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JAKARTA – With the slow development of its own phase three clinical trial of a Covid-19 vaccine candidate, Indonesia said it requested data from Brazil, where a similar trial is progressing smoothly.
It expects to receive the CoronaVac safety and efficacy data from Chinese company Sinovac Biotech by December 28, and hopes to finally start implementing its vaccination program in January.
The phase three clinical trial is the final stage that a vaccine candidate must pass before the regulatory agency gives it the go-ahead for use in the relevant country.
BPOM, the Indonesian equivalent of the US Food and Drug Administration, requested the data through its Foreign Ministry, which then contacted Brazil’s National Sanitary Surveillance Agency and Sinovac, a government official said, who spoke on condition of anonymity.
“Within days after receiving the data, BPOM can issue its authorization for the emergency use of the vaccine, when a comprehensive evaluation is conducted,” the official told The Straits Times.
Brazil carried out a strict clinical trial at Sinovac’s CoronaVac and started the trial before Indonesia, the official added.
Dr. Penny K. Lukito, Director of BPOM, has said that she is always ready to adjust to the choice of a vaccine as long as it has gone through the proper trials.
“Clinical trials do not have to be conducted in Indonesia. Data from the country the vaccines originate from can be used as the basis for BPOM to evaluate and decide on approval for emergency use,” he said Nov. 26.
Indonesia has so far secured commitments to ship 189 million doses of vaccines from China-based Sinovac, Novavax and Covax, an international Covid-19 vaccine allocation platform co-led by the World Health Organization.
Brazil, Indonesia, Singapore and Turkey are among the countries that are expected to use CoronaVac as part of their vaccination program.
Indonesia, the most populous country in Southeast Asia, plans to vaccinate 107.2 million people between the ages of 18 and 59, out of a population of 270 million. Those with existing or considered unfit medical conditions will not be included in the program.
You have also reserved a 15% reserve for your vaccine reservation. With two doses each, he would need 247 million doses in his reserve for next year.
Indonesia had planned to start its vaccination program in November, but had to be delayed as a poorly organized phase three clinical trial of CoronaVac has so far failed to collect the data necessary for the vaccine to be approved.
State pharmacist Bio Farma and the University of Padjadjaran in West Java, which began conducting the trial in August, have not been able to conduct an interim analysis, a prerequisite before the independent food and drug agency BPOM can review the vaccine for your approval. for emergency use.
With only 1,600 volunteers in the trial and the lack of people to represent risk groups, such as medical workers, there is less chance that the required number of volunteers will be exposed to infections.
To test the efficacy of the candidate vaccine in the university’s clinical trial, a minimum of 1.5 percent of the 1,600 volunteers must have contracted the virus and then be monitored.
Brazil recruited more than 9,000 volunteers, and recruited a large number of volunteer medical workers, into its clinical trial candidate for the Sinovac vaccine and was thus able to make better progress.
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