COVID Vaccines/Therapeutics – Developer/Manufacturer Announcements
[Selected press releases/announcements from organizations from WHO EUL/PQ listing above and other organizations]
AstraZeneca
Press Releases – No new digest announcements identified
Bharat Biotech
Press Releases
Apr 26: COVAXIN® for Children: India approves COVAXIN® in Children 6-12 years
COVAXIN is the one of the first COVID-19 vaccines in the world to generate data in 2-18
year age group.
COVAXIN was earlier approved for children 12-18 years of age.
Whole-Virion inactivated SARS-CoV-2 Vaccine (BBV152) has proven to be safe, welltolerated,
and immunogenic in paediatric subjects in phase II/III study in children 2-18 years
of age.
Neutralizing antibodies in children on were 1.7 times higher than in adults.
No serious adverse event was reported. Pain at the injection site was the most commonly
reported adverse event. No cases of myocarditis or blood clots were reported, as is to be
expected with inactivated vaccines.
COVAXIN exhibits robust immune responses in children with 2 doses and 6 months follow
up, indicating durability of immune responses. Data was presented to the CDSCO Subject
Expert Committee and will be published in the weeks to come.
Hyderabad, April 26, 2022: Bharat Biotech International Limited (BBIL), a global leader in vaccine
innovation and developer of vaccines for infectious diseases, today announced that BBV152
(COVAXIN), its whole-virion inactivated COVID-19 vaccine candidate, has received emergency use
approval in children 6-12 years of age…
BioCubaFarma – Cuba
Últimas Noticias – Website not leading at inquiry
Biological E
News –
BE’s CORBEVAXTM Gets DCGI Nod for Emergency Use in 5-12 Years
:: The approval comes soon after CORBEVAXTM was given the nod for 12-15-year group
::As part of its Phase 2/3 clinical trials in 312 children aged between 5 and 12 years, Biological E administered two doses of 0.5 ml each of CORBEVAXTM or Placebo in 28 days’ gap
– April 26, 2022
Biontech
Press Releases
Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age
26 April 2022
CanSinoBIO
News – Website not responding at inquiry
CIGB
Latest News – No new digest announcements identified
Cinagen
Recent News
Researchers announced safety and effectiveness of ReciGen (interferon beta-1a 44 mcg manufactured by CinnaGen Co.) on COVID-19 patients
20 June 2020
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 – See Russia below.
IMBCAMS, China
Home – Website not responding at inquiry
Janssen/JNJ
Press Releases – No new digest announcements identified
Medicago
Media – No new digest announcements identified
Moderna
Press Releases
29 April, 2022
Moderna Files to Expand Conditional Marketing Authorization for Its COVID-19 Vaccine to Include Children Six Months to Under Six Years in The European Union
29 April, 2022
Moderna Finalizes Plan for Long-Term Strategic Partnership with The Government of Canada
:: Onshore manufacturing facility is expected to be based in Quebec and produce up to 100 million mRNA respiratory vaccine doses annually
:: The ten-year strategic partnership is expected to provide Canadians with rapid response capabilities to ensure future pandemic readiness
28 April, 2022
Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age
Nanogen
News – No new digest announcements identified
Novavax
Press Releases
Apr 29, 2022
FDA Announces Vaccines and Related Biological Products Advisory Committee Review of Novavax’ COVID-19 Vaccine
NVX-CoV2373 would be the first protein-based COVID-19 vaccine to be reviewed by VRBPAC in the U.S.
GAITHERSBURG, Md., April 29, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review NVX-CoV2373 COVID-19 Vaccine (recombinant, adjuvanted) for active immunization against SARS-CoV-2 at a meeting scheduled for June 7, 2022..
Pfizer
Recent Press Releases
April 29, 2022
Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use
04.26.2022
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate
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
China NMPA approved SINOVAC Omicron-specific vaccine for clinical trial
2022/04/26
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]
::::::
GSK
Press releases for media
29 April 2022
SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in a phase III study; Biologics License Application submitted for SKYCovione™(GBP510/GSK adjuvant) in South Korea
Merck
News releases – No new digest announcements identified
Novartis
News – No new digest announcements identified
SK Biosciences
Press Releases
SK bioscience and GSK’s Adjuvanted COVID-19 Vaccine Candidate Meets Coprimary Objectives in a Phase III Study; Biologics License Application Submitted for SKYCovione™(GBP510/GSK adjuvant) in South Korea
2022.04.29
Valneva
Press Releases
April 26, 2022
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate
April 26, 2022
Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate
vaccines and global health :: ethics and policy 