JAKARTA - The Food and Drug Supervisory Agency (BPOM) has increased the provisions for emergency use authorization (EU) or emergency use permit to become a regular distribution permit for the COVID-19 vaccine. The transition when the health emergency status in Indonesia is declared over.
"This provision is in order to guarantee protection to the public in the long term," said Head of BPOM Penny K Lukito while attending the Mass Vaccination agenda at PT Biotis Pharmaceuticals Indonesia, Gunung Sindur, Bogor Regency, West Java, Tuesday, May 30, was confiscated by Antara.
Although the vaccine currently in circulation is still EUA, Penny ensures that all products currently in circulation meet the safety, quality and effectiveness aspects monitored by BPOM and producers on a regular basis. Including the effectiveness of the vaccine that has been passed through a relatively long series of clinical trials.
Every technology or platform developed by the COVID-19 vaccine manufacturer has only recently obtained an emergency use permit due to a pandemic that requires vaccine protection for the public.
As a form of caution from the relevant authorities, BPOM conducts regular supervision every 3 months to ensure the safety, quality, and effectiveness of vaccines in the beneficiary body.
Producers also involve researchers and experts to participate in supervising side effects that may arise from COVID-19 vaccine products.
Since the World Health Organization (WHO) revoked its global health emergency status as of May 5, 2023, all countries in the world are preparing to respond to the policy by revoking the national COVID-19 emergency status, including in Indonesia.
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After the pandemic is declared over, continued Penny, the COVID-19 vaccine in circulation must be able to provide more complete and in-depth data related to security and effectiveness aspects to ensure public protection in the long term through the national immunization program.
"Currently, the Indonesian government is considering input related to the revocation of national health emergency status. producers are still researching and monitoring vaccine products, so they get more data and submitted to BPOM to obtain regular distribution permits," he said.
BPOM will open up opportunities for all vaccine manufacturers to increase their product permits to regular for 12 months, after the COVID-19 pandemic emergency status in Indonesia is declared complete by the government.
"We give the transition time in endemic, the opportunity for the owner of the distribution permit to get longer data. We have prepared a minimum time of one year to get a regular distribution permit, meaning it is not an emergency permit anymore, but a regular permit," he concluded.
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