COVID Vaccine Developer/Manufacturer Announcements

COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
AstraZeneca to discover and develop self-amplifying RNA therapeutics in new collaboration with VaxEquity
23 September 2021
AstraZeneca will invest in VaxEquity, an Imperial College spin-off
AstraZeneca has reached an agreement to collaborate with VaxEquity for the discovery, development and commercialisastion of the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London.
The strategic, long-term research collaboration aims to optimise and validate VaxEquity’s saRNA platform and apply it to advance novel therapeutic programmes. AstraZeneca will support VaxEquity with research and development funding and should AstraZeneca advance any of the research programmes into its pipeline, VaxEquity could receive development, approval and sales based milestones totalling up to $195 million and royalties in the mid-single digits per programme.
AstraZeneca has the option to collaborate with VaxEquity on up to 26 drug targets and will also make an investment in VaxEquity to further the development of the saRNA platform. VaxEquity was founded by Imperial College London and Morningside in 2020 based on the innovative saRNA technology developed by Professor Robin Shattock and his colleagues at Imperial College London, UK…

 

AstraZeneca to invest $360m in advanced manufacturing facility in Ireland
21 September 2021

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News
Sep 22,2021
Clover’s COVID-19 Vaccine Candidate Demonstrates 79% Efficacy Against Delta in Global Phase 2/3 SPECTRA Trial Dominated by Variants of Concern and Interest
Trial enrolled over 30,000 adult & elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants (Delta was predominant strain)
Primary and secondary efficacy endpoints were successfully met
100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2 in SPECTRA
79% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
Favorable safety profile; no significant differences in systemic adverse events or severe/serious adverse events compared to placebo
First COVID-19 vaccine to demonstrate significantly reduced risk of COVID-19 disease in previously infected individuals

 

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
Sep 21, 2021 United States
Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
Additional data show a booster increases protection 94 percent protection in the U.S. with booster given at two months Four-fold increase in antibodies when given at two months 12-fold increase in antibodies when booster given at six months

 

Moderna
Press Releases
September 24, 2021
Moderna Announces Supply Agreement with Peru for 20 Million Doses of Its COVID-19 Vaccine

 

Novavax
Press Releases
Novavax and Serum Institute of India Announce Submission to World Health Organization for Emergency Use Listing of Novavax’ COVID-19 Vaccine
Sep 23, 2021
Novavax and Serum Institute of India file regulatory submission for World Health Organization Emergency Use Listing of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine
GAITHERSBURG, Md., Sept. 23, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The submission to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India (DCGI).
“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “It represents another major milestone in Novavax’ transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic.”…

 

Pfizer
Recent Press Releases
09.22.2021
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
EUA is supported by clinical data showing a booster dose of the Pfizer-BioNTech vaccine elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
A booster dose given at least six months after completion of the primary vaccination series may help preserve a high level of protection against COVID-19

09.22.2021
Pfizer and BioNTech Expand Collaboration with U.S. to Provide 500 Million Additional COVID-19 Vaccine Doses at Not-for-Profit Price for Donation to Poorest Countries
Expanded agreement brings the total number of COVID-19 vaccine doses to be supplied to the U.S. government for donation to one billion
Effort contributes to companies’ pledge to deliver two billion COVID-19 vaccine doses to low- and middle-income countries by the end of 2022
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies’ COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them. This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion…

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

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

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

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]

 

::::::

GSK
Press releases for media
22 September 2021
Changing attitudes to vaccination after the COVID-19 pandemic could increase adult vaccination rates, improving health outcomes over the longer term
GSK-sponsored Kantar survey shows that people 50 years of age and older value good health and improved quality of life significantly more than financial security in a post-pandemic world.
Public health messaging to encourage vaccination could be more successful if it focused on immune fitness rather than age.

 

SK Biosciences
Press releases – No new digest announcements identified

 

PAHO
BioManguinhos and Sinergium Biotech selected by PAHO to develop COVID-19 mRNA vaccines
Washington DC, September 21, 2021 (PAHO) – The Pan American Health Organization (PAHO) has announced the selection of Sinergium Biotech, in Argentina and Bio-Manguinhos, in Brazil, as regional hubs for the development and production of mRNA-based vaccines in Latin America in a bid to tackle COVID-19 and future infectious-disease challenges.
The Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation (FIOCRUZ) has a long tradition in vaccine manufacturing and has made promising advances in the development of an innovative mRNA vaccine against COVID-19. Sinergium Biotech, a private sector biopharmaceutical company, will partner with pharmaceutical mAbxience, to develop and manufacture active vaccine ingredients. The two companies have extensive experience in the production and development of vaccines and biotechnological medicines..