Calls for TGA to withdraw Covid drug approval

17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...

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FDA authorises Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups

12 October 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine, Bivalent and the ...

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Nearly a fifth of Australia’s Covid vaccine stock binned amid warning of fresh wave of cases

11 October 2022 - Dwindling demand for booster shots causes concern immunisation gaps leaving country open to new variants. ...

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Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots

10 October 2022 - Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer's COVID-19 booster shot targeting ...

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Australian adults can now get Moderna's Omicron COVID-19 booster. Here's what we know

10 November 2022 - The first combination COVID booster has now been introduced to Australia's vaccine program, with Moderna's Omicron ...

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Health Canada authorises COVID-19 vaccine booster targeting the Omicron BA.4/BA.5 sub-variants

7 October 2022 - Today, Health Canada authorised a second bivalent COVID-19 vaccine booster.  ...

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COVID-19 vaccine safety report (6 October 2022)

6 October 2022 - To 2 October 2022, the TGA has received 703 reports which have been assessed as likely to ...

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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 ...

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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), ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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