COVID Vaccines/Therapeutics – Developer/Manufacturer Announcements

COVID Vaccines/Therapeutics – Developer/Manufacturer Announcements
[Selected press releases/announcements from organizations from WHO EUL/PQ listing above and other organizations]

 

AstraZeneca
Press ReleasesNo new digest announcements identified

Bharat Biotech
Press Releases No new company announcements identified

Suspension of supply of COVID-19 vaccine (COVAXIN®)
2 April 2022
Today, WHO confirmed the suspension of supply of Covaxin (Bharat Biotech) through UN procurement agencies, and recommended that countries using the vaccine take action as appropriate.
The suspension is in response to the outcome of a WHO inspection on 14–22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP).
Bharat Biotech has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future.
The risk assessment to date does not indicate change in the risk–benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concerns exist…

BioCubaFarma – Cuba
Últimas Noticias – Website not leading at inquiry

 

Biological E
News
BE to Get mRNA Tech from WHO to Produce COVID-19 Vaccines
WHO selects BE as a recipient of mRNA technology
Biological E. Limited produces a number of critical & life-saving vaccines, including CORBEVAXTM
Hyderabad, April 4, 2022: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that it has been selected as a recipient of mRNA technology from the World Health Organisation (WHO) technology transfer hub.

 

Biontech
Press Releases
BioNTech Granted Pandemic Preparedness Contract by German Federal Ministry of Health
MAINZ, Germany, April 8, 2022 — BioNTech SE (Nasdaq: BNTX) today announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Germany. The framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany.
“There is growing evidence that viral pandemics will continue to pose a public health challenge for years. This contract with the German government will ensure significant supply of vaccine doses to address potential public health threats by 2027,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech…

 

CanSinoBIO
News – Website not responding at inquiry

 

CIGB
Latest NewsNo new digest announcements identified

 

Cinagen
Recent NewsNo new digest announcements identified

Clover Biopharmaceuticals – China
NewsNo new digest announcements identified

 

Curevac [Bayer Ag – Germany]
NewsNo new digest announcements identified

 

Gamaleya National Center
Latest News and Events – See Russia below.

IMBCAMS, China
Home – Website not responding at inquiry

 

Janssen/JNJ
Press Releases
Apr 04, 2022 United States
World Health Organization Updated Emergency Use Listing Recommends Johnson & Johnson COVID-19 Vaccine for Booster Us
:: WHO supports vaccine for use as same-dose and ‘mix-and-match’ booster following a primary mRNA vaccine regimen
:: WHO also recommends extended shelf-life of up to 11 months for Johnson & Johnson COVID-19 vaccine when stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit)

 

Medicago
Media – No new digest announcements identified

 

Moderna
Press Releases
07 April, 2022
IAVI and Moderna Partner to Tackle Broad Global Health Priorities Using mRNA for Vaccines and Antibodies

 

Nanogen
News – No new digest announcements identified

 

Novavax
Press Releases
Novavax and Serum Institute of India Receive Emergency Use Authorization for Novavax’ COVID-19 Vaccine in Thailand
Apr 8, 2022

 

Pfizer
Recent Press Releases
04.07.2022
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
:: Proposed acquisition strengthens Pfizer’s capabilities in infectious disease research and development with a complementary strategy to help improve patient outcomes through treatment for respiratory syncytial virus (RSV) infections and prevent illness through vaccination
:: Expands Pfizer’s innovative anti-infective pipeline and utilizes the company’s R&D, manufacturing and commercialization expertise with the goal of addressing a significant unmet need for RSV treatments

 

R-Pharm
https://rpharm-us.com/index.php
[No news or media page identified]

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

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

Shifa Pharmed [Iran]
http://shafapharmed.com/
No news page 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

 

WestVac Biopharma
Media – 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

 

Merck
News releases
Expansion of Elkton, Virginia Manufacturing Facility to Further Increase Merck’s HPV Vaccine Supply and Support Broader and Equitable Access
April 04, 2022
KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, reaffirmed its commitment to enable broad equitable access to the company’s HPV vaccines. To support this, the company has invested significantly in manufacturing, and recently expanded its vaccines manufacturing facility located in Elkton, VA, completing the construction of 120,000 square feet and adding 150 new jobs at the site to further increase capacity and supply of the company’s human papillomavirus (HPV) vaccines, following regulatory reviews and approvals…

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases
SK bioscience Submits Post Approval Change Application of Protein-Based COVID-19 Vaccine for Adolescent Authorization to KMFDS
2022. 04. 07

 

Valneva
Press Releases – No new digest announcements identified