Pfizer and BioNTech’s Omicron New COVID-19 Vaccine Receives CHMP Recommendation

In a significant development in the fight against the ever-evolving COVID-19 virus, Pfizer and BioNTech have received a crucial recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, known as COMIRNATY® Omicron XBB.1.5. This recommendation opens the door for the vaccine's marketing authorization, and it comes with some notable updates.

The CHMP has advised the use of this adapted vaccine as a single dose for individuals aged 5 years and older, regardless of their previous vaccination history. For children between 6 months and 4 years old, it may be administered as part of the primary three-dose vaccination series or as a single dose, depending on their prior vaccination status or SARS-CoV-2 infection history.

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This recommendation reflects the evolving nature of the virus and the need for tailored vaccines to combat specific variants. The Omicron XBB.1.5 variant has presented unique challenges due to its antigenic distance from prior Omicron strains and its continued prevalence as a major cause of COVID-19 cases worldwide.

Pfizer and BioNTech are gearing up for potential increased demand in the fall and winter seasons by proactively manufacturing this adapted vaccine. Once the European Commission (EC) makes its decision following the CHMP's recommendation, the revised vaccine will be swiftly distributed to EU member states.

Albert Bourla, Chairman and CEO of Pfizer, emphasized the urgency of this decision, stating, "It's been nearly a year since many EU citizens were vaccinated against COVID-19, and the improved formulation allows them to receive a vaccine more precisely matched to current sublineages."

Dr. Ugur Sahin, CEO and Co-founder of BioNTech, highlighted the importance of adapting vaccines to address the evolving nature of the virus, especially as COVID-19 is expected to adopt a seasonal pattern. He explained, "The improved COVID-19 vaccination attempts to prevent severe illness and hospitalization."

The CHMP's recommendation is based on a comprehensive assessment of clinical, non-clinical, and real-world safety and efficacy data provided by Pfizer and BioNTech. Also, pre-clinical data showed that the Omicron XBB.1.5-adapted monovalent vaccine works better against multiple XBB sublineages than the previous BA.4/BA.5-adapted bivalent vaccine, making it a stronger defense against the virus.

Notably, Pfizer and BioNTech have also submitted their applications for approval of this adapted vaccine to the FDA for individuals aged 6 months and older. Decisions from the FDA and other global regulatory agencies are expected in the coming days.

Both Pfizer and BioNTech have been at the forefront of the battle against COVID-19, utilizing BioNTech's groundbreaking mRNA technology to develop vaccines that have received emergency use authorizations in the US and various other countries. This latest adaptation underscores their commitment to evolving with the virus and providing effective solutions to protect public health.

As we move forward in the fight against COVID-19, the recommendation for the Omicron XBB.1.5-adapted vaccine represents a crucial step in tailoring our defenses against this ever-changing threat, offering hope for better protection in the upcoming seasons.