The first company to apply for an emergency use authorisation for its COVID-19 vaccine in India, US pharma giant Pfizer has withdrawn its application.
On December 4, Pfizer India became the first pharmaceutical organisation to apply to the Indian regulator for an emergency approval for its COVID-19 vaccine. The application had come shortly after the mRNA vaccine had received an emergency approval in the UK.
Since then, Pfizer has been approved in US, Canada, and European Union, too, for emergency use.
However, in India, top officials monitoring the vaccine administration had made multiple statements on the fact that cold storage requirements in the country are inadequate for the Pfizer vaccine that requires storage temperature of -70 degrees.
THE WEEK had reported how merely an application did not guarantee that approval would be given.
“In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. 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,” a company spokesperson said.
“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.”
Despite its application to the drug regulator though, Pfizer had skipped multiple meetings of the SEC, citing “time zone” and “short notice”. These include the meetings in December when the subject expert committee had met to discuss, and later, recommend the two vaccines that are currently in use in India.
On February 3, however, Pfizer made a presentation to the subject expert committee. The committee noted that “incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated.”
According to the minutes of the meeting, Pfizer did not propose any plan to generate safety and immunogenicity data in the Indian population. “After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” the minutes read.
Pfizer had also asked for a waiver of the bridging trial study in India—Serum Institute’s Covidshield, for instance, in doing a bridging trial with 1,600 subjects in India—but the subject experts have not agreed, health ministry sources suggest.
Central government officials have also insisted that aside of Covishield and Covaxin, India is expecting to consider the application for Russian vaccine Sputnik V, Zydus Cadila’s candidate, and another candidate by Biological E, all of which are in advanced phases of human trials.
