The state of the vaccines

I've been waiting for you to chime in on this. The optics don't look good at all and I think you're correct that it's in everybody's best interest to keep moving forward in spite of it. As you know, there are a ton of conspiracy theories out there and a good percentage of people are already hesitant about these vaccinations. I hope this is the last of this kind of thing.

 

I don't really understand why they would take the chance on eroding public trust if the true numbers were still high enough to meet the minimum requirements. Isn't that a dangerous risks for their reputation and stocks?

 

Yes, that's why I said that if the FDA says no people will die, then I said that my reaction was the emotional one, not the rational one. The rational one is, the vaccine should be approved.

 

Me too.

 

You know, some marketing department guy must have said "79% looks better, people think of it like almost 80%, puts our product more aligned with the competition, we'll see more if we say it's 79%" and some greedy exec agreed.

I mean, they had lied before, when they didn't want to acknowledge that the half dose was a mistake, and when they combined together trials with different end points and methodology, because the isolated data was showing numbers in the 60's.

The fact that Pfizer and Moderna set the bar at 95% must have upset the competition, so they tried to cook the numbers to look better.

Because, what's the alternative? To think that a major drug maker doesn't have enough high caliber statisticians so they simply miscalculated it? No, I think the intent was to make the product look better than it is.

 

The anti-vaxers are winning this "competition. Anti-vaxers only need a small percentage of the population to win. Europe is in a dire straits

What we need is actual statistics based on those who have had the vaccine showing whether they have since been infected and whether they died, hospitalized or very mild or no symptoms together with a comparison made between each type of vaccine. We have 400 million doses administered so far. Then compare that with those not vaccinated

There has not been enough emphasis that the Oxford vaccine does significantly reduce deaths and hospitalization for which the company is at fault here and unfortunately the media picks up only the very rare serious side effects of the vaccine

 

The media's need to generate outrage and controversy to generate revenue is a problem in most serious issues. Add to that the EU's need to divert from their mistakes in procurement and you end up with a deadly mistrust that will cost lives.
I have vaccine sceptic friends who were already reluctant who will now feel even more justified in refusing to take one.

 

There might be an other little scandal.
Apparently AZ has around 30million doses in storage in Italy and is not releasing them.

 

I just heard that. They're bound for Canada and other places around the world but the EU seem to want to grab them.
There was also another story about a batch of AZ not being used because of faulty labelling despite their being no evidence of a problem with the contents.
They're making it difficult for me to remain pro-EU.

 

The 30million dose question has been solved. It a storage facility, from were those doses will be distributed. Over 15million will go to the EU and the rest to WHO.
Germany has a problem with Moderna. Moderna is very sensitive to movement. If it gets loaded and unloaded to often, the vibration, shaking etc. makes it useless.
Germanies medical distribution system is strictly regulated, as are any form of medications.
In order to get Moderna under the current system to the family Doctors, it would have to go through 4 Stations of distribution from the Moderna warehouse and that would render the vaccine useless. To much shaking. Now Moderna and family Doc are of the table, till they solve that problem, the -20C transport. They talked briefly to a very large company, distributing frozen food. Their vehicles do -25, 3000 of them.
They are very busy right now, lock down. But they could do the job on the side and are willing.
But than Moderna, just talked briefly to them weeks ago.
BioNtech has filed with EMA, that its vaccine can be stored at -20 to -25C for 4 weeks, approval still outstanding.

I wonder how Moderna is distributed in the US? How it is handled and how often.
BioNtech/Pfizer opted for their own distribution system, because of the extrem storage temps, -70C.

 

mRNA vaccines are very fragile and should never be shaken. Only a gentle swirl with the vial upright is indicated, between doses. If someone shakes a vial, they should contact the manufacturer before using that vial. But that's only after it is thawed.

I am unaware of any problem with shaking the boxes while the vaccine is still frozen, during transport. That's exactly one of the reasons why the vaccine is frozen; so that it doesn't move around during transport. If you have a link for that, I'd be interested in reading it. I'll check tomorrow with our chief pharmacist if he has heard anything about this.

Here is how we are handling it, in terms of temperature control and thawing.

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/storage-summary.pdf

This is even more complete information:

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html

Click on the + sign next to "how to prepare the vaccine" and see #4.

The Pfizer one is handled differently: we are supposed to gently invert the vial ten times after dilution, at room temperature, before use. But again, we do NOT shake it.

