January 26, 2021 3:43:16 am
An expert body looking into requests by Serum Institute of India and Bharat Biotech to conduct human testing of additional Covid-19 vaccines has asked the companies to revise their clinical trial protocols.
The Subject Expert Committee (SEC) under India’s apex drug regulatory body (CDSCO) has recommended that SII conduct its mid- to late-stage clinical trials (phase 2/3) “with placebo or other vaccine as the comparator for which justification is required”. This follows a meeting on January 13, where the SEC had asked the Pune firm to replace its proposal to compare the vaccine, Covovax (developed by American biotech firm Novavax), with a “comparator” vaccine instead of a placebo.
A comparator vaccine is one that has already been launched for the purpose that the new vaccine is being tested, while a placebo is an inactive vaccine that looks like the vaccine being tested. In this case, the SEC had noted that vaccines against Covid-19 — Covishield and Covaxin — have already been approved in the country and should therefore be used as the comparator in SII’s testing of Covovax.
However, the SEC changed its opinion on January 18 and 19 after SII presented its proposal along with “various comparator options”. It has asked the Pune firm to once again revise its protocol accordingly.
In the case of Bharat Biotech, which is attempting to test a single-dose intranasal Covid-19 vaccine ‘BBV154’, the SEC on Jan 18 and 19 recommended that the company conduct phase 1 clinical trials using 75 volunteers. The committee asked the firm to submit safety and immunogenicity data for its consideration before it proceeds to the second phase of the trial. Bharat Biotech would have to revise its protocol accordingly.
So far, SII and Bharat Biotech have received restricted approvals in an emergency situation for their Covishield and Covaxin respectively.
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