WHO Director General Speeches [selected]

WHO Director General Speeches [selected]
https://www.who.int/director-general/speeches
30 October 2021 Speech
WHO Director-General’s remarks at Session 1- Global Economy and Global Health at the G20 Summit – 30 October 2021
[See G20 above for detail]

28 October 2021 Speech
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 28 October 2021

 

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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
October 29, 2021
Moderna Announces Additional Supply for Q2 2022 of Vaccine for COVAX To Help End COVID-19 Pandemic in Lowest Income Countries
:: Q2 deliveries almost double – a further 56.5 million in options exercised by COVAX, for a total 116.5 million doses for delivery in the second quarter of 2022
:: Per the original APA, COVAX Facility retains options for up to 233 million additional doses in 2022
:: Doses provided at lowest tiered price, in keeping with Moderna’s global access principles commitment
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 29, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced an agreement with Gavi, the Vaccine Alliance to supply up 116.5 million doses of Moderna’s COVID-19 vaccine to be delivered in the second quarter of 2022. The exercise of these options for additional doses represents an increase from an earlier agreement for 60 million doses of Moderna’s COVID-19 vaccine that was communicated earlier this year. As per the advance purchase agreement signed on behalf of the COVAX Facility, Gavi continues to retain the option to procure 233 million additional doses in 2022 for a potential total of 500 million doses between 2021 and 2022 under the agreement. All doses are offered at Moderna’s lowest tiered price, in line with the Company’s global access commitments.
This agreement covers the 92 Gavi COVAX Advance Market Commitment (AMC) low- and middle-income countries. COVAX is a global initiative co-led by Gavi, the Vaccine Alliance (Gavi), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels.
“I am grateful to our partners at Gavi and COVAX for their work and collaboration to reach this agreement. This is another important milestone as we work to ensure that people around the world have access to our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We support COVAX’s mission to ensure broad, affordable and equitable access to COVID-19 vaccines and we remain committed to doing everything that we can to ending this ongoing pandemic with our mRNA COVID-19 vaccine. We have recently offered to COVAX to access more vaccines for Q2 and Q3 2022.”…

October 26, 2021
Moderna Announces First Participant Dosed in Phase 3 Pivotal Registration Study of Its mRNA Cytomegalovirus (CMV) Vaccine

October 26, 2021
Moderna Announces Swissmedic Authorizes Booster Dose of Moderna’s COVID-19 Vaccine
:: Authorization granted for particularly vulnerable individuals 12 years of age and older
:: Swissmedic also authorized a third dose for individuals 12 years of age and older with a weakened immune system

October 26, 2021
Moderna Announces Memorandum of Understanding to Supply up to 110 Million Doses of Its COVID-19 Vaccine to the African Union
:: Doses offered at Moderna’s lowest tiered price in line with its global access commitments
:: This agreement is in addition to Moderna’s agreement with COVAX for up to 500 million doses of the Moderna COVID-19 vaccine through 2022
:: Discussions ongoing for fill/finish manufacturing in Africa in 2023, as stepping stone to Moderna drug substance plant in Africa
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 26, 2021– Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new Memorandum of Understanding (MoU) to make up to 110 million doses of the Moderna COVID-19 vaccine available to the African Union. The Company is prepared to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in second quarter 2022. All doses are offered at Moderna’s lowest tiered price, in line with the Company’s global access commitments…
…The Company is also working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa. This new MoU would be in addition to Moderna’s agreement with COVAX to supply up to 500 million doses of its COVID-19 vaccine from the fourth quarter of 2021 through 2022. Additionally, the Company recently announced an investment of up to $500 million to plan to build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines at the 50 µg dose level each year.

October 25, 2021
Moderna Announces European Medicines Agency’s Committee for Medicinal Products for Human Use Recommends Booster Dose of Moderna’s COVID-19 Vaccine in the European Union

October 25, 2021
Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age

 

Novavax
Press Releases
Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia Oct 29, 2021

Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom Oct 27, 2021

 

Pfizer
Recent Press Releases
10.29.2021
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years

10.28.2021
Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs

10.26.2021
FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

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

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases
SINOVAC actively discusses COVID-19 Vaccine application and the industry development with other countries [Egypt, Indonesia, Philippines]
10/26/21

 

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
The Medicines Patent Pool (MPP) and Merck Enter Into License Agreement for Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, to Increase Broad Access in Low- and Middle-Income Countries
October 29, 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 25, 2021

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified