MOSCOW (Pakistan Point News / Sputnik - 19th July, 2020) Chinese pharmaceutical giant Sinovac, which is due to start the first part of Phase 3 trials of the potential COVID-19 vaccine candidate in Brazil on Monday, said in a statement emailed to Sputnik that it plans more Phase 3 trials of the vaccine, which will soon be announced.
In June, Joao Doria, the governor of Brazil's most populous state Sao Paulo, announced that Instituto Butantan, the main producer of immunobiological products and vaccines in the country, signed a contract on the production of the vaccine with Sinovac. The trials were approved by the Brazilian health regulator Anvisa. Earlier in July, Doria and Instituto Butantan confirmed that the trials of the vaccine are scheduled to start on July 20.
"Sinovac will conduct the first of Phase III Trials in twelve clinical sites located in several states in Brazil. There are not enough active cases of Covid 19 to conduct the research in China. We plan more Phase III trials, which will be announced soon," Sinovac said.
According to the Beijing-based company, the first part of Phase 3 trials of the vaccine will involve 9,000 volunteers recruited among health care professionals.
Brazil, where the number of COVID-19 cases has surpassed two million, is the second worst-hit country after the United States. Currently, the Latin American nation is one of the appealing grounds for testing the vaccine candidate as it has a rapid rate of transmission and, at the same time, reliable and internationally recognized research facilities.
"Sinovac chooses to conduct the trials in Brazil, among other countries, because we have the strong research partner. Instituto Butantan has the excellent scientific reputation and knowledge base and is the main producer of immunobiological products and vaccines in the country," Sinovac said, adding that Anvisa also granted approval to conduct the study fast.
The company eyes an ambitious total capacity of 100 million dosages per year. Yet commercial production will be only possible after the completion of Phase 3 clinical trials.
"All people in our organization do everything possible to bring the new vaccine to the market as fast as possible. At the same time, we want to conduct all stages of the development process with the highest possible quality, so the regulatory agencies and consumers all over the world should know that our product safe and effective," the spokesman said.
The race intensifies for nations around the globe to develop an effective vaccine against the coronavirus, which has already infected over 14 million people and killed over 600,000. Sinovac, which has a nearly 20-year history, is one of many biotech and pharmaceutical companies that are working around the clock, conducting clinical trials to find a vaccine that can challenge the current pandemic.
Sinovac, which is the first company in the world to market the H1N1 vaccine, initiated the development of the COVID-19 vaccine dubbed CoronaVac in late January. Phase 1 and Phase 2 of the trials on healthy volunteers aged 18-59 started in Jiangsu Province of China back in April. The company says that Phase 2 study on elderly adults is currently being conducted and will be followed by the child and adolescent groups.
WHO's COVID-19 register currently includes 23 candidate vaccines that have already launched trials on humans and another 140 that are at the stage of preclinical evaluation.
The WHO protocols say that a vaccine has to go through three phases of studies to be approved for large-scale production. Phase 1 normally involves small-scale studies on up to 100 participants to determine a candidate vaccine's safety and clinical tolerance, while Phase 2 includes a larger number of participants, up to 1,000 and more representative with regard to age, ethnicity and other statistically significant factors. This phase pursues to the optimal dose, intervals between doses and the minimum necessary number of doses of a candidate vaccine in a target population.
Phase 3 trials are the largest and can include up to 10,000 participants with the maximum representation of target population categories. A candidate vaccine is ready to move into industrial production if this last phase provides clear and definitive evidence of its safety and efficacy.
