Page 108 - E-Klipping EUA Vaksin Comirnaty Produksi Pfizer and BioNTech

Judul : Indonesia Issues Emergency Use Authorization for Pfizer Vaccine

Nama Media : en.tempo.co

Tanggal : 16 Juli 2021

Halaman/URL: https://en.tempo.co/read/1483690/indonesia-issues-emergency-use-
authorization-for-pfizer-vaccine Tipe Media : Media Online

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.