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Post Info TOPIC: Vaccine Trials Information
Tig


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RE: Vaccine Trials Information
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Hi 5! I agree, let's find out. Allow me to ask our CV-19 guru! He's the best smile

Mike, would you like to set up a poll for our members? Our software allows that and if we set it to terminate in a couple of weeks, we'd get a better sampling. I'm sure you could establish a better set of parameters than I can. You've got a lot more knowledge on the most recent changes and what's in and what's out.



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Tig

64 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 6+ years!

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I'm waiting too. Hubby is beside himself with his multiple underlying's and bad reaction to harvoni.

He got cured and his liver is regenerating but the treatment and after affects were bad.

I have had chronic sinus/allergy my whole so not in a big hurry to test the shot out.

What a conundrum we all face.

I wish more ppl from this forum would report on if they took it or not.



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Gt:1a-36yrs .Started Intron-A in 96' for 2.5mo-VL still too high.taken off. Labs on 3.6.18:. A1 activity.  f3@60: fibrosur bloodtst. AFP=norm. enz=mostly norm.VL=3.9 million.sot=5.1.18>Harvoni>[8wks]: 4WEEKS=UND. Eot 6/25=L.J*13weeks=UND * 6 m =UND: CLUB ZERO.1yr.=0



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Vaccine 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

 __________________________________

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

_________________________________

 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)

___________________________________

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

___________________________________

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)

_____________________________________

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 Sunday 28th of February 2021 06:57:11 PM

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60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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