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FDA updates emergency use authorisation for mRNA 1273 in COVID-19 – Moderna

Written by | 29 Aug 2021

Moderna announced that the FDA has approved an update to the emergency use authorization for the Moderna mRNA 1273 COVID-19 vaccine to include a third dose for immunocompromised… read more.

Ronapreve, the first monoclonal antibody treatment for COVID-19 approved for use in the UK – Regeneron + Roche

Written by | 26 Aug 2021

Following on from a thorough review of the evidence carried out by the MHRA, and recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific… read more.

TGA Australia grants provisional approval to COVID-19 Vaccine Moderna to prevent COVID 19 – Moderna Inc

Written by | 17 Aug 2021

Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by… read more.

Vaxzevria and mRNA COVID-19 vaccines showed similar and favourable safety profiles in a population-based cohort study of over a million people – AstraZeneca

Written by | 14 Aug 2021

In a large real-world study, data published as a pre-print on The Lancet server from over one million individuals assessed the incidence rates of blood clotting disorders of… read more.

Vaxzevria showed no increased incidence of thrombosis with thrombocytopenia after second dose for COVID-19 – AstraZeneca

Written by | 6 Aug 2021

Rates of the very rare clotting disorder, thrombosis with thrombocytopenia syndrome (TTS), following a second dose of Vaxzevria are comparable to the background rate in an unvaccinated population… read more.

Johnson & Johnson single-shot COVID-19 vaccine demonstrated a durable immune response and elicited dual mechanisms of protection against delta and other SARS-CoV-2 variants in data published in NEJM

Written by | 30 Jul 2021

Interim results from a Phase 1/IIa sub-study published in the New England Journal of Medicine (NEJM) demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by… read more.

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

Written by | 18 Jul 2021

Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants…. read more.

TGA Australia approves COVID-19 vaccine Janssen to prevent COVID-19 – Janssen Cilag Pty. Ltd.

Written by | 29 Jun 2021

On 25 June 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making… read more.

Gilead’s Veklury is associated with a reduction in mortality rate in hospitalized patients with COVID-19 across three analyses of large retrospective real-world data sets

Written by | 26 Jun 2021

Gilead Sciences, Inc. announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge… read more.

MHRA approves Ad26.COV2-S [recombinant] for active immunisation against COVID-19 within the United Kingdom – Janssen

Written by | 30 May 2021

Ad26.COV2-S [recombinant] a single-dose coronavirus vaccine from Janssen, part of Johnson & Johnson, has been approved by the MHRA (UK) and is indicated for active immunisation to prevent… read more.

AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan

Written by | 22 May 2021

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and… read more.

FDA expands approval of Comirnaty for young people with COVID-19 – Pfizer and BioNTech

Written by | 18 May 2021

Pfizer and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) for their Comirnaty COVID-19 vaccine to include individuals 12 to 15 years of… read more.

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