Page 132 - Badan POM Pastikan Terus Kawal Keamanan dan Mutu Vaksin COVID-19 Sebelum dan Selama Peredaran

Brazil. Turkey revealed last month that CoronaVac’s efficacy from the trials was 91.25
percent, based on data from 1,322 of the 7,000 participants, Reuters reported.

Meanwhile, Brazilian officials announced on Thursday that its trials showed an efficacy
of at least 78 percent from a pool of 13,000 participants, although the lack of detailed
data has prompted calls for transparency.

Reuters reported that from Brazil’s interim data, as many as 218 participants had
contracted the virus, with over 160 of those cases occurring among participants who
received a placebo instead of the vaccine.

The efficacy figures are below those reported by the vaccines from United States firms
Pfizer and Moderna, but they are also above the minimum efficacy rate of 50 percent
set by the World Health Organization, which BPOM uses as a guideline for authorizing
use.

The trials in Indonesia are being carried out by Padjadjaran University researchers
and state-owned pharmaceuticals company Bio Farma and involve 1,620 participants,
a figure experts fear is too small to determine efficacy. They have suggested that
BPOM also consider trial data from other countries as a precaution.

Biotechnology researcher Wien Kusharyoto, for instance, has said that interim reports
of other vaccines required data from around 150 subjects who have contracted
COVID-19 to be able to draw accurate conclusions on efficacy, after comparing their
results with those of healthy subjects in a placebo test.

that its interim analysis, with 170 confirmed cases among the trial participants, showed
an efficacy rate of 95 percent. The United Kingdom's Medicines and Healthcare
products Regulatory Agency (MHRA) approved the vaccine for emergency use on
Dec. 2, 2020, followed by the US Food and Drug Agency (FDA) on Dec. 11.

Penny, however, brushed off such concerns, claiming that her agency was already
following statistical methodology recommended by the WHO and other countries’
agencies. She did not disclose any exact figures, saying they would be released upon
the EUA’s announcement.

The implicit nod by BPOM comes as Indonesia saw its daily tally of new confirmed
COVID-19 cases reach new heights for three days in a row. Friday saw the cases
reaching five digits for the first time with 10,617 new cases, surpassing Wednesday’s
8,854 new cases and Thursday’s 9,321 cases.

According to the government's tally, the accuracy of which has been questioned by
many, the country now has over 117,000 active cases with a total of 23,753 deaths.
Read also: Yearender 2020: What went wrong with Indonesia’s virus response? The
surge in COVID-19 cases stands in stark contrast to the government’s eagerness to
carry out the immunization of some 181 million people within a year, which has been
touted as overly ambitious by experts.

Hospitals across regions in the country have also reported rising bed occupancy rates,
with the government announcing that it would reimpose a tweaked version of large-
scale social restrictions (PSBB) on Jan. 11.