Local firm IP Biotech Inc. is confident the clinical trials will confirm the safety and more than satisfactory results of the SARS CoV-2 vaccine CoronaVac, developed by Chinese company Sinovac Biotech Ltd.
While Sinovac successfully conducted a global multi-country phase 3 trial, it will be pursuing a localized trial as a higher level of long-term commitment to the Philippines.
CoronaVac was recently granted approval by the Food and Drug Administration of the Philippines and the Department of Health’s Single Joint Research Ethics Board to conduct clinical trials in the Philippines.
Sponsored by IP Biotec, the study will be a randomized, double-blind, placebo-controlled clinical trial, starting within the first quarter of 2021.
As the local sponsor of CoronaVac trials, IP Biotech has agreed to finance the trial as part of its ongoing commitment to help the Philippines combat COVID-19.
The FDA-approved detailed trial protocol adhering to strict ethical and safety standards will be used to ensure accurate and unbiased results.
Based on the approved parameters of the trial, the sample population are all senior citizens between 60 and 80 years old. The principal investigators who will oversee the study are Dr. Lulu Bravo, Dr. Jacqueline Dominguez, and Dr. Maria Rosario Capending.
"We are confident that the Philippine CoronaVac will pass these clinical trials and confirm the exceptional safety of Sinovac’s COVID-19 vaccines with more than satisfactory results,” said Dr. Noel Miranda, former ASEAN Regional Coordinator for Multi-Sectoral Pandemic Preparedness and Response and a member of the scientific team of IP Biotech.
“Finally, with the Philippine clinical trials, we will be able to generate data that will help facilitate emergency public health decisions. The health and welfare of our families are at stake if we make misinformed and unfounded decisions during this crucial moment in history. We must rely on accurate, well-evaluated, and credible results to make important decisions about our health and the health of our loved ones," he added.
CoronaVac is classified as an "inactivated vaccine" – also known as a "traditional vaccine"—which uses deceased viral particles to expose the body's immune system to the virus without risking a serious disease response.
Inactivated vaccines for various diseases have been administered to millions of people globally, from infants to the elderly such as the Hepatitis A vaccine, the polio shot, the flu shot, or the rabies vaccine.
CoronaVac can also be stored in standard refrigerator temperatures (2-8 degrees Celsius), compared to mRNA vaccines that require temperatures ranging from -20C and -70C.
“Apart from the fact that CoronaVac uses a time-tested and medically-proven approach to vaccination, its cold storage temperature requirement makes it ideal for tropical countries like the Philippines," IP Biotech Commercial Director Carlos Garrucho said.