COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]

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COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]


Press Releases – No new digest announcements identified

Bharat Biotech, India
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – No new digest announcements identified


News – No new digest announcements identified

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]

Home – No new digest announcements identified


Press Releases
May 07, 2021
Access Arrangements for Janssen COVID-19 Vaccine
Johnson & Johnson is committed to enabling equitable global access to the Janssen COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending local regulatory authorizations and direct procurement agreements with governments. In December 2020, the Company entered into an agreement in principle in support of COVAX, the global procurement mechanism for COVID-19 vaccines. We expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Janssen vaccine to COVAX through 2022.
At this time, the Company is only negotiating with government bodies and supranational organizations (e.g., European Commission, African Union, Gavi/COVAX) at a central level for vaccine procurement or purchase. We are not working with or through third parties for vaccine access during the current emergency pandemic period. National governments may reach out to us directly with any procurement questions by contacting:
Johnson & Johnson recognizes the role of the private sector in addressing the pandemic and, at a future date, we will inform stakeholders when other options for vaccine procurement become available.


Press Releases
May 6, 2021
Moderna Announces New Supply Agreement with Switzerland for 7 Million Booster Vaccine Doses in 2022 and Option for Additional 7 Million Doses

May 5, 2021
Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern

May 4, 2021
Moderna Announces Expansion of its Manufacturing Technology Center in Massachusetts

May 3, 2021
Moderna Announces Supply Agreement with Gavi for up to 500 Million Doses of COVID-19 Vaccine Moderna for COVAX To Help End COVID-19 Pandemic in Lowest Income Countries
:: 34 million doses to begin delivery in the fourth quarter of 2021
:: Option granted to COVAX Facility for up to 466 million additional doses in 2022
:: Doses provided at lowest tiered price, in keeping with Moderna’s global access principles commitment


Press Releases
Novavax Statement in Opposition to the WTO TRIPS Waiver
5/7/2021 Statement

Novavax Statement on Ministry of Health, Labour and Welfare’s Announcement Regarding Procurement from Takeda of NVX-CoV2373 for Japan
5/7/2021 Statement
…Takeda is in the process of establishing vaccine procurement based on technology transfer by Novavax of NVXCoV2373, a recombinant protein vaccine candidate, and will be responsible for manufacturing and commercialization in Japan. Takeda will have the capability to manufacture 250 million doses yearly of the vaccine at its manufacturing site in Japan…

Novavax and Gavi Execute Advance Purchase Agreement for COVID-19 Vaccine for COVAX Facility
:: Novavax to deliver 350 million doses beginning Q3 2021
:: 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX
:: Serum Institute of India to provide balance of doses for LMICs
:: Underscores commitment to global equitable access to Novavax vaccine

New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant

Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine


Recent Press Releases
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency…

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021…


Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified
[See Financial Times coverage in Media Watch below]


News – No new digest announcements identified


Press Releases – No new digest announcements identified
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
News 04/05/2021


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]