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RSS FeedPosted by Michael Wonder on 28 Oct 2022
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of second adapted Spikevax vaccine
19 October 2022 - The EMA’s CHMP has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 ...
Posted by Michael Wonder on 15 Oct 2022
Takeda receives positive CHMP opinion recommending approval of Dengue vaccine candidate in EU and Dengue endemic countries
14 October 2022 - TAK-003 recommended for the prevention of Dengue disease caused by any Dengue virus serotype in individuals four ...
Posted by Michael Wonder on 29 Sep 2022
European Medicines Agency accepts Moderna's conditional marketing authorisation filing for its Omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
28 September 2022 - Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 ...
Posted by Michael Wonder on 17 Sep 2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s ...
Posted by Michael Wonder on 17 Sep 2022
Take whatever COVID booster you can get, says head of EU drugs watchdog
14 September 2022 - People in Europe should take whatever COVID-19 booster is available to them in the coming months, ...
Posted by Michael Wonder on 17 Sep 2022
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in infants and children
16 February 2022 - Merck announced today that the EMA’s CHMP has recommended the approval of Vaxneuvance (pneumococcal 15 valent conjugate ...
Posted by Michael Wonder on 13 Sep 2022
Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorisation in the European Union for use as a booster for adults aged 18 and older
12 September 2022 - Nuvaxovid is now authorised in the EU for use in adults aged 18 and older as ...
Posted by Michael Wonder on 12 Sep 2022
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
12 September 2022 - The EMA’s CHMP has recommended authorising an adapted bivalent vaccine targeting the Omicron sub-variants BA.4 and ...
Posted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 06 Sep 2022
ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
6 September 2022 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 01 Sep 2022
EMA CHMP adopts positive opinion recommending authorisation for the use of Moderna's Omicron targeting bivalent booster in the European Union
1 September 2022 - Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 sub-variants when ...
Posted by Michael Wonder on 01 Sep 2022
First adapted COVID-19 booster vaccines recommended for approval in the EU
1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19. ...