Green light from the European Medicines Agency, the vaccine will be shipped to the Member States of the European Union that have specifically ordered this formulation
The European Medicines Agency EMA also gave the green light to Pfizer-BioNTech mRNA Covid vaccine updated for KP.2 variant. The Committee for Medicinal Products for Human Use (CHMP) expressed a positive opinion to Comirnaty* in the monovalent version targeting the Omicron KP.2 variant of Sars-CoV-2 during its last meeting, on 16-19 September, and the EU regulatory body announced it today. The European Commission, explain the companies Pfizer and BioNTech in a note, “will examine the recommendation of the CHMP and is expected to make a final decision soon” on the marketing authorization. Following this final step, “the KP.2-adapted Covid vaccine will be shipped to the European Union Member States that have specifically ordered this formulation.” It should be remembered that in July the version of the Pfizer-BioNTech vaccine targeting the JN variant had already been authorized in the EU.
1 (progenitor of the family of Covid variants to which KP.2 also belongs).
The CHMP recommendation of September 19, the companies explain, is based on nonclinical and manufacturing data from the Omicron KP.2-adapted vaccine and on clinical and real-world evidence supporting the safety and efficacy of previous formulations of the Pfizer-BioNTech vaccines. Nonclinical data showed that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, compared to the older XBB.1.5-adapted vaccine. Once the European Commission’s final decision is received, “both the KP.2-adapted and JN.1-adapted vaccines will be available across the EU,” the companies continue, “although availability will vary based on individual national government requests and national recommendations.”
As he explains to Adnkronos Salute Marco Cavaleri, who is responsible for the Health Risks Department at the European Medicines Agency (EMA) and chairs the Emergency Task Force (Etf), it was decided to also approve the vaccine aimed at KP.2 following “the request of Pfizer/BioNTech”, and “in case some EU country wanted to use this too”.
Moreover, the latest EMA ETF document on Covid vaccines, published in July, confirmed the indication to adapt vaccines by targeting the JN.1 family of Omicron subvariants, to ensure cross-reactivity against the dominant strain (JN.1) and emerging strains and increase the breadth of immunity against descendant lineages. But it also specified that vaccines for specific JN.1 subvariants could be considered. In Usa the FDA’s choice, for example, ultimately fell on vaccines against KP.2. The EMA ETF had reasoned that the KP.2 variant, which is part of the Sars-CoV-2 variants sometimes called FLiRT variants, is a closely related descendant of JN.1, from which it differs by a few mutations. And the experts also considered that KP.2 may no longer be among the dominant variants in the fall. Now in the EU, after the EC’s approval, both options will be available.