Covid-19 vaccine: SII & Bharat Biotech emergency vaccine approval put on hold, DCGI cites lack of data
SII & Bharat Biotech: India’s hopes of getting Covid-19 vaccines in a matter of days flickered away – India might have to wait just a bit longer to get a country-made vaccine rolled out for the coronavirus. Drug Controller General of India (DCGI) has put the Covid-19 vaccines Covishield and Covaxin on hold for emergency use authorization, produced by Serum Institute of India and Bharat Biotech, respectively. DCGI has put a hold on authorization citing incomplete data and is awaiting more evidence to back vaccine before giving clearance for emergency use in India.
Regarding Covishield Vaccine, manufactured by Pune based Serum Institute of India, the DCGI committee said, “…recommended that the firm should submit updated safety data of the Phase II/ III clinical trial in the country, Immunogenicity data from the clinical trial in UK and India, and the outcome of the assessment of UK-MHRA for grant of EUA.”
This was uploaded as part of MOM (minutes of meeting) on DCGI’s website on Wednesday. The response to Bharat Biotech’s Covaxin was also similar – post phase 3 completion data was needed to make a complete evaluation of vaccine and was incomplete.
A source from DCGI said, “Neither company presented complete data from their ongoing Phase 3 trials. We also wanted more information on the reported case of a volunteer in Chennai, who reportedly had a severe adverse reaction.”
A Chennai based volunteer had sued Serum Institute of India last month after he developed neurological condition, allegedly as an adverse reaction to the vaccine. SII however denied any link to vaccine and counter-sued the person. ICMR has said that though initial investigation into the matter doesn’t show any link established between reaction developed and vaccine, a complete report and explanation is still required.
DCGI committee, comprising of 10 members, meets periodically to extend recommended approvals, rejections of new drugs and vaccines. This committee is called Subject Expert Committee, and has members from various specialties, like microbiology, paediatrics, pharmacology and pulmonary medicine.
According to Indian law any potential vaccine or drug can receive commercial approval, even without trials completion, on a condition that it has been approved in any other country. But the decision is left on discretion of committee members.