Posted on 05/01/2021 8:23:32 PM PDT by SeekAndFind
Clinical trial operator Panthera has begun vaccinating volunteers in a world-first trial of Valneva’s inactivated Covid-19 vaccine at its site in Rochdale.
The study, which will include 4,000 participants across 24 sites in the UK, is being overseen by the global contract research organisation, Pharm-Olam.
Panthera’s clinical trial sites in Rochdale, Preston and London will be vaccinating healthy volunteers over the age of 18 who have not had a Covid-19 vaccination.
The double-blind phase three trial will compare Valneva’s inactivated vaccine, VLA2001, with AstraZeneca’s conditionally approved vaccine Vaxzeria. Unlike earlier Covid-19 vaccine trials, which involved a placebo dose, everyone involved in this study will receive two active vaccine doses.
Those enrolled in the study over the age of 30 will be randomised to receive two doses of either the Valneva vaccine, or the approved Oxford/AstraZeneca vaccine. Participants aged 18-29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca vaccine.
Valneva’s VLA2001 vaccine is the only inactivated, adjuvanted Covid vaccine in clinical development in Europe. Adjuvants are ingredients used in vaccines to create a stronger immune response.
Earlier this month, the specialty vaccine company reported positive Phase 1/2 trial data, which found that its inactivated vaccine was well tolerated with no safety concerns identified, and highly immunogenic.
Valneva plans to make a regulatory license submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in Autumn 2021, subject to successful Phase 3 data.
Last year Valneva entered a major partnership with the UK government. The UK has the option to purchase up to 190 million doses through to 2025 and has ordered 100 million doses to date, to be delivered in 2021 and 2022.
Stuart Young, CEO of Panthera, commented: “Every new vaccine is another weapon with which we can fight this pandemic and we are very pleased that we have been able to assist in these trials.
“We have put in place strict procedures, SOPs, and PPE at all our sites across the UK to make sure that patients, volunteers, and staff are as safe as possible. It is vital that clinical trials continue to ensure that there are new medications available to prevent and treat, not only Covid-19, but the many other conditions which afflict so many people.”
The Chief Medical Officer at Valneva, Juan Carlos Jaramillo, addeed: “We’re delighted that the trial is underway and would like to applaud the efforts of everyone involved in making this happen. We hope that people across the UK continue to volunteer for studies so that we can continue to make progress against the pandemic.”
This is the third Covid study being undertaken by Panthera, which includes one study where patients with Covid received an antibody to treat symptoms. Panthera also runs trials in chronic disease and cancer.
WHAT IS THE VALNEVA CORONAVIRUS VACCINE?
See here: https://www.sciencefocus.com/news/covid-19-everything-you-need-to-know-about-the-valneva-vaccine/
What type of vaccine is the Valneva candidate jab?
Valneva’s offering falls into a category of jabs known as inactivated whole virus vaccines.
These vaccines contain viruses whose genetic material has been destroyed by heat, chemicals or radiation so they cannot infect cells and replicate but can still trigger an immune response.
Have whole virus vaccines been used before?
Yes, this technology is well-established and has been used in seasonal influenza, hepatitis A, polio and rabies vaccines.
The COVID-19 vaccines developed by Chinese companies Sinovac and Sinopharm, and India’s Bharat Biotech, which have all been approved for emergency use in their countries, are also inactivated vaccines.
How does the Valneva vaccine work?
SARS-Cov-2, the virus that causes COVID-19, is studded with spike proteins which it uses to enter human cells.
While the genetic material virus in the Valneva vaccine candidate has been destroyed, the inactivation process preserves the structure of the spike protein. This helps the body identify the substance as a “foreign invader” and induces an immune response.
So later, when a vaccinated person comes into contact with the virus, the immune system is primed for the attack.
How does it compare to the Pfizer/BioNTech and Oxford/AstraZeneca vaccines?
Unlike the Pfizer/BioNTech vaccine, which needs to be kept at a temperature of about -70°C, both the Valneva and Oxford/AstraZeneca jabs conform with the standard cold chain requirements, which is between 2°C and 8°C.
All three vaccines require a second booster shot to maximise immune response.
Are there clinical trials of the Valneva jab in the UK?
The Valneva candidate vaccine is being tested on 150 volunteers at testing sites in Birmingham, Bristol, Newcastle and Southampton. These tests will show whether the vaccine produces a safe and effective immune response against COVID-19.
If successful, larger tests will be planned for April 2021, with more than 4,000 UK volunteers taking two doses. These trials will include those aged 18-65 as well as over-65s.
It is the fifth vaccine supported by the National Institute for Health Research (NIHR) to enter clinical trials in the UK, alongside those from Oxford/AstraZeneca, Imperial College London, Novavax and Janssen.
If proven to be a successful candidate, Valneva’s vaccine could be available by the end of 2021.
Has the UK Government secured Valneva vaccine doses?
