Two COVID-19 vaccines have been granted Emergency Use Authorization (EUA) in

Pakistan.

Drug Regulatory Authority of Pakistan (DRAP) has granted EUA to two COVID-19 vaccines.
These registrations are an emergency use authorization (EUA) with certain conditions. Two
different vaccines of COVID-19 with following particulars have been approved:

i. Adeno virus COVID-19 vaccine by the name of CoviShield manufactured by Serum

Institute of India and imported by M/s Sind Medical Store, Karachi for active
immunization

ii. Inactivated SARS COV-2 vaccine (SinoPharm-BIBP) manufactured by M/s Beijing

Institute of Biological Products, Beijing China and imported by M/s National Institute
of Health, Islamabad for active immunization

Importers of the above-mentioned vaccines will be responsible for supply of vaccines in

Pakistan. It is the responsibility of the importers along with their manufacturers to comply the
conditions for manufacturing of vaccine and product release. This authorization shall be
reviewed on quarterly basis keeping in view safety, efficacy and quality data of product.

The EUA holders are responsible to ensure strict compliance of Cold Chain (2°C-8°C) during
transportation, storage and distribution cycle. The importers will maintain complete records of
distribution of vaccine.

Furthermore, EUA holders will submit Adverse Events Following Immunization (AEFI) to
National Pharmacovigilance Center at DRAP. Product can be recalled in case of any quality
issues or adverse reports regarding safety/ efficacy or as decided by registration Board.