BPOM Releases AstraZeneca's COVID-19 Vaccine Emergency Use Permit

JAKARTA - The Food and Drug Administration (BPOM) has issued an emergency use authorization (EAU) for AstraZeneca's COVID-19 vaccine in Indonesia.

"Based on the evaluation of the data on the safety and quality of vaccines, the POM has issued an emergency used authorization on February 22 with EUA number 215810143A1," said the spokesperson for the COVID-19 vaccine from BPOM Lucia Rizka Andalusia in a press conference. , Friday, 19 March.

The UAE release, he continued, was based on an evaluation process for the safety, efficacy and quality of the British vaccine.

This process, continued Lucia, has been carried out together with a team of experts from the National Committee for Drug Evaluation, The National Immunization Technical Advisory Group (NITAG), and a number of other experts.

The results of the evaluation of clinical trials of injecting AstraZeneca vaccines twice with an interval of 8-12 weeks in a total of 23,745 subjects, this vaccine is safe and well tolerated. "The incidence of side effects reported in clinical studies was generally mild or moderate or grades 1 and 2," said Lucia.

Commonly reported reactions include pain when pressed, redness, and itching and swelling. "As well as systemic reactions such as fatigue, headaches, malese, fever, chills, and joint pain," he explained.

Furthermore, the AstraZeneca vaccine can also stimulate the formation of antibodies in both the adult and elderly population. Lucia explained, the average antibody titre or antibody geometry after the second dose in adults was 32 times and in the elderly 21 times.

Meanwhile, for efficacy, the two standard doses of AstraZeneca vaccine reached 62.1 percent. "These results generally meet the requirements, there are several conditions that must be updated related to longer data stability," he said.

The AstraZeneca vaccine is packaged in boxes containing 10 files with a volume of 5ml and each file can be used for 10 vaccine doses and is based on a non-replicating vector file platform developed by Oxford University in collaboration with AstraZeneca.