The Indonesian Drug and Food Control Agency (BPOM) said it will penalize two pharmaceutical companies after ethylene glycol (EG) and diethylene glycol (DEG) were detected in their syrups.
The decision was also based on recommendation issued by the Indonesian Technical Advisory Group on Immunization (ITAGI).
Booster shots will be made mandatory for Indonesians over the age of 18 who are traveling abroad.
TheIndonesia.id - Indonesia’s Drug and Food Control Agency (BPOM) has approved the use of COVID-19 vaccine Sinopharm as booster, making it the sixth authorized vaccine booster in the country.
The Agency issued emergency use authorization (UEA) upon evaluation on the safety and efficacy aspects of Sinopharm vaccine, which will be used as homologous booster.
“In accordance with the emergency use requirement, BPOM has evaluated the efficacy and safety aspects by referring to COVID-19 vaccine evaluation standard for Sinopharm vaccine as homologous booster does for adults aged 18 and above,” head of BPOM Penny Lukito said on Wednesday, February 2, as reported by Antara.
Sinopharm, produced by Beijing Bio-Institute Biological, China, has been registered in state-owned pharmaceutical company PT Kimia Farma for use on adults at least six months after second dose is given.
Evaluation revealed that Sinopharm is generally safe as a booster as frequency, type, and severity of the adverse events following immunization (AEFI) are generally lower compared to side effects after prime doses. Some of the most reported side effects are local reactions, such as injection-site soreness, swelling and redness as well as systemic reactions like headache, fatigues, and muscle pain – with grade one to two severity.
Meanwhile, based on study of the immunogenicity aspect, humoral immune response increased on neutralizing antibody and anti-IgG at 8.4 and 8 times, respectively, compared to pre-booster.
Lukito added that immune response after the injection of Sinopharm booster is higher than the prime doses.
Previously, BPOM has also approved the use of CoronaVac, Pfizer, AstraZeneca, Moderna, and Zifivax for booster shots in Indonesia.
“This EUA for Sinopharm adds more alternatives to homologous booster for platform inactivated virus,” she said.
