KARACHI: The Drug Regulatory Authority of Pakistan (DRAP) has authorised AGP Limited, a Pakistani pharmaceutical company, to import and introduce Russian coronavirus vaccine, Sputnik V, in the country.
In a notification to Pakistan Stock Exchange (PSX) on Tuesday, AGP Ltd said that DRAP has granted emergency use authorisation (EUA) for the vaccine to prevent coronavirus infection to the company.
The company has said that it is now making efforts to ensure the availability of sufficient supplies of the vaccine on an emergency basis in order to play a key role in supporting the government’s objective of vaccinating the masses.
The vaccine has been developed by the Gamaleya National Centre of Epidemiology and Microbiology, Russia, one of the world’s leading research institutions. This vaccine has been approved by 15 countries including Russia, Hungary, Argentina and the United Arab Emirates with registrations underway in several other countries.
“As per the Interim Clinical Study Report which is based on the Phase III trials of 21,862 volunteers the efficacy of Sputnik V has been determined at 91.6 per cent with 100 per cent efficacy against severe cases of Covid-19. The vaccine has a good safety profile and in particular, there is no strong allergy that is caused by the vaccine,” stated the pharma.
“This is by far the most effective Covid-19 vaccine to have received EUA in Pakistan and can be administered two persons aged 18 and above including persons aged above 60,” it added.
“We would like to extend our heartfelt gratitude to DRAP and the Ministry of National Health Services Regulations and Coordination, for their tireless efforts in ensuring registration of the Vaccine on a fast track basis,” the notification said.