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RSS FeedPosted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of second adapted Spikevax vaccine
19 October 2022 - The EMA’s CHMP has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 ...
Posted by Michael Wonder on 17 Oct 2022
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 ...
Posted by Michael Wonder on 12 Oct 2022
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 ...
Posted by Michael Wonder on 11 Oct 2022
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. ...
Posted by Michael Wonder on 11 Oct 2022
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 ...
Posted by Michael Wonder on 10 Oct 2022
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 ...
Posted by Michael Wonder on 08 Oct 2022
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. ...
Posted by Michael Wonder on 07 Oct 2022
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 ...
Posted 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 ...