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 – 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
Sep 29, 2021 United States
Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
Positive Phase 2b data supporting further evaluation will be presented at IDWeek 2021

 

Moderna
Press Releases
October 1, 2021
Joint Statement from Moderna and Takeda
STATEMENT REGARDING Moderna COVID-19 Vaccine Recall Investigation Report – October 2021
Takeda and Moderna today published a report of the investigation prompted by the observation of foreign particles in unpunctured vials from a single lot of Moderna’s COVID-19 vaccine distributed in Japan by Takeda. The lot was suspended on August 26, 2021, JST and voluntarily recalled on September 2, 2021, JST. Two other lots manufactured in the same series were included in the suspension and voluntary recall as a precautionary measure…

September 30, 2021
Moderna to Invest in New Science Center in Cambridge, MA
462,000 square foot state-of-the-art building targeting LEED Zero certification and designed to be the most sustainable commercial lab building in Cambridge
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 30, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is investing in a new science center, known as the Moderna Science Center, at 325 Binney Street in Cambridge, Massachusetts to create a purpose-built space to support the Company’s next chapter of discovery….

 

Novavax
Press Releases – No new digest announcements identified

 

Pfizer
Recent Press Releases
09.29.2021
Positive Top-line Results of Pfizer’s Phase 3 Study Exploring Coadministration of Prevnar 20™ With Seasonal Flu Vaccine in Older Adults Released

09.28.2021
Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate

09.28.2021
Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
Formal submission to request Emergency Use Authorization to follow in the coming weeks
…The Companies announced positive topline results from the pivotal trial on September 20, 2021. In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses… 09.27.2021 Pfizer Starts Study of mRNA-Based Next Generation Flu Vaccine Program

09.27.2021
Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults

 

Sanofi Pasteur
Press Releases
September 28 2021
Press releases
Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate
Recent positive interim results of Sanofi’s mRNA-based COVID-19 vaccine candidate Phase 1/2 study confirm the company’s platform robust capabilities and strategy in mRNA.
Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply can be expected going forward, Sanofi has decided not to pursue the development of its COVID-19 mRNA candidate into a Phase 3 clinical study and will focus on completing the final development steps of its COVID-19 recombinant vaccine, developed in partnership with GSK.
Building on its positive results, the company will focus its mRNA resources in its newly created mRNA Center of Excellence to address future pandemics and other infectious diseases and therapeutics where there is a strong unmet need.

September 28 2021
Press releases
Sanofi announces positive Phase 1/2 study interim results for its first mRNA-based vaccine candidate
:: High seroconversion across the three dosages tested and comparable tolerability to other unmodified mRNA COVID-19 vaccines
:: Now accelerating transformation of acquired platform to modified mRNA and targeting a modified quadrivalent flu mRNA vaccine in the clinic in 2022

September 27 2021
Press releases
New research presented at IDWeek 2021 reinforces Sanofi’s robust vaccines pipeline and commitment to advancing public health protection

Enrollment begins for Sanofi and GSK’s Phase 3 efficacy trial of COVID-19 vaccine candidate in Nepal, led by IVI
Sept. 28, 2021

 

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

 

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
28 September 2021 FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV

28 September 2021 ViiV Healthcare announces exclusive license agreement with Shionogi to develop third-generation HIV integrase inhibitor with potential for ultra long-acting dosing intervals

Enrollment begins for Sanofi and GSK’s Phase 3 efficacy trial of COVID-19 vaccine candidate in Nepal, led by IVI
Sept. 28, 2021
…International Vaccine Institute (IVI) will lead the clinical trial in Nepal to assess the safety, efficacy and immunogenicity of an adjuvanted recombinant-protein COVID-19 vaccine candidate
Phase 3 international clinical trial includes volunteers from several countries, including sites in the US, Asia, Africa and Latin America…

 

Merck
News releases
Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study
:: At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died
:: Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide
:: If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19
October 1, 2021

 

SK Biosciences
Press releases – No new digest announcements identified