With data from UK and India, Covishield and Covaxin go to regulator

“This (Bharat Biotech’s) is an application (under the category of) issue of permission to either import, manufacture a drug or for grant of clinical trial NOC (no-objection certificate),” a person close to the development told The Indian Express.

Separately, a different set of sources told The Indian Express that SII had completed the application process for its candidate Covishield – a variant of the University of Oxford-AstraZeneca candidate that SII is manufacturing and testing under licence in India – on Saturday. SII submitted efficacy data from the late stage human trials of the AZD1222 vaccine candidate in the United Kingdom, and safety data from the trials of the candidate that are ongoing in India.

Senior officials at the Indian Council of Medical Research (ICMR), the country’s top biomedical research body, said that a candidate intended for use in India must submit data from clinical trials conducted in India. However, the authorisation committee of experts, while considering the Indian data, can also draw conclusions based on data from international trials. Approval can be granted given the extraordinary emergency in the country, experts told The Indian Express.

The source close to the Bharat Biotech development said India does not have specific regulations or permissions for emergency use authorisation (EUA) – and therefore, the portal under which these submissions are made – SUGAM – does not have an EUA category. This means that firms have to seek regular market authorisation, and a subject expert committee looking into the application may decide to allow speedy access to the vaccine with certain restrictions.

This was also the case for the requests made by Pfizer and SII when they approached the Central Drugs Standard Control Organisation (CDSCO), according to a senior government official.

“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” SII CEO Adar Poonawalla posted on Twitter on Monday. “This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”

While it is unclear how effectively Covaxin will bring down the number of symptomatic Covid-19 cases – given that its efficacy information is yet to be released – it is likely that SII’s EUA request for Covishield may give India early access to a vaccine with an efficacy of a little over 60 per cent. By comparison, Pfizer’s vaccine may provide over 90 per cent reduction in the number of symptomatic Covid-19 cases, trial data suggest.

Preliminary findings of AZD1222, on which Covishield is based, showed the candidate provided around 90 per cent efficacy if given in a two-dose regimen where the first dose was around half the strength of the second dose. A senior government official privy to SII’s application to CDSCO said the firm has so far only sought marketing approval for the regimen where both shots of the vaccine were full doses – a regimen that had yielded only around 62 per cent efficacy.

Bharat Biotech, which is currently conducting phase 3 trials on over 25,000 participants across the country, is expected to complete the process by February, according to a person privy to progress in the vaccine’s testing.