The WHO and the CDC are using the exact same safety protocol for mRNA as for any vaccine - they have speeded development up by risking money not lives.
The mRNA vaccines are very clean vaccines. They don't do anything to the cell DNA. They are instructions to make the spike of the protein, your body then fights off the spike and then the mRNA and the spike are gone and all that is left is the memory of how to fight the disease.
The spikes can't harm you as they can't infect by themselves, they need the virus attached to them- they don't have instructions needed to tell a cell to make more spikes. So once the original mRNA is gone and the spikes are gone there is nothing left except the memory of how to fight them.
HOW MRNA VACCINES WORK
This is how the mRNA vaccines work, basically the mRNA gets taken up by cells, that then readhe instructions in the mRNA and use them to make lots and lots of the virus spikes. The mRNA doesn’t replicate - it is not a virus itself. It is just a set of instructions. But each strand of mRNA can make many spikes.
Vaccine developers do have to be careful about auto immune reactions. This is a result of the reaction of your body to the spike, it could also happen as a reaction to the natural virus.
(click to watch on Youtube)
KATALIN KARIKO WHOSE DISCOVERY IN 2004 WAS THE KEY TO SUCCESS
This is Katalin Karikó who found a way to get the mRNA into your body without your body destroying it.
David, you have a huge role in this. We have performe and published together the first mRNA transfection studies https://t.co/9JuQDWmb9c and you saved me many times after I was demoted from my faculty position and subject of termination. Thanks so much believing me and the mRNA! https://t.co/5YMY97P3fk— Katalin Kariko (@kkariko) July 24, 2020
This is a photo of her in 1980 as a PhD student chemically synthesizing RNA
However she found that mRNA when injected caused an inflammatory reaction.
In 2004 she found the solution, a way of modifying the mRNA by altering one of the genetic code chemicals (nucleoside) so that the body didn’t react to it.
That was the “big 'oh!' moment, at that moment I felt okay, this is very, very important.”
She published the paper in 2005. This is the key that lead to Biontech and Moderna developing their COVID19 vaccine in 2020.
To find out more:. 'Redemption': How one scientist's unwavering belief in mRNA gave the world a Covid-19 vaccine
ORIGINS OF MODERNA - COMPANY SET UP JUST TO MAKE MRNA VACCINES
There were several other scientists involved who then discovered how to use mRNA to make a vaccine and then set up Moderna (the name is short for “modified RNA”). This was a company set up just to make mRNA vaccines.
The complete story is here.
. The story of mRNA: From a loose idea to a tool that may help curb Covid
WHAT ABOUT AUTO IMMUNE REACTIONS?
This is something to be checked for any of these vaccines as they all AFAIK target the spike.
The spike is made in a similar way to proteins that are needed for the body and by injecting the spikes or a virus with those spikes or getting the body to make spikes - however you do it - you need to be careful that the spike doens't trigger an immune systerm reaction that will then attack natural proteins in your own body.
You can deal with this by being careful to check the spike protein to make sure it doesn't trigger these reactions.
This is not particularly about the mRNA vaccines but any vaccine that uses the spikes. The vaccine developers will have had this in mind and the WHO and CDC would bear it in mind also in their review.
This describes the issue:
. Covid-19 and autoimmunity
"The extent of the molecular mimicry between SARS-CoV-2 and the human proteome should be carefully analyzed as a mandatory step preliminarily to any vaccine formulation As a matter of fact, because of the pathogen–host peptide commonality, a potential consequence of vaccination might consist of a specific autoimmune reactions hitting self-antigens such as the already analyzed alveolar surfactant protein. Only peptide sequences uniquely belonging to the virus can represent the basis for safe and specific vaccinations protocols "
This is one of the things the WHO, the US CDC etc will look at. We have lots of experience with vaccines and every decade we learn more.
It would need an expert to answer properly about why and how they ensure that there are no risks from auto immune reactions like this. But for sure they will not approve it until it has gone through all the necessary safety tests whatever they are.
It’s important to realize that Pfizer are only asking for emergency approval right now.
