BPOM Issues Emergency Use Authorization for Zifivax Vaccine
Date 7 Oktober 2021
On Thursday (07/10), the Food and Drug Monitoring Agency (BPOM) issued an Emergency Use Authorization (EUA) for Zifivax COVID-19 vaccine developed by Anhui Zhifei Longcom Biopharmaceutical with a recombinant protein subunit platform.
The Zifivax vaccine is recommended for people aged 18 years and older for the prevention of SARS-CoV-2 that causes COVID-19. The vaccine is administered intramuscularly with an interval of one month between each dose. Recipients of this vaccine must receive three 25 mcg (0.5 mL) jabs. Similar with other vaccines, Zifivax must also be stored at 2-8°C.
Head of the BPOM Penny K. Lukito revealed that the Zifivax vaccine received the EUA after a series of pre-clinical and clinical trials that focused on the safety, immunogenicity, and efficacy of the vaccine.
The EUA was also issued after the vaccine passed an intensive study by the BPOM and the National Committee for Special Assessment of Coronavirus Disease 2019 (COVID-19) Vaccine and the Indonesian Technical Advisory Group on Immunization (ITAGI) related to vaccine safety, efficacy, and quality.
“We’d like to express our appreciation to the National Committee for Special Assessment of COVID-19 Vaccine and ITAGI for their cooperation in assessing this vaccine so it can be released to the public,” Penny said in a press statement.
Previously, the BPOM has issued the EUA for the use of nine COVID-19 vaccines, namely CoronaVac vaccine (Sinovac), Bio Farma COVID-19 vaccine, AstraZeneca vaccine, Sinopharm vaccine, Moderna vaccine, Comirnaty vaccine (Pfizer and BioNTech), Sputnik-V vaccine, Janssen COVID-19 vaccine, and Convidecia vaccine.
“Through the issuance of EUA for the Zifivax vaccine, the BPOM has approved ten types of COVID-19 vaccines,” she said.
The Zifivax vaccine has also gone through phase III clinical trials on approximately 28,500 experiment subjects. The implementation of phase III vaccine clinical trials was carried out in Indonesia, Uzbekistan, Pakistan, Ecuador, and China. The number of test subjects from Indonesia who participated in the vaccine clinical study was around 4,000 subjects.
Based on the results of the clinical trials, the Zifivax vaccine administration was well tolerated. The most common side effects of the vaccine include pain at the injection site, headache, fatigue, fever, muscle aches (myalgia), cough, nausea, and grade 1-grade 2 diarrhea.
The results of phase I and 2 clinical trials have shown good immunogenicity in adults aged 18-59 years at 14 days after completion of a COVID-19 vaccination series. The highest response has been shown in the administration of three low-dose Zifivax vaccines based on the measurement of neutralizing antibodies with seroconversion rate and Geometric Mean Titer (GMT) of 83.22 percent and 102.5, as well as the measurement of Receptor-Binding Domain (RBD) antibody binding protein with seroconversion rate and GMT at 99.31 percent and 1782.26.
Meanwhile, for the results of the efficacy assessment, phase 3 clinical trial interim data has shown a good efficacy of the Zifivax vaccine, including against the SARS CoV-2 variant Alpha (92.93 percent), Gamma (100 percent), Delta (77.47 percent), and Kappa (90.0 percent). The vaccine efficacy reaches 81.71 percent starting seven days after getting a complete vaccination or reaches 81.4 percent starting 14 days after getting a complete vaccination.
Based on an analysis of several age ranges, the efficacy of the vaccine in adults aged 18-59 years was 81.51 percent, the elderly aged 60 years and older was 87.58 percent, and for the Indonesian population as a whole was 79.88 percent.
“The assessment of the vaccine quality has been carried out through an evaluation of vaccine quality and an assessment of the fulfillment of the Good Manufacturing Practices (GMP) aspect of 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 requirements for vaccine quality,” Penny said.
Currently, the Zifivax vaccine is not indicated for booster use. The Zifivax vaccine and other vaccines must go through a booster clinical trial which is carried out after data on persistent immune responses from primary clinical trials are known. The use of vaccines with booster indications can be carried out after obtaining the BPOM’s approval.
For the record, the holder of EUA for Zivifax is PT Jakarta Biopharmaceutical Industry (JBio), a national private company that is currently in the stage of building a vaccine production facility (fill and finish) with vials and prefilled syringes. This stage is part of the roadmap for facility development from upstream-downstream up until vaccine formulation.
“We hope that the commitment of PT JBio to invest in Indonesia can be followed by other parties to also invest in the drug and vaccine production sector in order to support pharmaceutical independence in the country,” she remarked.
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