COVID-19 – Indonesia issues emergency use Authorization for Janssen, Convidecia vaccines

Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (locally known as BPOM) on Tuesday (Sep. 7) issued an Emergency Use Authorization (EUA) for Janssen and Convidecia COVID-19 vaccines.

Indications for the use of these two types of vaccines are for the prevention of COVID-19 caused by SARS-CoV-2 in people aged 18 years and over, with one injection or a single dose of 0.5 ml intramuscularly.

Head of BPOM Penny K Lukito emphasized that the issuance of the EUA for the two types of vaccines had gone through an intensive study in terms of safety, efficacy, and quality.

“BPOM always collaborates with experts in ensuring the fulfillment of vaccine safety, efficacy and quality standards. We involve experts in the fields of pharmacology, immunology, clinicians, pharmacists, epidemiology, virology, and biomedicine that are members of the National Committee for the Special Assessment of the Corona Virus Disease 2019 (COVID-19) Vaccine, the Indonesia Technical Advisory Group on Immunization (ITAGI), and associated clinician associations,” explained Penny.

The results of the study indicate that in terms of safety, in general, the administration of the two vaccines was well tolerated. Local and systemic reactions to the Janssen vaccine are grade 1 and 2 in severity.

Meanwhile, post-immunization side effects from the Convidecia vaccine showed mild to moderate reactions.

Local side effects which commonly happen include pain, redness and swelling of the skin, while the systemic side effects which commonly occur are headache, fatigue, muscle pain (myalgia), drowsiness, nausea, vomiting, fever (pyrexia), and diarrhea.

In terms of efficacy, based on interim phase 3 clinical study data at 28 days after vaccination, the ability of the Janssen vaccine to prevent any symptoms of COVID-19 is 67.2 percent and efficacy to prevent moderate to severe COVID-19 symptoms in subjects over 18 years is 66.1 percent.

As for the Convidecia vaccine, the efficacy for protection against all COVID-19 symptoms is 65.3 percent and protection from severe COVID-19 cases is 90.1 percent.

“In terms of vaccine quality, BPOM has also assessed the quality of the two vaccines by referring to the internationally applicable vaccine quality evaluation guidelines and also the evaluation results of the Good Manufacturing Practices (GMP) aspect at production facilities in the countries of origin. As a result, the two vaccines have met the standard of quality requirements,” explained Penny.

Janssen was developed by Janssen Pharmaceutical Companies with a Non-Replicating Viral Vector platform using an Adenovirus (Ad26) vector.

The vaccine is produced in several production facilities, including Grand River in the United States, Aspen in South Africa, and Catalent Indiana in the United States.

In Indonesia, this vaccine is registered by PT Integrated Health Indonesia (IHI) as the EUA holder and is responsible for ensuring safety, efficacy and quality.

Meanwhile, the Convidecia vaccine was developed by CanSino Biological Inc. and the Beijing Institute of Biotechnology with a Non-Replicating Viral Vector platform, using an Adenovirus (Ad5) vector.

This vaccine is registered by PT Bio Farma as the EUA permit holder who will be responsible for ensuring the safety, efficacy and quality of vaccines in the country.

Both vaccines require storage conditions at a special temperature, which is 2-8 degrees Celsius.

Janssen can also be stored at minus 20 degrees Celsius.

Previously, BPOM had issued EUA for seven COVID-19 vaccine products, namely CoronaVac (Sinovac), COVID-19 vaccine Bio Farma, AstraZeneca, Sinopharm, Moderna, Comirnaty (Pfizer and BioNTech), and Sputnik-V.

Reporting by Indonesia Window