BPOM Issues Emergency Use Authorization for Moderna Vaccine
2 July 2021 13:02 WIB
TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) has issued an emergency use authorization (EUA) for the Covid-19 vaccine produced by the United States, Moderna.
“We added one more vaccine brand that has received EUA from the BPOM, namely the Moderna vaccine,” said the BPOM Head Penny Lukito in a press conference on Friday, July 2, 2021.
Penny said Moderna was the first vaccine with an mRNA platform that was granted an emergency use authorization by BPOM. This vaccine brand would enter Indonesia through the COVAX scheme.
Based on the results of phase III clinical trials, Penny said the vaccine efficacy showed 94.1 percent in the 18-65 year age group and 86.4 percent in people aged 65 and over.
This vaccine was also said to provide a similar safety and efficacy profile in comorbid groups. Penny said the U.S.-made vaccine could be given to individuals with chronic lung disease, heart disease, severe obesity, diabetes, liver disease, and HIV.
“The POM Agency appreciates the expert team of the national committee for the Covid-19 vaccine assessment and ITAGI who have jointly conducted an intensive study so that the Moderna vaccine EUA can be issued in response to the high vaccine need,” Penny added.
Besides Moderna, BPOM has previously provided EUA for four other vaccine brands, namely CoronaVac produced by Sinovac China, Sinovac vaccine developed by Bio Farma, AstraZeneca, and Sinopharm.