Results of clinical test demonstrate COVID-19 vaccine safety: BPOM

Jakarta The Drug and Food Control Agency (BPOM) conducted clinical test of China-made Sinovac COVID-19 vaccine and discovered two types of data indicating vaccine safety based on result of administration in the past couple of months.

The two types of data are immunogenicity and efficacy, BPOM spokesman for COVID-19 vaccination Lucia Rizka Andalusia noted in a written statement released on Tuesday.

"This vaccine is quite safe. It has no serious side effects on its users," Andalusia noted during an Alinea Forum themed “Halal and Security of COVID-19 Vaccine.”

The BPOM spokesman revealed that the immunogenicity triggered a good immune response in the body resulting in antibody production.

The data may help to dispel lingering doubts about the vaccine among the public, she stated.

The BPOM currently awaits several data from other clinical tests, she noted.

Andalusia affirmed that the clinical test offered several advantages to Indonesia, including the data of clinical tests and experience in the use of the vaccine.

Nevertheless, the BPOM offers an opportunity to utilize data of clinical tests of the COVID-19 vaccine from other countries to expedite the national vaccination program, on condition that their clinical test protocols are the same as those of Indonesia.

In fact, conducting a domestic clinical test of the COVID-19 vaccine before using it is not obligatory, especially if neighboring countries had conducted the clinical test earlier, Andalusia pointed out.

Several types of vaccine have been used in Indonesia without undergoing clinical tests in the country, she stated.

"Remember there have been many types of vaccines before the COVID-19 pandemic, and only a few of them underwent clinical tests in Indonesia," she remarked.

The BPOM spokesman noted that clinical tests of the influenza and polio vaccines were not conducted in Indonesia, although the vaccines are produced by state-owned pharmaceutical firm Bio Farma.

Executive Director of the Institute for Food, Drug, and Cosmetic Studies at the Indonesian Ulemas Council (LPPOM MUI) Muti Arintawati said he is yet unable to ascertain whether the Sinovac vaccine is halal since other information was awaited.

The LPPOM MUI is not passive to receive vaccine information, while on the contrary, its auditors have intensively studied raw materials for production of the vaccine through literature, journals, and experts’ information, he stated.

"If the information is complete, the MUI will still await BPOM's decision on safety and efficacy to decide whether to issue a halal certificate," he added.

Source: Antara News

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