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American drugmaker Pfizer said it was withdrawing its application for an emergency approval on its Covid-19 vaccine, in India.
However, the company added that it would resubmit its approval request with additional data shortly.
“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,” a company 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,” the spokesperson added, without giving details on the additional information required.
Foreign companies bringing in their Covid-19 vaccine into India are required to undertake “bridging studies”. And a Health Ministry source familiar with the Pfizer development told Business Line, the company wanted a waiver on the bridging studies, but this was declined by the Subject Expert Committee (SEC).
Bridging studies
On the February 3rd meeting to discuss accelerated approvals on the vaccine, the SEC noted, “the firm (Pfizer) has not proposed any plan to generate safety and immunogenicity data in Indian population.” After detailed deliberation, it said, “the committee has not recommended for grant of permission for emergency use in the country at this stage.”
Internationally, Pfizer’s vaccine is the only one to have a pre-qualification or an Emergency Use Listing from the World Health Organisation, allowing it to be adopted by countries without an elaborate regulatory system to evaluate the vaccine. The Ministry source pointed out that India would consider products against its regulation and requirements. Pfizer did not comment on the bridging studies issue.
Another challenge for the Pfizer-BioNTech vaccine was its steep requirement for storage and distribution at over – (minus) 70 degrees Celsius.
Supply shortages
The multinational is presently dealing with supply shortages on home ground (US) and in Europe and was also reported to have asked for a purchase commitment in India. Another person familiar with the development indicated that the decision to withdraw its India application was not linked to these reports.
Presently, India has two vaccines with emergency approvals - the AstraZeneca-OxfordUniversity vaccine by Serum Institute of India and the Bharat Biotech product. A third is on its way, as Russia’s Sputnik V vaccine undergoes bridging studies in India.
However, Pfizer said it remained committed to making its vaccine available for use by the Indian government and pursuing the requisite pathway for a EUA that would facilitate its deployment.
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