Vaccine/Antiviral Trials information

Pfizer /  Biontech

Pfizer - Biontech Registered trial in US - BNT162

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine (11-10-2020)

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. (New England Journal of Medicine)(12-10-2020)

The U.K. says people with severe allergies should not take the Pfizer-BioNTech vaccine while two reactions are under investigation -(NY Times - 12-11-2020)

INFORMATION FOR UK HEALTHCARE PROFESSIONALS (.pdf file) (12-10-2020)
(See section 4.4 for Special warnings and precautions for use / 4.5 Interactions / 4.6 Fertility, pregnancy and lactation / 4.7 Effects on ability to drive and use machines / 4.8 Undesirable effects / 4.9 Overdose

 US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Dec. 10 2020
https://youtu.be/owveMJBTc2I

ADVISORY COMMITTEE
BRIEFING DOCUMENT download in .pdf format HERE.

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine (USDFA 12-11-2020)

Pfizer-BioNTech COVID-19 Vaccine EUA Letter. > FDA - in .pdf format HERE

2-12-2021  - From NIH Preprint server  (Discovery of a Novel Inhibitor of Coronavirus 3CL Protease for the Potential Treatment of COVID-19)

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Moderna

 Moderna Registered Trial in US - mRNA-1273

Modernas COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study (Moderna 11-16-2020)

FDA News Release
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate (11-30-2020)

Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement
(12-17-2020)

Watch Live: https://www.youtube.com/watch?v=94OMGzrQzvQ

FDA Briefing Document
Moderna COVID-19 Vaccine in .pdf format is HERE

The F.D.A. approves Modernas Covid vaccine, adding millions more doses to the U.S. supply

June 4 2021 - Moderna Applies to F.D.A. for Full Vaccine Authorization

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 Johnson & Johnson / Janssen

Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S. (10-23-2020)

A Study of Ad26.COV2.S in Adults (COVID-19)
Janssen Vaccines & Prevention B.V. (last update (11-27-2020)

Interim Results of a Phase 12a Trial of Ad26.COV2.S Covid-19 Vaccine (NEJM 1-13-2021)

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial (1-29-20201)

Phase 3 Clinical Trial Protocol (12/24/2020)

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate  (2-4-2021)

FDA Briefing Document
Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 (2-26-2021) (.pdf file download)

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine (2-28-2021)

4-13-2021 - CDC, FDA To Review J&J Shot After 6 Blood Clot Cases Reported Out Of Nearly 7M Doses

4-23-2021 - Science Magazine FDA and CDC OK resuming J&J COVID-19 shots paused over rare clot concerns

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Oxford /AstraZeneca

 AstraZeneca Registered Trial in US - AZD1222

Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial (11-18-2020)

Efficacy of ChAdOx1 COVID-19 vaccine (Lancet 12-8-2020) - (.pdf File is HERE)

U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca (12-31-2020)

Expert reaction to reports from Germany that the Oxford-AstraZeneca COVID-19 Vaccine has 8% efficacy in over 65s (1-25-2021) 

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 Novavax / SEPI

Novavax Announces COVID-19 Vaccine Clinical Development Progress
Nov 30, 2020 at 6:30 AM EST

Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant (last update 11-9-2020)

Novavax sees some COVID-19 vaccine trial dropout as Pfizer, Moderna rollouts gear up. (1-20-2021)

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
Jan 28, 2021 at 4:05 PM EST

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Sanofi / GlaxoSmithKline

Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older (Last update 11-19-2020)

Coronavirus Vaccine Trial Delayed After Results Show Lack of Efficacy in Older Adults (US NEWS and World Report 12-11-2020)

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Merck; IAVI

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates (1-25-2021)

 -- Edited by wmlj1960 on Friday 4th of June 2021 10:59:01 PM