ISLAMABAD, May 03 (NNI): The clinical trial on the coronavirus vaccine is in progress at Maroof International Hospital (MIH) in the wake of a prevailing surge in the COVID-19 pandemic.
According to a hospital spokesperson, the Clinical Trial Unit of MIH is conducting the trial involving a covid-19 vaccine LVRNA021 (mRNA-based) booster dose targeting the Delta BA.5 strain as well as Omicron variant B.1.1.529.
He said that Maroof International Hospital is part of a multicenter phase III study for the COVID-19 booster vaccine LVRNA021. The trial has been approved by the National Bioethics Committee (NBC) Pakistan and the Drug Regulatory Authority of Pakistan (DRAP).
He said that the LVRNA021 vaccine is co-developed by AIM Vaccine Co., Ltd., Ningbo Rongan Biological Pharmaceutical Co., Ltd LiveRNA Therapeutics Inc. It is an mRNA-based vaccine targeting different variants of COVID-19 encoding the SARS-CoV-2 S protein of the Delta and Omicron BA.5 strain (Delta:BA.5=1:3) as well.
The phase 1 and phase 2 Investigator Initiated Trials (IIT) of the SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) have been completed and the study results demonstrated a favorable safety profile. The results have proved that the vaccine is well tolerated, safe, and immunogenic, supporting the next stage of clinical trials, he added.
These trials are also being conducted at seven different sites in many cities including Islamabad, Lahore, Peshawar, and Karachi for recruiting volunteers in Pakistan.
The trial participants are selected after necessary blood tests and after meeting the eligibility criteria mentioned in the trial protocol and standard operating procedures as approved by DRAP, NBC, and the Maroof ethics committee.
Screening of volunteers for vaccine administration has been initiated at the Maroof clinical trial unit which is run by foreign-qualified researchers. The trial is going on and will continue for 14 months to check the safety and effectiveness of this vaccine.
Due to emerging new variants of COVID-19, researchers all over the world are developing new vaccines to cater to and decrease the transmission of new variants. NNI
