The state of the vaccines

The dance of the variants continues. The Pfizer and Moderna vaccine seem less effective against the South African variant (B.1.351) than initially thought, with drops in antibody response, previously thought to be about 6 fold, now thought to be respectively 10 fold and 13 fold, grossly, when the real life virus is considered rather than synthetic lab versions.

https://www.nature.com/articles/s41586-021-03398-2_reference.pdf

So that's the bad news. Now for the good news.

The very opposite, the Pfizer vaccine seems to be more effective against the even more dangerous Brazilian variant P.1. than initially thought.

https://www.nejm.org/doi/full/10.1056/NEJMc2102017?query=featured_home

Both the Pfizer and the Moderna vaccines continue to be good against the British Kent variant B.1.1.7.

The second study actually indicates that the Pfizer vaccine still had some important effect on the B.1.351 spike mutations.

A limitation of the second study is that it takes into account synthetic viruses, unlike the first one.

The study highlights what we keep saying: this is all related to antibodies, not to cellular immunity. The Pfizer vaccine does elicit T-cell response too. So antibodies are not the only protection elicited by the vaccine.

 

I heard of preliminary data from Oxford University, nothing published yet, suggesting that the AstraZeneca shot is effective against the P.1 variant. Supposedly the paper will come out in late March.

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This post of mine in another thread talks about a potential problem for updated vaccines:

http://www.politicalforum.com/index...es-and-new-variants-of-the-sars-cov-2.585865/

 

A report today from Brazil said that preliminary data from the Butantan Institute confirms that the CoronaVac is effective against the P.1; the Chinese had previously said it is also effective against the B.1.1.7 and the B.1.351.

 

Italy signed an agreement with Sputinik V to manufacture it on site. The EMA has finally started reviewing it. It's been approved in 46 countries and actually seems to be very good. One laments the fact that the Russians seem to experience the need to spread misinformation against the Western vaccines, in order to sell theirs, rather than just highlighting their vaccine's apparent good quality and efficacy.

 

It has been said that Russians would rather sneak in the back door even when the front door is open.

 

There were 22 cases of thrombosis (blood clots) in 3 million people vaccinated with the AstraZeneca shot. One person died of it. The European Medicines Agency ruled out the death, which occurred in a 49-year-old nurse (a middle-aged woman who probably spent the bulk of her professional life standing, a known risk factor for varicose veins which in its turn is a known risk factor for thrombosis), as being caused by the vaccine, underlining that the regular incidence of blood clots, a relatively common and spontaneous issue among the general population, is not smaller than 22 in 3 million so nothing indicates that this occurrence is related to the vaccine. Still, six European countries paused vaccination with the AstraZeneca shot: Denmark (where the death happened), Iceland, Latvia, Lithuania, Estonia, and Luxembourg.

Now, let's think of it. Thrombosis has an incidence of 1 in 1,000 people per year. So in 3 million people we'd expect 3,000 cases of thrombosis per year. Divided by 12, that's 250 cases per month. The AstraZeneca shot is being used for two months and 11 days. That is, one would have expected 591 cases in this population even without the vaccine, over two months and 11 days. So, 22 cases happened, which is an incidence 27 times smaller than the regular incidence of thrombosis in a population this size and over a similar amount of time. If anything, one would have to conclude that the vaccine... protects against thrombosis!!! OK, let's not go there, but how in the hell does it mean that the vaccine is causing it???

But see, we're in the middle of a huge amount of hysteria among the population and the authorities, regarding the Covid-19 vaccines. The EMA is the proper venue to investigate these cases (it's their FDA). It's been investigated. The conclusion was, no relation. That should have been the end of it. Still, six countries over-reacted and paused the vaccination. I'm quite sure that some of the people who will have their shots delayed, will die of Covid-19. Great.

 

Moderna has started a phase 1 trial with 60 subjects. Half are receiving an updated Moderna shot targetting the B.1.351 variant (South African) and half are receiving a bivalent vaccine that combines the current ancestral strain one with the updated B.1.351 one. Moderna is therefore the first company to test an updated version of their vaccine. Pfizer is testing a 3rd dose booster to see if that makes it better for the variants, but it's not an updated shot; it's the same one given in the first two doses.

 

A curiosity: I hear a lot of people talking about the Russian main vaccine (they have 3, now) as Sputnik 5, assuming that the V is the Roman numeral 5. Nope. It's the letter V as in Vaccine. You can confirm it here, directly from the mouth of Kirill Dimitriev, the CEO of the Russian fund that is marketing the vaccine.



You'll hear people in the media saying Sputnik 5. They're misinformed.

 

Here are the 11 vaccines currently in phase 3, country, who is doing them, and platform (three of them, the first three I listed, with imminent approval March/April, the other 8 still have a way to go until they complete phase 3):

Novavax - USA - protein subunit - imminent approval
Curevac- Germany - mRNA - imminent approval
RIBSP - Kazakhstan - Inactivated virus - imminent approval
ZyCov-D - India (Zydus Cadilla) - DNA
AGO302-COVID19 - Japan (AnGes - Osaka University - Takara) - DNA
GRAd-COV2 - Italy (ReiThera) - Adenovirus vector
ZF2001 - China (Anhui Zhifei Longcom) - Receptor binding domain subunit
Soberana 2 - Cuba (Instituto Finlay de Vacunas) - Spike protein subunit fused with tetanus vaccine
CoVLP - Canada (Medicago) - plant-based infused with viral genes producing protein shells
Cover Biopharmaceuticals - Dynavax - China - USA - Spike protein subunit
Institute of Medical Biology - China - Inactivated virus

 

The phase 3 trial of the Novavax protein subunit vaccine has concluded in the United Kingdom, showing a whooping 96.4% efficacy, thus becoming the vaccine with the highest efficacy in a phase 3 trial, even higher than Pfizer's and Moderna's. The company also released the full set of data for their IIb trial in South Africa with the B.1.351 variant, and over there the vaccine fared a lot worse, with 55.4% efficacy among non-HIV+ subjects. On the other hand, there was 100% protection against severe disease in both trials.

