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RSS FeedPosted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 16 Oct 2021
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in individuals 18 years of age and older
15 October 2021 - Merck today announced that the EMA’s CHMP has recommended the approval of Vaxneuvance (Pneumococcal 15 valent ...
Posted by Michael Wonder on 15 Oct 2021
Highlights from CHMP 11-14 October 2021 meeting
15 October 2021 - EMA’s CHMP recommended six medicines for approval at its October 2021 meeting. ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 02 Sep 2021
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
2 September 2021 - Based on current evidence, there is no urgent need for the administration of booster doses of vaccines ...
Posted by Michael Wonder on 24 Aug 2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna
24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...
Posted by Michael Wonder on 06 Aug 2021
Novavax and European Commission finalise advance purchase agreement for up to 200 million doses of COVID-19 vaccine
4 August 2021 - Agreement for 100 million doses with option for additional 100 million doses through 2023. ...