Vaccine procurement steps up amid mpox resurgence
A few weeks after the World Health Organisation (WHO) declared the resurgence of mpox on 14 August as a public health emergency of international concern requiring a coordinated international response, an emergency tender for the procurement of vaccines was issued.
According to the organisation's latest epidemiological report for the period from January to 8 September, the countries most affected are Burundi and the Democratic Republic of the Congo (DRC).
Meanwhile, the WHO has declared the MVA-BN vaccine as the first vaccine against mpox to be placed on its pre-qualification list.
Approval for pre-qualification is expected to ensure increased access to the product, particularly in communities with an urgent need to reduce transmission in order to contain the outbreak.
According to the WHO, its evaluation for pre-qualification is based on information issued by the manufacturer Bavarian Nordic A/S and reviewed by the European Medicines Agency, the regulatory agency for the vaccine.
“A rapid, coordinated and equitable response is critical to prevent the current monkeypox emergency and future outbreaks,” said Dr Maria van Kerkhove, the WHO’s incident manager for the global mpox response and acting director for epidemic and pandemic preparedness and prevention.
“We all need to act decisively now, or we risk allowing monkeypox to spread further and become an even greater global threat.”
She explained: “The emergency tender is designed to ensure immediate access to available vaccines against monkeypox and to expand production. Depending on demand, the production capacity of manufacturers, and funding, agreements for up to 12 million doses may be put in place by 2025.”
Off-label use
The MVA-BN vaccine can be administered to individuals over the age of 18 in two doses, which are injected four weeks apart.
According to the WHO's strategic advisory group of experts (SAGE) on immunisation, the MVA-BN vaccine can be used in the context of an mpox outbreak for individuals at high risk of exposure.
Currently, the vaccine is not licensed for individuals under 18, but it can be used “off-label” for infants, children and teenagers, as well as pregnant women and individuals with weakened immune systems. This means the vaccine can be used in outbreaks where the benefits of immunisation outweigh the potential risks.
The WHO’s Access and Allocation Mechanism (AAM) will increase access to vaccines, treatments and diagnostic tests for residents at the highest risk and ensure that limited supplies are used equitably and efficiently.
To date, 3.6 million doses of vaccines have been pledged in response to the mpox outbreak. This includes 620 000 doses of the MVA-BN vaccine and three million of the LC16 vaccine.
Unicef previously announced that it has issued an emergency tender for the procurement of vaccines against mpox to help secure vaccines for countries most affected by the outbreaks, including the DRC.
In collaboration with partners such as Gavi and the Vaccine Alliance, the goal is to increase access and work together to facilitate donations of vaccines from existing supplies in high-income countries to stop the continued transmission of mpox.
Under the emergency tender, Unicef will establish conditional supply agreements with vaccine manufacturers to enable Unief to procure and distribute vaccines without delays as soon as countries and partners have secured funding, confirmed demand and readiness, and the regulatory requirements for accepting the vaccines are in place.
According to the organisation's latest epidemiological report for the period from January to 8 September, the countries most affected are Burundi and the Democratic Republic of the Congo (DRC).
Meanwhile, the WHO has declared the MVA-BN vaccine as the first vaccine against mpox to be placed on its pre-qualification list.
Approval for pre-qualification is expected to ensure increased access to the product, particularly in communities with an urgent need to reduce transmission in order to contain the outbreak.
According to the WHO, its evaluation for pre-qualification is based on information issued by the manufacturer Bavarian Nordic A/S and reviewed by the European Medicines Agency, the regulatory agency for the vaccine.
“A rapid, coordinated and equitable response is critical to prevent the current monkeypox emergency and future outbreaks,” said Dr Maria van Kerkhove, the WHO’s incident manager for the global mpox response and acting director for epidemic and pandemic preparedness and prevention.
“We all need to act decisively now, or we risk allowing monkeypox to spread further and become an even greater global threat.”
She explained: “The emergency tender is designed to ensure immediate access to available vaccines against monkeypox and to expand production. Depending on demand, the production capacity of manufacturers, and funding, agreements for up to 12 million doses may be put in place by 2025.”
Off-label use
The MVA-BN vaccine can be administered to individuals over the age of 18 in two doses, which are injected four weeks apart.
According to the WHO's strategic advisory group of experts (SAGE) on immunisation, the MVA-BN vaccine can be used in the context of an mpox outbreak for individuals at high risk of exposure.
Currently, the vaccine is not licensed for individuals under 18, but it can be used “off-label” for infants, children and teenagers, as well as pregnant women and individuals with weakened immune systems. This means the vaccine can be used in outbreaks where the benefits of immunisation outweigh the potential risks.
The WHO’s Access and Allocation Mechanism (AAM) will increase access to vaccines, treatments and diagnostic tests for residents at the highest risk and ensure that limited supplies are used equitably and efficiently.
To date, 3.6 million doses of vaccines have been pledged in response to the mpox outbreak. This includes 620 000 doses of the MVA-BN vaccine and three million of the LC16 vaccine.
Unicef previously announced that it has issued an emergency tender for the procurement of vaccines against mpox to help secure vaccines for countries most affected by the outbreaks, including the DRC.
In collaboration with partners such as Gavi and the Vaccine Alliance, the goal is to increase access and work together to facilitate donations of vaccines from existing supplies in high-income countries to stop the continued transmission of mpox.
Under the emergency tender, Unicef will establish conditional supply agreements with vaccine manufacturers to enable Unief to procure and distribute vaccines without delays as soon as countries and partners have secured funding, confirmed demand and readiness, and the regulatory requirements for accepting the vaccines are in place.
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