NEW DELHI, Feb 5: Pfizer for the time being has decided to withdraw its application for emergency use approval of its Corona vaccine in India after the country’s drug regulator sought more data and information on its vaccine being manufactured along with the German biotechnology company BioNTech.
Pfizer was the first company to apply for emergency use approval in India but it did not work out.
The company had forwarded its application to the drugs controller general of India office on December 7 but missed at least three slots since to make a presentation before the central drugs standard control organisation (CDSCO) subject expert committee of the Drug Controller General of India (DCGI).
The decision was taken after the company was asked to produce more data during the CDSCO subject expert committee held on Wednesday, February 3, a spokesman for the pharma major said on Friday.
“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,” the spokesman said in a statement.
“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,” the statement added.
Officials in CDSCO confirmed the development, and said the main point of contention was that the company wanted waiver of local trials. “Their data is robust but it is always good to know how the product will work or behave in the local population, for which the regulatory authorities ask for bridging studies. So far, no foreign product has been allowed for import and to be marketed in India without a local study. It doesn’t have to be a large study, just a small study. But it is important,” said a CDSCO official.
Pfizer-BioNTech is a two-shot mRNA vaccine to be given 21 days apart. India currently is using two made in India vaccines, “Covishield” being manufactured by the Serum Institute of India under license from its developer Oxford University/AstraZeneca and “Covaxin” indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
(Manas Dasgupta)
