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RSS FeedPosted by Michael Wonder on 30 Sep 2022
TGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccine
30 September 2022 - On 28 September 2022, the TGA granted a provisional determination to Moderna's bivalent COVID-19 vaccine candidate: elasomeran ...
Posted by Michael Wonder on 29 Sep 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran) for use in children aged 6 months to less than 5 years
29 September 2022 - On 29 September 2022, the TGA provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran), ...
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 27 Sep 2022
COVID-19 vaccine procurement review says rapid access to vaccines and treatments key to on-going protection of Australians
27 September 2022 - Medicines Australia welcomes the independent review of Australia’s COVID-19 vaccine and treatment procurements by Professor Jane ...
Posted by Michael Wonder on 26 Sep 2022
Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorisation of Omicron BA.4/BA.5 adapted bivalent vaccine booster in children 5 through 11 years of age
26 September 2022 - Pfizer and BioNTech today announced they have completed a submission to the US FDA requesting Emergency Use ...
Posted by Michael Wonder on 26 Sep 2022
Novavax appeals to ATAGI to change advice as vaccine uptake falls behind
25 September 2022 - Novavax was hailed as the fix to Australia’s low inoculation rate and “the vaccine for anti-vaxxers”. So ...
Posted by Michael Wonder on 26 Sep 2022
ATAGI recommend the COVID-19 vaccination for some children aged 6 months to under 5 years
26 September 2022 - Australia’s immunisation experts, the Australian Technical Advisory Group on Immunisation, recommend COVID-19 vaccination for some children aged ...
Posted by Michael Wonder on 24 Sep 2022
Moderna asks FDA to authorise omicron Covid boosters for children as young as 6 years old
23 September 2022 - The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to ...
Posted by Michael Wonder on 23 Sep 2022
COVID-19 vaccine safety report (23 September 2022)
23 September 2022 - To 18 September 2022, the TGA has received 712 reports which have been assessed as likely to ...
Posted by Michael Wonder on 23 Sep 2022
Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine
22 September 2022 - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further ...
Posted by Michael Wonder on 21 Sep 2022
EU health regulator says COVID pandemic not over
20 September 2022 - An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not ...
Posted by Michael Wonder on 21 Sep 2022
TGA provisionally approves Pfizer's COVID-19 vaccine, Comirnaty (tozinameran), for use as a booster dose in individuals 5 years and older
21 September 2022 - On 20 September 2022, the TGA provisionally approved Pfizer's COVID-19 vaccine, Comirnaty (tozinameran) for use as ...
Posted by Michael Wonder on 19 Sep 2022
Pharmacists can now prescribe Paxlovid, but barriers persist
19 September 2022 - Recently, the FDA expanded access to COVID-19 treatment by authorising state-licensed pharmacists to prescribe Paxlovid to eligible ...
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, ...