Interim results of the phase 3 clinical trial of the Sinovac vaccine, which only causes pain and minor aches

BANDUNG, KOMPAS.com – Kusnandi Rusmil, head of the Covid-19 vaccine clinical trial research team at the University of Padjajaran (Unpad), presented the preliminary results of the Covis-19 vaccine clinical trial in Sinovac, China.

Until the end of December 2020, the only side effects caused were local reactions.

“So far, the side effects that have emerged are local reactions. Like injection site pain with most of the light intensity. Then muscle pain, most are also mild,” he said, on Wednesday (30 / 12/2020).

Kusnandi explained that the vaccine injection in volunteers was completed on November 6, 2020. After that, all subjects were monitored, especially for the effects of the injection.

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Currently, antibody tests are performed using the neutralization method. His report will be sent to BPOM in early January 2021. However, he did not explain the exact date of presentation of the results to BPOM.

Meanwhile, the director of the Food and Drug Supervision Agency (BPOM), Peni Kusumastuti Lukito, said that the safety and efficacy aspects of the Covid-19 Sinovac vaccine, China, would be obtained from the results of the trials. clinical trials conducted in Bandung.

Simultaneously, clinical trials were also underway in Brazil, Turkey and Chile. By the results, Brazil and Turkey already exist.

“We continue to coordinate with these countries,” he said.

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There are no serious side effects.

So far it has been reported that there have been no serious side effects from the vaccine. The safety aspects are consistent with phases 1 and 2.

Researchers are currently completing data analysis for the aspect of increasing antibody levels. So far, the data has shown good results, thus increasing self-confidence.

Bio Farma’s head of corporate communication, Iwan Setiawan, said that the Covid-19 vaccine from Sinovac, China, began to be distributed in 34 provinces as of January 3, 2021.

“It will be distributed gradually,” he concluded.