India may get vaccine nod for emergency use by year-end

New Delhi: India is likely to have a Covid-19 vaccine approved for emergency use before December ends as Central Drugs Standard Control Organization’s (CDSCO) expert panel is set to to review the applications of Serum Institute of India (SII) and Pfizer for the emergency use authorization (EUA) of their candidates, multiple sources associated with the development were quoted as saying in media reports.

The sources told the media that the approval may come after the go-ahead from the Subject Expert Committee, which is likely to meet by the end of this week.

They also strongly indicated that the approval may come first for Adar Poonawalla’s SII vaccine.

Pfizer and BioNTech’s mRNA-based coronavirus vaccine requires a minus 70 degrees Celsius temperature for long term storage while SII’s Covishield, developed from the master seed of Astrazeneca/Oxford University’s Covid vaccine — ChAdOx1 nCoV-2019, can be stored in the domestic fridge at temperature not difficult to maintain (2 to 8 degrees Celsius).

If SII receives approval, then India could be the first country to give regulatory approval to AstraZeneca’s vaccine even as the medicine regulator of the UK, Medicines and Healthcare products Regulatory Agency (MHRA), continues to examine data from the trials.

The US pharma giant, Pfizer, whose vaccine has been authorizd in the US, the UK and Canada, has written to the DCGI seeking a fresh date to present its case for the EUA of their vaccine candidate BNT162b2, after it failed to present its data before the reviewing committee of CDSCO earlier.

A day ago, the European Commission (EC) granted Pfizer/BioNTech’s Covid-19 vaccine a conditional marketing authorization (CMA), under the new name Comirnaty.

Pfizer was the first to apply for the EUA in India on December 5, followed by Pune-based SII on December 6. Bharat Biotech sought EUA for its Covid vaccine, Covaxin, on December 7.

While Pfizer sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9, the SEC had asked SII and Bharat Biotech to furnish further safety and efficacy data in order to receive the EUA for their Covid vaccines.

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