DCGI gives nod for conducting a study on mixing Covaxin & Covishield
A study on mixing Covishield and Covaxin has been given the go-ahead by the Drugs Controller General Of India (DCGI)
A study on mixing Covishield and Covaxin has been given the go-ahead by the Drugs Controller General Of India (DCGI).
The study and its clinical trials will be conducted by Vellore's Christian Medical College.
"Permission has been granted for a research study by CMC Vellore (Tamil Nadu) on mixing of vaccines doses," Dr VK Paul, NITI Aayog Member (Health), said during a press briefing on Tuesday.
A Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended conducting the study on July 29.
The trial will involve 300 healthy volunteers.
"The aim of the study is to assess the feasibility on whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the inoculation course," a source said.
The study by CMC Vellore will be different from the one by the Indian Council of Medical Research (ICMR). ICMR study said mixing the two Covid vaccines elicited better safety and immunogenicity results.
The mixing of doses had raised considerable anxiety.
The study conducted on people in the northern state of Uttar Pradesh in India received Covishield as the first dose followed by inadvertent administration of Covaxin as the second dose at an interval of six weeks.
The ICMR said the study suggested immunization with a combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine was not only safe but also elicited better immunogenicity.