BPOM issues EUA for Sinopharm's COVID-19 vaccine

BPOM issues EUA for Sinopharm's COVID-19 vaccine

Head of the Food and Drug Control Agency (BPOM) Penny Lukito handed over the Emergency Use Authorization (EUA) for Sinopharm's vaccine to a representative of PT Bio Farma during a virtual press conference on Friday (April 30, 2021). ANTARA/Andi Firdaus

Today, we have issued EUA for the vaccine produced by Beijing Bio-Institute Biological Products, which is a unit of Sinopharm, a subsidiary of the China National Biotech Group. This is Sinopharm vaccine
Jakarta (ANTARA) - Indonesia's Food and Drug Control Agency (BPOM) has issued emergency use authorization (EUA) for the COVID-19 vaccine manufactured by China's pharmaceutical company Sinopharm.

"Today, we have issued EUA for the vaccine produced by Beijing Bio-Institute Biological Products, which is a unit of Sinopharm, a subsidiary of the China National Biotech Group. This is Sinopharm vaccine," BPOM Head Penny Lukito stated during a virtual press conference here on Friday.

The agency has conducted evaluation involving the National Committee on COVID-19 Vaccine Assessor and the Indonesian Technical Advisory Group on Immunization (ITAGI) before issuing the EUA.

The team reported that the Sinopharm vaccine has an efficacy rate of 78 percent based on the third phase of clinical test conducted in the United Arab Emirates and several other countries involving 42 thousand human subjects.

"Based on the result of data evaluation of the quality, production, and preclinical and clinical trials, we can conclude that two doses of the Sinopharm vaccine administered during an interval of 21-28 days is safe, and its efficacy to increase the body’s immunity is good," she stated.

The result of the phase-three clinical trial has shown minor local side-effects, including swelling and redness, with frequency of occurrence of 0.01 percent or rarely occurring.

"Severe local side-effects reported were also very less, with the frequency of occurrence of 0.01 percent, or very rare. The systemic side-effects frequently reported are headaches, 12 percent; muscle soreness, 3.3 percent; cough; and others. The systemic side-effects are minor and commonly occur after vaccination," she remarked.

Based on the result of comprehensive quality control that also included the origin material and production process, the BPOM head noted that the vaccine had met the quality requirements and could be used for immunization.

"Based on the evaluation and taking into account the risks and benefits as we are in a pandemic situation, the BPOM has issued approval to use the Sinopharm vaccine during the emergency period, or EUA, on April 29, 2021, with each vial or dose containing 0.5 ml of the vaccine," she remarked.

The vaccine will be used for vaccination in mutual cooperation or the Gotong Royong vaccination program targeting office workers.
Related news: Nearly 12 million Indonesians vaccinated against COVID-19

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