New Delhi [India], January 4 (ANI): In its permission to Serum Institute of India for "manufacture for sale or distribution" of COVID-19 vaccine 'Covishield', the DGCI has said that the second dose should be administered between four to six weeks after the first dose and also noted that there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies.
The permission document also states that the firm should ensure that "factsheet for the vaccine recipient or attendant is provided prior to administration of vaccine".
It said the vaccine is for the active immunisation of the individuals above 18 years of age for the prevention of the coronavirus disease when administered in two doses schedule.
"The second dose should be administered between 4 to 6 weeks after the first dose. However there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies," the permission document said.
Specifying the "shelf life with storage condition", the order said it is "six months when stored at 2 to 8 degrees Celsius".
"Once opened, the multi-dose vials should be used as soon as possible and within six hours when kept between 2 to 8 degrees Celsius," it said.
The permission, which was signed on Sunday by Drug Controller General India VG Somani, said that the "permission is for restricted use in emergency situation for COVID-19 subject to various regulatory provisions".
"Vaccine to be supplied for immunization programme. The vaccine should be supplied along with factsheet for recipients and prescribing information/package insert (PI)".
It also said that the firm should should "disseminate the instructions and educational material including factsheet,PI, SmPC (Summary of Product Characteristics) and storage instructions etc through their website prior marketing/supplies of the product".
The document said the firm should submit safety, efficacy, and immunogenicity data from the ongoing clinical trials for every fifteen days up to two months and every month thereafter till the completion of the trial.
The DCGI had on Sunday said that Covishield, the COVID-19 vaccine being manufactured by Serum Institute of India, and Bharat Biotech's Covaxin have been granted permission for restricted use in an emergency situation. (ANI)