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

Milestones :: Perspectives :: Research

 

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

 

AstraZeneca
Press Releases
Vaxzevria induced immunity for at least one year following a single dose and strong immune responses following either a late second dose or a third dose
28 June 2021
A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose.
The results, published by the University of Oxford on the pre-print server of The Lancet, demonstrated that antibody levels remain elevated from baseline for at least one year following a single dose…

 

First COVID-19 variant vaccine AZD2816 Phase II/III trial participants vaccinated
27 June 2021
Trial to enrol approximately 2,250 adults to assess safety and immunogenicity of AZD2816 against the SARS-CoV-2 virus
The first participants in a Phase II/III trial for the new COVID-19 variant vaccine AZD2816 were vaccinated today to assess its safety and immunogenicity in both previously vaccinated and unvaccinated adults.
The trial will recruit approximately 2,250 participants across UK, South Africa, Brazil and Poland.
AZD2816 will be administered to individuals who have previously been fully vaccinated with two doses of Vaxzevria or an mRNA vaccine, at least three months after their last injection. In non-vaccinated individuals, AZD2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart.
AZD2816 has been designed using the same adenoviral vector platform as Vaxzevria, with minor genetic alterations to the spike protein based on the Beta (B.1.351, South African) variant.
Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “It is important we continue to stay ahead of genetically distinct variants of the coronavirus. AZD2816 should help broaden individuals immune response against emerging variants of concern. Initiating the Phase II/III trial for AZD2816 means we can be prepared should a variant vaccine be required in the future.”…

BioCubaFarma – Cuba
Últimas Noticias
Recibe la vacuna cubana SOBERANA 02 autorizo de uso de emergencia en la República Islámica de Irán
01/07/2021 19:45:41

[google translate: Cuban vaccine SOVEREIGN 02 receives authorization for emergency use in the Islamic Republic of Iran]

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
News
Jun 30,2021 Clover Announces Advance Purchase Agreement with Gavi for Over 400 Million Doses of Clover’s COVID-19 Vaccine for the COVAX Facility

Jun 30,2021 Clover and Dynavax Announce Commercial Supply Agreement of Dynavax’s CpG 1018 Adjuvant for Clover’s COVID-19 Vaccine Candidate

 

Curevac [Bayer Ag – Germany]
News
June 30, 2021
CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60
Unique pivotal study conducted in 10 countries in fast changing variant environment; 15 COVID-19 variant strains present for efficacy analysis; original strain almost completely absent
Statistical success criteria for primary endpoint met on basis of 228 adjudicated cases
Vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants
Significant vaccine efficacy demonstrated in participants aged 18 to 60 and across all 15 variants:
Efficacy of 53% against disease of any severity
Efficacy of 77% against moderate and severe disease
Full protection against hospitalization or death
CureVac in ongoing dialogue with EMA; continuing regulatory submission

 

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

IMBCAMS, China
HomeReceiving 502 Bad Gateway message upon inquiry

 

Janssen/JNJ
Press Releases
Jul 01, 2021 United States
Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response
Demonstrated strong neutralizing antibody activity against the Delta (B.1.617.2) variant
Persistent immune responses through at least eight months

 

Moderna
Press Releases
July 1, 2021
Moderna Announces Recipharm Site in France Manufacturing COVID-19 Vaccine Moderna Following Approval by European Medicines Agency

June 29, 2021
Moderna Announces Emergency Use Authorization for its COVID-19 Vaccine Granted by Government of India

June 29, 2021
Moderna Provides a Clinical Update on the Neutralizing Activity of its COVID-19 Vaccine on Emerging Variants Including the Delta Variant First Identified in India
Serum samples from eight participants obtained one week after second dose of the primary series in the Phase 1 clinical trial of the Moderna COVID-19 Vaccine
Serum neutralization assays performed on emerging variants including 2 additional versions of the Beta variant (B.1.351) and 3 lineage variants of B.1.617, including the Kappa (B.1.617.1) and Delta (B.1.617.2) variants

 

Novavax
Press Releases
Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine
Jun 30, 2021
-Publication of final analysis highlights the robust safety and efficacy data of NVX-CoV2373 in large, pivotal placebo-controlled trial
…The manuscript published today in NEJM, ‘Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine,’ provides the final trial analysis, building on an initial interim analysis conducted in January 2021, and the updated analysis announced in March 2021, while additional data from the study was subsequently shared in preprint server medRxiv in May 2021. Today’s publication may be accessed here.

Novavax Statement on Proof of Vaccination for Phase 3 Clinical Trial Participants: Updated June 30, 2021
Jun 30, 2021
The participation of volunteers in clinical trials is critical to medical research, and Novavax is grateful to those who stepped forward to advance COVID-19 vaccine development to help create a safer future for all. Novavax firmly believes that clinical trial participants should not be disadvantaged with respect to providing proof of vaccination. We are actively supporting authorities working to provide proof of vaccination for all who volunteered in our pivotal Phase 3 clinical trials…

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Sanofi Pasteur
Press Releases
June 29 2021 Press releases
Sanofi launches dedicated vaccines mRNA Center of Excellence
Approximately €400million investment annually to accelerate end-to-end R&D of next-generation vaccines, fully financed through resource reallocation
Focus on innovating mRNA vaccines beyond pandemic to routine use in diseases with high unmet need
Expected minimum of six clinical candidates by 2025

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No corporate announcements identified
[Last media release still posted dated February 15, 2021; media release of April 21, 2021 apparently removed]

 

Sinopharm/WIBPBIBP
News – Website not responding at inquiry

 

Sinovac
Press Releases
The Lancet Inf. Dis. Published Data from Sinovac’s Phase I/II Study, World’s First Published Study on Clinical Trial Results of a COVID-19 Vaccine in Healthy Children
21/07/02

 

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

 

SK Biosciences
Press releases
SK Bioscience Submitted Phase 3 IND for COVID-19 Vaccine
2021. 06. 28
GBP510 submitted for Phase 3 clinical study in Korea and extend to multi-country studies
The COVID-19 vaccine to be supplied globally through COVAX Facility, if proven to be safe and effective.