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RSS FeedPosted by Michael Wonder on 17 Sep 2022
Swiss regulator gives green light to first drug to prevent Covid-19
16 September 2022 - Swissmedic has issued a temporary marketing authorisation for AstraZeneca’s drug Evusheld, making it the first Covid-19 prophylaxis ...
Posted by Michael Wonder on 17 Sep 2022
CHMP adopts positive opinion to extend indication of Veklury (remdesivir) for the treatment of paediatric patients with COVID-19
16 September 2022 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment for ...
Posted by Michael Wonder on 14 Sep 2022
ATAGI update following COVID-19 meeting (7 September 2022)
14 September 2022 - An update from the Australian Technical Advisory Group on Immunisation following their meeting on 7 September 2022. ...
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 12 Sep 2022
ATAGI statement on use of the Moderna bivalent original/Omicron vaccine
12 September 2022 - A statement from the Australian Technical Advisory Group on Immunisation regarding COVID-19 Moderna Spikevax Bivalent Original/Omicron BA.1 ...
Posted by Michael Wonder on 09 Sep 2022
Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5
9 September 2022 - Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5. ...
Posted by Michael Wonder on 08 Sep 2022
COVID-19 vaccine safety report (8 August 2022)
8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
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 07 Sep 2022
First combination COVID-19 and influenza self-tests approved for Australia
7 September 2022 - The TGA has approved the first two nasal combination self-tests (for use at home) that detect ...
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 06 Sep 2022
Swissmedic authorizes Novavax Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as a booster in adults aged 18 and older
5 September 2022 - Novavax, today announced that Swissmedic has expanded its temporary authorisation of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland ...
Posted by Michael Wonder on 03 Sep 2022
ATAGI update following weekly COVID-19 meeting (31 August 2022)
2 September 2022 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 31 August ...