IPB University is Ready to Help Preclinical Testing of the Merah Putih COVID-19 Vaccine
One of the precautionary measures to prevent the COVID-19 pandemic can be the development and use of safe and effective vaccines. After nearly eleven months of the pandemic period (since March 2020), Indonesia uses the Sinovac vaccine originating from China for application. Smoke imports vaccines from China, currently Indonesia is also developing a domestic COVID-19 vaccine (the Merah Putih vaccine).
It is hoped that the development of the Merah Putih vaccine can become a mainstay of the Indonesian government to tackle COVID-19.
In general, the vaccines used by the public must be guaranteed safety, efficacy, and quality. This guarantee can be done through preclinical and clinical trials. Preclinical testing is carried out using experimental animals. This is an important step in vaccine development before clinical trials in humans are carried out.
The Food and Drug Administration (FDA) and the Indonesian Food and Drug Administration (BPOM) require preclinical testing as a source of guaranteeing the safety and efficacy of new drugs.
Preclinical testing can be used as an initial test to ensure the response to vaccine administration, whether acute, subchronic, chronic, teratogenicity, pharmacodynamic, and bio-distribution using experimental animals. The experimental animals commonly used for preclinical testing consist of non-primates (mice, rats, rabbits) and non-human primates (rhesus monkeys).
"IPB University is a university that is competent, independent, and accredited, and has the ability, facilities, and adequate infrastructure in the medical and health fields including various preclinical testing of drugs, both veterinary and human drugs, including vaccines. IPB University has experience in conducting various clinical trials on veterinary and human drugs for both registration and product development purposes, "said the Dean of the Faculty of Veterinary Medicine (FKH) IPB University, Prof. Dr. Deni Noviana, Ph.D., DAiCVIM.
According to him, preclinical testing of the COVID-19 Red and White vaccine that can be carried out by IPB University consists of three main activities. Namely preclinical in vitro (immune response testing), in vivo (acute, subchronic, chronic toxicity testing, teratogenicity, pharmacodynamics, and biodistribution) in mice, as well as testing for immunogenicity and adverse effects on non-human primates.
FKH and Primate Animal Study Center (PSSP), Institute for Research and Community Service (LPPM) IPB University have complete facilities and are supported by superior human resources (HR) and experts in the field of drug testing, including preclinical testing.
FKH and PSSP's areas of expertise in preclinical testing include Pharmacology and Toxicology, Medical Microbiology (Immunology and Virology), Pathology, and other fields related to drug testers. FKH and PSSP also have adequate infrastructure, including the Laboratory Animal Management Unit (UPHL), Animal Biosafety Level 3 (ABSL-3) standardized experimental animal facilities, Educational and Service Laboratories with BSL-3 facilities, Educational Animal Hospital (RSHP). ) and divisions related to preclinical testing (Pharmacology, Toxicology, Medical Microbiology (MHM), Pathology, Immunology, and others).
"Everyone is ready to play a role in helping the Indonesian government's preclinical testing of the Red and White COVID-19 vaccine," he said. (** / Zul)
Published Date : 23-Feb-2021
Resource Person : Prof drh Deni Noviana, PhD, DAiCVIM
Keyword : Red and White Vaccine, IPB University, FKH, COVID-19