The Food and Drug Supervisory Agency Issues Sinopharm Emergency Permit For Independent Vaccination

Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito in a virtual press conference (Photo: Capture Screen of BPOM)

JAKARTA - The Food and Drug Supervisory Agency (BPOM) has issued an emergency use authorization (EUA) for the Sinopharm vaccine. The Sinopharm vaccine is a production company from China.

"The EUA has been given to vaccines produced by the Beijing Bio Institute of Biological Products, which is a unit of Sinopharm, which is a subsidiary of the China National Biotech Group, this Sinopharm Vaccine with an inactivated virus or virus that is killed off", said the Head of the Food and Drug Administration. (BPOM) Penny K. Lukito in a virtual press conference, Friday, April 30.

Penny explained that the Sinopharm vaccine works with an inactivated virus platform or a virus that is turned off. This vaccine is registered and distributed by PT Kimia Farma.

Based on the results of the safety evaluation of the efficacy and quality of the Sinopharm vaccine, Penny concluded that the Sinopharm vaccine, which was injected with 2 doses at an interval of 21 to 28 days, showed a well-tolerated safety profile and a good immune-boosting response.

"In general, the safety of vaccines can function well. The most frequently reported incidence of local side effects is the category of swelling, redness. That is in the mild category. The incidence is also rare, around 0.01 percent. So from a safety aspect, it is safe", she explained.

Sinopharm vaccine clinical trials were carried out in the United Arab Emirates and a number of other countries, with about 42 thousand people as subjects. The resulting vaccine efficacy is about 78 percent.

For information, the government has designated the Sinopharm vaccine to be used as a standalone vaccine, under the name Gotong Royong (mutual cooperation) Vaccine. This vaccine is given to employees, families, and individuals free of charge.

This means that companies implementing this program must provide the COVID-19 vaccine for free to employees and their families.

The government will bring in 15 million doses of Sinopharm Vaccine from China which is divided into several stages of delivery during 2021, the delivery process will be regulated by state-owned company PT Kimia Farma.

In the fourth week of April, it is scheduled to receive 500 thousand doses of Sinopharm Vaccine, then from April to July 2021 there will be an additional 7 million doses, then in the 3rd and 4th quarters, there will be another 7.5 doses.