The third phase of clinical trials for the Covid-19 vaccine produced by Sinovac in China has begun. This is an important step in the effort to overcome the disease caused by the SARS-CoV-2 virus.
By
KOMPAS TEAM
·5 minutes read
AFP/AZWAR IIPANK
This handout photo taken and released on August 11, 2020 by Presidential palace shows President Joko Widodo (C) visiting the Bio Farma Pharmacy that produce vaccines for COVID-19 coronavirus in Bandung, West Java. - Indonesia on August 11, 2020 launched human trials of a Chinese-made coronavirus vaccine with some 1,600 volunteers slated to take part in the six-month study.
BANDUNG, KOMPAS — The third phase of clinical trials for the Covid-19 vaccine produced by Sinovac, a pharmaceutical company from China, began in Bandung, West Java, on Tuesday (11/8/2020). Even though this gives new hope for stopping the transmission of the SARS-CoV-2 virus, efforts to control the Covid-19 pandemic must continue at this time. We cannot just wait for a vaccine to become available.
President Joko “Jokowi” Widodo witnessed the injection of the vaccine. The President expressed hope that the production of the Covid-19 vaccine will start in January. This hope is based on the development of the vaccine that has entered the third phase of the clinical trial.
"We hope that we can produce in January. If production is ready, the public will receive the vaccination," the President said in a press release of the Presidential Secretariat.
The President had a close look at the implementation of the third stage of the clinical trial of the Covid-19 vaccine at the School of Medicine, Padjadjaran University (Unpad), Bandung, yesterday. He was accompanied by the chief executive of the Committee for Mitigating Covid-19 and National Economic Recovery, Erick Thohir, Health Minister Terawan Agus Putranto, West Java Governor Ridwan Kamil and the president director of state-owned Bio Farma, Honesti Basyir, among other people.
We hope that we can produce in January.
A total of 1,620 volunteers were included in the third phase of the clinical trial, which involved PT Bio Farma, the School of Medicine of Unpad, the Food and Drug Administration (BPOM) and the Health Research and Development Agency. The first vaccine injection at the Unpad Education Hospital was attended by 19 volunteers.
The volunteers passed tests for immunogeneity (immune system response) and efficacy (response against viruses). The majority of volunteers are residents of Bandung, because their health condition has to be monitored for six months.
According to the head of the Covid-19 vaccine clinical trial research team at Unpad’s School of Medicine, Kusnandi Rusmil, more than 1,200 people registered as volunteers. The registration is still open until 31 August.
A member of the research team for the Covid-19 vaccine clinical trial runs a series of health checks to screen a volunteer on Thursday (6/8/2020) at the School of Medicine, Padjadjaran University (Unpad) in the city of Bandung, West Java. The clinical trial of the candidate vaccine produced by Sinovac, China, began on Tuesday (11/8/2020) at six locations: the Unpad Education Hospital, the Unpad Health Center and four puskesmas (community health centers) in the city.
After having their health checked, volunteers underwent blood sampling and injections of the Covid-19 vaccine or placebo twice in an interval of 14 days. Phase-three clinical trials of the vaccine are also being carried out in other countries, including Brazil and India.
According to BPOM head Penny K Lukito, collaboration among parties is needed in finding the Covid-19 vaccine. If the clinical trial is completed, her office will be able to issue a permit for the use of the vaccine, but this requires a guarantee of safety, quality and efficacy.
President director of Bio Farma Honesti Basyir explained that the government was aiming to give 160 million people access to the Covid-19 vaccine. His company will prepare 320 million doses of the vaccine because each person will get two doses. "In December, we will be ready to produce 250 million doses per year," he said.
So far, more than 100 potential Covid-19 vaccines have been developed worldwide. Of these, four have entered the third phase of clinical trials, including CoronaVac, which is developed by Sinovac.
Russian President Vladimir Putin said Russia was the first country to approve a distribution permit for a Covid-19 vaccine after clinical trials of less than two months. That paved the way for the vaccination of all Russian citizens, although the final stage of the clinical trials to test its safety and efficacy is ongoing.
However, some have raised concerns that Moscow is prioritizing national dignity over scientific evidence. Food and drug licensing agencies around the world emphasize that the desire to quickly have a Covid-19 vaccine must not sacrifice safety aspects.
A volunteer holds up his queue number for the COVID-19 vaccine clinical trial after taking a health screening on Tuesday (11/8/2020) at the Dago Health Center in Bandung, West Java. The phase III clinical trial for the COVID-19 candidate vaccine, which involves at least 1,620 volunteers, began with a series of health checks and swab tests, followed by vaccine injections
Steps before production
"The third stage of the clinical trial is the final step to find any side effects and assess the efficacy of a vaccine before it can be produced and given to the public. We hope that the tested Sinovac vaccine will be successful," said the head of the Eijkman Institute for Molecular Biology, Amien Soebandrio.
Vaccination aims to create herd immunity. For Covid-19, at least 70 percent of the population must be vaccinated to break the chain of transmission.
The vaccine made by Sinovac, China, which is being clinically tested in Indonesia, is developed with the base material of the SARS-CoV-2 virus. Meanwhile, the vaccine developed by Eijkman uses the recombinant protein technology. The target is that the research results will reach the industry in February or March. "We are starting to develop an antigen. If successful, it will then be tested on animals," he said.
An epidemiologist from Griffith University in Australia, Dicky Budiman, said that, to overcome this pandemic, we cannot just wait for the availability of a vaccine. The government must also remain focused on efforts to control Covid-19 by increasing its tracking, testing and isolation capabilities. The community must change its behavior by maintaining a distance from each other and limiting mobility.
We hope that the tested Sinovac vaccine will be successful.
President Joko Widodo emphasized the importance of a local intervention strategy. Social restrictions are no longer enforced at the provincial or regency/city level but at the village and kampung level to make it easier to solve the problem.
According to the Covid-19 mitigation task force, the number of Covid-19 cases in Indonesia increased by 1,693 people on Tuesday, bringing the total to 128,776 cases. Of the total number of cases, 83,710 patients have recovered and 5,824 have died. Meanwhile, the first phase of clinical trials of the mesenchymal stem cell therapy will be conducted on Covid-19 patients in Indonesia. The test, which is a collaboration between the Health Ministry and Daewong Infion in South Korea, will be carried out on patients at Wahidin Sudirohusodo Hospital in Makassar. (REUTERS/ADH/ LAS/ HAR/ TAN/ RTG/ TAM/AIK)
/https%3A%2F%2Fkompas.id%2Fwp-content%2Fuploads%2F2020%2F08%2F20200806TAM05_1597073886.jpg){kind=logo}
