COVID-19 vaccine: Pfizer cites short notices, different time zones for approval delay

COVID-19 vaccine: Pfizer cites short notices, different time zones for approval delay

Pfizer is yet to submit additional data sought by India authorities regarding its COVID-19 vaccine for granting emergency use approval to it; the company has missed last three SEC meetings too

Pfizer blamed "extremely short notices" and "time-zone limitations" for its inability to secure approval for its coronavirus vaccine in India. Despite the arguments against it, Pfizer's COVID-19 vaccine was one of the three products being considered by Indian authorities for emergency use approval. However, the company has been a no-show at the last three meetings of subject expert committee (SEC) under Central Drugs Standard Control Organisation (CDSCO).

Following recommendations from the expert panel, Indian drug regulator, Drug Controller General of India (DCGI), approved Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin for emergency use in the country. Centre has already placed an order for Covishield with Serum Institute of India, which has been licensed to manufacture and market the jab in India, and is expected to receive the first consignment in days to come.

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Meanwhile, additional data was sought from Pfizer for the vaccine it has developed in collaboration with BioNTech. The company is yet to provide the same. It, however, has assured that responses to queries from Indian authorities are being compiled.

"Pfizer sought an opportunity to participate in the SEC consultations towards an Emergency Use Authorization for our COVID-19 vaccine. However, the company representatives have been unable to participate in previous meetings due to 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," a Pfizer spokesperson said.

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As India marches on to kick-start its pan-nation coronavirus vaccination drive, Pfizer reiterated its intention to roll out its COVID-19 vaccine in the country. The US pharmaceutical major said that it remains committed to working with the Indian government to introduce and ensure equitable access to its COVID-19 vaccine in India.

"In the meantime, we are in the process of compiling responses to queries raised by the regulator on the data provided. We remain committed to engaging with the Government of India to make this vaccine available for use by the government in the country," the company pokesperson further added.

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Published on: Jan 11, 2021, 10:13 PM IST
Posted by: Vivek Punj, Jan 11, 2021, 10:13 PM IST