DOH-6 warns public on unauthorized mpox vaccines

By Mariela Angella Oladive

The Department of Health (DOH) Region 6 issued a public advisory on Friday, Sept. 13, warning against unauthorized mpox vaccines being imported and offered by various organizations and individuals.

According to the DOH, these vaccines are entering the country without the necessary regulatory approval from the Food and Drug Administration (FDA).

The advisory emphasized the risks of using these vaccines, as they have not undergone the safety and efficacy checks required for legal vaccines.

“Mpox vaccines require certain storage and handling conditions, such as maintaining the cold chain. Without DOH and FDA safeguards, there is no assurance of safety and efficacy,” the advisory said.

The DOH urged the public to wait for the official release of authorized mpox vaccines to ensure they receive legitimate and safe products.

“It is better to get mpox vaccines in the Philippines once they are legally available to ensure that you are receiving real, safe, and effective vaccines—not just a false sense of security,” it added.

The warning comes amid growing global attention on mpox, formerly known as monkeypox.

The viral disease, caused by the monkeypox virus, presents symptoms such as skin rashes or mucosal lesions and spreads through direct contact with lesions, respiratory secretions, or contaminated objects like bedding or clothing.

Earlier, the DOH logged 15 confirmed mpox cases. Fourteen of the cases are males, and one is female. Eleven cases are from the National Capital Region, three from Calabarzon, and one from Cagayan Valley. Fourteen cases remain active and are in home isolation.

The public is encouraged to stay updated through the DOH’s official social media accounts and website to avoid falling victim to illegal vaccine offers.

MVA-BN VACCINE

Meanwhile, the World Health Organization (WHO) has announced the MVA-BN vaccine as the first mpox vaccine to be added to its prequalification list.

However, its use is currently limited, varying by country.

The prequalification approval is expected to facilitate timely and increased access to this critical product in communities with urgent needs, helping to reduce transmission and contain outbreaks.

WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency, the regulatory body for this vaccine.

“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in the future,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus.

“We now need urgent scale-up in procurement, donations, and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission, and save lives.”

The MVA-BN vaccine can be administered to people over 18 years old as a two-dose injection given four weeks apart. After cold storage, the vaccine can be kept at 2–8°C for up to eight weeks.

“The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of mpox vaccines by governments and international agencies, such as Gavi and UNICEF, to assist communities on the frontlines of the ongoing emergency in Africa and beyond,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

“This decision can also help national regulatory authorities fast-track approvals, ultimately increasing access to quality-assured mpox vaccines.”

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed available evidence and recommended the use of the MVA-BN vaccine during mpox outbreaks for persons at high risk of exposure.

While the vaccine is currently not licensed for individuals under 18, it may be used “off-label” in infants, children, adolescents, pregnant women, and immunocompromised individuals in outbreak settings, where the benefits outweigh potential risks.

WHO also recommends a single-dose administration in supply-constrained outbreak situations.

Data shows that a single-dose MVA-BN vaccine given before exposure has an estimated 76% effectiveness in protecting against mpox, while the two-dose schedule achieves around 82% effectiveness.

Vaccination after exposure is less effective than pre-exposure vaccination.

The MVA-BN vaccine has shown a good safety profile and performance in clinical studies and real-world use during the ongoing global outbreak since 2022.

As new virus strains emerge, it remains crucial to collect data on vaccine safety and effectiveness in different contexts.

Since the WHO Director-General triggered the emergency use listing for mpox vaccines on Aug. 7, 2024, the organization has conducted product and programmatic suitability assessments of the MVA-BN vaccine.

“These findings are particularly relevant in the context of the declaration of a Public Health Emergency of International Concern (PHEIC) due to the rise of mpox cases in Africa,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification.

“We are progressing with prequalification and emergency use listing procedures for two other mpox vaccines: LC-16 and ACAM2000. So far, we have also received six expressions of interest for mpox diagnostic products under the emergency use listing.” (With a report from WHO)