The Pharmacy and poisons board says the Russian vaccine Sputnik V has been authorized for emergency use after evaluation.
The board says the approval doesn’t amount to registration saying the Ministry of Health has not yet decided to use Sputnik V Vaccine.
“The vaccine has only got emergency use authorization from the Pharmacy and Poisons Board; It is yet to be included in the National Vaccination Program,” The board said.
In a statement, the board has however given Sputnik V a clean bill of health saying, “In reviewing the Sputnik V we considered all aspects of quality, safety and efficacy. It is wholesomely safe.”
The Board says the first round of assessment on quality, efficacy and safety was initiated on 08th February 2021 (with rolling submission of data) and completed on 24th February 2021 and communication sent out the same day.
“The application was not successful and a second round of assessment following the applicant’s response to outstanding questions was completed on 5th March during which it met all requirements.”
The Government has not ordered a supply of the said virus, with the board clarifying that, “It’s the duty of the Ministry of Health as guided by the National Vaccine and immunization programme to determine what vaccine (s) to buy based on factors, such as, cost and cold chain considerations.”
“The only order placed through Gavi COVAX facility is the Covishield vaccine (AstraZeneca vaccine) manufactured by Serum Institutive of India that has already been delivered (on 2nd March 2021) and deployed (on 05th March 2021) for use within the country,” The board said.
Sputnik V is however available in the Country after a private entity imported the vaccine on a commercial basis.