BUMN Vaccine Now Enters Phase Three Clinical Trials, Tested On 4,050 Subjects
JAKARTA - PT Bio Farma (Persero) has officially announced the third phase clinical trial for the domestically produced COVID-19 vaccine, which is named the BUMN Vaccine.
"Alhamdulillah, today we will carry out the third phase of clinical trials," said Bio Farma President Director Honesti Basyir at the Kick Off Phase III Vaccine Clinical Test for BUMN which was monitored in Jakarta, Thursday, June 9, quoted from Antara.
The third phase clinical trial of the BUMN vaccine will be given to 4,050 subjects with an age limit of 18 years to 70 years.
Honesti said that if the clinical trial goes well and gets an emergency use authorization, Bio Farma will produce the vaccine in July 2022.
"We have prepared a fairly large production capacity, where for this BUMN Vaccine we have prepared a capacity of 120 million doses per year," he said.
Bio Farma will use the BUMN Vaccine as a booster for adults and children considering that the vaccine coverage in Indonesia is currently very large.
Meanwhile, the Head of the Food and Drug Supervisory Agency (BPOM) Penny Lukito said the BUMN vaccine was the first vaccine whose development was carried out from upstream to downstream in Indonesia.
The BUMN Vaccine Research was obtained from abroad, but its development into a vaccine that meets various commercial product standards is carried out in Indonesia starting from the pre-clinical stage, first phase clinical trial, second phase clinical trial, and final phase clinical trial with various knick-knacks.
According to him, the BUMN Vaccine is a big step as well as a leap for Indonesia towards national drug and vaccine independence.
"Thanks to industrial partners who together with BPOM follow international standard rules. We want the vaccines developed in Indonesia to be competitive products. Hopefully we can finish this on time," said Penny.