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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
CHMP, Last updated: 16/12/2022Spikevax … -
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News: ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
Last updated: 06/12/2022infected ones. Comirnaty: EPAR Spikevax (previously COVID-19 Vaccine … mRNA vaccines (Comirnaty and Spikevax) have been adapted to provide … microgram doses4. Also, for Spikevax (100 micrograms original … -
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News: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
CHMP, Last updated: 11/11/2022mRNA vaccine (Comirnaty or Spikevax) or an adenoviral vector vaccine … -
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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: 19/10/2022approval of Comirnaty and Spikevax COVID-19 vaccines for children … the use of Comirnaty and Spikevax targeting the original strain … aged 6 months to 5 years for Spikevax. Comirnaty and Spikevax are already approved in both … -
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News: EMA recommends approval of second adapted Spikevax vaccine
CHMP, Last updated: 19/10/2022approval of second adapted Spikevax vaccine … recommended authorising an adapted Spikevax COVID-19 vaccine targeting … SARS-CoV-2. The adapted vaccine, Spikevax bivalent Original/Omicron … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
CHMP, Last updated: 19/09/2022Spikevax bivalent Original/Omicron … -
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News: EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
CHMP, Last updated: 16/09/2022authorisations for Comirnaty and Spikevax COVID-19 vaccines … BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into … upcoming adapted Comirnaty and Spikevax vaccines, including the recently-approved … -
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News: ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
Last updated: 06/09/2022Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron … Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron … -
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News: First adapted COVID-19 booster vaccines recommended for approval in the EU
CHMP, Last updated: 01/09/2022Original/Omicron BA.1 and Spikevax bivalent Original/Omicron … Original/Omicron BA.1 and Spikevax bivalent Original/Omicron … Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron … -
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News: Start of rolling review for adapted Spikevax COVID-19 vaccine
CHMP, Last updated: 17/06/2022rolling review for adapted Spikevax COVID-19 vaccine … rolling review for adapted Spikevax COVID-19 vaccine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
PRAC, Last updated: 10/06/2022mRNA vaccines Comirnaty and Spikevax. Heavy periods may be defined … COVID-19 vaccines Comirnaty and Spikevax and cases of absence of menstruation … administration of Comirnaty and Spikevax. Overall, the Pharmacovigilance … -
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News: EMA adopts first list of critical medicines for COVID-19
Last updated: 08/06/2022injection Parenteral All Spikevax (previously COVID-19 Vaccine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
PRAC, Last updated: 08/04/2022COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune … 13 4.1.2. Elasomeran - SPIKEVAX (CAP … -
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News: ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
Last updated: 06/04/2022Comirnaty and Moderna’s Spikevax ) in the general population … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022information becomes available. Spikevax: new warning for flare-ups … for the COVID-19 vaccine Spikevax. CLS is an extremely rare … administration of the mRNA vaccines Spikevax and Comirnaty. The Committee … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/2022Spikevax … -
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News: EMA recommends approval of Spikevax for children aged 6 to 11
CHMP, PDCO, Last updated: 24/02/2022EMA recommends approval of Spikevax for children aged 6 to 11 … EMA recommends approval of Spikevax for children aged 6 to 11 … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022
PRAC, Last updated: 11/02/2022COVID-19 vaccines Comirnaty and Spikevax. The Committee had previously … vaccine (nucleoside-modified) - SPIKEVAX (CAP) ............ 14 4.2.2 … vaccine (nucleoside-modified) - SPIKEVAX (CAP) ............ 14 4.2.3 … -
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News: COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
CHMP, PRAC, Last updated: 18/01/2022vaccines ( Comirnaty and Spikevax ). EMA will also review data … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022vaccine (nucleoside-modified) - SPIKEVAX (CAP) - EMEA/H/C/005791/SDA/052 … -
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News: Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer
CHMP, Last updated: 16/12/2021Janssen. Scale-up process for Spikevax from Moderna The Committee … increase in production of Spikevax, the COVID-19 vaccine from … million additional doses of Spikevax every month to the European … -
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News: COVID-19 Vaccine Janssen: EMA recommendation on booster dose
CHMP, Last updated: 15/12/2021from Pfizer/BioNTech) or Spikevax (from Moderna). As for all … -
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News: EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters
Last updated: 07/12/2021of viral vector vaccine or Spikevax tend to give more An untoward … included. Vaxzevria, Comirnaty, SpikeVax, Janssen COVID-19 vaccine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
PRAC, Last updated: 03/12/2021COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine … unexposed persons. In the case of Spikevax, the French study showed that … after the second dose of Spikevax there were around 1.9 extra … -
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News: EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
CHMP, Last updated: 10/11/2021evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11 … evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11 …