabitants.
The first vaccination round was at 30 million healthcare and frontline employees and 270 million people over the age of 50 or have an underlying medical condition, increasing the risk for COVID-19.