Moderna files for FDA authorisation of its updated COVID-19 vaccine

22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...

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European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults

7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...

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EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants

6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...

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US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus in older adults

31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 ...

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SK bioscience receives marketing authorisation of COVID-19 Vaccine from UK MHRA

30 May 2023 - SKYCovion is the world's first-ever vaccine developed utilising the RoseTTAFold, a software tool that uses deep learning. ...

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Valneva files for Chikungunya vaccine authorisation with Health Canada

30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...

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Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants

30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...

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ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older

30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...

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Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU

26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...

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Consultation for various vaccine supply agreements

29 May 2023 - PHARMAC is consulting on potential new supply agreements for multiple vaccines listed in the National Immunisation Schedule. ...

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Cases of invasive pneumococcal disease 'sharply' rose after PHARMAC downgraded vaccine programme - study

10 May 2023 - A few years after New Zealand downgraded its vaccine programme against pneumococcal disease, cases of the ...

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FDA approves first respiratory syncytial virus vaccine

3 May 2023 - Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine ...

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US FDA approves Prevnar 20, Pfizer’s 20 valent pneumococcal conjugate vaccine for infants and children

27 April 2023 - Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect ...

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Moderna’s COVID-19 vaccine Spikevax receives approval for full registration

24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...

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First vaccine to protect older adults from respiratory syncytial virus (RSV) infection

26 April 2023 - EMA has recommended a marketing authorisation in the European Union for Arexvy (recombinant, adjuvanted), the first vaccine ...

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