Indonesia's BPOM Issues EUA for Zifivax Covid-19 Vaccine

Jakarta: The National Agency of Drug and Food Control (BPOM) has issued an emergency use authorization (EUA) for China's Zifivax vaccine.
 
"Today, the BPOM has approved (the use of) one new COVID-19 vaccine under the brand name of Zifivax," BPOM Head Penny K. Lukito notified the press here on Thursday.
 
Zifivax is developed and produced by China's firm Anhui Zhifei Longcom Biopharmaceutical. In Indonesia, it is developed in cooperation with PT JBIO, with the recombinant protein sub-unit vaccine platform.

"Vaccine efficacy has reached 81.71 percent as calculated from seven days after completing the vaccination," she remarked.
 
However, the efficacy reaches 81.4 percent if it is calculated from 14 days after the three doses of vaccination are administered.
 
The agency head noted that vaccine efficacy for people in the age bracket of 18-59 years could reach 81.5 percent and 87.6 percent for those above 60 years of age.
 
"The vaccine will be given in jab form, intramuscularly, in three doses, with a month's interval," she elaborated.
 
Each dose contains 25 mcg or 0.5 mL of vaccine. Zifivax vaccine should be stored at 2-8 degrees Celsius.
 
"I think this (storage temperature) is suitable for a tropical country, such as Indonesia," Lukito added.
 
The EUA was issued after the agency conducted a series of pre-clinical and clinical studies to test the safety, immunogenicity, and efficacy of the Zifivax vaccine.
 
It has also cleared an intensive review by the Indonesian government, the BPOM, National Committee on COVID-19 Vaccine Assessor, and the Indonesian Technical Advisory Group on Immunization (ITAGI) regarding safety, efficacy and quality of the vaccine.
 
Zifivax is the 10th COVID-19 vaccine approved for use in Indonesia throughout the covid-19 pandemic after the BPOM had earlier issued the EUA for CoronaVac (Sinovac), COVID-19 Bio Farma, AstraZeneca, Sinopharm, Moderna, Comirnaty (Pfizer and BioNTech), Sputnik-V, Janssen, and Convidecia. 
 
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