Showing posts with label Novavax. Show all posts
Showing posts with label Novavax. Show all posts

18 October 2021

Vaccines against SARS-CoV-2

 

I am compiling basic information about the Covid-19 vaccines here as it is published. I am reporting both peer-reviewed publications and press release information because this is the era of clinical trial reporting by PR channels. I do not certify the accuracy of anything on this page. I will be updating it as information is released primarily for myself.

Vaccines

Reuters Vaccine Tracker

Developer/country

Vaccine type

Seroconversion Rate

Protective Efficacy

Status

Pfizer/BioNTech – US/Germany
'Comirnaty'

mRNA spike LNP

95.2% CD4+ T cell 

95% after 2 doses
Effective against variants

75%+ against variants and 97% against severe inf

Full FDA Approval Dec 10, 2021
EU Dec 21

Children 12-15 US

Booster recommended

Best for boosters of 6 vaccines tested

Moderna/NIAID - US Prescribing info
'Spikevax'

mRNA spike

100% @30mcg

94.1% after 2 doses

FDA Dec 17
EU Jan 6
UK Jan 8
Full FDA Approval 
1/31/22

Oxford/Astra Zeneca - UK
ChAdOx1

'Vaxzevria'

'Covishield'

Chimp adenovirus vectors - spike 

Germany approve use only in under 65s due to lack of data

Over 65s now getting it preferentially due to blood clots in younger subjects

70.4% overall
(90% w/low-high dose regimen)
11-03-21 EU countries suspend use due to clots

UK  30 Dec
EU Jan 29

US submission 25/03/21

Several countries hold off due to rare blood clots.  
Approved in Japan and sublicensed to 165 countries.

Gamaleya (Russia)
'Sputnik V'

Human adenovirus vector - 2 spike

100% seroconversion

91.4% after 2 doses Lancet

Russia approved in Aug 2020
EMA reviews Mar 2021

CureVac (Germany)
CVnCoV

mRNA

May cover variants - no need for sub-zero

2 dose schedule

Deal w/UK to focus on variants
Has begun production- Phase 3 fully enrolled

EU begins review 03/21  

Phase 3 ends mid-May

Supply a challenge

Sanofi/Translate Bio

mRNA1 or 2 dosesPhase 1/2 Trials initiated
03/21

Sanofi/GSK

 rDNA/adjuvant

89.6% 18-49 yo
85% >50
62.5% >60

Interim results w/new formulation  = 95-100% seroconversion 

Manufacturing 
issue - reformulation

Delayed due to poor response in older subjects 11/12/20
Trials restarted 02/21

Novavax 
NVX-CoV2373

(Nuvaxovid, CovoVax) 

Covid-NanoFlu combination vaccine

rDNA/Matrix-M™ adjuvant:
baculovirus spike nanoparticles

Production by India's SII the world's largest producer of vaccines by volume

100% after dose 2

96.4% effective against original strain in UK trial, 86% UK, 55% SA strains

Effective as booster against variants

89.3% in US/Mex
60% in SA
89.3% UK

60% in SA in HIV neg subj

90.4% Efficacy in US Phase 3

Phase 3 complete

Delayed (Q3)

Delayed again (Q4)

EMA started a rolling review of NVX-CoV2373 in early 2021

Novavax filed for WHO approval. 4 Nov 2021

EU approved 20 Jan 2022 - shipping to EU Feb 23

EU approved as booster

Sinopharm (China)

Inactivated virus

 

79.34%

China approved Dec31
Serbia to produce

WHO approved 07-05-21

Clin Trial results JAMA 26/5/21

Sinovac (China) –
CoronaVac

Inactivated virus - 2nd vaccine in China

 

50.4% Brazil, 78% Brazil, 65.3% Indonesia, 91.25 Turkey

 WHO approval expected 03/21

J&J /Janssen (US)
Ad26.COV2.S 



AdVac® human attenuated adenovirus vectors carrying complete spike protein rDNA

98% After 1 dose, 100% in interim results 1 vs 2 dose trial

enrolment completed -
57-72% effective in protecting against mod-sev Covid-19 28d after 1 dose

Risk of Guillain-Barré syndrome

US approved Jan 27
EU applied 16/02/21
EU approved 11-03-21

Merck/Sanofi/others to help manufacture, fill & pack

J&J temp suspended release due to rare blood clots in younger, mostly women. 

