JAKARTADAILY.ID - PT Bio Farma, the holding company of a number of Indonesian pharmaceutical state-owned enterprises, plans to produce 20 million Covid-19 primary series vaccines this year according to a company statement on Wednesday, September 7, 2022.
Honesti Baasyir, the President Director of PT Bio Farma said the company has partnered with Baylor College of Medicine, a private, independent health sciences center in Houston, Texas, the United States to develop a recombinant protein subunit vaccine produced from yeast.
The state-owned company is currently in the process of manufacturing the primary series of Covid-19 vaccines for people 18 years of age and above. Apart from that, Bio Farma is also working on making Covid-19 booster vaccines and Covid-19 vaccines for children.
The Bandung-based company said it has been developing the primary series vaccines since November 2021 and it has completed Phase 1 and Phase 2 clinical trials and is currently working on Phase 3 trials.
“IndoVac uses vaccine technology platforms, which are compatible with our equipment and facilities within our factories. The technology platforms to produce protein recombinant vaccine also offer other benefits: they can be adapted into the new strains of Covid-19," Honesti said in the statement.
"Results from the Phase 1 and Phase 2 clinical trials showed that the IndoVac vaccine offers good quality for its safety and efficacy. They are no less competitive with the other Covid-19 vaccines. Next, we are completing a report to wrap up the Phase 3 stage,” Honesti added.
The EUA from BPOM
PT Bio Farma said it is working on the paperwork to secure the Emergency Use Authorization (EUA) permit, or a permit to expedite the availability of medical products, including drugs and vaccines from a regulator in a country, during a public health emergency, which include pandemics or disease outbreaks.
PT Bio Farma said it has been in close communication with the Indonesian Food and Drug Authority (BPOM) since July 2022 to provide the necessary data. The company expects the EUA can be released by BPOM in the near term.
BPOM requires vaccine manufacturers to conduct clinical trials to ensure to decide if a vaccine is safe whether it can boost immunity against Covid-19 and determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.
The EUA, released by a country’s regulator, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays a key role as a regulatory gatekeeper of medicines and vaccines used in the country.
Also Read: Bio Farma Said Its IndoVac Covid-19 Vaccines Will Contain 80 Percent Locally-Sourced Ingredients
BPOM’s head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac’s primary series vaccines in mid-September 2022.