The WHO has given its authorisation to a first vaccine to protect against mpox, the decision announced so hastily last Friday that the head of the company producing the jab was also caught unawares.
The vaccine from Danish pharmaceutical-maker Bavarian Nordic has been approved in Europe as well as the US and other high-income countries since a global mpox outbreak in 2022, reports The New York Times. But low- and middle-income countries rely on the WHO through the prequalification process that determines which drugs, vaccines and health technologies are safe, and efficient uses of limited health funding.
Until now, the WHO had declined to act, but has come under increasing criticism for declaring a global public health emergency for mpox last month without giving a vaccine that prequalification stamp of approval, or emergency use authorisation.
Bavarian Nordic first submitted its safety and effectiveness data on the vaccine – Jynneos – to the agency in 2023, which has defended its slow pace of review. It said it needed to subject the shot to scrutiny because it, and two others that have been used to protect against mpox, were originally designed as smallpox immunisations, and because delivery in low-resource settings like Central Africa would involve factors different from those relating to their use in high-income countries.
But on Friday morning, the WHO suddenly announced it was green-lighting the shot.
“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,” said Dr Tedros Adhanom Ghebreyesus, director-general of the agency.
Paul Chaplin, Bavarian Nordic’s CEO, said he was among the many who had been caught off guard.
“We’ve got there eventually – I don’t know quite how,” he said. “But it’s good news. It’s going to make the regulatory pathway much easier.”
No vaccines have yet been publicly administered in the Congo.
About 245 000 donated shots, from the European Union, the United States and Bavarian Nordic, began to arrive in the capital, Kinshasa, last week, which the Congolese Government has said it hoped to begin to distribute by 2 October.
In its announcement, the WHO said that it was authorising the vaccine for adults but that it could be used at the discretion of healthcare providers for children and adolescents under 18.
More than half of the mpox cases in Congo this year have been in children, according to Unicef. The WHO’s expert committee on vaccination said last month that the benefits of using the vaccine for children at high risk of exposure outweighed the risk.
In late August, the WHO had instructed Gavi, which funds vaccines for low-income countries, and Unicef, which procures the shots, to issue a tender for mpox vaccines even before the emergency use licence had been considered by its experts.
Bavarian Nordic submitted a bid, Chaplin said, and could supply 2m doses this year and an additional 11m in 2025. The Africa CDC said that as many as 10m doses could be required to respond to the outbreak that now involves more than a dozen African countries, including Burundi and Uganda, which have never before reported mpox.
The vaccine must be given in two shots for strongest protection, although use of a single shot should be considered in emergency situations where supply is constrained.
Earlier, the DRC vaccine response chief Cris Kacita told Reuters that the vaccination campaign will last 10 days and target only adults, including healthcare professionals, park rangers and sex workers in Congo’s six provinces.
He has previously said that work was ongoing to combat mistrust of the vaccine in some communities and to manage the logistical challenge of rolling out the programme across six provinces in a country the size of Western Europe.
The DRC had received, in total 265 000 donated doses from the United States and the European Union, he added, but these would not be enough to cover many areas in the central African country. “There have been promises from France and Belgium, and the number of doses is expected to be known soon.”
Japan has promised to donate 3.5m doses, but discussions were still continuing, while this week, Canada also offered support, saying it was working with the WHO and GAVI to deliver “up to 200 000” doses of the vaccine, a government spokesperson said.
The number of doses of the vaccine Imvamune will depend on the receiving countries’ capacity for storage and administration, a spokesperson for Canada’s international development minister told Reuters.
Canada would not say to whom it would deliver the vaccines, or in what time frame, but said more details would be provided once a delivery timeline had been finalised.
Health Canada has previously refused to say how many mpox vaccine doses the country has, “for national security reasons”, saying only that the country “has secured sufficient supply of vaccines to support provincial and territorial programmes for the prevention and control of mpox in Canada”.
Based on previous years’ announcements from Bavarian Nordic, Adam Houston, medical policy and advocacy adviser for Médecins Sans Frontières Canada, estimates that Canada has, at a conservative estimate, more than 2m doses of mpox vaccine.
“We'd like to see Canada first be more transparent about its own supplies and its own needs,” Houston said before news of the donation was made public. “And then we'd like to see transparency on its plans for what it's going to do with these vaccines. We think the priority is that vaccines should be shared.”
Reuters article – Canada to donate ‘up to 200 000’ doses of mpox vaccine (Open access)
See more from MedicalBrief archives:
Africa still awaiting mpox jabs from the West, despite promises
Urgent global action needed stop Mpox pandemic