Illustration: COVID-19 vaccine. (Image via Shutterstock/siam.pukkato)

IDAI: Emergency use of COVID-19 vaccine needs efficacy and security

Speaking on Friday, the Professor of Medical Faculty at Padjajaran University and Head of the Immunization Task Force of the Indonesian Pediatric Society (IDAI), Prof. Cissy Prawira Kartasasmita, stated that besides the health protocol, other efforts are needed to tackle the novel coronavirus (SARS-CoV-2) transmission. One of the efforts is through vaccination.

Prof. Cissy admitted that a vaccine indeed requires a long time to formulate. However, she quoted that the World Health Organization (WHO) allows the acceleration of the vaccine for novel coronavirus disease (COVID-19) for emergency use in the pandemic. Furthermore, the WHO also stated that the local regulators could release the emergency use authorization (EUA) for medicine, medical instruments, and vaccine

However, the release of EUA requires the consideration of the pandemic situation which also calls for vaccine availability. Prof. Cissy stated that in Indonesia, the National Agency of Drug and Food Control (BPOM) is responsible. The EUA is only for limited use during the pandemic, not distribution permit. She added that the EUA should pay attention to the security, quality, and efficacy.

RISK AND EFFICACY

Furthermore, Prof. Cissy stated that the EUA given by BPOM should consider the efficacy and risk ratio, according to the quality, non-clinical, & clinical data, and risk of people's health condition triggered by the pandemic. Furthermore, the clinical trial data should also be included to ensure the safety and efficacy of the vaccine for public use.

She quoted that WHO's EUA requirement for a vaccine is that at least 50% of the participant is fully vaccinated and monitored for 3 months after the last injection. The same procedure also applies to the imported vaccine.

Previously, the Acting Deputy I of BPOM, Togi Hutadjulu, asserted that the decision of EUA for COVID-19 vaccine should be done under the consideration that its efficacy is higher than its risk. The decision is also taken following the result of the vaccine's efficacy and security evaluation data. If the vaccine has met the safety, efficacy, and quality requirement, BPOM will give the EUA.

Source: https://bit.ly/3ets7Uc