BPOM Ensures Phase 3 Clinical Trial of Sinovac Vaccine Receives Strict Assistance
Head of the Food and Drug Supervisory Agency (BPOM) Penny Kusumastuti Lukito ensured that the phase 3 clinical trial process and protocol of the Sinovac Covid-19 vaccine will receive strict assistance. The vaccine is planned for completion of clinical trials in 2021.
"This is the most important and advanced stage, meaning that we are almost at the point of discovering and producing the vaccine. Of course, the POM guarantees the protocol of this clinical trial to be valid," Penny said at the Presidential Palace after meeting President Joko Widodo on Tuesday (7/21).
He explained that the production process will be carried out by PT Bio Farma. BPOM will also contribute to the vaccine production process. "So indeed, when the clinical trial is finished, we will issue a distribution permit, we can immediately distribute it, and have distributed it," Penny said.
It is known, the government is currently seeking phase 3 clinical trials for the Sinovac vaccine imported from China. Cabinet Secretary (Seskab) Pramono Anung explained that the vaccine will be produced on a large scale, especially in eight major provinces. Namely East Java, DKI Jakarta , Central Java, West Java, South Sulawesi, South Kalimantan, North Sumatra, and Papua,
"We will produce massively and later this vaccine we will distribute to all provinces. Includes priority of the eight main provinces," Pramono said.
Pramono hopes that the vaccine will be completed in December or early 2012. Which will be carried out later stages. "Hopefully the vaccine will be able to work with Sinovac in December or January," explained Pramono.
Furthermore, the Head of State also assigned Bio Farma to ensure its production capacity can meet domestic needs after clinical trials are conducted.
"According to the direction of our President Mr. Bio Farma, he has a duty to ensure that the vaccine production capacity can be managed properly. Until now, we have prepared 100 million doses per year and we will expand to 250 million doses per year," said Bio Farma President Director Basyir Honesti.