BPOM issues EUA for Janssen, Convidecia COVID-19 vaccines

09-Sep-2021 Intellasia | AntaraNews | 5:02 AM Print This Post

The Indonesian Drug and Food Monitoring Agency (BPOM) has authorised the emergency use of the US-made Janssen and China-manufactured Convidecia COVID-19 vaccines in Indonesia.

“We are optimistic that the presence of the two types of COVID-19 vaccine will increasingly help the government catch up with the vaccination coverage to achieve herd immunity soon,” BPOM Chief Penny K. Lukito noted in a press statement released on Tuesday night.

According to Lukito, the Janssen and Convidecia COVID-19 vaccines will protect people aged 18 years and above from contracting SARS-CoV-2 that causes COVID-19.

Both Janssen and Convidecia vaccines are administered in one intramuscular dose of 0.5 mL, she noted.

“The two types of vaccines must be stored at 2-8 degrees Celsius. The Janssen COVID-19 vaccine can also be kept at minus 20 degrees Celsius,” she remarked.

The Janssen COVID-19 vaccine is developed by Janssen Pharmaceutical Companies with a non-replicating viral vector platform using the vector Adenovirus (Ad26).

The vaccine is manufactured at several production facilities, including those in Grand River and Catalent Indiana, the US, and Aspen, South Africa.

PT Integrated Health Indonesia (IHI) has registered the Janssen vaccine with BPOM for emergency use authorisation (EUA) that necessitates it to take responsibility for the safety, efficacy, and quality of the vaccine.

Meanwhile, the Convidecia vaccine is developed by CanSino Biological Inc and Beijing Institute of Biotechnology using the vector Adenovirus (Ad5).

PT Bio Farma has registered the Convidencia vaccine with BPOM for EUA that necessitates it to take responsibility for the safety, efficacy, and quality of the vaccine in Indonesia.

As part of the process to issue EUA, the BPOM has conducted intensive testing on the safety, efficacy, and quality of the two vaccines as it did to other COVID-19 vaccines earlier.

“The BPOM always collaborates with experts to ensure that the vaccines meet safety, efficacy, and quality standards. We involve pharmacologists, immunologists, clinicians, pharmacists, epidemiologists, virologists, and biomedicinists, who join the National Committee for COVID-19 Vaccine Appraisal, the Indonesian Technical Advisory Group on Immunisation (ITAGI), and related clinicians association,” she affirmed.

Based on the study of their safety, the two types of vaccines on administration are well-tolerated by the recipients, she stated.

Adverse events following immunisation (AEFI) of Convidecia vaccine indicate minor to moderate reactions, such as pain, redness and swelling at the site of the injection as well as systemic AEFI that commonly include headache, fatigue, myalgia, nausea, vomiting, pyrexia, and diarrhea.

Based on data of the phase 3 clinical study on the 28th day after vaccination, the Janssen COVID-19 vaccine has a 67.2-percent efficacy in preventing all symptoms of COVID-19 and 66.1-percent efficacy in preventing moderate to severe symptoms of COVID-19 for people above 18 years of age.

“Meanwhile, the Convidecia vaccine has a 65.3-percent efficacy to protect against all symptoms of COVID-19 and 90.1-percent efficacy to protect against severe COVID-19,” she remarked.

The BPOM had earlier granted EUA to seven types of COVID-19 vaccines: CoronaVac (Sinovac), COVID-19 Bio Farma, AstraZeneca, Sinopharm, Moderna, Comirnaty (Pfiser and BioNTech), and Sputnik-V.



Category: Indonesia

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