Geneva, Switzerland:
The WHO said on Friday it has prequalified an MPox vaccine for the first time – a move expected to speed up access to the jabs to fight an epidemic raging in Africa.
The announcement came shortly after the arrival of the first MVA-BN vaccines in the Democratic Republic of Congo (DRC), the epicenter of the epidemic.
“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,” WHO chief Tedros Adhanom Ghebreyesus said in a statement.
“We now urgently need to scale up procurement, donations and rollout to ensure equitable access to vaccines where they are needed most… to prevent infections, stop transmission and save lives.”
The WHO Prequalification List is used to evaluate the quality, safety and efficacy of medical products such as vaccines, paving the way for the United Nations and other international organizations to purchase them.
The list is also used by lower-income countries that do not have the resources to conduct their assessments to expedite procurement approvals.
“WHO’s prequalification of the MVA-BN vaccine will help accelerate the ongoing procurement of the mpox vaccines by governments and international agencies… on the frontlines of the ongoing emergency in Africa and beyond,” said Yukiko Nakatani, Assistant Chief of the WHO and responsible for access to medicines and health products.
Mpox, formerly known as monkeypox, is caused by a virus transmitted to humans by infected animals, but can also be spread from person to person through close physical contact.
It causes fever, muscle aches and large boil-like skin lesions, and can be fatal in some cases.
The WHO declared an international emergency over mpox last month, concerned about the increase in cases of the new Clade 1b strain in the DRC that was spreading to nearby countries.
The DRC has recorded nearly 22,000 cases and 716 deaths linked to the virus since January.
So far, about 200,000 vaccine doses have been delivered to the DRC by the European Union, along with about 50,000 from the United States.
Safe and effective
The WHO said it based its prequalification assessment on information submitted by the manufacturer of the MVA-BN vaccine, Bavarian Nordic A/S, and on an assessment by the European Medicines Agency.
“A good safety profile and good vaccine performance have been consistently demonstrated in clinical trials, as well as in real-world use,” the report said.
According to the prequalification, the vaccine can be administered to people over 18 years of age as an injection of two doses, four weeks apart.
Because the majority of MPox cases and deaths occur among children in the DRC, WHO emphasizes that the vaccine can be used ‘off-label’ in infants, children and adolescents, as well as in pregnant people and people with weakened immune systems.
“This means that the use of vaccines is recommended in outbreaks where the benefits of vaccination outweigh the potential risks,” the WHO said.
The agency also recommends the use of a single dose in outbreaks where supply of the vaccine is limited, although it stressed that more data on the vaccine’s safety and effectiveness is needed in such circumstances.
Currently available data show that a single dose of the MVA-BN vaccine, administered before exposure, is an estimated 76 percent effective in protecting against MPox, while two doses are an estimated 82 percent effective.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)