India’s drug regulator awaits UK move before nod to SII’s Covid vax

NEW DELHI: The drug regulatory body of India is looking at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval to AstraZeneca/Oxford’s Covid-19 vaccine before giving a nod for Emergency Use Authorisation (EUA) to its Indian counterpart developed by Serum Institute of India (SII), sources told IANS.

The sources indicated that the Central Drugs Standard Control Organisation (CDSCO) would hold meeting of its Subject Expert Committee (SEC) to review the safety and immunogenicity data of SII’s Covishield once the Oxford’s Covid-19 vaccine is given a go-ahead by the MHRA. As per the English dailies of the UK, the drug regulatory body there is likely to grant approval to Oxford’s candidate before January 5.

However, the officials at the CDSCO did not comment on the information.

Meanwhile, AstraZeneca’s Chief Executive Officer Pascal Soriot had stated a day ago that his vaccine candidate which is co-developed with Jenners’s Institute of the Oxford University, the company’s coronavirus vaccine is 100 per cent effective against the Covid-19 disease. He said the vaccine has a “winning formula” for efficacy.

Soriot had also hoped for approval from the MHRA by the end of the year.

Currently, the applications by three firms for EUA of their Covid vaccine are pending for the review at India’s drug regulatory authority. Pfizer, SII along and Bharat Biotech had applied for the EUA to Drug Controller General of India earlier this month. However, their applications were not approved as the SEC found inadequate safety and efficacy data of the vaccines in a review meeting held on December 9.

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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 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 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 data from the clinical trial in the UK and India, along with the outcome of the assessment by MHRA. While it had recommended Bharat Biotech to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further consideration.

IANS had reported a few days ago that the SII has submitted the additional data sought by the CDSCO.

Pfizer’s vaccine has already been approved by several countries including the UK, the US, and Bahrain. Meanwhile, the SII has already manufactured 40 million doses of its vaccine under the at-risk manufacturing and stockpiling license from the DCGI, the officials had informed recently.