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

Milestones :: Perspectives :: Research

 

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

 

AstraZeneca
Press Releases – No new digest announcements identified

Bharat Biotech, India
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias
Actualización del proceso de vacunación en Cuba durante los ensayos clínicos en curso
14/04/2021

…Como parte del Ensayo clínico Fase III con Soberana 02, se ha aplicado la segunda dosis a 4 534 sujetos y en el Ensayo Clínico Fase III con Abdala, 22 108 sujetos, ya tienen aplicada la segunda dosis.

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
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
Apr 14, 2021 United States
Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 14, 2021 – The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened today to consider reports of an extremely rare disorder involving blood clots in combination with low platelets observed in a small number of individuals following vaccination with the Johnson & Johnson COVID-19 vaccine.
“The safety and well-being of the people who use our products is our number one priority, and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We continue to believe in the positive benefit-risk profile of our vaccine. We value the consideration of the Advisory Committee, and we will continue to collaborate with medical experts and global health authorities, including the CDC, U.S. Food and Drug Administration (FDA), European Medicines Agency and the World Health Organization, as we work toward continuing vaccinations to end the global pandemic.”
Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. The Company has made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.
The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

 

Moderna
Press Releases
April 14, 2021
Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development
:: CMV 7-month data shows all GMT measures at or above CMV seropositive baselines; pivotal Phase 3 study of at least 8,000 participants expected to begin in 2021
:: First interim analysis of Phase 1 RSV vaccine candidate (mRNA-1345) shows >11- fold increase in RSV neutralizing antibodies in younger adults (ages 18-49 years); both 50 μg and 100 μg dose levels generally well-tolerated
:: Phase 1 clinical study of mRNA flu vaccine candidate expected to begin in 2021
:: Phase 1 study evaluating HIV mRNA vaccines with novel strategy expected to begin in 2021

April 13, 2021
Moderna Provides Clinical and Supply Updates on COVID-19 Vaccine Program Ahead of 2nd Annual Vaccines Day
:: Phase 3 COVE Study: Updated cases show continued strong efficacy, including greater than 90% against cases of COVID-19 and greater than 95% against severe cases of COVID-19, with approximately 6 months median follow-up post dose 2
:: Antibody persistence data out to 6 months published in The New England Journal of Medicine
:: New preclinical data shows variant-specific booster vaccine candidates (mRNA-1273.351 and mRNA-1273.211) increase neutralizing titers against SARS-CoV-2 variants of concern
:: Supply Update: As of April 12, approximately 132 million doses have been delivered globally

 

Novavax
Press Releases
Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations
– Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers
– Will assess potential for flexibility in the delivery of COVID-19 vaccines
GAITHERSBURG, Md., April 14, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its participation in a newly expanded investigator-initiated Phase 2 clinical trial called Comparing COVID-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2), to be conducted by the University of Oxford and supported by the UK Vaccines Taskforce. Novavax’ recombinant protein vaccine candidate, NVX-CoV2373, is one of four COVID-19 vaccines that will be studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19…

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

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]