Kalbe Farma, A Pharmaceutical Company Owned By The Conglomerate Boenjamin Setiawan, Is Developing A GX-19N COVID-19 Vaccine, Can It Be For Children?

JAKARTA - PT Kalbe Farma Tbk in collaboration with Genexine Inc, a company from South Korea will conduct phase IIB and III clinical trials of the COVID-19 GX-19N vaccine. The plan is that clinical trials will begin in July 2021 for the next six months.

The clinical trial was carried out after obtaining permission from the Food and Drug Supervisory Agency (BPOM). Can the GX-19N COVID-19 vaccine be used for children?

The Head of the Research Team for the COVID-19 GX-19N vaccine clinical trial, Iris Rengganis, said that the clinical trial of the GX-19N COVID-19 vaccine was only carried out with samples of adults aged 18 years and over. This means that this vaccine is not intended for use in children.

"In us (Indonesia) the GX-19N vaccine is only for adults", she said at a virtual press conference, Friday, July 9.

On the same occasion, Director of Kalbe Farma, Sie Djohan, said that clinical trials were conducted for adult patients over 18 years of age, so the results of phase IIB and III trials have not produced data to answer whether this vaccine can be used for children.

"Can this vaccine be used for children? I think what we are currently doing clinical trials are for adult patients over 18 years old, maybe up to elderly patients. So the results of the IIB and III tests have not yet produced the data we need, can they be used? for children or not", said Djohan.

According to Djohan, to find out whether the COVID-19 GX-19N vaccine can be used for children, clinical trials on children must be carried out.

"To (know) that, we have to do separate clinical trials for children", he said.

Even so, Djohan did not explain further whether Kalbe would conduct a separate clinical trial of the COVID-19 GX-19N vaccine to children.

For your information, the COVID-19 vaccination for children and adolescents aged 12 to 17 years has begun. This age group is considered vulnerable to infection, especially by several new variants of COVID-19.

According to data from the Ministry of Health of the Republic of Indonesia, as of June 29, 2021, at 18.00 WIB, there were more than 2 million confirmed cases of COVID-19, of which 10.6 percent, i.e. more than 200 thousand, were active cases. It has also been confirmed that nearly 260,000 are children aged 0-18 years, of which more than 108,000 cases are in the 12-17 year age range.

Therefore, the government continues to aggressively seek various ways to suppress the positive number of COVID-19 cases, one of which is by conducting a vaccination program which is an important part of a series of efforts to overcome the pandemic.