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Pfizer withdraws EUA application for Covid vaccine in India

Pfizer withdraws EUA application

Pfizer has decided to withdraw its application for regulatory approval of its COVID-19 vaccine under emergency circumstances in India nearly two months after approaching authorities here for this permission, the American drug giant said Friday.

The decision follows a meeting earlier this week of an expert body under India’s apex drug regulator, which may have needed more information from Pfizer than what the company had provided in support of its application.
“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,” stated a Pfizer spokesperson.

The company says it will “continue to engage” with the authority and resubmit its approval request with additional information “as it becomes available in the near future.”
At this stage, it is unclear what additional information has been sought from the firm, which developed its mRNA Covid-19 vaccine in collaboration with German biotech firm BioNTech.
“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,” said the spokesperson.
Pfizer was the first firm to approach the Central Drugs Standard Control Organisation (CDSCO) for an EUA in early December after it had received such an approval in the United Kingdom. While the firm had not conducted local trials or bridging studies of its vaccine in India, provisions under India’s Clinical Trial Rules, 2019, allowed for the firm to seek an approval with waivers on local testing as it had received an approval in a different country whose regulatory authority is recognised by CDSCO as valid for such waivers, a senior government official earlier told The Indian Express.

However, the firm initially was unable to present its case for an EUA in subsequent meetings held by the CDSCO Subject Expert Committee that was looking into its application.
Pfizer India’s spokesperson earlier told The Indian Express the company’s representatives had been unable to participate in previous meetings “due to the extremely short notices of a few hours or less and time-zone limitations given that the participating team is primarily based out of the United States.”


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