COVID Vaccine Developer/Manufacturer Announcements

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

 

AstraZeneca
Press Releases
AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
20 August 2021
:: 77% reduced risk of developing symptomatic COVID-19
:: First long-acting antibody combination to prevent COVID-19
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca’s AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial’s primary endpoint.
AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis…

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

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
August 16, 2021
Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study
:: Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
:: Data demonstrate high protective efficacy of second-generation lead candidate, CV2CoV, in animal model during SARS-CoV-2 challenge study
:: Neutralizing capacity of induced antibodies tested against a range of variants, including the Beta, Delta and Lambda variant

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – – [Website not responding at inquiry; receiving 502 Bad Gateway]

 

Janssen/JNJ
Press Releases
Statement on Boosting with the Johnson & Johnson COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 18, 2021 — We are engaging with the U.S. FDA, CDC and other health authorities and will share new data shortly regarding boosting with the Johnson & Johnson COVID-19 vaccine.
In July, Johnson & Johnson shared data demonstrating that our single-shot COVID-19 vaccine generated strong, persistent immune activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. Interim results from a Phase 1/2a study published in the New England Journal of Medicine also showed that the durability of the immune response was strong, with no waning for at least eight months, the length of time that had been evaluated to date.
Ensuring long-term and durable protection against hospitalization and death are critical in curbing the COVID-19 pandemic.

 

Moderna
Press Releases
August 16, 2021
Moderna Announces Supply Agreement with Canada for Expanded Supply of Moderna’s COVID-19 Vaccine in 2022, in 2023 and in 2024

 

Novavax
Press Releases – No new digest announcements identified
Novavax Appoints Biopharmaceutical Veterans Jim Kelly as Chief Financial Officer and Nasir Egal, Ph.D., as Senior Vice President of Quality Assurance
Aug 16, 2021

 

Pfizer
Recent Press Releases
08.16.2021
Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine
:: Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses
:: The booster dose elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), and the Beta and Delta variants, compared to the levels observed after the two-dose primary series
:: After the booster dose, neutralizing titers for variants were similar to wild type
:: Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
SCHOTT and Serum Institute of India Announce Joint Venture for Pharmaceutical Packaging
Serum Institute of India (SII) acquires 50% stake of SCHOTT Kaisha to become SCHOTT’s joint venture partner and secure pharma packaging supply
17 August 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
16 August 2021
Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study
:: Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
:: Data demonstrates high protective efficacy of second-generation lead candidate, CV2CoV, in animal model during SARS-CoV-2 challenge study
:: Neutralizing capacity of induced antibodies tested against a range of variants, including the Beta, Delta and Lambda variant

 

SK Biosciences
Press releases – No new digest announcements identified