Summary of opinion: Comirnaty,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,COVID-19 mRNA Vaccine (nucleoside modified), 22/06/2023, Positive
On 22 June 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Comirnaty. The marketing authorisation holder for this medicinal product is BioNTech Manufacturing GmbH.
The CHMP adopted an extension to an existing indication to include the use of Comirnaty Original/Omicron BA.4-5 (15/15 micrograms) in individuals 12 years of age and older who have not previously received at least a primary vaccination course against COVID-19. For information, the full indication for Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose will be as follows1:
Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1)
The use of this vaccine should be in accordance with official recommendations.
The CHMP also adopted an extension to an existing indication to include the use of Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose in children aged 5 to 11 years who have not previously received at least a primary vaccination course against COVID-19. For information, the full indication for Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose will be as follows1:
Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1).
The use of this vaccine should be in accordance with official recommendations.
The CHMP also adopted an extension to an existing indication to include the use of Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose in infants and children aged 6 months to 4 years. For information, the full indication for Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose will be as follows1:
Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.
The use of this vaccine should be in accordance with official recommendations.
For information, the indications for other presentations of Comirnaty are provided in the summary of product characteristics (SmPC).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
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