• Sunday, 22 December 2024

The Ministry of Health: MPOX Vaccine Has Been Approved by WHO and BPOM

The Ministry of Health: MPOX Vaccine Has Been Approved by WHO and BPOM
Mpox cases. (WHO)

SEAToday.com, Jakarta - Indonesian Ministry of Health Spokesperson Dr. Mohammad Syahril said the use of the Mpox vaccine in Indonesia has received approval from WHO and BPOM, and is not an experimental vaccine, so it can be given in health emergency situations.

In a statement received by on Thursday (9/12), Syahril said this in response to a narrative claiming that the Mpox vaccine being prepared is an experimental vaccine. In fact, the claim was accompanied by an invitation for the public to reject the Mpox vaccine. According to him, this claim is wrong.

“The Mpox vaccine has received an Emergency Use Listing (EUL) from WHO (World Health Organization) and an Emergency Use Authorization (EUA) from BPOM (Food and Drug Administration), which means that this vaccine can be used in emergency conditions,” Syahril said.

During the implementation of vaccination, he said, the National Commission for Post-Immunization Adverse Events (Komnas KIPI) also monitors the safety and ensures the benefits of administering the Mpox vaccine as an effort to prevent transmission of the Mpox virus (MPXV).

Currently, he said, the Mpox vaccine used in Indonesia is the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) type, which is a third-generation smallpox-derived vaccine that is non-replicating. The implementation of Mpox vaccination with MVA-BN has been carried out since 2023, he said, after a confirmed case of Mpox was found in Indonesia.

He referred to the 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 for Mpox prevention.

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

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

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

Second, LC16m8. He explained that in Japan, LC16m8 was licensed in 1975 for smallpox without age restriction and was extended for Mpox prevention in August 2022. The LC16m8 used is the third generation smallpox vaccine.

The third is ACAM2000. Syahril added that this second-generation smallpox vaccine has been approved by the US Food and Drug Administration (FDA) for smallpox immunization since 2007. In 2024, this vaccine was approved to prevent Mpox under the Expanded Access Investigational New Drug protocol.

According to an expert review of the journal titled, “Vaccines against mpox: MVA-BN and LC16m8” published in Taylor & Francis Online on September 1, 2024, he said, the probability of MVA-BN reducing Mpox disease is 62 percent to 85 percent. In people already exposed to Mpox, MVA-BN reduces the risk of disease by 20%.

Based on clinical trial results, he added, LC16m8 provides protection against the Mpox virus. MVA-BN and LC16m8 consistently developed neutralizing antibody responses against orthopoxviruses, including Clade I MPXV.

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

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