WHO Director General Speeches [selected]

WHO Director General Speeches [selected]
https://www.who.int/director-general/speeches
Selected
4 November 2021
Speech
WHO Director-General’s  remarks at the opening session of the VIII Global Baku Forum entitled “The World After COVID-19” – 4 November 2021

4 November 2021
Speech
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 4 November 2021
More than 5 million deaths have now been reported, and we know the real number is higher. Last week, 56 countries, from all regions, reported an increase in deaths from COVID-19 of more than 10%.
Yesterday we added another new tool, with the Emergency Use Listing of Covaxin, the 8th vaccine to receive WHO validation for safety, efficacy and quality.
We continue to call on manufacturers of vaccines that already have WHO Emergency Use Listing to prioritize COVAX, not shareholder profit. No more vaccines should go to countries that have already vaccinated more than 40% of their population, until COVAX has the vaccines it needs to help other countries get there too. 
The world was not prepared for COVID-19 – and we knew we weren’t prepared. In 2018, WHO and the World Bank formed the Global Preparedness Monitoring Board – the GPMB – an independent panel of experts to identify gaps in the world’s defences, and make recommendations on how to close them.
The GPMB published its third report last week. Instead of making more recommendations, the GPMB is calling the world to act on the recommendations it has already made, which are more relevant now than before the pandemic, but on which there remains little action.

 

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 20 October 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 – No new digest announcements identified

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 – No new digest announcements identified

 

Moderna
Press Releases
Moderna Provides Update on Timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for Adolescents
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 31, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update that the U.S. Food and Drug Administration (FDA) has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.
On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022. The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence…

 

Novavax
Press Releases
Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization Nov 4, 2021
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO

Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand Nov 3, 2021

Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia Nov 3, 2021

Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency Nov 3, 2021

 

Pfizer
Recent Press Releases
11.05.2021
Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study
:: PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
:: In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
:: Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia Monday, November 01, 2021

 

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 and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World
October 29, 2021
:: U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Adults With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Risk Factor for Developing Severe Illness
:: Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified