SII vaccine approval only after UK nod to AstraZeneca

Serum Institute of India's Covid-19 vaccine not to get nod till UK authorises AstraZeneca shot

UK and Indian regulators are expected to take on both cases for emergency use approval next week

An employee in personal protective equipment (PPE) removes vials of AstraZeneca's COVISHIELD, coronavirus disease vaccine from a visual inspection machine inside a lab at Serum Institute of India, Pune. Credit: Reuters Photo

Nearly three weeks after it sought the Indian pharmaceutical regulator’s nod for emergency use of its Covid-19 vaccine, Pune-based Serum Institute of India is yet to receive an approval from the Central Drug Standards Control Organisation primarily due to the absence of such an approval from the UK drug regulator to the original vaccine created by a partnership between Oxford University and AstraZeneca.

Since the SII vaccine is the same as the Oxford-AstraZeneca one, Indian regulators would like to look at the vaccine’s efficacy data from the clinical evaluations carried out abroad before permitting its emergency use in India.

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The Indian trial of the Serum vaccine on 1,600 volunteers is only to test the vaccine’s safety and immunogenicity or immune response in the Indian population. There would be no efficacy trial in India.

As a consequence, the CDSCO will have to rely on the assessment made by the UK Medicine and Healthcare Product Regulatory Agency, which is likely to take up the Astra vaccine case next week after the company submits its final tranche of clinical trial data.

Authorisation by the MHRA, sources said, would give confidence to the regulators in other countries in the wake of a controversy surrounding the trial protocols after it was found that two doses of the vaccine yielded two different levels of protection – 62 per cent and 90 per cent protection – depending on the quantity of the vaccine administered.

The SII sought an Emergency Use Authorisation license from the CDSCO on December 7. Two days later, the regulator reviewed the application and sought updated safety data of the phase 2/3 clinical trial in India, immunogenicity data from the clinical trial in the UK and India and lastly, outcome of the assessment of the MHRA to grant the EUA license.

Sources said the SII had furnished the data to the CDSCO last week and the regulator would now review the data to take a call.

Pfizer and Bharat Biotech, Hyderabad also approached the CDSCO for the EUA approval. The former has even asked for a waiver for the clinical trial requirement.

But the multinational giant that got approval for its vaccine in the UK, EU and US markets is yet to make a presentation before the CDSCO while additional data was sought from Bharat Biotech when their case was taken up earlier this month.

Meanwhile, SII tied up with two other companies for clinical trials of their Covid-19 vaccines in India.

Last week, it approached the regulator seeking clinical trial permission of a novel vaccine manufactured by Novovax, but the regulator asked the company to modify the trial protocols. The Pune-based company has also partnered with the US firm Dynavax for the clinical trial of their vaccine in India.