US Food and Drug Administration accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

24 October 2023 - Potential to be the first and only self-administered flu vaccine. ...

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FDA approves Penbraya, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents

20 October 2023 - The FDA’s decision is based on data from Phase 2 and Phase 3 trials, which demonstrated that ...

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Novavax receives full marketing authorisation for prototype COVID-19 vaccine Nuvaxovid in United Kingdom

18 October 2023 - Full authorisation of prototype enables rapid authorisation of updated Novavax COVID-19 vaccines in future. ...

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EU delays approval of Novavax's revised COVID vaccine

16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...

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MimiVax granted fast track designation from FDA for SurVaxM for newly diagnosed glioblastoma

12 October 2023 - MimiVax announced today that the US FDA has granted fast track designation to MimiVax’s SurVaxM vaccine ...

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Shingles vaccine now free for nearly 5 million Australians

8 October 2023 - From 1 November 2023, older Australians will have free access to the best protection against shingles through ...

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FDA authorises updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants

3 October 2023 - Today, the US FDA amended the emergency use authorisation of the Novavax COVID-19 vaccine, adjuvanted for use ...

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Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5

28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...

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Pfizer and BioNTech receive Health Canada authorisation for XBB.1.5 adapted monovalent COVID-19 vaccine

28 September 2023 - The updated vaccine is expected to be available in Canada in the coming weeks. ...

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Supply and insurance issues snarl fall COVID-19 vaccine campaign for some

20 September 2023 - It has been just over a week since the US FDA and the US Centers for ...

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MHRA approves Moderna’s adapted COVID-19 vaccine (Spikevax) that targets Omicron XBB.1.5

15 September 2023 - The vaccine was approved after it was found to meet the MHRA’s standards of safety, quality and ...

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COVID-19 vaccine contract summary

18 September 2023 - The Ministry of Health has released a summary of the New Zealand Government’s procurement process for ...

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Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...

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Health Canada authorises Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 sub-variant

12 September 2023 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine targeting the Omicron XBB.1.5 ...

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European Commission expands Merck’s Ervebo [Ebola Zaire vaccine, live] indication to include children 1 year of age and older

7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...

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