The National Agency of Drug and Food Control (BPOM) officially approved the COVID-19 Sinovac vaccine for seniors aged 60 years and above, as stated in their letter to PT Bio Farma.
The letter was signed by the Head of the National Agency of Drug and Food Control, Penny K Lukito, on 5th February 2021.
Within the letter, it stated that considering the limited evidence of the usefulness and safety of the vaccine for the prevention of COVID-19, approval was being given for additional indications and dosage for limited Emergency Use Authorisation (EUA) under the conditions of a pandemic with the following provisions:
- Post-approval clinical studies must be conducted to ensure the effectiveness of the CoronaVac vaccine for the prevention of COVID-19.
- BPOM has the right to review or re-evaluate aspects of the efficacy and safety of vaccines if new evidence is found regarding efficacy and safety.
- Mandatory monitoring of pharmacovigilance and reporting of drug side effects to the BPOM.
Bio Farma, in its letter to the National Agency of Drug and Food Control, submitted an application for additional indications for those aged over 60 years old, with injection intervals of 0 and 28 days.
The addition of an alternative injection interval of 0 and 28 days for the adult population of 18-59 years was also included in the letter. The elderly population will be injected intramuscularly with 0.5 mL in two doses with an interval of 28 days.
Meanwhile, adults aged 18 – 59 years will be injected intramuscularly with 0.5 mL in two doses with an interval of 14 days for vaccination during the pandemic, or an interval of 28 days for routine vaccination.