COVID Vaccine Developer/Manufacturer Announcements [relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

Featured Journal Content

 

COVID Vaccine Developer/Manufacturer Announcements [relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
AstraZeneca welcomes Court ruling on supply of its COVID-19 vaccine to Europe
18 June 2021
AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had requested 120 million vaccine doses cumulatively by the end of June 2021, and a total of 300 million doses by the end of September 2021. The judge ordered delivery of 80.2 million doses by 27 September 2021. To date, the Company has supplied more than 70 million doses to the European Union and will substantially exceed 80.2 million doses by the end of June 2021. All other measures sought by the European Commission have been dismissed, and in particular the Court found that the European Commission has no exclusivity or right of priority over all other contracting parties…

 

COVID-19 Vaccine AstraZeneca effective against Delta (‘Indian’) variant
15 June 2021
New data from Public Health England (PHE) demonstrated COVID-19 Vaccine AstraZeneca offers high levels of protection against the Delta variant (B.1.617.2; formerly the ‘Indian’ variant).
Real world data from PHE, published as a pre-print, demonstrated two doses of COVID-19 Vaccine AstraZeneca are 92% effective against hospitalisation due to the Delta variant and showed no deaths among those vaccinated. The vaccine also showed a high level of effectiveness against the Alpha variant (B.1.1.7; formerly the ‘Kent’ variant) with an 86% reduction of hospitalisations and no deaths reported…

 

Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19
15 June 2021
– Website not responding at inquiry [fourth week]

BioCubaFarma – Cuba
Últimas Noticias
Inicia aplicación de la 1ra dosis en el ensayo con población pediátrica. 
14/06/2021

Resumen:  Los primeros voluntarios son 25 adolescentes de 12 a 18 años reciben la primera dosis del candidato vacunal  desarrollado por el Instituto Finlay de Vacunas (IFV).
[Google translate:
Application of the 1st dose begins in the trial with the pediatric population.
Summary: The first volunteers are 25 adolescents from 12 to 18 years of age who receive the first dose of the vaccine candidate developed by the Finlay Vaccine Institute (IFV).]

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV
June 16, 2021
:: Pivotal study conducted in 10 countries in fast changing environment of at least 29 COVID-19 variant strains; original strain almost completely absent
:: At second interim analysis, statistical success criteria not met. Favorable safety profile confirmed
:: Initial analyses show trend for age and variant dependent efficacy
:: Results communicated to EMA, study progressing to final analysis within the next few weeks
CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac’s first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy. Available data were communicated with the European Medicines Agency (EMA). The Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway…

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases – No new digest announcements identified

 

Moderna
Press Releases
June 16, 2021
U.S. Government Purchases Additional 200 Million Doses of Moderna’s COVID-19 Vaccine

June 15, 2021
Moderna and Magenta Partner to Distribute Moderna’s COVID-19 Vaccine and Updated Variant Booster Candidates in United Arab Emirates

June 14, 2021
Dr. Paul Burton to Join Moderna as Chief Medical Officer
June 14, 2021

Moderna Submits Authorization Application for its COVID-19 Vaccine in Adolescents in Switzerland

 

Novavax
Press Releases
Novavax to Participate in National Vaccine Advisory Committee Meeting
6/17/2021

Novavax Announces Positive Results from First Study of Influenza Vaccine and COVID-19 Vaccine Candidate Administered Simultaneously
6/14/2021
– COVID-19 vaccine candidate efficacy in those 18 to <65 years old was preserved in influenza vaccine recipients – Influenza vaccine immunogenicity preserved – Study demonstrated no early safety concerns – Data available ahead of publication via preprint server, medRxiv Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
6/14/2021
:: 93% efficacy against predominantly circulating Variants of Concern and Variants of Interest
:: 91% efficacy in high-risk populations
:: 100% efficacy against variants “not considered Variants of Concern/Interest”
:: All COVID-19 hospitalizations/death occurred in the placebo group
:: Company to host investor conference call today at 8:30 am ET

 

Pfizer
Recent Press Releases
Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia
Wednesday, June 16, 2021

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No corporate announcements identified
[Last media release April 21, 2021]

 

Sinopharm/WIBPBIBP
News – Website not responding at inquiry

 

Sinovac
Press Releases
SINOVAC’s EV71 vaccine Inlive® is approved for children aged from 6 to 71 months [Enterovirus]

2021/06/12

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

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GSK
Press releases for media – No new digest announcements identified