Indonesia Issues Emergency Use Authorization for Pfizer Vaccine
Translator
Editor
15 July 2021 21:53 WIB
TEMPO.CO, Jakarta - Indonesian Food and Drugs Monitoring Agency (BPOM) on Thursday officially issued the emergency use authorization for Pfizer-BioNtech Covid-19 vaccines after studying its safety aspect and efficacy.
“As of Wednesday, July 14, the BPOM has issued an EUA for the comirnaty vaccine produced by Pfizer and BioNTech with the m-RNA platform,” BPOM Head Penny K. Lukito wrote in a statement on July 15.
She said that the quality assessment of the vaccine complies with the international guidance. The BPOM along with the National Expert Team for Covid-19 Vaccine Assessment Committee and the Indonesian Technical Advisory Group on Immunization (ITAGI) acknowledged the Pfizer vaccine to be safe and tolerable across all age demographics.
The most common reactions prior to immunization include pain at the location of the injection, fatigue, headaches, muscle pain, joint pain, and fever.
The BPOM Head also explained that the use of Covid-19 vaccine is safe for people aged 12 years and above. The vaccine must be given in a three-week interval between the first and second doses.
The third clinical trial of the Pfizer vaccine showed that the efficacy for people aged 16 years and above is 95.5 percent and 100 percent for teenagers aged 12-15 years.
The BPOM has issued EUA for five Covid-19 vaccines in Indonesia, namely Coronavac from Sinovac, AstraZeneca that is obtained from COVAX scheme, Sinopharm from China, Moderna from the United States, and the latest is Pfizer.
Read: FDA Warns about Rare Heart Inflammation to Pfizer, Moderna Covid-19 Vaccines
BUDIARTI UTAMI PUTRI
