HQ Team
June 28, 2024: The European Medicines Agency has granted marketing authorisation for the variant Covid-19 vaccine made by Pfizer and BioNTech SE for children aged six months and older, according to a joint statement.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended Comirnaty JN.1 for immunisation to prevent Covid-19 caused by SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign.
The authorisation was based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force.
The task force stated that “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”
Fall and winter season
“The European Commission will review the committee’s recommendation and is expected to make a final decision soon, “ according to the statement.
Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.
The application also included manufacturing and pre-clinical data which showed that the JN.1-adapted monovalent COVID-19 vaccine generated a “substantially improved response” against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.
Pfizer and BioNTech will start rolling applications with the U.S. Food and Drug Administration (FDA), as per the recent FDA recommendation, requesting approval of Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals six months of age and older.
‘Continue to monitor’
BioNTech is the marketing authorization holder for Comirnaty and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States, jointly with Pfizer, and other countries.
“The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.
Last year Pfizer announced a cost-cutting campaign came amid a sharp drop in demand for its COVID-19 vaccines and antivirals. In 2023, Pfizer’s Comirnaty and Paxlovid generated a combined $12.5 billion in global sales — a 78% decline from the previous year.
