Pfizer’s COVID vaccine may get Centre’s nod for emergency use

Since the government has waived off the need of submitting local bridge trial data for vaccines, the US pharma major could make its vaccine available in the domestic market soon

On Wednesday (April 21), the US-based vaccine manufacturer said it is exploring opportunities to make the COVID-19 vaccine available in India instead of manufacture it here.

As the country opens up its COVID vaccine market to foreign players, global drug manufacturer Pfizer has once again shown interest in engaging with the Union government in providing a vaccine to support India’s massive immunisation programme.

On Wednesday (April 21), the US-based vaccine manufacturer said it is exploring opportunities to make the COVID-19 vaccine available in India instead of manufacture it here.

Pfizer has developed a two-dose COVID-19 vaccine in partnership with BioNtech and has made its doses available in Europe and the US besides other countries, but not India.

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The US pharma major had applied for emergency-use authorisation (EUA) of its COVID-19 vaccine in India in February, but withdrew later after failing to meet the Drugs Controller General of India’s (DCGI) requirement for a local safety and immunogenicity study.

Now, the Government of India has waived off the need of submitting local bridge trial data for vaccines approved by the USFDA, European Medicines Agency (EMA) or those listed with the WHO under Emergency Use listing. Therefore, Pfizer has become eligible to directly seek emergency-use authorisation from DCGI in India to import its COVID-19 vaccine.

Also read: All adults can register for vaccine from April 24. Here’s how

The Pfizer vaccine, which has been cleared by Britain, reported an efficacy rate of more than 90%.

In a statement, a Pfizer spokesperson said, “Right now we are in discussions with many governments around the world and remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.”

Also read: Amid shortage, SC asks Centre: ‘What’s the national plan on oxygen?’

The company statement further read: “During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval.”

As per the Centre’s new policy, states can procure COVID-19 vaccine doses directly from the manufacturers, who can also sell their doses to private players like hospitals. The Centre has mandated both the vaccine makers to sell the jabs at pre-declared prices.

India has so far given approval to three coronavirus vaccines — Serum Institute’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V.

On Thursday (April 22), India made a dubious record of topping the global tally of daily COVID cases, reporting 3,14,835 new cases and fatalities of 2,104 in a single day.

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