Another huge difference is that the Moderna shot doesn't need diluting. The Pfizer one needs to be diluted before administration, with 1.8 mL of normal saline, preservative-free.

Thawing methods are different too, and the amount of time the vaccines can stay at room temperature are different.

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@MJ Davies I think you asked me about choice of vaccines, right?

The above differences are one of the reasons why we either do a Moderna vaccine clinic, or a Pfizer one. The day we do Moderna, it's just Moderna, and the day we do Pfizer, it's just Pfizer, because we don't want to have two vaccines that need to be handled very differently, the same day, which would increase opportunity for error (someone inattentively handling one the way the other one needs to be handled).

So in the morning before starting, we say to the staff: This is Pfizer! No more than 2 hours at room temperature! Dilute with 1.8 cc of diluent (saline). Invert vial gently 10 times. DO NOT SHAKE!!! You can get 5, up to 6 doses per vial. The dose is 0.3cc. If you get 5 and there is less than 0.3cc left, discard, don't try to get a 6th dose by combining with another vial.

Or we say:

This is Moderna! No worries about room temperature limit today, it can stay at room temp for 12 hours, but once punctured the vial needs to be used in up to 6 hrs. No dilution needed. Just swirl the vial once, upright, DO NOT SHAKE!!! You can get 10, up to 11 doses per vial. The dose is 0.5cc. If you get 10 and there is less than 0.5cc left, discard, don't try to get an 11th dose by combining with another vial.

And there are a few other specifics; for example, the Pfizer vials come inside a multi-vial flat box (195) that looks like a tray and has a printed expiration date for that lot, while the Moderna ones come with a QR code on the outer carton that needs to be scanned, to find the expiration date, and the boxes are smaller (10 vials in each).

We haven't done Janssen yet.

 

1) Cold virus closest relative to Covid
2) Cold virus mutates too quickly for an
effective vaccine approach.
H*ll we can not effectively keep up
with influenza virus strains to effectively
acquire "herd immunity" for this season's
epidemic. The strain was not in the
trivalent / quadravalent designated
vaccine of the year


The Primary error was "leaders"
investing in vaccines while ignoring
anti viral medicines.
I gave up on flu vaccine years ago
and keep a pack of Tamiflu in house
should I need it.

Conclusion: Too much faith in vaccines 'lest you
be termed an "anti vaxer".
Polio, yes vaccinate
Diphtheria and tetanus too.
Not Covid, colds, and hardly flu


Moi M.D. ret.

 

AstraZeneca has released updated Phase 3 data, after the DSMB berated them for cherry-picking their data.

The overall efficacy dropped to 76%. On the other hand, the efficacy for those older than 65 went up, to 85%.
There are still 14 possible infections that are being investigated and could still change these numbers.

The issue is, can we trust their data?

If we can, the vaccine surely does meet the FDA criteria for approval.

So, like another poster said here, we should berate the company for their blunders and possibly their intentional attempts to mislead, but still uphold the vaccine, if it is safe and efficacious and this is the truth, despite the company's misrepresentations (and it isn't the first time they do that).

 

Center Field I read it in the FAZ.

Here a interesting little story about curevac.
How a Promising Covid-19 Vaccine Lost Its Way — And Found It Again — Update | Morningstar

 

Fascinating, thanks for posting! I've been following the Curevac with interest. An mRNA vaccine that is stable in higher temperatures, that's a dream!

 

I bought curevac when they went public, NASDAQ. A few weeks ago there were several editorial about curevac in German News papers.
They called it the curevac disaster. I could not understand it, because curevac decided last year, in May or June, to develop their mRNA so far that it could be stored at fridge temps. That took a little longer and they were not anymore front runners, like bioNtech and Moderna.
The disaster, if you want to call it that way, was that curevac reacted in its Phase 3 to the new variances and is including them in its current trials.
Which means a further delay, of a month or so.
I think it is rather prudent. While you are at it, get the data.
Than this portable bioreactor/DNA Printer, with which you can produce at the location of a outbreak.
That is cutting edge technology, which will have a huge impact for the world.
Right now everything is about C19, but it is just a episode. But it produces medical technology, now, which would have taken probably 10 more years to be established.
As I wrote last year, research is all about money. If the researchers do not have to worry about it, just spent and spent to get results, science explodes.
When Germany invested in curevac those scientist could take a deep breath. They did not have to rush anymore to get a product on the market, to make money. They were able to finish the job, to produce a great mRNA vaccine, which can be stored at fridge temps.

