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Jakarta, CNN Indonesia –
Corona vaccine development results Bio Pharma with Sinovac has entered the follow-up period.
Data as of November 6, 2020 show that 1,620 volunteers have received the first injection, 1,603 have received the second injection, and 1,335 have entered the follow-up stage.
For the follow-up stage it will be checked immunogenicity, efficacy (efficacy) and safety. In its official statement, Bio Farma revealed that there have been no reports of serious Post-Immunization Follow-up incidents (AEFI) or serious unwanted events (Serious adverse event /SAE).
“Each volunteer who has received the first and second injections, until the clinical trial is completed, will be supervised and monitored by the clinical trial team, so that everything that happens to the volunteers must be monitored,” said the Dr. oficial, Wednesday (11/11).
The Bio Farma Novilia Pharmacovigilan team revealed that SAE experienced by a person can occur both for vaccines that have been marketed, and for vaccines that are currently in the clinical trial stage such as the covid-19 vaccine.
“For products that are as in-depth as clinical trials, SAE will report to the Ethics Committee, BPOM and DSMB (Data Security Monitoring Board). Meanwhile, for products that have been commercialized, research or investigations will be conducted, and they will be analyzed by independent institutions such as KOMNAS KIPI, and BPOM will be informed. Report to know if the main cause of this event is directly related to the vaccine (associated with the vaccine), or are there other factors (coincident) “, said Novilia.
He added that for the SAE incident currently occurring in Brazil, further investigations are needed to determine if this SAE was related to vaccines or not (coincident).
In this SAE investigation, the local Drug Enforcement Agency will certainly be involved. Pausing or postponing the implementation of clinical trials of drugs or vaccines is a standard procedure and is commonly used to conduct previous investigations of serious AEFI found in investigations.
Regarding the SAE case for the Covid-19 Sinovac vaccine in Brazil, there has been an official statement from Sinovac, where the company contacted the Butantan Institute and stated that the SAE incident was not found related to the vaccine (coincident).
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