"Short Notice, Different Time Zone": Pfizer On Delay In Vaccine Approval

Last week Union Health Secretary Rajesh Bhushan said Pfizer had been given three opportunities to present data, but did not appear before the subject expert committee

'Short Notice, Different Time Zone': Pfizer On Delay In Vaccine Approval

The Pfizer vaccine was developed in association with German company BioNTech (Representational)

New Delhi:

American pharma giant Pfizer, whose coronavirus vaccine has a 95 per cent efficacy rate but has yet be approved, told NDTV on Monday it had been "unable to participate in previous meetings (to present safety and efficacy data to an expert panel) due to extremely short notice" and time zone differences.

The company, however, said it was "committed to working with the government (to) provide equitable access to our vaccine".

"Pfizer sought an opportunity to participate in SEC (subject expert committee) towards Emergency Use Authorisation for our COVID-19 vaccine. However, representatives have been unable to participate... due to extremely short notice, of a few hours or less, and time-zone limitations given that the participating team is primarily based out of the United States," a spokesperson said.

However, last week Union Health Secretary Rajesh Bhushan said the firm had been given three opportunities to present data, but "have not appeared before the SEC (subject expert committee)".

"After their application, Pfizer has been given three opportunities so far by the Subject Expert Committee of the CDSCO (Central Drugs Standard Control Organization). But they have not appeared before the SEC...the SEC, to the best of our knowledge, is willing to listen to their presentation," Mr Bhushan said January 5.

"... 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 Pfizer spokesperson said today.

The Pfizer vaccine, which has been cleared and rolled out in the UK, the US, Canada and several mainland European countries, was one of three being considered for restricted use in India.

The other two - Covishield (produced by Pune-based Serum Institute), which has a 70.42 per cent efficacy rate, and Covaxin (by Hyderabad-based Bharat Biotech) were both approved last week.

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India will begin the first phase of its Covid vaccination drive on January 16 (File)

The latter drug was cleared despite lack of Phase III trial data (which tests for vaccine efficacy), with the expert panel and government's decision based on "a tremendous amount of immunogenicity and safety data" from Phase I and II trials (which test for vaccine safety).

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The green light for Covaxin and Covishield were hailed by Prime Minister Narendra Modi. He said it would make every Indian proud that the two were "made in India".

On Saturday the government said the first phase of vaccination would begin January 16.

This evening sources said the government had agreed on a price of Rs 200 per dose for the first 100 million doses of Covishield. The first shipment will consist of 11 million doses, the sources added.

The government plans to cover 300 million people - 30 million front-line workers and 27 million over 50 years and under 50 but with comorbidities - in the first phase.

This will require 600 million doses. The Serum Institute has 50 million for immediate distribution. The rest will be supplied "a few million every week", sources said. There are around 20 million doses of Covaxin ready, leaving a potentially massive shortfall in the number of shots needed for the first phase.