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 – Website not responding at inquiry

BioCubaFarma – Cuba
Últimas Noticias
Más de 1 millón 115 mil cubanos ya han recibido al menos una dosis de los candidatos vacunales cubanos
24/05/2021 10:57:58    |   Redacción de Cubadebate
[Google translate: More than 1,115,000 Cubans have already received at least one dose of the Cuban Soberana 02 vaccine candidates.

“Cuba será posiblemente el primer país en vacunar a toda su población con una vacuna propia”
24/05/2021 10:47:43    |   Redacción Cubadebate
[Google translate: “Cuba will possibly be the first country to vaccinate its entire population with its own vaccine”]

Más de 440 000 personas han sido vacunadas en Cuba como parte de la intervención sanitaria
24/05/2021 10:40:58    |   Redacción de Cubadebate
[Google translate: More than 440,000 people have been vaccinated in Cuba as part of the health intervention ]

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
May 28, 2021
CureVac’s First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation

 

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
May 25, 2021
Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June
:: Primary endpoint of non-inferior immunogenicity versus the Phase 3 study adult comparator group was met
:: No cases of COVID-19 observed after two doses of vaccine using the primary case definition, consistent with a vaccine efficacy of 100%
:: Safety and tolerability generally consistent with Phase 3 COVE study in adults; no significant safety concerns identified
:: Company plans to submit data to regulators globally in early June

May 24, 2021
Moderna and Aldevron Announce Expanded Partnership for mRNA Vaccine and Therapeutic Pipeline
:: Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.

 

Novavax
Press Releases
Novavax to Present at International Society for Vaccines Virtual Congress COVID-19 Vaccine Update 5/24/2021

 

Pfizer
Recent Press Releases
Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents
NEW YORK and MAINZ, GERMANY, May 28, 2021 — Pfizer Inc.(NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY is valid in all 27 EU member states.
COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. Distribution and administration of COMIRNATY by the EU member states will continue to be determined according to the populations identified in the EU and per national guidance…

Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of the Pfizer-BioNTech COVID-19 Vaccine in Older Adults
Monday, May 24, 2021
NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.
The trial will include 600 adults who will be recruited from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine trial and will have received their second dose of the vaccine at least six months prior to entering the coadministration study. The participants are being randomized to one of three groups:
:: 20vPnC plus Pfizer-BioNTech COVID-19 Vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 Vaccine
:: 20vPnC plus placebo
:: Pfizer-BioNTech COVID-19 Vaccine booster plus placebo

 

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

 

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]