Novavax 

COVID-NanoFlu™

Combination vaccine - recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccines with Matrix-M™ adjuvant

 

 


Walvax Biotechnology (China)

ARCoV 


 mRNA vaccine

 

 

Recruited 28,000 patients for phase 3 trial. 

Also recruited 1000 patients for booster trial. 



APC/Vaxine
CoVax-19

Advanced tech with Advax-SM adjuvant

 

Phase 2 initiated

Manufacturing scale-up in Dublin

Valneva (France)

VLA2001    

inactivated adjuvanted whole virus vaccine

89.8% in the medium-dose and 100% in the high-dose group after 2 doses

95% response

95% seroconversion

Phase 1/2 results positive

Phase 3 better response than AZ vaccine - sig better tolerability

Phase 3 trial underway 

Completed and showed superior response to AZ vaccine and good antibody response. 


Zydus Cadila
ZyCoV-D
India

1st plasmid DNA vaccine (3 dose)

 

 

Clin trials in 50 centers
applied for emergency use

HDT Bio Corp
HDT-301 COVID-19 RNA
USA

Lipid InOrganic Nanoparticle (LION) - protects against variants

 

 

Phase 1 in 60 patients - 2 dose

Medicago, Canada
Covifenz

1st plant-based vaccine 

plant related to tobacco manufactures a protein similar to spike

71% effective against infection 

Approved in Canada Feb 25

 

 

 

 

 

 

 

 

 

 


Multivalent, Multiviral Vaccines

Moderna
mRNA-1010

Quadrivalent flu

Phase 1
50 mcg, 100 mcg, 200 mcg

GMT against all strains at 29 days

A/H1N1, A/H3N2, influenza B/Yamagata- and B/Victoria-lineages

Phase 2 trial fully enrolled

 

Phase 3 prep underway

 

Moderna

mRNA-1011
mRNA-1012

Multivalent flu

 

Strategic planning mRNA

 

 

 

Moderna

mRNA-1020
mRNA-1030

Sars-CoV-2/Flu/RSV booster

 

Strategic planning

 

 

 

US Army
Walter Read

SpFN

Phase I study completed 

Spike Ferritin Nanoparticle COVID-19 vaccine

Elicits antibodies that are expected to protect against all known strains and variants of coronaviruses incl Covid and SARS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


The story of adenoviral vector vaccines and prior immunity to adenovirus. 



WHO Coronavirus vaccine landscape tracks 173 vaccines in development, 64 have reached clinical trials. 


Merck drops two candidate vaccines due to poor results in early-stage trials. 

AZ vaccine data lacking in over 65. 


Coronavirus stats Worldometer and Johns Hopkins
Animated graphic covid-related deaths by week
Animated graphic shows deaths due to Covid-19 vs other causes over time

Which vaccines are in use around the world - Feb 2021. 
 



Cov-Boost Trial in UK is evaluating 7 different vaccines as boosters. Data due Sep 2021.

Treatments

Veklury (remdesivir)

Gilead

IV 10 days

Shorter time to recovery and less progression to severe disease

Viral RNA polymerase inhibitor

Lageviro (molnupiravir)

Merck

50 % effective  given within 5 days of the onset of symptoms

PO

40 pills over five days

5 days no detectable virus

Cut death and  hospitalization by 50% 

nucleoside analog antiviral

Filed for approval.

Approved in UK 4 Nov 2021

Approved in US Dec 23

Yeliva (opaganib)

RedHill Biopharma

PO

Reduces need for oxygen in hospitalised patients

sphingosine kinase-2 (SK2) selective inhibitor

upamostat

RedHill Biopharma

PO

 

Serine protease inhibitor Phase 2/3 trial

bamlanivimab/etesevimab

Lilly

IV infusion

Reduces risk of hospitalisation and death by 87%

Mab

Lilly withdrew from EMEA rolling review

Paxlovid (PF-07321332 +ritonavir)

 Pfizer

 PO

30 pills given over five days
(3 pills b.i.d.)

89% effective at preventing hospitalization or death if given within 3 days of symptom onset 

 protease inhibitor

FDA approved Dec 22, 2021

Xevudy (sotrovimab antibody cocktail)

GlaxoSmithKline (GSK) with U.S. partner Vir

IV Infusion over 30 min

retains effectiveness against Omicron variant

Monoclonal antibodies

Approved in UK

 

Regeneron and AstraZeneca 

 

May be less effective against Omicron variant

Monoclonal antibodies