Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 29 September 2021

Milestones :: Perspectives :: Research

 

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 29 September 2021
For 23 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

[Full scale view available at title ling above]

 

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

 

AstraZeneca
Press Releases
AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US
05 October 2021
:: Filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic COVID-19 with long-acting antibody combination (non-vaccine)
:: Potential to provide protection for those not expected to mount an adequate immune response following vaccination
AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo…

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 – No new digest announcements identified

 

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
Oct 06, 2021 Belgium
Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature

Oct 05, 2021 United States
Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
:: Submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S.
:: Substantial increase in immune response when booster was given at six months
:: The Company’s single-shot vaccine has demonstrated strong and long-lasting protection and durable immune responses in clinical studies

 

Moderna
Press Releases
October 7, 2021
Moderna to Build State-of-the-Art mRNA Facility in Africa to Manufacture up to 500 Million Doses Per Year
:: Facility to manufacture drug substance with opportunity for fill/finish and packing capabilities
:: Moderna will invest in building mRNA capabilities in Africa
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 7, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level. The Company anticipates investing up to $500 million in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. The Company expects to begin a process for country and site selection soon…

October 6, 2021
Moderna Announces the Launch of Global Fellowship Program for Young Researchers Exploring mRNA Medicines

October 5, 2021
Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older

 

Novavax
Press Releases
Novavax Announces Leadership Appointment and Updates Oct 4, 2021
– Denny Kim, M.D. appointed Senior Vice President, Chief Safety Officer
– Raburn Mallory, M.D. promoted to Senior Vice President, Head of Clinical Development
– Marco Cacciuttolo, Ph.D. promoted to Senior Vice President, Process and Analytical Development

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Sanofi Pasteur
Press Releases
Sanofi: Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations
October 07 2021
:: First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
:: Timely new data for the start of the influenza vaccination campaigns across the Northern Hemisphere

 

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

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

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]

 

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GSK
Press releases for media
06 October 2021 GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine
[See Malaria above for detail]

04 October 2021 ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV

 

Merck
News releases – No new digest announcements identified

 

SK Biosciences
Press releases
SK bioscience and CEPI Extend Agreement Contract Production of COVID-19 Vaccines by the End of 2022
2021.10. 06
…SK bioscience said, it has entered into extension of its capacity reservation agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), on October 5th in Brussels, Belgium, for extended use of parts of manufacturing capacity in its plant, the L House for the production of COVID-19 vaccines developed by biopharmaceutical companies under the support of CEPI. Further, the two organizations agreed to continue to cooperate closely to overcome the current pandemic situation and support research and development of vaccines against various infectious diseases which have been frequently breaking out recently…