Islamabad : The Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) is the first public sector university in Islamabad to become a DRAP-approved site for Phase III clinical trials of COVID-19 vaccine. SZABMU-PIMS is now becoming part of a multicentre phase III study for COVID-19 vaccine ZF2001. These trials have been approved by National Bioethics Committee (NBC) Pakistan and Drug Regulatory Authority of Pakistan (DRAP).
Prof. Dr. Tanwir Khaliq, Vice Chancellor of SZAMBU, expressed these views during a briefing given to Secretary Health Aamir Ashraf Khwaja when he visited the university here on Friday.
As of December 2020, ZF2001 was in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan and Uzbekistan. These trials are also being conducted in many cities including Islamabad, Lahore, Faisalabad, Karachi for recruiting 10,000 volunteers in Pakistan. ZF2001 has been approved for marketing in Uzbekistan and China and its production capacity is expected to be one billion doses a year.
Those who participate in the trial will have several benefits such as free of cost PCR and antibody tests of volunteers during screening for assessing active or previous COVID-19 exposure; provision of inconvenience allowance of Rs16,000 periodically; insurance of volunteers by the company for any adverse effects occurring due to the vaccine; and administration of free of cost vaccine will be administered to the placebo control group after the end of trials.
ZF2001 is halal and can be administered in during fasting hours in Ramadan as well.
Screening of volunteers for vaccine administration has been initiated at the clinical assessment unit, Controller examination building, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS hospital, G-8/3, Islamabad. In order to fight against COVID-19 become a volunteer, participate in ZF2001 Phase III trials for making this pandemic a history.
Due to the global pandemic, medical researchers all over the world are rushing into the research and development of vaccines. ZF2001 vaccine is co-developed by the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS) and Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. It is a protein subunit based vaccine targeting different variants of COVID-19 as well. It is expected to prevent respiratory diseases caused by novel Coronavirus with an efficacy of 92 to 97% when administered in 3 doses over a period of 2 months, the Secretary was briefed.
As of today, no serious adverse events directly related to the vaccine occurred in the phase I/II clinical trials. The results have proved that the vaccine is well tolerated, safe and immunogenic, supporting the next stage of clinical trials. These attributes of ZF2001 greatly enhance confidence in the final victory over COVID-19, and also provide strong support for the feasibility of global use.