Gov’t to Ensure COVID-19 Vaccine Safety, Effectiveness
Date 19 Desember 2020
The Government has announced it is still waiting for approval of clinical trial results from the Food and Drug Supervisory Agency (BPOM) to follow-up a plan on free COVID-19 vaccination programs for all Indonesian people as directed by President Joko “Jokowi” Widodo.
According to Coordinating Minister for Human Development and Culture Muhadjir Effendy, the approval from BPOM is pivotal, particularly to ensure the safety and effectiveness of potential vaccines. The BPOM is one of the government institutions under Coordinating Ministry for Human Development and Culture.
Based on Minister of Health Decree Number 01.07/MENKES/9860/2020, six types of COVID-19 vaccines to be used in the national vaccination program must come from local pharmaceutical company PT Bio Farma, United Kingdom-based AstraZeneca, China’s Sinopharm or Sinovac Biotech, US pharma Moderna, US firm Pfizer and German company BioNTech.
“I do not think the BPOM will mess around. I guarantee that the BPOM will be professional since the vaccines involve people’s life and death. I also order the BPOM to conduct the trials with a high degree of precision,” Muhadjir said in his written statement, Friday (18/12).
Muhadjir went on to say that the BPOM must be able to ensure the vaccines can generate immunity to ward off the virus. The vaccines may generate immunity yet the body’s immune system cannot respond to infection.
“We will not carry out a safe vaccination yet ineffective, not to mention if it is unsafe and ineffective vaccination. Thus, the decision is in the hands of the BPOM called Emergency Use Authorization,” he said.
In the meantime, the BPOM Director for Drug Registration Lucia Rizka Andalucia said that Emergency Use Authorization means the approval of the use of drugs in a public health emergency while still paying attention to safety and effectiveness factors, including the COVID-19 vaccines distribution permit.
“The BPOM will oversee the clinical trial process to obtain truly valid results. Once the clinical trial results come out, the vaccines will be tested again to identify the vaccine’s efficacy and side effects so the quality of the vaccines is guaranteed,” Rizka said.
Rizka further said that the BPOM puts forward the principle of prudence in granting permits to use drugs or vaccines in public health emergencies. In overcoming the ongoing pandemic, she added, we cannot rely on one type of vaccine.
“Those six types of vaccines that can be used in the country are all good, namely Pfizer vaccine that has 90% effectiveness and has been used by several countries. However, we cannot just rely on one type of vaccine since there will be other types of vaccines,” she said.
Nevertheless, Rizka continued, the public should remain disciplined in implementing the 3M health protocols (wearing a face mask, keeping a safe distance, and washing hands). (PR of Coordinating Ministry for Human Development and Culture/UN) (RIF/MUR)