| Editorial staff
|
22.09.2024
Approval by the European Commission is still pending, but a corresponding recommendation has now been received by the authority for review. The new vaccine is adapted to the KP.2 variant, which is particularly prevalent in early summer, but should also offer increased protection against the virus type that is currently prevalent.
Between May and July of this year, KP.2 was the predominant variant of the coronavirus; the seven-day incidence at that time was approximately between 200 and 300 cases per 100,000 inhabitants. KP.2 has since been replaced by KP.3.1.1 as the dominant variant in this country.
While BioNTech and Pfizer are certainly already working on a vaccine tailored to this purpose, the companies have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has now initially given a positive assessment for the marketing authorization of their product adapted from Omikron KP.2.
Approval is still pending
The CHMP’s recommendation was made on September 19 and is based “on non-clinical data and data from the manufacture of the vaccine adapted to Omikron KP.2, as well as data from clinical and practical use, which demonstrated the safety and efficacy of the previous COVID-19 vaccines from Pfizer and BioNTech.” Nevertheless, risks and side effects exist, which must be weighed up personally and possibly under medical advice.
It is now up to the European Commission (EC) to examine the recommendation. Once approved, the vaccine, called Comirnaty KP.2, will be available for use by people aged six months and over throughout the EU, “although availability will depend on demand from individual national governments and will vary according to national recommendations.”
“Significantly better immune response”
The non-clinical data underlying the CHMP’s recommendation confirm that the vaccine adapted to Omikron KP.2 provides “a significantly better immune response against several currently circulating Omikron JN.1 sublines” compared to the COVID-19 vaccine from BioNTech and Pfizer adapted to Omikron XBB.1.5. In addition to KP.2, LB.1 and KP.3, the currently rampant KP.3.1.1.1 variant is also mentioned in this context.
BioNTech is based in Mainz and generated sales of over 3.8 billion euros last year. The Comirnaty vaccines are based on the company’s own mRNA technology and were jointly developed with the US pharmaceutical company Pfizer.
The Ugur Sahin and Ozlem Tureci The company, founded in 1997, holds marketing authorization for Comirnaty and “variant-adapted vaccines in the United States, the European Union, the United Kingdom” and several other countries.
