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 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial
11 October 2021
:: Trial met primary endpoint
:: AZD7442 is the only long-acting antibody combination shown to both prevent and treat COVID-19

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 to Shift Focus of COVID-19 Vaccine Development to Second-Generation mRNA Technology
October 12, 2021
:: COVID-19 vaccine efforts to be re-allocated to accelerate the development of second-generation program in collaboration with GSK
:: First-generation vaccine candidate, CVnCoV, to be withdrawn from regulatory review due to potential overlap with approval timelines for a second-generation candidate

 

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 15, 2021 United States
Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
:: Recommendation informed by Phase 3 findings showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S.
:: Johnson & Johnson COVID-19 vaccine, when given as a booster or primary dose, was generally well-tolerated
:: FDA to decide whether to authorize a booster dose in the coming days

 

Moderna
Press Releases
October 14, 2021
Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
:: Positive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high risk of contracting COVID-19 at least 6 months after completion of the primary series
:: Company estimates that booster at the 50 µg dose level could result in up to 1 billion additional doses

October 12, 2021
Moderna Announces COVAX Exercises Option to Purchase 176.5 Million Additional Doses of Moderna’s COVID-19 Vaccine for Low Income Countries in First Half of 2022

 

Novavax
Press Releases
Complete PREVENT-19 Phase 3 Clinical Trial Results Manuscript for COVID-19 Vaccine Posted to medRxiv Oct 11, 2021 [https://www.medrxiv.org/content/10.1101/2021.10.05.21264567v1 ]

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Sanofi Pasteur
Press Releases
Update from Sanofi regarding Kevzara® (sarilumab): Supply constraints anticipated until early 2022
October 12, 2021
:: Sanofi is currently experiencing an increase in worldwide demand for sarilumab (Kevzara®) due to an increase in the global demand for IL-6 receptor blockers and the temporary tocilizumab shortage.1
:: Due to this exceptional demand, supply for all four formats of sarilumab (150mg or 200mg pre-filled syringe or auto-injector) is expected to be constrained until early 2022 based on current forecasts.
:: Various country and global health authorities have recommended IL-6 receptor blockers for the treatment of patients with severe or critical COVID-19. Sarilumab is not approved or authorized for emergency use for the treatment of COVID-19 anywhere in the world, and Sanofi will continue to prioritize access for indicated patients with rheumatoid arthritis.
:: Sanofi is working diligently to manage supply to minimize the impact of this increase in demand, and we are committed to proactive and timely communication as the situation evolves.

 

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 – No new digest announcements identified

 

Merck
News releases
Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Individuals 18 Years of Age and Older
October 15, 2021

Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
October 15, 2021

 

SK Biosciences
Press releases – No new digest announcements identified