Bavarian Nordic A/S applies for EU label extension of mpox vaccine

After Africa CDC declared on 13 August a Public Health Emergency of Continental Security due to an mpox outbreak followed by a recent WHO warning, Bavarian Nordic A/S said it will donate 40,000 doses of its smallpox and mpox vaccine Imvanex to the European Commission’s Health Emergency Preparedness and Response Authority HERA committed donate 175,420 doses of the MVA-BN^® vaccine as an immediate response to the mpox outbreak in Africa. According to Q1/24 figures, the EU Commission has already stockpiled Imvanex for €65m for supply of smallpox vaccine to rescEU, the EU strategic reserve, in 2025. However, revenues with the vaccine, that is approved in the EU, the US, Canada and Switzerland, went down compared to the record Q1/2023 from DKK848m to DKK344 in Q1/2024.

Now, Bavarian Nordic now published data supporting a label extension application at the EMA that support label extension of its mpox vaccine Imvanex that is marketed in Europe and the US for adults  to include adolescents 12 to 17 years of age. The application follows an US FDA Emergency Use Authorization for use in adolescents during the 2022 global mpox outbreak.

The EMA submission is based on interim results from an ongoing study sponsored by the US National Institutes of Allergy and Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, demonstrating non-inferiority of the immune responses as well as a similar safety profile, between both age groups after vaccination with two standard doses of the MVA-BN vaccine.

Bavarian Nordic said it expects an EMA recommendation by Q4/2024. The vaccine maker is currently preparing a clinical trial to assess immunogenicity and safety of MVA-BN in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations. The study  is planned to be started in the Democratic Republic of Congo and Uganda later this year, potentially also supporting a regulatory approval of MVA-BN in African countries.

The new variant of the clade I Mpox virus continues to spread in Africa. The Democratic Republic of Congo the worst affected country, but cases are being reported in more and more other African countries. The WHO emergency  committeethis week declared the African mpox outbreak as an emergency of international concern.

Previously, the Africa CDC declared a state of emergency across the African continent. According to the latest figures, 2,863 people have fallen ill in Africa, with 517 deaths. However, experts suspect that the number of unreported cases is significantly higher, as diagnostic options are limited in many African countries. Dr Jean Kaseya, Director of the Africa CDC, pointed out that this is not just an African problem: ‘The fight against Mpox requires a global response. We need your support, your expertise and your solidarity. The world cannot afford to turn a blind eye to this crisis.’

Clade I is reported to be more easily transmitted than the previous variant of Clade II as it can be transferred nonsexually direct and indirect physical contact. Infected people may fall more seriously ill and mortality is higher, particularly in children. However due limited access to medical care and limited capacities in laboratory diagnostics, statements on mortality and icanfectivity of Clade I compared to Clade II are still difficult. That is also the reason for the WHO was unable to calculate  the R-value.

In the Northern hemisphere transmission is possible through travel-associated infections, but  further spread is conceivable, epidemiolists told European Biotechnology.  In contrast to the African continent, there is a sufficient number of diagnostic laboratories for the monkeypox virus so that the incidence of infection can be well contained thanks to vaccinations, but these are mostly lacking in African countries.vNevertheless, intensive monitoring and typing of Mpox infections remains crucial in order to be able to react quickly.

According to GlobalData, additionally, KM Biologics’ LC16 vaccine is available in Japan and Emergent BioSolutions’ ACAM2000, which has shown side-effects that limit its target group as a smallpox vaccine, is also under regulatory review for mpox in the US.

The results of a Phase I dose escalation study launched in September 2023 by the German mRNA vaccine specialist BioNTech SE and supported by CEPI with the BNT-166 vaccine programme directed against three or four mpox antigens (A35, B6, M1 with or without H3) have not yet been published. Nevertheless, the Coalition for Epidemic Preparedness Innovations (CEPI) seems optimistic. In addition to the US$90m in funding already provided to support this and other studies on mRNA vaccines, CEPI pledged a further US$145m in May 2024 to support BioNTech in expanding its modular BioNtainer production facility in Kigali (Rwanda). The aim is to establish an ecosystem for vaccine production in Africa. The capacities of the production unit inaugurated in December 2023 should enable a better response to epidemic and pandemic threats in Africa.