WHO, BPOM Approve Mpox Vaccine For Indonesia, Says Health Ministry

JAKARTA, Sept 12 (Bernama-ANTARA) -- The World Health Organisation (WHO) and the Food and Drug Authority (BPOM) have approved the use of the mpox vaccine in Indonesia, according to the Ministry of Health.

These vaccines are not experimental and can be administered during health emergencies, said Mohammad Syahril, the ministry's spokesperson, in a statement on Thursday, reported ANTARA.

He made this statement in response to claims that the mpox vaccine being prepared was experimental, with some even urging the public to reject it. Syahril refuted this claim.

"The mpox vaccine has received Emergency Use Listing (EUL) from WHO and Emergency Use Authorisation (EUA) from BPOM, meaning it is approved for use in emergency situations," he clarified.

He added that the National Commission for Adverse Events Following Immunisation (Komnas KIPI) monitors safety and ensures the benefits of administering the vaccine to prevent transmission of the mpox virus (MPXV).

The mpox vaccine currently in use in Indonesia is the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), a third-generation non-replicating smallpox-derived vaccine.

Mpox vaccinations using the MVA-BN vaccine have been administered since 2023, following confirmed cases of mpox in Indonesia.

Syahril referenced the WHO document "Weekly Epidemiological Record: Smallpox and Mpox (Orthopoxviruses) Vaccine Position Paper", published on Aug 23, which lists three vaccines that can be used for mpox prevention.

He noted that these three vaccines were initially developed to prevent smallpox but were later expanded for use in preventing mpox.

The first vaccine, MVA-BN, was approved in 2013 for smallpox prevention in Canada and the European Union, targeting individuals aged 18 and over. In 2019, it was also approved for smallpox and mpox prevention in adults in the United States.

That same year, Canada expanded MVA-BN’s use to include mpox prevention. On July 22, 2022, the European Union approved it for mpox prevention in adults. MVA-BN is not licensed for use in individuals under 18.

The second vaccine, LC16M8, was licensed in Japan in 1975 for smallpox without age restrictions and was expanded for mpox prevention in August 2022. LC16M8 is a third-generation smallpox vaccine.

The third vaccine, ACAM2000, is a second-generation smallpox vaccine approved by the US Food and Drug Administration (FDA) for smallpox immunization since 2007.

In 2024, ACAM2000 was approved for mpox prevention under the Expanded Access Investigational New Drug protocol.

Syahril also cited an expert review of the journal "Vaccines Against Mpox: MVA-BN and LC16M8" on Sept 1, which found that MVA-BN can reduce the risk of mpox by 62 per cent to 85 per cent. Among those already exposed to mpox, it reduces the risk by 20 per cent.

He added that clinical trials show LC16M8 provides protection against mpox. Both MVA-BN and LC16M8 consistently generate neutralising antibody responses against orthopoxviruses, including Clade I MPXV.

Syahril also mentioned that animal model studies found ACAM2000 to be effective in combating the mpox virus when compared to unvaccinated control groups.

-- BERNAMA-ANTARA