New Delhi: Pfizer has decided to withdraw the application for emergency use authorisation of its COVID-19 vaccine in India, the pharmaceutical major said on Friday.
Incidentally, the US company was the first firm to seek the emergency use authorisation from the Drugs Controller General of India (DCGI) for its vaccine, after it had secured similar approvals in the UK and Bahrain.
According to sources, Pfizer’s decision to withdraw its application followed a meeting with DCGI’s Subject Expert Committee earlier on Wednesday.
Confirming this, a Pfizer statement said, “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.”
The company, however, added that it will resubmit the approval request with additional information in the near future, NDTV reported.
“Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment,” the statement said.
Behind The Scenes
Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots — one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer.
Pfizer’s Take
The US company had claimed that its application was supported by data from a global study that showed an overall efficacy rate of 95 per cent with no vaccine-related, serious safety concerns, Reuters reported.
Drugs Controller Stand
However, the Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, according to an India Today report.
Health officials said they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in Indian citizens whose genetic makeup can be different from people in Western nations.
