Padang Pariaman, W Sumatra (ANTARA) - State-owned pharmaceutical firm PT Bio Farma said there have been no adverse events following immunization (AEFI) in the clinical trials for its locally-made COVID-19 vaccine, named State-Owned Enterprise (SOE) vaccine, so far.
Currently, the SOE vaccine has entered Phase 3 clinical trials. "No headaches or fever have been found in volunteers, except for pain from the injection, and it usually does not last long," President Director of Bio Farma Honesti Basyir said at a press conference during a visit to a center of the SOE vaccine’s Phase 3 trial here on Tuesday.
Since the end of last year, Bio Farma has been working with a number of parties to carry out clinical trials, and no AEFI case has been detected so far, he informed. This has demonstrated the capability of the 132-year-old state-owned firm as one of the largest companies in the world in terms of vaccine production. In fact, Bio Farma can meet 70 percent of the global polio vaccine needs and is the only vaccine company in the world to have produced a new type of polio vaccine, Basyir noted.
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Even though the SOE vaccine has been audited by the Indonesian Ulema Council (MUI) and has been declared halal, the company will still wait for the halal certificate to be issued, he said.
After the Phase 3 clinical trial ends and the National Agency of Drug and Food Control (BPOM) grants an emergency-use permit (EUA) at the end of July, the SOE vaccine will be used for booster vaccinations in adults and in the children’s immunization program.
"Because so far, the COVID-19 vaccine for children is still very rare," Basyir added. He said that although his firm has been considered slow in producing a COVID-19 vaccine compared to other companies in the world, he hoped that the vaccine that Bio Farma produces would target people who have not been vaccinated and who have not received the booster dose.