A doctor has a bottle of BioNTech and Pfizer coronavirus vaccine between his fingers in the pharmacy of Tübingen University Hospital (UKT).
Sebastian Gollnow | alliance image | Getty Images
Pfizer has withdrawn an application for emergency use authorization of its Covid-19 vaccine in India that it has developed with German BioNTech, the company told Reuters on Friday.
The US company, which was the first drug manufacturer to apply for emergency use authorization for its Covid-19 vaccine in India, had a meeting with the drug regulator of the country on Wednesday and the decision was made after that, the company said.
“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,” he said in a statement to Reuters.
“Pfizer will continue to work with the authority and resubmit its request for approval with additional information as it becomes available in the near future.”
Pfizer had applied for permission for its vaccine in India late last year, but the government approved two much cheaper shots in January: one from Oxford University / AstraZeneca and another developed in home for Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer.
The Standard Drug Control Organization of India had refused to accept Pfizer’s application for approval without conducting a small local trial on the safety and immunogenicity of the vaccine for Indians, Reuters reported.
Health officials in India say they are asking for so-called connection tests to determine if a vaccine is safe and generates an immune response in their citizens whose genetic makeup may be different from that of Western nations. However, there are provisions of the New Medicines and Clinical Trials Standards of India, 2019, to waive these trials under certain conditions.
Pfizer previously told Reuters that its application was backed by data from a global study that showed an overall 95% efficacy rate with no vaccine-related safety issues.