Despite being the first company to have applied for emergency use authorisation of its coronavirus disease (Covid-19) vaccine to India’s drugs regulator, pharma major Pfizer has now withdrawn its application, the company spokesperson said in a statement on Friday.
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..
The decision was taken after the company was asked to produce more data during the CDSCO subject expert committee held on Wednesday, February 3.
The company had made a presentation before the committee regarding its application for emergency use approval of its Covid-19 vaccine that it is manufacturing along with the German biotechnology company- BioNTech. However, it did not work out, and the company decided to withdraw its application for time being.
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“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 Pfizer company spokesperson said in a statement.
{{/usCountry}}“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 Pfizer company spokesperson said in a statement.
{{/usCountry}}“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 in the know of things confirmed the development, and said that 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 one of the officials, requesting not to be identified.
Pfizer-BioNTech is a two-shot mRNA vaccine to be given 21 days apart.