TheIndonesia.co - PT Jakarta Biopharmaceuticals Industry (JBio) produces 1 million doses of Zifivax vaccine through technology transfer collaboration with Chinese pharmaceutical company Anhui Zhifei Longcom Biopharmaceutical.
"Through this collaboration, we have produced three batches or around 1 million doses of Zifivax vaccine with a sub-unit recombinant protein platform," said JBio President Director Mahendra Suhardono in Jakarta, Sunday night, April 10, 2022.
Suhardono said the Zifivax vaccine is produced using a pharmaceutical facility owned by PT Biotis Pharmaceuticals Indonesia in Gunung Sindur District, Bogor Regency, West Java. The Zifivax vaccine had obtained an Emergency Use Authorization (EUA) from the Indonesian Food and Drug Administration (BPOM) for as complete primary and booster doses in Indonesia.
In addition, Jbio has also obtained a halal permit from the Indonesian Ulema Council (MUI) for the content of the Zifivax vaccine in Indonesia. "A total of 1 million doses of this vaccine are prioritized for domestic needs," he said.
Baca Juga
JBio is in talks with the Ministry of Health (Kemenkes) so that the Zifivax vaccine can be used immediately in Indonesia. "This is an ongoing discussion. Hopefully, it can be used in Indonesia soon because to our knowledge, the government also conveys that the stock of COVID-19 vaccine is quite large because many are donated," he said.
Meanwhile, Head of BPOM RI Penny K Lukito appreciated the technology transfer collaboration in the development of the Zifivax vaccine as a pharmaceutical product made by the nation's children. This is because PT JBio takes a long time to prepare production facilities that meet Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.
PT Biotis has obtained a Good Manufacturing Practice (CPOB) or Good GMP certificate from BPOM to support the development of the Red and White Vaccine. "There are three batches or 1 million doses of Zifivax vaccine ready to be produced, but it will pass stability tests to obtain UAE registration data," she said.
Zifivax vaccine is used for preventing COVID-19 caused by SARS-CoV-2 in people aged 18 years and over. The vaccine was given three times by injection intramuscularly (IM) with an interval of one month from the first injection to the next injection. The dose of vaccine given at each injection is 25 mcg (0.5 mL).
President Director of Biotis Pharmaceutical Indonesia, FX Sudirman, said that domestic vaccine production is part of the nation's independence. He hopes to get full support from BPOM for the commercial process.
"Biotis is collaborating with JBio to produce Zifivax vaccine because as a new player in the vaccine field, we need to accelerate development in the industry and the technology transfer process is very good," he said.
The technology transfer process, said Sudirman, in the short term, can improve the quality of human resources (HR) and vaccine production facilities according to the standards of the team from Anhui Zhifei Longcom Biopharmaceutical. "This process can upgrade instantly in the short term, the capabilities of our people and our facilities," he said.
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