The Use Of Mpox Vaccine In Indonesia Has Been Approved By WHO And BPOM

Illustration of the vaccine (ANTARA)

Spokesperson for the Indonesian Ministry of Health, dr. Mohammad Syahril said the use of the Mpox vaccine in Indonesia had received approval from WHO and BPOM, and was not an experimental vaccine, so it could be given in a health emergency situation.

Syahril mentioned this as a response to the narrative claiming that the Mpox vaccine prepared was an experimental vaccine. In fact, the claim was accompanied by an invitation for the public to reject the Mpox vaccine. According to him, the claim was wrong.

The Mpox vaccine has received Emergency Use Listing (EUL) from WHO (World Health Organization) and Emergency Use Authorization (EUA) from BPOM (Food and Drug Supervisory Agency), which means this vaccine can be used in emergency conditions, Syahril was quoted by ANTARA, Thursday, September 12.

In carrying out vaccinations, he said, the National Commission for Post-Immunization Follow-up Events (Komnas KIPI) also monitors security and ensures the benefits of administering the Mpox vaccine as an effort to prevent the transmission of the Mpox virus (MPXV).

Currently, he said, the Mpox vaccine used in Indonesia is the third generation Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine (smallpox) which is non-replicating.

"The implementation of the Mpox vaccination with MVA-BN has been carried out since 2023," he said, after the Mpox confirmation case was found in Indonesia.

He referred to a WHO document entitled "Weekly Epidemiological Record: Smallpox and Mpox (Orthopoxviruses) Vaccine Position Paper" published on August 23, 2024, there are three vaccines that can be used to prevent Mpox.

These three vaccines, he said, were originally for smallpox prevention, but later developed and expanded their use for Mpox prevention.

First, the MVA-BN. The vaccine was approved in 2013 for smallpox prevention in Canada and the European Union targeting groups of people aged 18 years and over. In 2019, the MVA-BN was approved to prevent smallpox and Mpox in adults in the United States.

In the same year, Canada expanded the MVA-BN to prevent Mpox. On July 22, 2022, the European Union approved the MVA-BN for the prevention of Mpox in adults. The MVA-BN is not licensed for people under the age of 18.

Second, LC16m8. He explained, in Japan, LC16m8 was licensed in 1975 for smallpox without age and expanded to prevent Mpox in August 2022. The LC16m8 used is the third generation smallpox vaccine.

Third, ACAM2000. Syahril added that this second-generation smallpox vaccine was approved by the United States Food and Drug Administration (FDA) for smallpox immunizations since 2007. In 2024, this vaccine was approved to prevent Mpox under the Expansive New Access Drug Investigation protocol (Expanded Access Investigation New Drug).

According to an expert review from a journal entitled Vaccines against mpox: MVA-BN and LC16m8 published in Taylor & Francis Online on September 1, 2024, he said, the probability of MVA-BN to reduce Mpox disease is 62 percent to 85 percent. In people who have been exposed to Mpox, MVA-BN reduces the risk of disease by 20%.

Based on the results of clinical trials, he added, LC16m8 provides protection against the Mpox virus. MVA-BN and LC16m8 consistently develop neutralizing antibody responses to orthopoxvirus, including the MPXV Clade I.

Furthermore, said Syahril, the ACAM2000 efficacy obtained from animal model studies found that the ACAM2000 vaccine was effective against the MPXV virus when compared to unvaccinated control groups.