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RSS FeedPosted by Michael Wonder on 19 Sep 2024
Program to protect SA newborns from RSV
17 September 2024 - South Australia will protect newborn babies from the impacts of respiratory syncytial virus for the winter ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 06 Sep 2024
EMA Committee for Medicinal Products for Human Use adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-COV-2 variant JN.1
5 September 2024 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European ...
Posted by Michael Wonder on 04 Sep 2024
MHRA approves Spikevax JN.1 COVID-19 vaccines for adults and children from infancy
3 September 2024 - On 2 September 2024, the MHRA approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 ...
Posted by Michael Wonder on 01 Sep 2024
FDA authorises updated Novavax COVID-19 vaccine to better protect against currently circulating variants
30 August 2024 - Today, the US FDA granted emergency use authorisation for an updated version of the Novavax COVID-19 vaccine ...
Posted by Michael Wonder on 30 Aug 2024
Emergent BioSolutions’ Acam2000 (smallpox and mpox (Vaccinia) vaccine, live) receives US FDA approval for mpox indication
29 August 2024 - Emergent BioSolutions today announced that the US FDA has approved the supplemental biologics license application for the ...
Posted by Michael Wonder on 29 Aug 2024
European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
29 August 2024 - This follows approval in US, with other countries anticipated, including Japan later this year. ...
Posted by Michael Wonder on 25 Aug 2024
Vulnerable Aussies may remain unprotected against severe RSV
24 August 2024 - There are mounting concerns that Australians at greatest risk of severe respiratory syncytial virus will miss ...
Posted by Michael Wonder on 25 Aug 2024
Moderna receives European Commission approval for RSV vaccine mRESVIA
23 August 2024 - Moderna today announced that the European Commission has granted marketing authorisation for mResvia (mRNA-1345), an mRNA respiratory ...
Posted by Michael Wonder on 22 Aug 2024
FDA approves and authorises updated mRNA COVID-19 vaccines to better protect against currently circulating variants
22 August 2024 - Today, the US FDA approved and granted emergency use authorisation for updated mRNA COVID-19 vaccines (2024-2025 formula) ...
Posted by Michael Wonder on 19 Aug 2024
Bavarian Nordic submits data to EMA to extend Mpox/smallpox vaccine approval to adolescents
16 August 2024 - Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and ...
Posted by Michael Wonder on 13 Aug 2024
Bavarian Nordic announces FDA acceptance and priority review of the BLA for its Chikungunya vaccine
13 August 2024 - PDUFA target action date of 14 February 2025. ...
Posted by Michael Wonder on 03 Aug 2024
Swissmedic authorises dengue fever vaccine
2 August 2024 - To date, no vaccine against dengue fever was authorised in Switzerland. ...
Posted by Michael Wonder on 01 Aug 2024
BioNet’s recombinant pertussis vaccine submitted to EMA
31 July 2024 - BioNet Europe has announced the submission of a centralised marketing authorisation application to the EMA for its ...
Posted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...