Indonesia added to the list of vaccines approved in the country. In addition to Sinovac and Sinopharm, the Food and Drug Administration (BPOM) also approved another Chinese vaccine, Zifivax in the Emergency Use Authorization (EUA).
This vaccine is given as many as 3 intramuscular injections (IM) at an interval of 1 month from the first injection to the next injection.
The dose of the vaccine given at each injection is 25 mcg (0.5 mL). This vaccine also requires special conditions for its storage, which is at a temperature of 2-8 degrees Celsius.
Head of the Food and Drug Administration Penny K. Lukito explained that the EUA approval was given after a series of pre-clinical trials and clinical trials to assess the safety, immunogenicity, and efficacy of the Zifivax vaccine.
EUA is also published after an intensive review by the POM Agency together with the National Committee for Special Assessment of Covid-19 Vaccine and ITAGI related to the safety, efficacy, and quality of vaccines.
“With the issuance of eua for zifivax vaccine, until now the POM agency has given approval for 10 types of Covid-19 vaccine,” Penny said in a virtual statement on Thursday (7/10).
Previously, the Zifivax vaccine had gone through phase 3 clinical trials in about 28,500 test subjects. Indonesia is one of the centers of the implementation of the phase 3 clinical trial, in addition to Uzbekistan, Pakistan, Ecuador, and China.
The number of test subjects from Indonesia who participated in the clinical study of this vaccine was about 4,000 subjects.
From the results of clinical trials conducted, the administration of Zifivax vaccine in general can be well tolerated.
The most common local side effect is pain at the injection site. While the most common systemic effects are headache, fatigue, fever, muscle pain (myalgia), cough, nausea, and diarrhea with severity of grades 1 and 2.
As for the results of the efficacy assessment, interim data of phase 3 clinical trials showed good efficacy of the Zifivax vaccine, including against the SARS CoV-2 alpha variant (92.93 percent), Gamma (100 percent), Delta (77.47 percent), and Kappa (90.0 percent).
Vaccine efficacy reached 81.71 percent calculated starting 7 days after getting a complete vaccination or reached 81.4 percent when calculated starting 14 days after getting a complete vaccination.
Based on analysis of several age ranges, vaccine efficacy in the adult population aged 18-59 years is 81.51 percent, the elderly population aged 60 years and above is 87.58 percent, and for the indonesian population as a whole is 79.88 percent.
“The assessment of the quality of Zifivax vaccine has been conducted through vaccine quality evaluation and assessment of the fulfillment of aspects of Good Drug Manufacturing Method (CPOB) to production facilities in the country of origin through desktop inspection.
The results of the evaluation of Zifivax vaccine quality data have met the standards and quality requirements of the vaccine,” penny said.