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

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

 

AstraZeneca
Press Releases
:: AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan
21 May 2021
AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and older, to prevent COVID-19 caused by SARS-CoV-2.
The Japanese Ministry of Health, Labour and Welfare granted the approval based on positive Phase III efficacy and safety data from the Oxford University-led clinical trial programme in the UK, Brazil and South Africa, and a Phase I/II trial in Japan…

Bharat Biotech, India
Press Releases – Website not responding at inquiry

BioCubaFarma – Cuba
Últimas Noticias
Intervención sanitaria en La Habana: Por todos y para el bien de todos
Resumen:  Tras la presentación voluntaria de sujetos entre los 19 y 60 años, comenzó esta semana la intervención sanitaria con el candidato vacunal Abdala en los municipios Regla, Guanabacoa, Habana del Este y San Miguel del Padrón.
[Google translate: Summary: After the voluntary presentation of subjects between the ages of 19 and 60, the health intervention with the vaccine candidate Abdala began this week in the municipalities of Regla, Guanabacoa, Habana del Este and San Miguel del Padrón.]

 

CanSinoBIO
News
:: CanSinoBIO Receives EU GMP Certificate
Tianjin, May 21, 2021
CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX: 06185)  today announced that its Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia), has been issued a Good Manufacturing Practice (GMP) certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI
The GMP certificate recognizes that CanSinoBIO’s manufacturing facilities and quality control system meet the European Union’s standards and guidelines, which paves the way for Convidecia™ to enter more markets globally…

Clover Biopharmaceuticals – China
News
:: Clover Announces Positive Preclinical Data for Second-Generation Protein-Based COVID-19 Vaccine Candidate Demonstrating Broad Neutralization Against Variants of Concern May 18,2021

 

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 – No new digest announcements identified

 

Moderna
Press Releases
Moderna and Samsung Biologics Announce Agreement for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine May 22, 2021

Moderna and South Korea Explore Collaboration on mRNA Vaccines May 22, 2021

Ministry of Food and Drug Safety of South Korea (MFDS) Authorizes Moderna’s COVID-19 Vaccine May 21, 2021

Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves Moderna’s COVID-19 Vaccine May 21, 2021

 

Novavax
Press Releases
Novavax Announces Memorandum of Understanding to Explore Expansion of COVID-19 Vaccine Activities in South Korea 5/22/2021

Novavax Statement on Proof of Vaccination for Phase 3 Clinical Trial Participants in the United Kingdom 5/22/2021

Novavax Statement on Participation in Mix-and-Match COVID-19 Vaccine Booster Trial in the United Kingdom 5/2212021

Complete Trial Results Manuscript of Novavax COVID-19 Investigational Vaccine Posted to Preprint Server medRxiv 5/21/2021

 

Pfizer
Recent Press Releases
Pfizer and BioNTech to Supply the European Union With up to 1.8 Billion Additional Doses of COMIRNATY®
Thursday, May 20, 2021 – 05:00am
:: New agreement to supply 900 million doses to the European Commission (EC), with option to request up to an additional 900 million doses
:: Additional dose deliveries beginning December 2021 through 2023
:: Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of COMIRNATY® to the EC since the beginning of the pandemic

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No corporate announcements identified [Last release April 21.2021]

New York Times May 19, 2021
A vaccine maker in India signals it won’t export doses before year’s end, slowing aid to the world’s poorest.
By Sameer Yasir
The vaccination woes of some of the world’s poorest nations will continue as the Serum Institute of India, a crucial manufacturing pillar in the plan to supply two billion doses of Covid-19 vaccines to low-income countries, signaled that it would not be able to provide vaccines beyond India before the year’s end.
The revelation, tucked into a statement by the vaccine manufacturing giant that attempted to deflect mounting criticism, was another setback for Covax, the global vaccine partnership for the poor. It is already more than 140 million doses behind schedule, and the Serum Institute’s announcement suggested it was all but impossible to meet the goal of two billion doses by the end of the year.
The announcement once again underscored the glaring contrast of inequality: As some of the richer nations tout levels of vaccinations that allow them to reopen their society, most of the poorer nations have barely gotten a start.
“We continue to scale up manufacturing and prioritize India,” the Serum Institute of India said in the statement on Tuesday. “We also hope to start delivering to Covax and other countries by the end of this year.”…

 

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]