The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on Thursday 19 September authorised the use of the vaccine for adolescents Bavarian Nordic against the mpox virus (IMVANEX).
This recommendation is based on interim results from a study that showed that adolescents had a similar immune response to the vaccine as adults. This expansion of the therapeutic indications is important because adolescents are particularly vulnerable to the disease if they become infected.
Until now, the vaccine could only be used for this category of the population when the benefits of vaccination outweighed the potential risks.
On September 13, the World Health Organization (WHO) announced that the vaccine was part of its prequalification, a milestone that led the Global Alliance for Vaccines and Immunization (Gavi) to pre-purchase 500,000 doses of IMVANEX, also known as JYNNEOS. They will be delivered through Gavi partner UNICEF.
The WHO supports the use of a single dose rather than two doses, with data showing that a single dose provides 76% protection against MPOX. The move is expected to allow the vaccine to be more widely distributed, given limited supplies.
New drugs for Covid-19 and cancer
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has approved two mRNA Covid-19 vaccines (Spikevax and Comirnaty), updated to target the JN.1 variant and the KP.2 substrain. The EMA had recommended these changes in July.
The CHMP also supports the approval of eight new medicines, as well as the extension of the therapeutic use of eleven others.
This list includes cancer drugs (Elahere for ovarian cancer, Hetronifly for small cell lung cancer, Pomalidomide Teva for a rare bone marrow cancer), two biosimilar drugs for age-related macular degeneration (Afqlir and Opuviz) and a drug for treating two types of haemophilia (Hympavzi).
The next CHMP meeting is scheduled for 14-17 October.
[Édité par Anna Martino]
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