GLOBAL — Pfizer Inc. and BioNTech SE have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for their Omicron KP.2-adapted monovalent COVID-19 vaccine, COMIRNATY.

This newly developed vaccine is intended for active immunisation against COVID-19 caused by SARS-CoV-2, the virus that causes the disease, and will be used for those aged 6 months and above.

This advice comes barely a week after Health Canada approved another mRNA vaccine, Moderna’s Spikevax, and Novavax’s protein-based Nuvaxovid.

The most recent Pfizer and Moderna vaccinations are approved for adults and children six months and older, while Novavax is approved for adults and those over 12.

According to the companies’ statement, the current CHMP recommendation, announced on September 19, 2024, is a crucial step in the regulatory process, and the European Commission (EC) is expected to evaluate the advice before making a final decision later.

Pfizer and BioNTech’s Omicron KP.2-adapted vaccination will be supplied to EU member countries that have explicitly requested this formulation if authorised.

The vaccine is intended to help reduce COVID-19 infections, especially considering the virus’s ongoing development.

The CHMP’s recommendation is based on a thorough analysis of non-clinical and manufacturing data and clinical and real-world evidence from earlier Pfizer-BioNTech COVID-19 vaccines.

The non-clinical data demonstrated that the Omicron KP.2-adapted vaccination induces a considerably greater immune response against several circulating Omicron sublineages, such as KP.2, LB.1, KP.3, and KP.3.1.1, as compared to the businesses’ previous Omicron XBB.1.5-adapted vaccine.

Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine received marketing authorisation from the European Commission in July 2024.

The JN.1-adapted vaccine, like the KP.2 variant, elicited a stronger immune response against many Omicron sublineages.

Once the KP.2 version achieves final approval, both the Omicron KP.2 and JN.1-adapted vaccines will be available throughout the EU, however availability may vary based on individual EU member states’ unique requests and recommendations.

On August 22, 2024, the United States Food and Drug Administration (FDA) approved the Omicron KP.2-adapted vaccine for individuals aged 12 and older.

Additionally, emergency use authorisation was granted for younger individuals aged 6 months to 11 years, giving greater protection for children as the epidemic progresses.

Pfizer and BioNTech have declared their intention to study the growing epidemiology of COVID-19 actively.

The firms are prepared to adapt and adjust their vaccination formulae as needed based on regulatory bodies’ most recent data and recommendations.

This constant vigilance ensures that vaccination formulations are effective against novel viral varieties and sublineages.

Pfizer and BioNTech’s COVID-19 vaccines, including the adapted variants, are built on BioNTech’s patented mRNA technology.

BioNTech has marketing permission for COMIRNATY and its adapted vaccines in the EU, the United States, the United Kingdom, and several other countries.

In the United States, the marketing authorisation is shared with Pfizer, and the two companies have emergency use authorisations or equivalents in many other countries.

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