So far we have six months data on the phase 1 trials of many vaccines. By the time they approve this we will have 2 months from the middle of phase 3. vaccination (from when half were vaccinated).
That is enough for emergency use approval for use with those most at risk. The first few thousands, tens of thousands maybe even hundreds of thousands are really “phase 4” trials - an extension of phase 3. It’s much the same as phase 3 except everyone is vaccinated, no longer any placebo branch. The focus is on such things as safety, also the best way to administer it.
One of the big questions remaining is, is it possible to give it as a single dose? If so how? That’s the sort of thing they can investigate in phase 4 after emergency use approval and indeed, after final approval too. They continue working on this, learning how best to use the vaccine, after approval.
For final approval the FDA requires six months from the phase 3 mid point which takes us to March if I get that right.
But we already have six months from the phase 1 point.
VAST AMOUNTS OF SAFTEY DATA COMPARED TO NORMAL PHASE 3 TRIALS
Not only that though we have massive amounts of data. Trials with tens of thousands of vaccinations. Also, unusually, we have many vaccine candidates all for thh same disease and with only slight differences.
There are nearly 50 vaccines in clincal trial and 11 in phase 3, one already completed the primary end point for phase 3 as of writing this,
- We don’t even have one example of a serious adverse example from any of the trials
Of the 11 in phase 3, 7 specifically present the spike to our bodies in various ways, and four are inactivated viruses
The vaccines in phase 3 that present the spike as mRNA are:
Then Novavax presents the spike itself as a nanoparticle, and then the ones that attach it to an adenovirus are
- Astrazeneca (UK)
- Cansino (China)
- Gamelaya (Russia)
- Janssen (Belgium)
Then there are three inactivated viruses from China and one from India.
. See: Draft landscape of COVID-19 candidate vaccines
That’s very promising. For details see my. Why the COVID vaccines will be amongst the safest vaccines ever approved by the time they get to most people - Pfizer are talking about Emergency Use Authorization for most at risk
Video about this article
(click to watch on Youtube)
In that video I explain that the spike by itself is just a protein, and has no RNA in it so can’t replicate. This is the image of the spike:
It’s from this article
. MERS Vaccine that Fully Protects Mice Used as Basis for Coronavirus Candidate
I found it originally in:
. COVID-19 vaccines: How Pfizer's and Moderna's 95% effective mRNA shots work
I also explain in the video that the mRNA can’t replicate either. Messenger RNA is produced by the DNA but can’t replicate by itself in a normal mammalian cell. Cells can replicate DNA but not RNA.
So RNA viruses have to create their own replication machine. This diagram explains in broad terms how the SARS-CoV2 virus hijacks the cell to replicate itself.
I have no idea what it all means either I just want you to get an idea of how complex it is. If you are a biologist and want to check out the details it’s here.
. Coronavirus biology and replication: implications for SARS-CoV-2
Obviously the mRNA can’t do this nor can the spike.
Be sure to watch this if you haven’t already, Soumi
(click to watch on Youtube)
see this video
(click to watch on Youtube)
. "Safety would be paramount," says WHO Chief Scientist Soumya Swaminathan on speedy COVID-19 vaccine approvals
Also see my
. Why the COVID vaccines will be amongst the safest vaccines ever approved by the time they get to most people - Pfizer are talking about Emergency Use Authorization for most at risk
. Why vaccine development can be so fast for COVID19 - risking billions in funding - not risking lives
On how we don't have to vaccinate everyone:
. COVID vaccines plug holes in our public health armour - don’t need to vaccinate everyone - #DoItAll and get to zero COVID faster
. 20% of the world population is like this already - without a vaccine - the rest of us need to learn how to do this ourselves
On the other new vaccines
. Good news again - promising for Astrazeneca - Russia’s Gamaleya COVID vaccine 92% effective preliminary data - looks like nearly all vaccines will work
. Second COVID19 vaccine success - Moderna - 94.5% effective - can be stored in a normal freezer and for 30 days in a fridge - promising for the other 9 still in phase 3 already
. Wow brilliant! - Preliminary data at 94 infections shows the Pfizer vaccine is 90% effective - far better than was hoped for