COVID Vaccine Developer/Manufacturer Announcements

Milestones :: Perspectives :: Research

 

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021
For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[No updates since 19 Aug 2021]
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COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403=Forbidden message]

 

CanSinoBIO
News – [Website not responding at inquiry]

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 – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – – [Website not responding at inquiry; receiving 502 Bad Gateway]

 

Janssen/JNJ
Press Releases
Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine
Johnson & Johnson COVID-19 vaccine booster, after single dose primary regimen, provided rapid and
robust increase in spike-binding antibodies
New studies build on data demonstrating strong durability through eight months after immunization
NEW BRUNSWICK, N.J., August 25, 2021 – Johnson & Johnson today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine.
In July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization.
In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals previously vaccinated with its single-shot vaccine. New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination. Significant increases in binding antibody responses were observed in participants between ages 18 and 55, and in those 65 years and older who received a lower booster dose. The study summaries were submitted to medRxiv on August 24…

 

Moderna
Press Releases
August 25, 2021
Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 25, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation…

 

Novavax
Press Releases – No new digest announcements identified
Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems
GAITHERSBURG, Md., Aug. 25, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Novavax’ recombinant nanoparticle protein vaccine candidate is being studied in OCTAVE-DUO, now underway in the UK to evaluate the safety and immunogenicity of a third COVID-19 vaccine dose in participants with impaired immune systems.
Funded by the UK government’s Vaccines Taskforce and the UK Research and Innovation (UKRI), the study is being led by the University of Glasgow and University of Birmingham. It is a follow-on to OCTAVE (Observational Cohort Trial -T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2), which evaluated the immune response to COVID-19 vaccines in participants with impaired immune systems due to cancer, inflammatory arthritis, kidney or liver diseases, or a stem cell transplant…

 

Pfizer
Recent Press Releases
08.26.2021
Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma to Manufacture COVID-19 Vaccine Doses for Latin America
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America…

08.25.2021
Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older
New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile
SARS-CoV-2 neutralizing titers against the wild-type strain one month after booster dose were 3.3 times the titers one month after the second dose
Pfizer and BioNTech intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in coming weeks

08.23.2021
Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

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]

 

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GSK
Press releases for media – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified