Food And Drug Control Agency Will Issue The EUA For AstraZeneca COVID-19 Vaccine

DOCK. ANTARA / Head of the Food and Drug Administration (BPOM) Penny Lukito ..

JAKARTA - The Food and Drug Control Agency (BPOM) will issue an emergency use authorization (EUA) for the AstraZeneca brand of COVID-19 vaccine.

This is related to the news that the World Health Organization (WHO) has issued an emergency use listing of the vaccine made by the British pharmaceutical company.

"We have also received information that there is indeed an emergency use listing from WHO for the AstraZeneca vaccine which will be distributed through multilateral cooperation. The Food and Drug Control Agency's task is to publish the UAE for the vaccine", said Head of the Food and Drug Control Agency Penny Lukito in a virtual press conference, Tuesday, February 16.

Penny explained, although WHO has included AstraZeneca in the list of approval for emergency use, each country will follow up by issuing the EUA. In this case the Food and Drug Control Agency.

Currently, the Food and Drug Control Agency as the drug regulatory authority is still waiting for a comprehensive, professional dossier or collection of documentation on pharmaceutical raw materials produced by AstraZeneca.

"Regarding the aspects of quality, quality, efficacy, the data must still be submitted to the respective governments and to the respective medicinal authorities. We are waiting for that in the near future", said Penny.

Penny estimates that the Food and Drug Control Agency will receive dossier data from WHO so that it can issue AstraZeneca's EUA vaccine in the next 5 to 10 days.

"As soon as we receive dossier data from WHO in this regard. Hopefully, in the near future we can provide the UAE, so that the AstraZeneca vaccine products through multilateral distribution can be imported to Indonesia", she concluded.