There is an in-principle agreement for 60 million doses, with an option to acquire a further 130 million doses from 2022-2025.
Valneva is also in advanced discussions with the European Commission for the supply of up to 60 million doses of its vaccine.
Its manufacturing facility in Livingston, Scotland, is expected to have the capacity to produce up to 250 million doses annually for shipment across the UK and around the world.
Valneva’s facility in Solna, Sweden, which currently produces the cholera vaccine, is expanding its capacity for fill and finish operations for its coronavirus vaccine – which is the process of filling vials with the medicine and finishing the process of packaging it for distribution.
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Still has the spike protein.
I’ll pass.
The SARS-CoV-2 virus has spike proteins too. And unlike the vaccines, the virus is self-replicating, happily churning out billions of copies of itself inside your body’s cells and flooding your whole system with spike proteins.
But hey, your choice.
yet ANOTHER adjuvanated vaccine, that is, one that contains bizarre chemicals whose sole purpose is to artificially over hyper-stimulate the immune system because the native vaccine itself is too weak to do the job without said adjuvants ...
this is similar technology to cheap feline vaccines that have resulted in an epidemic of feline hyperthyroidism and fatal feline injection site sarcomas ... woe be to anyone like myself who already has a plethora of autoimmune diseases to subject themselves to an adjuvanated vaccines ....
RE: yet ANOTHER adjuvanated vaccine, that is, one that contains bizarre chemicals whose sole purpose is to artificially over hyper-stimulate the immune system because the native vaccine itself is too weak to do the job without said adjuvants ...
OK, here’s a question - what makes the Polio and Small Pox vaccine so different? Why do they last almost a lifetime while these Covid-19 vaccines do not guarantee that?
Antigenic drift and shift. The longer the antigen(s) remain(s) stable, the longer the vaccine is effective. For some things, this may be a year or less. For some, it may be three or five years. For some, it may be a human lifetime.
This is partially down to how prone to errors the replication process is for the particular pathogen and partially down to how stable the protein(s) making up the antigen is/are. If they happen to refold easily enough, that structural change can present problems for dendritic recognition.
Thanks for posting this.
One would think this should be national news here in the UK, rather than local news.
“Why do they last almost a lifetime while these Covid-19 vaccines do not guarantee that?”
Someone may give you a better answer, but I’m pretty sure it is not the “vaccines” but the nature of the diseases.
I don’t think polio, smallpox, measles, etc. are caused by viruses. So those diseases don’t change/mutate over time. Covid is a virus, like the flu. You know how they change the flu shot ever year, because the flu is not the same from year to year. And those shots are never 100% effective I don’t think.
My understanding is that calling ANY of these treatements “vaccines” is a complete misnomer. We should be calling them covid “shots”.
All three are viral. :-)
NHS bosses raking in £300,000-a-year plus bonuses in 'slap in the face' to nurses
BTW, I think most of the UK's WuFlu issues can be layed at the door of the NHS.
US Department of Defense selects Pharm-Olam as CRO for Adalimumab COVID Therapeutic Trial
HHS, too, last year...
Well then why the difference in the efficacy of the vaccines?
“OK, here’s a question - what makes the Polio and Small Pox vaccine so different? Why do they last almost a lifetime while these Covid-19 vaccines do not guarantee that?”
there are two factors regarding the longevity of immunity from vaccination:
1. The first factor is whether the bugs mutate or not; polio, tetanus, rabies, small pox, and a whole slew of bugs don’t mutate, so annual vaccinations are not required as is the case, with bugslie influenza, which mutate wildly ...
2. The second factor is how long immunity persists after infection or vaccination: some immunity is persistent for a lifetime, but immunity fades over time for other infections as the immune system loses its memory of previous infection/vaccination. Polio vaccination provides lifetime immunity for example, but tetanus requires re-vaccination every ten years ...
thus a bug that doesn’t mutate and which the immune system doesn’t forget requires only a single infection/vaccination to provide lifetime immunity, but bugs that mutate or the immune system knowledge fades, requires either a NEW vaccine or a booster vaccination of the original vaccine ...
btw, there’s another wrinkle in all of this, namely that the quick and dirty experimental vaccines offer extremely limited immunity due to the way they’re constructed compared to conventional vaccines made from weakened or killed whole-bugs ...
whole-bug vaccines trigger the immune system to make thousands of DIFFERENT antibodies, whereas the current crop of Q&D covid vaccines are built to trigger only a tiny number of different antibodies, thus conventional vaccines are more prone to offer protection against bug mutation, whereas the Q&D vaccines are almost guaranteed to require a NEW vaccine and vaccination annually, thus providing tens of billions of annual profits to Big Pharm in perpetuity paid for by we taxpayers ...
another adjuvanated vaccine; no thanks ...
https://www.google.com/search?q=Valneva+covid+vacine+ingredients
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