Pfizer Yet to Be Approved by DCGI; ‘Diff Time Zone Caused Delay’

Pfizer was amongst three vaccines being considered for emergency use approval by Indian drug regulator, DCGI.

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Pfizer-BioNTech is yet to be approved by DCGI. 

Pfizer claimed on Monday, 11 January that the reason it has skipped three meetings of subject expert committee (SEC) under Central Drugs Standard Control Organisation (CDSCO) was due to ‘time zone limitations’ and ‘ extremely short notices’. Pfizer was amongst three vaccines being considered for emergency use approval by Indian drug regulator, Drug Controller General of India (DCGI).

"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, quoted NDTV.

The spokesperson added, “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,” quoted NDTV.

First Phase of Vaccines On 16 January

Last week, DCGI approved Oxford-AstraZeneca's Covishield (produced by Serum Institute) and Bharat Biotech's Covaxin for emergency use in the country.

Covaxin has been cleared without adequate Phase III trial data but on the basis of ‘immunogenicity and safety data’ from earlier trials. 20 million doses of the vaccine will be ready for distribution, reported NDTV.

There is a potential shortage of shots needed for the first phase as the government is planning to vaccinate 300 million people (including health workers and elderly individuals). The first shipment is of 11 million Covishield doses, reported NDTV. Covishield has 50 million doses available for immediate distribution.

Holding a virtual meeting with chief ministers on the coronavirus vaccination programme in India, due to commence on 16 January, Prime Minister Narendra Modi on Monday, 11 January, said the Centre will bear the expenses for the first-phase vaccination of three crore ‘corona warriors’ and frontline workers

(With inputs from NDTV)

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