An effective vaccine against SARS-CoV-2 will save countless lives in Bangladesh and around the world. If the Phase III trial of the Sinovac vaccine in Bangladesh demonstrates the vaccine to be safe and protective, Sinovac has agreed to provide over 110,000 free vaccine doses for the nation.

And more importantly, Sinovac has committed to transfer the technology for production of the vaccine, as well as bulk vaccine, to a qualified Bangladeshi producer at a discounted price to meet the needs of the larger population of Bangladesh.

Planned Phase III trial

Based on the very promising results of preclinical studies in animals and human studies in Chinese adults for the Sinovac SARS-CoV-2 vaccine, Sinovac now plans to conduct Phase III, individually randomised, double-blind, placebo-controlled trials in order to determine the safety and efficacy of the vaccine against human SARS-CoV-2 disease when tested in adults in Brazil, Saudi Arabia, Turkey, Chile, Indonesia and Bangladesh.

The trials in Brazil have already commenced. Already Phase 3 trials for Sinovac's CoronaVac began last week in Indonesia involving 1,620 volunteers. These trials have been designed to ensure that results will meet the highest regulatory standards for vaccine licensure. It is critical that these trials be conducted in multiple countries and differing populations as the epidemiology of SARS-CoV-2 differs from population to population, and different human populations may respond differently to any given vaccine.

In Bangladesh, the plan to enrol 4,200 literate healthcare workers (doctors, nurses, ward attendants) who have not yet been infected by SARS-CoV-2, from seven hospitals in metropolitan Dhaka that are caring for SARS-CoV-2 patients.

Participants will be randomised at a 1:1 ratio to receive two doses of either the Sinovac vaccine or a placebo via intramuscular injection. Intensive follow-up of all participants will be conducted to detect adverse reactions to the vaccine as well as SARS-CoV-2 disease.

Appropriate management will be provided for all illnesses of the participants. Although all participants will be followed in this manner for a year after dosing—to make sure that the vaccine is safe and does not cause immunological enhancement of SARS-CoV-2 disease— expected that enough SARS-CoV-2 cases will have occurred within six months of dosing to draw conclusions about the ability of the vaccine to protect against SARS-CoV-2 disease.

Importantly, all of these data have been carefully reviewed by the Ethical and Research review committees at the icddr,b and by the Bangladesh Medical Research Council, and have been submitted for review to the Directorate General of Drug Administration (DGDA) of Bangladesh. Moreover, approval for human trials of the Sinovac vaccine has been obtained after review of all preclinical and clinical data by the WHO-approved Brazilian National Regulatory Authority.

The statement has been jointly given by Prof John D Clemens, MD Executive Director, icddr,b, Prof Jan Holmgren, MD, PhD, University of Goteborg, Sweden, Dr K Zaman, MBBS, MPH, PhD, Senior Scientist, icddr,b, Dr Firdausi Qadri, PhD, Senior Scientist, icddr,b, and Prof Allen Ross, MD, PhD, Senior Director, Infectious Diseases Division, icddr,b.

Source: https://www.thedailystar.net/opinion/news/sinovacs-covid-19-vaccine-shows-great-promise-1948749