COVID Vaccines/Therapeutics – Developer/Manufacturer Announcements

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

 

AstraZeneca
Press Releases
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19
24 March 2022

Bharat Biotech
Press Releases No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – Website not leading at inquiry

 

Biontech
Press ReleasesNo new digest announcements identified

 

CanSinoBIO
News – Website not responding at inquiry

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
Mar 24, 2022 United States
U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with CABENUVA (cabotegravir and rilpivirine), the First and Only Complete Long-Acting Injectable HIV Treatment

 

Moderna
Press Releases
March 24, 2022
Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day
COVID-19 vaccine Phase 2/3 study in children 6 months to under 6 years has successfully met its primary endpoint with robust neutralizing antibody titers similar to adults. Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children 6 months to under 6 years of age.
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age; mRNA-1273 is approved for use in this age group in Europe, Canada, and Australia.
In an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010, no significant safety concerns were identified, and the immunogenicity data is consistent with a potential for superiority to standard dose vaccine for influenza A strains.
Moderna is advancing vaccine candidates against five viruses that cause latent infections, three of which are in clinical trials. In a Phase 2 study, the CMV vaccine (mRNA-1647) was observed to be generally well tolerated and interim data demonstrates strong immunogenicity.
Moderna announces an increase in signed Advance Purchase Agreements for 2022 from $19 billion announced on February 24, 2022, to $21 billion.

March 23, 2022
Moderna Finalizes Strategic Partnership with Australian Government
On-shore manufacturing facility based in Melbourne, Australia, expected to produce up to 100 million mRNA respiratory vaccine doses annually

March 23, 2022
Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint

March 21, 2022
Moderna Announces New Supply Agreement for 2023 with Switzerland for Additional Seven Million Doses of Moderna’s COVID-19 Booster Vaccine

 

Novavax
Press Releases
Novavax Announces Participation in Two Booster Studies Using its COVID-19 Vaccine
Mar 25, 2022

Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents ≥12 to <18 in India
Mar 22, 2022

 

Pfizer
Recent Press Releases
03.24.2022
Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults

03.22.2022
Pfizer to Supply UNICEF up to 4 Million Treatment Courses of Novel COVID-19 Oral Treatment for Low- and Middle-Income Countries
Treatment courses will be available for supply to 95 low- and middle-income countries that account for approximately 53% of the world’s population beginning in April 2022
Agreement is part of Pfizer’s comprehensive strategy to work toward worldwide equitable access of COVID-19 oral treatment

 

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
Three doses of SINOVAC COVID-19 vaccine well prevent the worst outcomes during HK Omicron wave
2022/03/23
A study of University of Hong Kong revealed that three shots of CoronaVac offered appromixtely 98% protection against death or severe illness in those over 60 years old, underscoring the importance of boosters for those who have received that Covid-19 shot…

The BRICS Vaccine R&D Center Launched SINOVAC Actively Responds to Common Initiatives
2022/03/23
In order to implement the consensus of the BRICS leaders’ meeting on the early launch of the BRICS Vaccine R&D Center, on March 22, 2022, the Chinese Ministry of Science and Technology held an online launch ceremony of the BRICS Vaccine R&D Center and the Vaccine Cooperation Workshop. Leaders from science and technology and health departments of BRICS countries and representatives from each country’s center witnessed the launch of the center and discussed vaccine cooperation…

 

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 – No new digest announcements identified

 

Merck
News releases
Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer
March 23, 2022

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases – Website not responding at inquiry

 

Valneva
Press Releases – No new digest announcements identified