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

Milestones :: Perspectives :: Research

 

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

 

AstraZeneca
Press Releases – No new digest announcements identified

Bharat Biotech, India
Press Releases – Website not responding at inquiry [third week]

BioCubaFarma – Cuba
Últimas Noticias
Se aprueba primer ensayo clínico en Cuba para población pediátrica.
Resumen:  El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) aprueba el primer ensayo clínico a ejecutarse en el país en población pediátrica con el candidato vacunal Soberana contra la Covid 19, desarrollado por el Instituto Finlay de Vacunas (IFV).
04/06/2021 16:15:31    |   BioCubaFarma
[Google translate: The first clinical trial in Cuba for the pediatric population is approved…CECMED) approves the first clinical trial to be carried out in the country in a pediatric population with the Sovereign vaccine candidate against Covid 19, developed by the Finlay Vaccine Institute (IFV).]

 

CanSinoBIO
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]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases
Jun 11, 2021 United States
Johnson & Johnson Statement on Supply of its Single-shot COVID-19 Vaccine
Johnson & Johnson confirms the United States Food & Drug Administration (FDA) has authorized two batches of drug substance, manufactured at the Emergent BioSolutions, Inc. Bayview facility, under the Emergency Use Authorization (EUA) for its single-shot COVID-19 vaccine.
“Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” said Kathy Wengel, Executive Vice President and Chief Global Supply Chain Officer, Johnson & Johnson. “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.”
The Company continues to substantially expand its global vaccine manufacturing network as we work with regulatory and health authorities to supply our COVID-19 vaccine worldwide…

Jun 10, 2021 United States
Johnson & Johnson statement on FDA approval of shelf life extension for company’s COVID-19 vaccine
We are pleased to confirm the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months. The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius)…

 

Moderna
Press Releases
June 11, 2021
Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

June 10, 2021
Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States

June 7, 2021
Moderna and Medison Pharma Partner to Commercialize Moderna’s COVID-19 Vaccine Across Central Eastern Europe and Israel

June 7, 2021
Moderna Files for Authorization with Health Canada for its COVID-19 Vaccine in Adolescents

June 7, 2021
Moderna Files for Conditional Marketing Approval for its COVID-19 Vaccine in Adolescents in the European Union

 

Novavax
Press Releases
Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine
6/11/2021
– New vaccine based on the recombinant spike protein antigen (rS-B.1.351) from Beta (B.1.351) virus lineage highly immunogenic in mice and produced neutralizing antibodies
– Primates boosted with rS-B.1.351 vaccine induced strong neutralizing immune response to original SARS-CoV-2, Alpha (B.1.1.7) and Beta (B.1.351) variant strains
– Humans immunized with original NVX-CoV2373 vaccine demonstrated robust antibody responses to original SARS-CoV-2 strain, as well as to the Alpha (B.1.1.7) and Beta (B.1.351) variant strains
– Data available ahead of publication via preprint server, bioRxiv

 

Pfizer
Recent Press Releases
Pfizer and BioNTech to Provide 500 Million Doses of COVID-19 Vaccine to U.S. Government for Donation to Poorest Nations
Thursday, June 10, 2021
:: U.S. government to purchase at not-for-profit price 200 million doses in 2021 and 300 million in the first half of 2022
:: Doses to be donated to approximately 100 low- and lower middle-income countries including those in the African Union via the COVAX Facility
:: Effort is part of the companies’ recent pledge of two billion doses to ensure global equitable access to the vaccine

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older
Tuesday, June 08, 2021 – 07:12pm
:: First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.
:: Helps protect against more serotypes of pneumococcal disease than any other conjugate vaccine
:: Builds on Pfizer’s more than 20-year legacy and innovation in developing pneumococcal conjugate vaccines

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No corporate announcements identified
[Last media release April 21, 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