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Agenzia Italiana del Farmaco
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EMA raccomanda l’aggiornamento della composizione antigenica dei vaccini anti-COVID-19 autorizzati per il periodo 2024-2025
La Task Force per le Emergenza (ETF) dell’EMA si è consultata con l’Organizzazione Mondiale della Sanità (OMS), regolatori internazionali e titolari di autorizzazioni all’immissione in commercio di vaccini anti- COVID-19, ed è del parere che l'aggiornamento della composizione antigenica dei vaccini per contrastare la famiglia JN.1 delle sottovarianti Omicron è adeguato per garantire la reattività crociata contro gli attuali ceppi virali dominanti ed emergenti.
Tue Apr 30 00:00:00 CEST 2024 Safety of medicinal productsEMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.
Wed Nov 08 00:00:00 CET 2023 Safety of medicinal productsSpikevax: EMA recommends approval of adapted COVID 19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.
Mon Sep 18 00:00:00 CEST 2023 Safety of medicinal productsComirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
Wed Aug 30 00:00:00 CEST 2023 Safety of medicinal productsEMA recommends approval of Bimervax as a COVID-19 booster vaccine Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.
Tue Apr 04 00:00:00 CEST 2023 Safety of medicinal productsFourteenth AIFA Report on the surveillance of anti-COVID-19 vaccines Highlights News
The data collected and analysed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 December 2022.
Thu Mar 02 00:00:00 CET 2023 COVID-19 emergency > Vaccini COVID-19Direct communication with healthcare professionals on Spikevax bivalent booster vaccines Highlights News
Correct dosing of Spikevax bivalent booster vaccines
Fri Nov 11 00:00:00 CET 2022 Safety of medicinal productsEMA raccomanda l’approvazione del vaccino VidPrevtyn Beta come richiamo per la vaccinazione COVID 19 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine.
Fri Nov 11 00:00:00 CET 2022 Safety of medicinal productsThirteenth AIFA Report on the surveillance of anti-COVID-19 vaccines Highlights News
The data collected and analysed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 September 2022.
Thu Nov 03 00:00:00 CET 2022 Information and communication > Press releasesEMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age Highlights News
The Committee recommended including the use in children aged 6 months to 4 years for Comirnaty and use in children aged 6 months to 5 years for Spikevax.
Thu Oct 20 00:00:00 CEST 2022 Safety of medicinal productsEMA recommends approval of second adapted Spikevax vaccine Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.
Thu Oct 20 00:00:00 CEST 2022 Safety of medicinal productsEMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines Highlights News
EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty and Spikevax into standard marketing authorisations.
Wed Sep 21 00:00:00 CEST 2022 Safety of medicinal productsAIFA authorises Comirnaty Original bivalent vaccine for Sars-Cov-2 Omicron BA.4-5 variants Highlights News
On 14 September 2022 the AIFA Scientific-Technical Committee (CTS) decided to make available the use of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine, approved by the EMA, as a booster dose for all people covered by the authorised indication.
Wed Sep 14 00:00:00 CEST 2022 Information and communication > Press releasesAdapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval Highlights News
EMA’s CHMP has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.
Tue Sep 13 00:00:00 CEST 2022 Safety of medicinal productsCOVID-19: recommendations on use of adapted vaccines Highlights News
ECDC and EMA have issued a joint statement providing updated public health considerations on the use of the newly authorised adapted COVID-19 vaccines to support the planning of the autumn and winter vaccination campaigns.
Wed Sep 07 00:00:00 CEST 2022 Safety of medicinal productsAIFA approves booster dose with Comirnaty and Spikevax bivalent vaccines Highlights News
On 5 September 2022, AIFA’s Scientific-Technical Committee (CTS) gave the green light to the use of the Comirnaty and Spikevax bivalent vaccines.
Mon Sep 05 00:00:00 CEST 2022 Information and communication > Press releasesFirst adapted COVID-19 booster vaccines recommended for approval in the EU Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19.
Thu Sep 01 00:00:00 CEST 2022 Safety of medicinal productsEMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine Highlights News
EMA’s human medicines committee (CHMP) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19.
Thu Aug 18 00:00:00 CEST 2022 Safety of medicinal productsTwelfth AIFA Report on the surveillance of anti-COVID-19 vaccines Highlights News
The data collected and analysed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 June 2022.
Wed Jul 27 00:00:00 CEST 2022 Information and communication > Press releasesCOVID-19: extension of the target recipients of the second booster dose Highlights News
Circular letter of the Ministry of Health, joint statement by the Ministry of Health, CSS, AIFA and ISS, opinion of AIFA’s CTS.
Mon Jul 11 00:00:00 CEST 2022 COVID-19 emergencyUpdated joint statement from ECDC and EMA on additional booster doses of COVID-19 vaccines Highlights News
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have updated public health recommendations on the use of additional booster doses of COVID-19 vaccines this summer and in the upcoming autumn and winter seasons.
Mon Jul 11 00:00:00 CEST 2022 Safety of medicinal productsECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines Highlights News
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are recommending that second booster doses of mRNA COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.
Mon Jul 11 00:00:00 CEST 2022 Safety of medicinal productsEMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU Highlights News
EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years of age.
Fri Jun 24 00:00:00 CEST 2022 Safety of medicinal productsEMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 Highlights News
CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17 years. The vaccine, developed by Novavax CZ, a.s., is already approved for use in adults aged 18 and above.
Fri Jun 24 00:00:00 CEST 2022 Safety of medicinal productsStart of rolling review for adapted Spikevax COVID-19 vaccine Highlights News
EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that causes COVID-19.
Mon Jun 20 00:00:00 CEST 2022 Safety of medicinal products