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Jakarta, CNBC Indonesia – The Food and Drug Administration (BPOM) officially approved the Covid-19 vaccine manufactured by the Chinese pharmaceutical company Sinovac Life Sciences Co Ltd. for use by the elderly population over 60 years of age.
This is based on the BPOM document received by CNBC Indonesia this Saturday (2/6/2021).
In a letter signed by the Head of BPOM Penny K Lukito addressed to PT Bio Farma (Persero), it was noted that the approval was given considering the emergency situation of the pandemic outbreak of Covid-19.
Furthermore, considering the limited evidence of the usefulness and safety of the vaccine for the prevention of Covid-19, BPOM has approved additional indications and posology for CoronaVac vaccines for limited emergency use in conditions of a pandemic outbreak with the following provisions:
– Conducting post-approval clinical studies to ensure the efficacy of the CoronaVac vaccine for the prevention of Covid-19
– BPOM has the right to review / re-evaluate aspects of the efficacy and safety of vaccines if new evidence is found regarding efficacy and safety.
– Mandatory monitoring of pharmacacovigilance and notification of drug side effects to the POM.
Previous. Bio Farma in its letter to BPOM, presents a request for additional indications for the elderly population (60 years and over) with injection intervals of 0 and 28 days.
Furthermore, an alternative injection interval of 0 to 28 days is proposed for the adult population (18-59 years).
CNBC Indonesia has contacted BPOM represented by Lucia Rizka Andalusia and Covid-19 spokesperson Prof. However, no response has been made to Wiku Bakti Bawono.
Meanwhile, the confirmation came from Spokesman Bio Farma Bambang Heriyanto, when we contact you tonight. She provided information related to the accompanying document titled “Product Information for Vaccination Participants Using CoronaVac Vaccine for the Prevention of Covid-19 in Adults Over 18 Years of Age.”
“Please refer to this link” while providing the link.
The document states that in the elderly aged 60 years and over, this vaccine will be injected into the muscle (intramuscularly) up to 0.5 ml in two doses with an interval of 28 days.
Meanwhile, in adults aged 18 to 59 years, this vaccine will be injected into the muscle (intramuscularly) up to 0.5 ml in two doses with an interval of 14 days (for vaccination in pandemic emergency situations) or an interval 28 days (for routine vaccination).
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