Pfizer Inc. (PFE) and BioNTech SE (BNTX) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for their Omicron JN.1-adapted monovalent COVID-19 vaccine. This recommendation marks a significant step in the ongoing efforts to combat the COVID-19 virus, particularly the Omicron variant.
The CHMP has endorsed the approval of Comirnaty JN.1, an Omicron JN.1-adapted monovalent COVID-19 vaccine, for active immunization against COVID-19 in individuals aged six months and older. This decision follows recommendations from the World Health Organization (WHO) Technical Advisory Group and the European Medicines Agency’s Emergency Task Force (ETF), which advised updating COVID-19 vaccines to a monovalent JN.1 composition for the 2024-2025 vaccination season.
The CHMP’s positive opinion is grounded in a comprehensive body of clinical, non-clinical, and real-world evidence that underscores the safety and efficacy of the COVID-19 vaccines developed by Pfizer and BioNTech. The data also include manufacturing and pre-clinical studies demonstrating that JN.1-adapted monovalent vaccines elicit a significantly improved immune response against various Omicron JN.1 sublineages, such as KP.2 and KP.3, as well as other currently circulating variants.
The CHMP’s recommendation will now be reviewed by the European Commission, with a final decision anticipated shortly. This potential approval could pave the way for broader distribution and use of the Comirnaty JN.1 vaccine across Europe, providing enhanced protection against COVID-19.
Despite this progress, shares of Pfizer have declined by 3.5% year-to-date, in contrast to a 21.9% increase in the broader industry.
Under recent guidance from the U.S. Food and Drug Administration (FDA), Pfizer and BioNTech have initiated rolling applications seeking approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals aged six months and older.
In June 2024, Moderna (MRNA), another leading vaccine manufacturer, submitted an application to the FDA for approval of its Spikevax 2024-2025 formula, targeting the Omicron JN.1 variant. Moderna’s regulatory filing follows FDA advice to update COVID-19 vaccines to a monovalent JN.1 composition for the upcoming vaccination season. Moderna has also submitted regulatory applications globally to support the registration and supply of its updated Spikevax formula.
Earlier this month, Novavax (NVAX) also submitted an amendment to its Emergency Use Authorization (EUA) application to the FDA for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 years and older. Compared to Pfizer and Moderna, Novavax has faced challenges in capitalizing on the pandemic due to a delayed launch of its COVID-19 vaccine. The FDA has noted that the mRNA technology used by Pfizer and Moderna allows for quicker vaccine development compared to Novavax’s protein-based approach.
The market dynamics for vaccine manufacturers have been challenging, with a significant decline in COVID-19 cases reducing the demand for vaccines. Although a resurgence in COVID-19 infections could increase the demand for booster shots, the potential for substantial revenue from vaccine sales appears limited.