India may get vax nod for emergency use by year-end; SII's case strong

India is likely to have a COVID-19 vaccine approved for emergency use before December ends as THE Central Drugs Standard Control Organization's (CDSCO) expert panel is set to review the applications of Serum Institute of India (SII) and Pfizer for the emergency use authorisation (EUA) of their candidates, multiple sources associated with the development told IANS

Dec 23, 2020
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India is likely to have a COVID-19 vaccine approved for emergency use before December ends as THE Central Drugs Standard Control Organization's (CDSCO) expert panel is set to review the applications of Serum Institute of India (SII) and Pfizer for the emergency use authorisation (EUA) of their candidates, multiple sources associated with the development told IANS.

The sources said 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 c.

The sources said that the Pune-based SII's vaccine candidate has an edge over Pfizer's because of its low cost, effective logistics and easy storage.

However, no official confirmation came from the CDSCO.

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 authorised 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 authorisation (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.

The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity (is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal) data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for grant of the EUA.

The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.

Meanwhile, it has recommended Bharat Biotech to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further consideration.

(IANS)

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