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Jakarta, CNN Indonesia –
PT Bio Pharma (Persero) clarified the results of clinical trials on the efficacy of the finished vaccine COVID-19 from a biotech company Sinovac, China.
Bio Farma’s corporate secretary, Bambang Heriyanto, denied that 97 percent of the efficacy test results have been published as reported by various outlets.
This is because the vaccine just landed in Indonesia on Sunday (12/6) and is currently undergoing clinical trials by Bio Farma’s clinical trial team.
“So far there have been no publications related to the efficacy or results of clinical trials. Efficacy or inhomogeneity, so the clinical team has not conveyed the effectiveness of this because later the results of this clinical trial will be reported by the covid-19 vaccine clinical trial team to BPOM, “he told BPOM. CNNIndonesia.com, Tuesday (8/12).
He said the interim data was scheduled to be sent to BPOM in January for a schedule of vaccine use in an emergency (use of emergency authorization).
Under normal circumstances, a new permit can be granted in the final stages of a clinical trial, which usually takes up to 6 months. However, following WHO rules, the BPOM may allow its use in “flash” clinical trials.
[Gambas:Video CNN]“This interim report is a clinical trial full reportaround june. But due to the emergency, this plan is in the name of WHO. emergency use authorization Therefore, only half of clinical trials can submit interim reports to regulators, “he explained.
For information, the government received 1.2 million doses of China’s corona vaccine this week. According to the plan, they will receive 1.8 million doses again this month.
With a total of 3 million doses of this vaccine, after obtaining permission to use BPOM, the vaccine will be assigned to medical personnel.
The distribution scheme will be presented to the Ministry of Health through the Vaccine Program.
“The vaccination scheme is carried out by the Ministry of Health, who are the recipients? The first can be given to health workers because this is an emergency. But still the 3 million are waiting for the results of the clinical trial in January when the BPOM permit is issued, “he concluded.
(well / eight)
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