COVID-19 vaccine safety report (27 January 2023)

27 January 2023 - Since the beginning of the vaccine rollout to 22 January 2023, almost 65 million doses of COVID-19 ...

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Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients

26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...

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Update on US FDA emergency use authorisation of Evusheld

26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...

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TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine

23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...

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COVID-19 vaccine safety report (12 January 2023)

12 January 2023 - Since the beginning of the vaccine rollout to 8 January 2023, almost 65 million doses of COVID-19 ...

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Moderna considers price of $110-$130 for COVID-19 vaccine

9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...

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COVID-19 vaccine safety report (22 December 2022)

22 December 2022 - This is an abbreviated version of the COVID-19 vaccine safety report.  ...

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FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalised adults

21 December 2022 - Actemra is the first FDA approved monoclonal antibody to treat COVID-19. ...

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COVID-19 vaccine safety report (15 December 2022)

15 December 2022 - To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to ...

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Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age

9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...

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Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza

9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...

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FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age

8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...

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US backs delay to decision on COVID patent waiver extension

6 December 2022 - The United States on Tuesday urged delaying a decision on whether to waive patent protection for ...

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Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents

7 December 2022 - Novavax today announced that Health Canada has approved a supplement to a new drug submission for Nuvaxovid ...

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ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination

6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron ...

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