MUMBAI: Even as Pfizer announced it is withdrawing its application for emergency use approval of its Covid-19 vaccine on Friday, it has come to light that the government expert panel in India had decided against recommending it in the absence of local clinical trials’ data.
The subject expert committee (SEC) under the Union health ministry in its meeting on February 3 had observed that serious adverse events including palsy and anaphylaxis have been reported during post-marketing of the vaccine globally.
Since the causality of the events with the vaccine was being investigated, the committee did not recommend the messenger or mRNA vaccine for emergency use in the country at this stage. Further, the firm has not proposed any plan to generate safety and immunogenicity data in the Indian population, official sources said.
It is understood that Pfizer, the first company to apply in India for emergency use authorization in December for the vaccine, had sought drug regulator’s nod to import it, besides a waiver of clinical trials on Indian population.
A Pfizer spokesperson 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. Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. 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.”
Over 4,000 adverse events have been reported after people received the Pfizer-BioNTech Covid-19 vaccine in US, with 21 cases of anaphylaxis, a severe, life-threatening allergic reaction that occurs rarely after vaccination, according to a report by the Centers for disease control and prevention (CDC) in January. The US food and drug administration had issued an emergency use authorization for the vaccine on December 11 last year.
Typically, the drug regulator gives its nod for an emergency licence or full marketing approval, only when it is recommended by the SEC.