- The emergency use authorization is only granted for limited use during the pandemic, not as a product distribution approval
- Data on quality, both non-clinical and clinical, as well as the public health risks are the main considerations
Emergency use authorization (EUA) for a Covid-19 vaccine is one of the government’s efforts to stop the Covid-19 transmission chain. By prioritizing the safety, efficacy and quality of a Covid-19 vaccine, EUA can accelerate the pandemic mitigation. The implementation of these strategic policies and breakthrough steps are also the focus of the Covid-19 Handling and National Economic Recovery Committee (KPCPEN) which is also supported by the Indonesian Pediatrician Association (IDAI) Immunization Task Force.
Prof. Dr. dr. Cissy Rachiana Sudjana Prawira-Kartasasmita, Professor at the Padjajaran University School of Medicine, says, “Normally, new vaccine development takes a significant amount of time. However, the WHO has allowed efforts to accelerate Covid-19 vaccine development due to the urgent need under the pandemic.”
According to Prof. Prawira-Kartasasmita, who also serves as Chair of the Indonesian Pediatrician Association (IDAI) Immunization Task Force, the government has made every effort to stop the Covid-19 transmission chain. However, there are still many in the public who do not comply with health protocols which results in a soaring transmission rate. That is why we need a breakthrough to reduce virus transmission namely by means of a vaccine.
EUA Is Only Granted During The Pandemic, Not A Product Distribution Approval
One effort to expedite Covid-19 mitigation that is allowed is granting the Emergency Use Permit or EUA, as “The EUA is granted by regulatory bodies of each country. In Indonesia, EUA is under the authority of the National Agency of Drug and Food Monitoring (Badan Pengawas Obat dan Makanan/Badan POM). For the record, EUA is only granted for limited use during the pandemic, not as a product distribution approval. Of course, EUA also adheres to safety, efficacy and quality aspects,” explained Prof. Prawira-Kartasasmita.
She adds that the EUA weighs the benefit-to-risk ratio. On the other hand, the EUA provision involves all data of quality, both non-clinical and clinical, as well as the public health risks posed by the disease. Clinical trial data is very much needed to ensure the vaccine safety, efficacy as well as quality.
“According to the WHO, EUA for a vaccine is granted if at least 50% of volunteers have been fully vaccinated. Their health is monitored continuously for three months after their last injection. This also applies to (imported vaccines),” said Prof. (Prawira-Kartasasmita).
Previously, the Interim Deputy I at Badan POM Togi Hutadjulu explained that an EUA would be granted based on the consideration that the benefits outweigh the risks. The process of evaluating the safety and efficacy of a vaccine candidate involves the National Committee Team for Drug Evaluation (Tim Komite Nasional Penilai Obat), consisting of pharmacologists, clinicians, and experts in various fields. Badan POM would only be able to grant an EUA if a vaccine has met the safety, efficacy and quality requirements based on the evaluation process.