Cape Times

Mpox vaccine access set to speed up as WHO approves first jab

THE WORLD Health Organizati­on (WHO) said on Friday that it had for the first time prequalifi­ed an mpox vaccine – a move expected to speed up access to the jabs to fight an epidemic raging in Africa. The announceme­nt came on the heels of the arrival of the first MVA-BN vaccines in the Democratic Republic of Congo, the epicentre 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 future,” WHO chief Tedros Adhanom Ghebreyesu­s said in a statement.

“We now need urgent scale-up in procuremen­t, donations and roll-out to ensure equitable access to vaccines where they are needed most … to prevent infections, stop transmissi­on and save lives.”

WHO's prequalifi­cation listing is used to evaluate the quality, safety and efficacy of medical products such as vaccines, paving the way for the UN and other internatio­nal agencies to procure them.

The list is also used by lower-income countries without the means to carry out their evaluation­s to fasttrack procuremen­t approvals.

“The WHO prequalifi­cation of the MVA-BN vaccine will help accelerate ongoing procuremen­t of the mpox vaccines by government­s and internatio­nal agencies … on the front lines of the ongoing emergency in Africa and beyond,” said Yukiko

Nakatani, WHO's assistant chief in charge of access to medicines and health products.

Mpox is caused by a virus transmitte­d to humans by infected animals, but can also be passed from human to human through close physical contact.

It causes fever, muscular aches and large boil-like skin lesions, and can be deadly in some cases.

The WHO declared an internatio­nal emergency over mpox last month, concerned by the surge in cases of the new Clade 1b strain in the DRC that spread to nearby countries. The DRC has recorded nearly 22 000 cases and 716 deaths linked to the virus since January.

So far, some 200 000 vaccine doses have been delivered to the

DRC by the EU, along with about 50 000 from the US.

The WHO said it had based its prequalifi­cation assessment on informatio­n submitted by the manufactur­er of the MVA-BN vaccine, Bavarian Nordic A/S, and a review by the European Medicines Agency.

“Good safety profile and vaccine performanc­e has been consistent­ly demonstrat­ed in clinical studies, as well as in real-world use,” it said. According to the prequalifi­cation, the vaccine can be administer­ed to people over the age of 18 as a two-dose injection given four weeks apart.

With a majority of mpox cases and deaths in the DRC in children, the WHO stressed that the vaccine could be used “off-label” in infants, children and adolescent­s, as well as in pregnant and immuno-compromise­d people.

“This means vaccine use is recommende­d in outbreak settings where the benefits of vaccinatio­n outweigh the potential risks,” the WHO said.

The agency also recommends single-dose use in outbreak settings where the supply of the vaccine is constraine­d, although it stressed that more data was needed on vaccine safety and effectiven­ess in such circumstan­ces.

The currently available data, it said, shows that a single dose of the MVA-BN vaccine given before exposure has an estimated 76% effectiven­ess in protecting against mpox, while two doses are estimated to be 82% effective.