JAKARTADAILY.ID - PT Bio Farma, the holding company for Indonesian state-controlled pharmaceutical companies, said it has started clinical trails for its "IndoVac" Covid-19 booster vaccines, the company said in a statement on Wednesday, September 7, 2022.
This Covid-19 booster vaccine is part of efforts to manufacture different types of Covid-19 vaccines, which will be distributed under the IndoVac brand, a name given by President Joko Widodo.
"We have secured approval for the clinical trial permits (PPUK) from BPOM (the Indonesian Food and Drug Authority) for IndoVac booster vaccine,” Bio Farma's President Director Honesti Baasyir on Wednesday's statement.
Also read: Bio Farma Plans to Produce 20 million Doses of 'IndoVac' Covid-19 Primary Series Vaccines This Year
As previously reported, Bio Farma is currently manufacturing Covid-19 primary series vaccines, or Covid-19 vaccines for people aged 18 and older, as well as Covid-19 vaccines for children.
Covid 19 booster vaccines and vaccines for children
Bio Farma said it has started clinical trials for its booster vaccine since September 1, 2022, at the Hasan Sadikin General Hospital in Bandung, West Java in collaboration with the Padjajaran University Faculty of Medicine.
The clinical trials for IndoVac booster vaccine was also held at the Dr. I.G.N.G Ngoerah General Hospital in Bali, in collaboration with the Children's Health Sciences Department of Udayana University.
Also Read: Bio Farma Said Its IndoVac Covid-19 Vaccines Will Contain 80 Percent Locally-Sourced Ingredients
The clinical trials in both hospitals involved 900 subjects with ages of 18 and older.
Bio Farma also said in the statement it is currently awaiting PPUK from BPOM before it can conduct clinical trials for its Covid-19 vaccine for children.
The primary series vaccines
The manufacturing process of its primary series vaccines has progressed further than the other type of vaccines, as it has completed clinical trials phase 1 and 2 and is currently in the phase 3, before the company can secure the necessary permits.
Vaccine manufacturers need to secure 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.
