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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
CHMP, Last updated: 15/09/2023Comirnaty … -
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News: Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
CHMP, Last updated: 30/08/2023Comirnaty: EMA recommends approval … recommended authorising an adapted Comirnaty vaccine targeting the Omicron … The vaccine – known as Comirnaty Omicron XBB.1.5 – is to … -
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News: EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
Last updated: 07/06/2023 -
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News: EMA recommends approval of Bimervax as a COVID-19 booster vaccine
CHMP, Last updated: 30/03/2023the authorised mRNA vaccine Comirnaty that targets the original … vaccination with 2 doses of Comirnaty and who were subsequently … dose of either Bimervax or Comirnaty. Although Bimervax triggered … -
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News: ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
Last updated: 06/12/2022destroying the infected ones. Comirnaty: EPAR Spikevax (previously … COVID-19 Vaccine Moderna): EPAR Comirnaty: Pending EC decision Comirnaty: Paediatric investigation … EU-approved mRNA vaccines (Comirnaty and Spikevax) have been adapted … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
CHMP, Last updated: 11/11/2022Comirnaty … -
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News: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
CHMP, Last updated: 11/11/2022the originally authorised Comirnaty vaccine targeting the wild-type … Omicron BA.1 subvariant than Comirnaty. In a second main study … course with an mRNA vaccine (Comirnaty or Spikevax) or an adenoviral … -
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News: EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
CHMP, Last updated: 19/10/2022EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines … recommended extending the use of Comirnaty and Spikevax targeting the … aged 6 months to 4 years for Comirnaty and use in children aged … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
CHMP, Last updated: 22/09/2022Comirnaty Original/Omicron BA.1 … -
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News: EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
CHMP, Last updated: 16/09/2022marketing authorisations for Comirnaty and Spikevax COVID-19 vaccine … of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine … existing and upcoming adapted Comirnaty and Spikevax vaccines, including … -
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News: Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
CHMP, Last updated: 12/09/2022adapted COVID-19 vaccine Comirnaty Original/Omicron BA.4-5 is … anticipated in the cold season. Comirnaty Original/Omicron BA.4-5 is … the mRNA COVID-19 vaccine Comirnaty (Pfizer/BioNTech). Vaccines … -
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News: ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
Last updated: 06/09/2022two new updated vaccines , Comirnaty Original/Omicron BA.1 and … countries. On 1 September 2022 Comirnaty Original/Omicron BA.1 and … -
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News: First adapted COVID-19 booster vaccines recommended for approval in the EU
CHMP, Last updated: 01/09/2022adapted COVID-19 vaccines Comirnaty Original/Omicron BA.1 and … protection against COVID-19. Comirnaty Original/Omicron BA.1 and … of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax … -
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News: Start of rolling review for adapted Comirnaty COVID-19 vaccine
CHMP, Last updated: 15/06/2022rolling review for adapted Comirnaty COVID-19 vaccine … rolling review for adapted Comirnaty COVID-19 vaccine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
PRAC, Last updated: 10/06/2022the COVID-19 mRNA vaccines Comirnaty and Spikevax. Heavy periods … between the COVID-19 vaccines Comirnaty and Spikevax and cases of … after the administration of Comirnaty and Spikevax. Overall, the … -
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News: EMA adopts first list of critical medicines for COVID-19
Last updated: 08/06/2022administration Strengths Comirnaty Tozinameran/ COVID-19 mRNA … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
PRAC, Last updated: 08/04/2022between COVID-19 vaccines Comirnaty and Spikevax and very rare … 14 4.1.4. Tozinameran - COMIRNATY (CAP … -
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News: ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
Last updated: 06/04/2022COVID-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax … -
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News: EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
CHMP, Last updated: 29/03/2022seen with the mRNA vaccine Comirnaty. Preliminary results suggest … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
CHMP, Last updated: 25/03/2022capacity for COVID-19 vaccine Comirnaty was approved by the Committee … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022mRNA vaccines Spikevax and Comirnaty. The Committee concluded … reported after vaccination with Comirnaty did not support such association … with Spikevax and 44 with Comirnaty. Global exposure at the time … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/2022Comirnaty … -
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News: EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
CHMP, Last updated: 24/02/2022authorisation of booster doses of Comirnaty from 12 years of age … authorisation of booster doses of Comirnaty from 12 years of age … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022
PRAC, Last updated: 11/02/2022with the COVID-19 vaccines Comirnaty and Spikevax. The Committee … 14 4.2.3. Tozinameran - COMIRNATY (CAP … 14 4.2.4. Tozinameran - COMIRNATY (CAP … -
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News: EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
CHMP, Last updated: 08/02/2022dose of COVID-19 vaccine Comirnaty in adolescents … dose of COVID-19 vaccine Comirnaty in adolescents …