BPOM to Ensure COVID-19 Vaccine’s Safety, Effectiveness before It is Distributed
Date 8 Desember 2020
In order to ensure the safety and effectiveness of potential COVID-19 vaccine, the Indonesian Food and Drug Monitoring Agency (BPOM) still observes clinical trial phase 3 of the vaccine.
“Currently, we are observing and monitoring the process to ensure the safety aspect, particularly the effectiveness. Therefore, the BPOM will issue Emergency Use Authorization (EUA) for the vaccine. The EUA can be granted if the vaccine demonstrates at least 50 percent of efficacy, while on normal condition the vaccine must demonstrate 70 percent of efficacy,” Head of the BPOM Penny Lukito said on Monday (7/12).
The BPOM, she said, will follow international standard set by the World Health Organization (WHO) and refer to the regulations set by the Food and Drug Administration (FDA) in the process to issue the EUA.
For the record, the BPOM has issued EUA to several medicines for the treatment of COVID-19, namely favipiravir for patients with light and moderate symptoms, and remdesivir for patients with severe condition.
In addition, the Agency along with the Indonesian Ulema Council (MUI), and Ministry of Health has inspected the vaccine manufacturer in China to ensure that the vaccine to be distributed in Indonesia is halal.
“(The vaccine) has met the quality aspect, there is no critical side effect. However, we are still waiting for the result of effectiveness and efficacy trials,” she added.
During clinical trial, the scientists took blood sample from the volunteers and analyzed the sample at a laboratory to test the effect on human antibody. Standards must also be met to ensure the effectiveness of vaccine in preventing virus infection.
Penny asserted that the Government only provides vaccine that meets the quality, efficacy, and safety aspects. For that reason, the BPOM needs time to analyze the vaccine by involving experts and virology specialists before issuing the EUA.
In the meantime, spokesperson of the Government for COVID-19 affairs Reisa Broto Asmoro, told the public to remain patience. While waiting the vaccine cleared for use, she said, the public must still be disciplined in following the health protocols, such as wearing face mask, maintaining a safe distance, and washing hands frequently. (COVID-19 Handling and National Economic Recovery Committee Communication Team/UN) (RAS/MMB)