BPOM Issues EUA Permit For Zifivax Vaccine From China

JAKARTA - The Food and Drug Administration (BPOM) has issued an emergency use authorization (EUA) for Zifivax vaccine from China.

"Today the POM again informs that it has given approval for a new COVID-19 vaccine product with the trade name Zifivax," said Head of BPOM Penny K.

Penny said the Zifivax vaccine was developed and produced by Anhui Zhifei Longcom Biopharmaceutical, and developed in Indonesia in collaboration with PT JBIO with a recombinant protein sub unit platform.

"The efficacy of this vaccine reaches 81.71 percent which is calculated starting seven days after getting a complete vaccination," he explained.

The efficacy of this vaccine reached 81.4 percent when calculated from 14 days after receiving a complete three-dose vaccination.

Penny said, the efficacy based on subgroup analysis of the adult population aged 18-59 years was 81.5 percent. For the elderly population above 60 years and over by 87.6 percent.

"This vaccine is given three times intramuscularly (IM) with an interval of one month from the first injection to the next injection," said Penny. While the vaccine dose given at each injection is 25 mcg (0.5 mL).

Like vaccines in general, this vaccine requires special conditions for storage, namely at a temperature of 2-8 degrees Celsius.

"I think this is a suitable range for a tropical country like Indonesia," said Penny.

In addition, the Head of BPOM stated that the EUA approval was given after a series of pre-clinical and clinical trials were carried out to assess the safety, immunogenicity, and efficacy of the Zifivax vaccine.

This EUA, he continued, was also published after going through an intensive study by the POM Agency with the National Committee for the Special Assessment of the Corona Virus Disease 2019 (COVID-19) Vaccine and ITAGI related to vaccine safety, efficacy and quality.

"We again express our appreciation to the Expert Team of the National Committee for Assessing the COVID-19 Vaccine and ITAGI for their cooperation in enabling this vaccine to be immediately released to the public," he said.

The Zifivax vaccine is the 10th type of COVID-19 vaccine that can be used in Indonesia.