BPOM Issues EUA for Janssen, Convidecia COVID-19 Vaccines

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation
Date 7 September 2021
Category: News
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The Indonesian Food and Drug Administration (BPOM) has granted emergency use authorization (EUA) to the Janssen COVID-19 Vaccine of Johnson & Johnson and Convidecia Vaccine.

The vaccines are used to provide protection against infection by SARS-CoV-2 in individuals 18 years of age and older which are administered as a single intramuscular injection of 0.5 ml.

Head of the BPOM Penny K. Lukito asserted that the issuance of EUA for both vaccines was based on intensive studies to ensure the safety, efficacy, and quality.

“The BPOM always cooperates with experts in ensuring that all standards in safety, efficacy, and quality aspects are met. We also involved experts on the fields of pharmacology, immunology, medical, apothecary, epidemiology, virology, and biomedical science who are also members of the National Committee for COVID-19 Vaccine Assessment, Indonesia Technical Advisory Group on Immunization (ITAGI), and related clinical associations,” Penny explained.

Based on results of the studies, it is declared safe to administer both vaccines. The severity of local and systemic reactions for Janssen COVID-19 Vaccine and Convidecia Vaccine is Grade 1 and Grade 2. Post Immunization Follow-up Events (KIPI) of Convidecia Vaccine showed mild and moderate reactions. The most common local adverse reactions are sore, swelling and redness at injection site, while the common systemic reactions are headache, fatigue, myalgia, drowsiness, nausea, vomiting, pyrexia, and diarrhea.

Regarding the efficacy, results of clinical study phase 3 showed that Janssen COVID-19 Vaccine, 28 days after inoculation, has an efficacy of 67.2 percent at preventing any symptoms of COVID-19, and 66.1 percent of efficacy at preventing moderate to severe/critical cases on individuals 18 years of age and older. Meanwhile, Convidecia Vaccine has an efficacy of 65.3 percent at preventing any symptoms of COVID-19, and 90.1 percent of efficacy at preventing severe cases.

“In the aspect of quality, the BPOM has also conducted studies to assess the quality of both vaccines by referring to international guideline in vaccine’s quality evaluation and the good medicine manufacturing practices certification (CPOB) of vaccine manufacturing facilities in their respective countries. The results showed that both vaccines have met the quality requirements,” she said.

For the record, Janssen COVID-19 Vaccine is developed by Janssen Pharmaceutical Companies that consist of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector. The vaccine is produced at several manufacturing facilities in different countries, such as Grand River USA, Aspen South Africa, and Catalent Indiana, USA. In Indonesia, the Janssen COVID-19 Vaccine was registered by PT Integrated Health Indonesia (IHI) as the holder of the EUA. The company is obliged to ensure safety, efficacy, and quality of the vaccine.

In the meantime, Convidecia Vaccine is a non-replicating vaccine developed by CanSino Biological Inc. and Beijing Institute of Biotechnology by using Adenovirus (Ad5) vector. The vaccine was registered by state-owned pharmaceutical company PT Bio Farma as the holder of the EUA that will ensure safety, efficacy, and quality of the vaccine in Indonesia.

Both vaccine vials must be stored between 2° and 8° C. In addition, Janssen COVID-19 Vaccine vials can also be stored frozen at -20° C.

To date, the BPOM has issued EUAs to seven COVID-19 vaccines, among others, CoronaVac (Sinovac), Bio Farma, AstraZeneca, Sinopharm, Moderna, Comirnaty (Pfizer and BioNTech), and Sputnik-V. (BPOM PR/UN) (RAS/MUR)

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