BPOM Issues Emergency Use Authorization for Covovax Vaccine

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 18 November 2021
Category: News
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The Food and Drug Monitoring Agency (BPOM) has officially issued an Emergency Use Authorization (EUA) for Covovax COVID-19 vaccine produced by the world’s largest vaccine manufacturer Serum Institute of India (SII).

“In accordance with the requirement of Emergency Use Authorization (EUA), the BPOM has evaluated the safety, efficacy, and quality aspects that refer to national and international standards for COVID-19 vaccine manufactured under good manufacturing practices (GMP) at Covovax vaccine production facility in India. Based on the evaluation results, Covovax vaccine can be used for adults aged 18 years and older at 5 μg/dose that will be administered twice at an interval of 21 days between doses,” Head of the BPOM Penny K. Lukito said, Wednesday (17/11).

The Covovax vaccine is a vaccine developed with recombinant glycoprotein spike protein subunit platform technology using Matrix-M1 adjuvant vaccine.

According to Penny, the evaluation of safety, immunogenicity, and efficacy aspects of the Covovax vaccine refers to the data from pre-clinical trials and clinical trials conducted in Australia, the United States, Mexico, England, and South Africa.

Serum Institute of India has also undertaken the second and third phases of clinical trials to ensure the efficacy and safety of the vaccine in order to meet the vaccine evaluation requirements issued by the World Health Organization.

On the safety aspect, the results of a detailed evaluation show that the vaccine has mild to moderate side effects during clinical trials.

The most common side effects include local pain (23.9 percent – 32 percent), tenderness (9.9 percent – ​​11.4 percent), headache (15.5 percent – ​​19.9 percent), fatigue (8.7 percent – ​​17.9 percent), muscle pain/myalgia (8.5 percent – ​​15.5 percent), and fever (3.5 percent – ​​14.4 percent).

On the efficacy aspect, the results of a seven-day observation show that adults aged 18 years or older who received Covovax complete doses with negative (seronegative) immune status stood at 89.7 percent – 90.4 percent in all cases of COVID-19 with various levels of severity, while moderate to severe cases stood at 86.9 percent -100 percent.

Vaccine efficacy in the elderly group based on the third phase of clinical trials in the UK reached 88.9 percent. In addition, the results of the second and third phases of clinical trials in India show a good immune response from 14 days measurement after the second dose of Covovax vaccine.

On the quality aspect and compliance with GMP Standards set by the WHO, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA), the results of vaccine quality evaluation show that Covovax vaccines have met the requirements according to internationally accepted vaccine quality assessment standards, which include raw materials, antigen bulk, and vaccine products.

In accordance with applicable regulations, Penny asserted that the BPOM as an independent and scientifically based institution takes all decisions to issue drug distribution permits and the EUA completely based on international standards that prioritize the fulfillment of requirements for safety, efficacy, and product quality.

In addition, the decisions were also made by taking into account scientific aspects based on the recommendations of the National Commission for Drug and COVID-19 Vaccines Evaluation, Indonesia Technical Advisory Group of Immunization (ITAGI), and clinical associations.

“Therefore, we’d like to express our appreciation to all parties involved for their cooperation so that the vaccines can be immediately released to the public,” Penny said.

For the record, the Covovax vaccine has become the 11th COVID-19 vaccine obtained the EUA from the BPOM.

Previously, the BPOM has also issued the EUA for ten COVID-19 vaccine products, namely CoronaVac vaccine (Sinovac), Bio Farma COVID-19 vaccine, AstraZeneca vaccine, Sinopharm vaccine, Moderna vaccine, Comirnaty vaccine (Pfizer and BioNTech), Sputnik-V vaccine, Janssen COVID-19 vaccine, Convidecia vaccine, and Zifivax vaccine.

Visit the official website of the BPOM through this link. (PR of BPOM/UN) (RIF/EP)

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