DRAP grants Emergency Use Authorization to AGP Ltd for Gam-COVID-Vac

February 02, 2021 (MLN): AGP Limited has informed via notification to PSX that the Drug Regulatory Authority of Pakistan (DRAP), on February 01, 2021, has granted Emergency Use Authorization (EUA) for "Gam-COVID-Vac" combined vector vaccine to prevent coronavirus infection caused by SARS-CoV-2 virus (Sputnik V or the Vaccine) to the Company.

The Company has also been authorized to import and introduce the Vaccine in Pakistan and is now making efforts to ensure the availability of sufficient supplies 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 Center of Epidemiology and Microbiology, Russia, one of the world's leading research institutions. This Vaccine has been approved by fifteen (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 Ill trials of 21,862 volunteers, the efficacy of Sputnik V has been determined at 91.6%, with 100% efficacy against severe cases of COVID-19. The Vaccine has a good safety profile and in particular, there are no strong allergies caused by the Vaccine. This is by far, the most effective COVID-19 vaccine to have received EUA in Pakistan and can be administered to persons aged 18 and above, including persons aged above 60.

‘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 notice said.

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