Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021

Milestones :: Perspectives :: Research

 

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021
For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[No updates since 19 Aug 2021]
::::::

 

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

 

AstraZeneca
Press Releases
AstraZeneca and European Commission reach settlement agreement over vaccine supply, ending litigation
03 September 2021
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]).
Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses…

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
CureVac’s CVnCoV Phase 2b/3 Study Data Published in Preprints with The Lancet
TÜBINGEN, Germany / BOSTON, USA – August 31, 2021
CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the publication of its pivotal Phase 2b/3 (HERALD study) primary data of CVnCoV, its first-generation COVID-19 vaccine candidate, in Preprints with The Lancet. The HERALD study enrolled approximately 40,000 participants in ten countries across Latin America and Europe, in the predefined age groups 18 to 60 and above 60. For the final analysis, COVID-19 cases were caused by 15 different virus variants…

 

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

IMBCAMS, China
Home – – [Website not responding at inquiry; receiving 502 Bad Gateway]

 

Janssen/JNJ
Press Releases
Aug 31, 2021 United States
Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa
:: Investigational vaccine candidate did not provide sufficient protection against HIV infection
:: No vaccine-related safety signals identified
:: J&J HIV vaccine program continues with global Phase 3 Mosaico HIV study evaluating a different composition of the vaccine regimen in different populations

 

Moderna
Press Releases
September 3, 2021
Moderna Announces Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster
mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)

September 1, 2021
Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster
mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)

 

Novavax
Press Releases – No new digest announcements identified
Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants
Aug 30. 2021
…the U.S. Centers for Disease Control and Prevention (CDC) has provided updated guidance for those who have been vaccinated as part of a clinical trial in the U.S. The CDC guidance states that participants in the Novavax PREVENT-19 Phase 3 clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the vaccine series…

 

Pfizer
Recent Press Releases
09.02.2021
Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)
First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

Sinovac
Press Releases – No new digest announcements identified

 

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]

 

::::::

GSK
Press releases for media
31 August 2021
SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate
:: Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data
:: Global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine
:: Aim is for global supply through the COVAX facility in the first half of 2022, subject to data and regulatory review

 

SK Biosciences
Press releases – No new digest announcements identified