Sinovac Bio Farma Vaccines Are Ready For Children, This Is A Guide For Use From BPOM

JAKARTA - The Food and Drug Supervisory Agency (BPOM) issued guidelines for the Sinovac COVID-19 vaccine produced by PT Bio Farma, Sunday, July 4. This was done after the issuance of approval for the use of the vaccine for children aged 12 to 17 years in Indonesia.

"This decision was taken based on a study conducted by BPOM together with the National Committee (Komnas) for Assessing the COVID-19 Vaccine, and the Indonesian Technical Advisory Group on Immunization (ITAGI), as well as the Indonesian Pediatrician Association (IDAI)," said a COVID-19 spokesperson. -19 from BPOM Lucia Rizka Andalusia confirmed via short message by ANTARA in Jakarta, Sunday.

According to Lucia, BPOM always monitors use to guarantee the safety, efficacy, and quality of vaccines after the vaccine is distributed to the public.

In the guidance letter for the use of the COVID-19 Vaccine produced by PT Bio Farma, it contains information regarding the benefits and risks of using the vaccine to health workers and the public.

In the statement explained, Bio Farma's COVID-19 vaccine is a vaccine made from a virus that is killed to form immunity against the SARS-CoV-2 virus so that it can prevent COVID-19 disease.

The vaccine is packaged in a box containing ten vials with a dose of 5 ml each and is used in the form of an injection suspension. Bio Farma's COVID-19 vaccine is stored at +2 to +8 degrees Celsius and dry. This vaccine should not be frozen.

"Bio Farma's COVID-19 vaccine does not protect 100 percent of people," said the statement in the guidance letter.

In adults aged 18 to 59 years, this vaccine will be injected into the upper arm muscle (intramuscularly) as much as 0.5 ml in two doses with an interval of 14 days for vaccination in pandemic emergency situations. Meanwhile, routine vaccination can be done at an interval of 28 days.

In the elderly aged 60 years or older, this vaccine will be injected into the upper arm muscle (intramuscularly) as much as 0.5 ml in two doses with an interval of 28 days.

In children and adolescents aged 12 to 17 years, this vaccine will be injected into the upper arm muscle (intramuscularly) as much as 0.5 ml in two doses with an interval of 28 days.

The guidelines also provide direction for potential beneficiaries to consult a doctor regarding the effects of the illness, such as having allergies, acute illness, bleeding disorders, confirmed immunodeficiency and other similar things.

Side effects that may occur after giving Bio Farma's COVID-19 Vaccine can be in the form of local reactions and systemic reactions.

Local reactions reported during clinical studies in humans are pain at the injection site, swelling, erythema, itching, induration, redness, decreased sensation, and discolouration of the skin.

Common systemic reactions reported based on clinical trial results are muscle pain, fever, fatigue, nausea, vomiting, and headache.

Based on clinical trials of the inactivated SARS-CoV-2 vaccine on 550 pediatric subjects in China, the side effects of Bio Farma's COVID-19 vaccine are mild to moderate. No serious side effects have been reported associated with the administration of Bio Farma's COVID-19 vaccine.

Pain at the injection site was the most commonly reported side effect. The results of the sub-group analysis based on age group showed that side effects were higher in the 12 to 17 year age group compared to the 3 to 5 and 6 to 11 year age groups.

For systemic side effects such as fever and runny nose, it was higher in the age group 3 to 5 and 6 to 11 years compared to the age group 12 to 17 years.

For the 12 to 17 year age group, systemic side effects of injection site pain and headache were higher than in the 3 to 5 and 6 to 11 year age groups.