The SARS CoV-2 vaccine CoronaVac, developed by Chinese company Sinovac Biotech Ltd., was recently granted approval by the Food and Drug Administration of the Philippines (FDA) and the Department of Health’s Single Joint Research Ethics Board (SJREB) to conduct clinical trials in the Philippines. Sponsored by local firm IP Biotech, Inc., 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 of CoronaVac in the Philippines as part of their 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.
CoronaVac can be stored in standard refrigerator temperatures (2-8 degrees Celsius), compared to mRNA vaccines that require temperatures ranging from -20C and -70C. IP Biotech Commercial Director Carlos Garrucho added, “Apart from the fact that CoronaVac uses a time-tested and medically-proven approach to vaccination, it’s cold storage temperature requirement makes it ideal for tropical countries like the Philippines.”
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.
In comparison, other COVID-19 vaccines being tested globally are classified as “mRNA vaccines” and require a new procedure wherein part of the SARS CoV-2 genetic code is injected into the body, triggering the production of enough viral proteins to train the immune system against attacks. “The technology used to create mRNA vaccines is very new, as the COVID-19 vaccines are the first mRNA vaccines in the world to be rolled out to the public,” stated Dr. Noel Miranda, former ASEAN Regional Coordinator for Multi-Sectoral Pandemic Preparedness and Response, and a member of the scientific team of IP Biotech, Inc. “mRNA vaccines require a hardy immune system and no pre-existing comorbidities such as hypertension or diabetes, making them potentially difficult for the elderly or many adults in the Philippines to take safely.”
While Sinovac successfully conducted a global multi-country phase 3 trial, Sinovac will be pursuing a localized trial as a higher level of long-term commitment to the Philippines.
“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,” stated Miranda. “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 concluded.