Issues Permit For Emergency Use Of Moderna COVID-19 Vaccine, BPOM: Safe For HIV And Heart Comorbidities

Vaksin Moderna (Wikimedia Commons / Airman 1st Class Anna Nolte ft. Zacharie Grossen)

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny Lukito has issued an emergency use authorization (EUA) for the Moderna brand vaccine from the United States.

The head of BPOM, Penny Lukito, said that the Moderna vaccine was the first vaccine to receive EUA from BPOM using a messenger RNA (mRNA) platform.

"Yesterday, we BPOM published EUA for Moderna vaccine. This is the first vaccine to get EUA from BPOM using the mRNA platform," said Penny in a virtual press conference, Friday, July 2.

Penny said that the Moderna vaccine would enter through a bilateral route, namely aid from America which was channeled through the COVAX Facility cooperation.

Moderna vaccine will be used by people aged 18 years and over. The vaccine is given by intramuscular injection at a dose of 0.5 milligrams with two injections with a time span of one month.

Based on the BPOM assessment, the expert team of the National Vaccine Assessment Committee, and the Indonesia Technical Advisory Group on Immunization (ITAGI), in general the safety of the vaccine can be tolerated, both local and systemic reactions.

"Reactions with severity grids 1 and 2 with the most frequent occurrences were pain, fatigue, headache, muscle and joint pain," explains Penny.

"This is generally obtained after the second dose of injection and the general safety profile in adults under 65 is similar to that in the over 65 age group. So, it is safe," he continued.

Meanwhile, the efficacy or efficacy based on phase 3 clinical trial data shows that there is an efficacy of 94.1 percent in the 18-65 year age group and 86.4 percent in the over 65 year age group.

"This vaccine also provides a similar safety and efficacy profile in comorbid population groups. So, it can be given to comorbid populations based on phase 3 clinical trials, namely individuals with chronic lung disease, heart disease, severe obesity, liver and HIV," he explained.

For information, the Moderna vaccine is the fourth type of COVID-19 vaccine that has received permission in Indonesia. Previously, BPOM had given emergency permits for Sinovac, AstraZeneca, and Sinopharm vaccines.