The Central Drugs Standard Control Organization (CDSCO) on Wednesday asked three pharma giants to provide more safety and efficacy data of their Covid19 vaccines before getting manufacturing and marketing authorization on an emergency basis in the country.
These pharma giants are Serum Institute of India (SII), Bharat Biotech International Limited and Pfizer India.
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These pharmaceutical companies have approached the drug regulator for emergency use authorization of their vaccine.
After a review meeting with the representatives of these pharma majors, CDSCO said SII should submit updated safety data of Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in the UK and India and the outcome of the assessment of UKMHRA for grant of EUA.
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SII’s COVISHIELD is leading the Covid19 vaccine race in India.
The firm presented their proposal for grant of Emergency Use Authorization (EUA) of ChAdOx1 nCoV-19 vaccine (COVISHIELD) along with the interim safety data from Phase II/III clinical trial carried out in the country.
The interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in the UK, other countries & India before the committee.
The CDSCO has asked for the same from Bharat Biotech.
The firm presented their proposal for grant of Emergency Use Authorization (EUA) of Whole Virion, Inactivated Coronavirus Vaccine (BBV152) along with the interim safety and immunogenicity data of Phase I and II clinical trials carried out in the country before the committee.
“After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration,” officials said.
On the other hand, Pfizer has asked for more time for making presentations before the committee.