Indonesia issues emergency use authorization for five booster vaccines

Jakarta, January 10 (ANTARA) - The National Agency of Drug and Food Control (BPOM) issued Emergency Use Authorization (EUA) for five COVID-19 vaccine products to be used for administering the booster shot. "Five vaccines had received the EUA through an evaluation process from the drug or vaccine expert team and had fulfilled the existing criteria," BPOM's Head, Penny K. Lukito, noted here on Monday. These COVID-19 vaccine products are CoronaVac produced by the state-run vaccine manufacturer PT Bio Farma, Pfizer vaccine, AstraZeneca vaccine, Moderna vaccine, and Zifivax vaccine. One additional dose of the homologous vaccine CoronaVac could be administered to people aged 18 years after six months since the primary vaccination. "Immunogenicity (test result) shows an increase in neutralizing antibody titer up to 21-35 times some 28 days after the provision of the CoronaVac booster vaccine to the adult subject," she pointed out. Follow-up incidents after the vaccine administration came in the form of local reactions, such as pain and skin redness at the jab site. The additional dose of Pfizer vaccine for booster shots should also be given at least six months after the primary vaccination for people aged 18 years and above, according to Lukito. The effects of the vaccine with mRNA platform are generally local in nature, such as pain at the administration site, headache, muscle ache, and fever. "Immunogenicity (test result) shows an increase in neutralizing antibody titer up to 3.3 times after one month (since the vaccine's provision)," she noted. The AstraZeneca vaccine could also be utilized as a booster shot. According to the immunogenicity test result, utilizing the vaccine product could increase antibodies to around 3.5 times. Meanwhile, the Moderna vaccine could be used to complement the two-dose administration of AstraZeneca, Pfizer, and Johnson and Johnson primary vaccines. Half dose of the vaccine with the mRNA platform could be administered as a booster after the primary vaccine. "Moderna shows 13 times the immunogenicity after the administration of the booster dose and with the subject being adults aged 18 years and above," Lukito elaborated. Zifivax could be used as a heterologous booster for other types of vaccines, such as Sinovac or Sinopharm, with the provision interval of above six months. "Zifivax shows an increase in neutralizing antibody titer more than 30 times," she remarked. In addition, the research result shows that immunity response declined to below 30 percent after six months of primary vaccination which is why the booster shot is necessary, she explained.