WHO said on Friday it had prequalified the mpox vaccine for the first time – a move that is expected to speed up access to the jabs to fight the epidemic spreading 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 pandemic.
“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 outbreak and the future in Africa,” WHO chief Tedros Adhanom Ghebreyesus said in a statement.
“We now need an urgent massive increase in procurement, donation and rollout to ensure equitable access to vaccines where they are needed most…to prevent infection, stop transmission and save lives.”
WHO’s 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 agencies to procure them.
The list is also used by low-income countries without the means to conduct their own evaluations for fast-track procurement approval.
“WHO prequalification of the MVA-BN vaccine will help accelerate the ongoing procurement of mPox vaccines by governments and international agencies…on the frontlines of the ongoing emergency in Africa and beyond,” said Yukiko Nakatani, WHO assistant chief of staff in charge of the MVA-BN vaccine. ” Access to medicines and health products.
Monkeypox, formerly known as monkeypox, is caused by a virus transmitted to humans by infected animals, but can also spread from human to human through close physical contact.
It causes fever, muscle pain and skin lesions like large boils, and in some cases can be fatal.
WHO declared an international emergency over Mpox last month, concerned by a surge in cases of the new clade 1b strain in the DRC that has spread to surrounding 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
WHO said it had based its prequalification assessment on information submitted by the MVA-BN vaccine’s manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency.
“The good safety profile and performance of the vaccine have been consistently demonstrated in clinical studies as well as in real-world use,” it said.
According to prequalification, the vaccine can be given to people above 18 years of age as a two-dose injection given four weeks apart.
Given the majority of MPox cases and deaths in children in the DRC, WHO stressed that the vaccine can be used “off-label” in infants, children and adolescents, as well as in pregnant and immunocompromised people .
“This means that the vaccine is recommended for use in outbreak situations where the benefits of vaccination outweigh the potential risks,” WHO said.
The agency also recommends single-dose use in outbreak situations where vaccine supplies are constrained, though it stressed that more data are needed on the vaccine’s safety and effectiveness in such circumstances.
It said currently available data shows that one dose of MVA-BN vaccine given before exposure is estimated to be 76 percent effective in protecting against mpox, while two doses are estimated to be 82 percent effective.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