BioNtech and Moderna did the right thing, go flat out to produce a vaccine and prove that the mRNA technology works

And always there is a human story behind it.

 

Very true.
Here is what is sad:
In the past, science was unable to rapidly react to crippling pandemics... Spanish flu... H1N1 1976... SARS... MERS... Ebola...
This time science WAS able to react fast and deliver game-changing safe and effective vaccines that can beat this virus...
But we are going through an era of science denialism and people won't accept the vaccine (and the masks).

 

No we are not. I would bet $1000, that the science denial has never changed, only its way of propaganda, through the internet.
That's were science is failing, propaganda, has left that field to the snake oil sales men and they make a killing of it.

Science needs 10.000 people like you, willing to engage.
But you are a fact base guy, not a entertainer. So at times boring. No offence, my friend.

If you want to bring science across to people you need snake oil sales men, entertainer.
Make it a show.

 

Correct.
And I'm aware that because I take the time to explain things, my posts are long and verbose and this, turns off the low attention span crowd.
It is difficult to convey a scientific view to lay people. Many won't accept that their supposedly common sense views may be entirely wrong. When confronted to the scientific facts that demonstrate it, they will chose to deny science instead of acknowledging that their views are inaccurate. It's part of the natural narcissism of human beings.
And you just can't win. Some here complain when I try to simplify things for their consumption. Others complain when I'm too technical.
I try to find a happy medium by using analogies, etc.
But yes, obviously I'm more a scientist than an entertainer, and sometimes it is hard to reach those who don't share this background. I try, though.

 

Great news for Europe. EMA has certified bioNtech's Marburg factory. The factory was certified by German authorities in January and had started production in February.
The stockpiled vaccines could not be distributed, without EMA certification. Nobody knows how many doses are stockpiled, but it will be a bunch.
Marburg is the largest vaccine factory in Europe, capable of 750 million to 1 billion doses.
Second EMA has certified bioNtech, for storage at -20C. That would bring family doctors into play.

 

Brazilian scientists are working on a new platform, first developed at the Ichan-Mount Sinai School of Medicine in New York, a new concept that is very promising. The SARS-CoV-2 does not cultivate well in eggs like the influenza virus. So they inserted the S protein code into an avian virus, the one that causes New Castle Disease (NDV of the paramyxoviridae family). Well, that one grows in eggs, which is the cheapest, simplest, and most diffused technology for viral vaccines. Also, this virus is harmless for humans but functions as an adjuvant (to enhance the immune response). Another advantage is that the NDV only requires a level 2 lab as it is not a dangerous virus, so, this makes it cheaper as well, to deal with it.

The vaccine is called ButanVac, and is about to enter phase 1. The Brazilians want to do it very fast, all phases in 90 days so that they would be able to start vaccination in July. If successful, this vaccine will deliver independence to Brazil as its production will be 100% domestic. In the Butantan factory they have the capacity to produce 100 million doses per year, and there is a possibility that this will be a 1-shot vaccine, so almost enough to vaccinate half of the Brazilian population. 40 million doses would be ready by July.

Thailand and Vietnam are interested in partnering with Brazil on this. Given that this would be a cheap vaccine, with technology that is shared by many countries in the world, it has a potential for being instrumental for the Third World.

 

You’re doing fine.

 

The Paul Ehrlich Institute in Germany said a total of 31 cerebral sinus venous thrombosis were reported by March 29 out of some 2.7 million doses of AstraZeneca that have been administered across the whole of Germany so far (that's 1 in 87,000 so the complication seems to be less rare than initially postulated). Nine of the people died (29%) and all but two of the cases involved women, who were aged 20 to 63. About 40% of the people with this complication have died of it, elsewhere in Europe.

Local officials in a third of Germany are now only giving the AstraZeneca shot to those older than 60. Canada did the same, but their cutoff age is 55.

My position on this is shifting. Given the existence of other vaccines for which this problem hasn't surfaced, I think at this point the AstraZeneca shot should indeed be reserved for senior citizens of both genders who don't seem to have this risk, and maybe younger males. Females younger than 65 should be vaccinated with other approved vaccines.

 

I suspect that EU pride and prestige may be in play.

 

Nope, simply numbers.