COVID-19 Vaccine AstraZeneca authorised for use in the EU

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Vaccine Developer Announcements

COVID-19 Vaccine AstraZeneca authorised for use in the EU
29 January 2021
AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks.
The CHMP recommends two doses of COVID-19 Vaccine AstraZeneca, formerly AZD1222, to be administered at a four- to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
AstraZeneca is working with the EU following the approval of a CMA for active immunisation to begin across member states…

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
:: Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination
:: 85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28
:: Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage¹ Observed in South Africa
:: Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting
Jan 29, 2021

Novartis signs initial agreement to provide manufacturing capacity for Pfizer-BioNTech COVID-19 vaccine
Jan 29, 2021
:: First of multiple agreements being explored by Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine
:: Initial agreement signed with BioNTech to use Novartis manufacturing plant in Stein, Switzerland, to support production of mRNA COVID-19 vaccine
::Production to commence in the second quarter for estimated delivery commencing in the third quarter 2021

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates
January 25, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines…