EU Clears BioNTech-Pfizer’s Adapted Comirnaty XBB.1.5 COVID-19 Vaccine for Fall Campaigns

EU Clears BioNTech-Pfizer’s Adapted Comirnaty XBB.1.5 COVID-19 Vaccine for Fall Campaigns

(IN BRIEF) The European Union Commission has given the green light for the use of the adapted Comirnaty XBB.1.5 COVID-19 vaccine, developed by BioNTech-Pfizer, in Member States’ upcoming fall vaccination campaigns. This marks the third adaptation of the Comirnaty vaccine and is a significant step in combating the pandemic. The authorized vaccine is suitable for all age groups, including adults and children above six months, with a single dose recommended for those aged five and above. The decision comes after a thorough evaluation by the European Medicines Agency, allowing Member States to prepare for their fall-winter vaccination efforts. The modified vaccine is designed to target the SARS-CoV-2 Omicron strain XBB.1.5 and enhance immunity against emerging variants. The updated contract ensures continued access to vaccines adapted to new COVID-19 variants in the years ahead. Stella Kyriakides, Commissioner for Health and Food Safety, urges eligible individuals to follow scientific recommendations and get vaccinated promptly as COVID-19 and seasonal flu coexist in the upcoming seasons.

(PRESS RELEASE) BRUSSELS, 1-Sep-2023 — /EuropaWire/ — The European Union Commission has granted approval for the use of the adapted Comirnaty XBB.1.5 COVID-19 vaccine, a product of the collaboration between BioNTech-Pfizer, in the upcoming autumn vaccination campaigns of Member States. This latest development signifies a significant stride forward in the ongoing battle against the COVID-19 pandemic. This iteration of the vaccine, designed to effectively address new strains of the virus, marks the third adaptation of the Comirnaty vaccine.

The newly endorsed vaccine is suitable for individuals spanning all age groups, encompassing adults, children, and infants aged six months and above. Aligned with prior recommendations set forth by the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), both adults and children aged five and above requiring vaccination will be administered a solitary dose, irrespective of their prior COVID-19 vaccination history.

This endorsement follows an exhaustive evaluation conducted by the European Medicines Agency, executed via the expedited assessment mechanism. The swift authorization of this modified vaccine under an accelerated procedure is designed to provide Member States with ample time to prepare for the upcoming autumn-winter vaccination campaigns.

Background

In its relentless commitment to the EU Vaccines Strategy, the Commission continues its concerted efforts to ensure Member States are equipped with access to the latest authorized COVID-19 vaccines in quantities requisite for safeguarding the more vulnerable segments of their populations and adeptly addressing the evolving epidemiological landscape influenced by the virus.

In concordance with the guidance provided jointly by the ECDC and EMA regarding the periodic enhancement of COVID-19 vaccine compositions to tackle emerging SARS-CoV-2 virus variants, BioNTech-Pfizer has meticulously tailored its COVID-19 vaccine to effectively target the SARS-CoV-2 Omicron strain XBB.1.5. This adapted vaccine is also projected to augment the scope of immunity against the existing dominant and emerging viral variants.

The augmentation of the contractual agreement with BioNTech-Pfizer, inked in May 2023, ensures that Member States will continue to possess access to vaccines suitably modified to counteract the progression of new COVID-19 variants throughout the impending years.

Stella Kyriakides, Commissioner for Health and Food Safety, commented:

“I enthusiastically embrace the timely approval of the updated COVID vaccine, designed to tackle evolving and disseminating variants. As the autumn and winter seasons approach, COVID-19 is projected to coexist alongside seasonal influenza, necessitating our preparedness. This potential dual challenge heightens the vulnerability of high-risk individuals and exerts further strain on healthcare facilities and personnel. Vaccination remains our most potent tool against both these viruses, underscoring the urgency for all eligible individuals, particularly those most at risk, to adhere to scientific guidance and expeditiously undergo vaccination.”

Media contacts:

Stefan DE KEERSMAECKER
Phone +32 2 298 46 80
Mail stefan.de-keersmaecker@ec.europa.eu
Célia DEJOND
Phone +32 2 298 81 99
Mail celia.dejond@ec.europa.eu

SOURCE: The European Commission