Covid-19 Vaccination Plan: Badan POM Set to Ensure and Safeguard the safety, efficacy, and quality of Covid-19 vaccine

Prudent approach and usability are among the top priorities

Efforts are underway to provide the best efficacy for public at large

JAKARTA,Indonesia,Nov. 9,2020 -- In a bid to support the government's plan to develop Covid-19 vaccine in Indonesia,the National Drug and Food Monitoring Agency (Badan POM) reveals three top priorities for vaccine development: safety,efficacy,and quality. As part of the Covid-19 Handling and National Economic Recovery Committee (KPCPEN),top priorities in Covid-19 vaccination plan will be carried out by Badan POM in order to ensure a prudent approach as instructed by President Joko Widodo.

Covid-19 Vaccination Plan: Badan POM Set to Ensure and Safeguard the safety,and quality of Covid-19 vaccine

"As a government agency responsible for safeguarding the safety of drugs and food,Badan POM is taking strategic measures to ensure the availability of Covid-19 vaccine while prioritizing the public health," Dra. Togi J. Hutadjulu Apt. MHA,Interim Deputy of Drugs,Narcotics,Psychotropic Drugs,Drug Precursors,and Additives at Badan POM.

Badan POM added that the Covid-19 vaccine will be subjected to proper and appropriate research before it is declared ready and safe for the public.

Normally,Badan POM takes strict measures for the approval of vaccine including:

Clinical trials or trials in human to verify its safety,and quality;

The quality of product must be ensured through the evaluation of quality;

Vaccine development needs to comply with the Proper Ways of Drugs Development (Cara Pembuatan Obat yang Baik/CPOB).

Clinical Trials as Basis for EUA

Under certain conditions,approval for the vaccine may be in the form of an Emergency Use Authorization (EUA). EUA is a special registration mechanism during emergencies,such as in the current Covid-19 pandemic in compliance with the World Health Organization (WHO) guidelines. "The decision to grant an Emergency Use Authorization must be made with the consideration that the benefits outweigh the risks," said Togi.

Badan POM added that EUA can provide certain flexibility. "So,for example,for safety,we may accept results of the phase one and two clinical trials. Meanwhile,for its efficacy,in addition to obtaining data on the immune system response after vaccination,we may accept the three month interim report data results. Of course,clinical trials are expected to continue while Badan POM continues to provide monitoring," said Togi.

Based on WHO data as of October 19,2020,154 vaccine candidates are currently in the preclinical testing phase and 44 Covid-19 vaccine candidates have entered the clinical trial stage. Clinical trials are testing the efficacy of new drugs in humans. Prior to this stage,the drug had gone through preclinical testing through animal testing. Clinical trials are conducted to ensure the effectiveness and safety,as well as to reveal potential side effects in humans.

A number of Covid-19 vaccine candidates have entered the third phase of clinical trials,including those developed by Sinopharm,Sinovac Biotech,AstraZeneca and the University of Oxford,Novavax,Moderna,Pfizer and BioNTech,as well as the Gamaleya Research Institute. "Indonesia is conducting clinical trials for the Covid-19 vaccine developed by Sinovac. The three month interim results will be completed by the end of the year,and the report will be submitted to Badan POM in early January 2021. This clinical trial has already been conducted in Brazil," Togi explained.

Continuous Monitoring

When the time comes for Covid-19 vaccine distribution,Badan POM will continue to monitor the distribution chain to ensure the quality of the vaccine. "When the vaccination process is rolled out,Badan POM will constantly supervise the vaccine safety through a program of monitoring side effects known as pharmacovigilance," said Togi.

In order for effective monitoring,Badan POM hopes for sound cooperation and participation from all health workers in the field as well as the pharmaceutical industry. According to Togi,health workers may monitor and report the possibility of adverse events following immunizationexperienced by the community after receiving the vaccine. If there is an increase in the frequency of side effects,Badan POM has the right to review aspects of the efficacy and safety of vaccines. The results of this monitoring are then reviewed by experts.

The government ensures that the distribution approval for vaccines has gone through a series of comprehensive research and tests. By prioritizing the prudent approach,all efforts are made for vaccines toprovide the best efficacy for public at large.

About KPCPEN

Based on the consideration that the handling of Coronavirus Disease 2019 (Covid-19) and the national economy recovery must be aligned in one integrated and inseparable strategic policy,President Joko Widodo issued Presidential Regulation (Perpres) No. 82 of 2020 on the Covid-19 Handling and National Economic Recovery Committee (KPCPEN) signed on July 20 2020.

The KPCPEN priorities respectively are INDONESIA SEHAT (Priority for people to be safe from Covid-19 and reforming health services),INDONESIA BEKERJA (Priority for empowerment and acceleration of employment),INDONESIA TUMBUH (Priority for national economy recovery and transformation).

Contact:

Lalu Hamdani 081284519595 / 081212865928

Email : media-kpcpen@covid19.go.id