So now Novavax will apply for EUA in several countries, using these results. I look forward to having this vaccine approved in the United States. We'd have 4 very good vaccines. I'd stop there. We don't need more. I actually don't want the AstraZeneca approved here, as this would trigger a redundant contractual obligation to purchase 300 million doses. Let these 300 million AstraZeneca doses be sold or donated elsewhere, in countries that do need them.

As of now, with Pfizer, Moderna, and Johnson & Johnson, we have purchased/reserved enough for 500 million Americans.. and if we get 100 million doses from Novavax as contracted in case of approval, that's enough for 550 million Americans... We have 74 million children not eligible for these vaccines. So we have 256 million people who are eligible and our stock is twice as many as needed (not to forget, a lot of adults simply don't want this vaccine). Why would we get 300 million doses from AstraZeneca?

 

Two Italians have died after plotting complications shortly after they received the AstraZeneca vaccine, bumping up to 3 (together with the Danish death) the number of Europeans who died in the wake of these complications. More European countries have halted vaccination with the AstraZeneca shot.
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Some people who suffer from "long Covid-19" are saying that their symptoms got better once they got vaccinated.

 

While the WHO and the EMA are both saying that the deaths from blood clotting disorders are not related to the AstraZeneca shot and have encouraged countries to resume vaccination, now heavy weights Germany, France, and Italy all halted vaccinations with the AstraZeneca product.

The plot thickens, with more deaths occurring. Two men in Italy, a woman in Norway (see below), and one person in Austria (I don't know the gender). So five now, counting the initial Danish case, which is different than just one at first.

Even more concerning is the Norway situation. Three healthcare workers there, all relatively young, all previously healthy, had the triad of symptoms of the Danish case: thrombocytopenia (low platelets), blood clots, and bleeding. Of the three, one died of cerebral hemorrhage.

These cases with this triad of symptoms go beyond merely having blood clots, which is the case for most of these Europeans (about 37 cases last I counted; probably more by now).

No cases so far have been unequivocally associated with the vaccine. It could still be a coincidence. But I'm starting to think that this is looking more and more vaccine-related, especially when you look at this cluster of 3 cases in Norway so similar to the one in Denmark, all four having unusual - and similar - symptoms. What are the odds that suddenly, three healthy and youngish individuals present this unusual triad of symptoms shortly after the AstraZeneca shot, but it's all a coincidence?

Again, this is still very rare. Even if it is confirmed that the AstraZeneca shot can cause life-threatening blood clotting disorders that wouldn't have spontaneously occurred in the population, there's been 17 million doses of AstraZeneca vaccine given, last I counted, so it's the tiniest of percentages, and the virus kills a far higher percentage of infected individuals (not to forget, the virus itself predisposes people to clotting disorders at much higher rates than that). But this is enough to warrant concerns and investigations.

 

The press conference explaining the results of the review is currently underway. I have posted about it here http://www.politicalforum.com/index...-19-vaccination.585909/page-5#post-1072512827

 

Yes, I saw it, and replied there, too.

 

Interesting op-ed about what the author calls Europe's vaccine lunacy:

https://theweek.com/articles/972321/europes-vaccine-lunacy

It makes a point I've made too: that in order to prevent a handful of cases of clotting disorders (less than 50 in 20 million people) that resulted in 5 deaths in 20 million, European countries are pausing the vaccination with a vaccine that prevents a disease that is... 100 times more likely to cause deadly blood clotting disorders, than the vaccines, even if it's really the vaccines that caused it.

It's crazy.

Thousands will die to save five.

Europe is usually a more rational society than the United States. Well, on this, they are certainly being extremely boneheaded.

Mario Draghi, Italy's new PM (who is a technocrat, and a very competent one who saved the Euro during its crisis a few years back), is a voice of dissent. He wants more vaccination speed, and wants to approve the Sputnik V (which actually seems to be a very good vaccine with high efficacy and safety).

 

Yup, let's hope they all resume taking the AZ vaccine after yesterday's report on the findings of the review.

 

I lived for several years in Europe and I have deep appreciation for the things they do well. But don't forget it's the continent of the paralyzing precautionary principle and irrational Luddite opposition to GMO's.

 

Yes. And apparently there is more vaccine hesitancy among the population in Europe than in the United States.

 

Interesting article on how the vaccines maybe are helping the long-haulers. Some mechanisms are proposed, such as clearing viral persistence or resetting the immune system, thus discouraging auto-antibodies:

https://www.mdedge.com/internalmedi...g COVID see relief after vaccination&sso=true

 

Just read that article. It seems to share the same views on the politicisation of the AZ suspension as me.

 

That's encouraging. I have 4 friends that I know about who are suffering from long covid including two with heart problems.

 

Good point.

 

Is it entirely irrational though?
Being able to produce your own seeds and grow a wide range of varieties is a rational desire.

 

Hybridization limits seed production and “varieties”, genetic modification does not. You are talking about an economics/patent/intellectual property problem, not a biological problem.

Most of the pushback I see from Europeans is based on the biological aspects, not economics/patents/intellectual property concerns.

If you want to grow your own seed, it isn’t GMO’s that are the barrier, it’s law allowing patenting of the traits. There are three solutions: Universities etc. developing open source traits, waiting for patents to run out, and then open sourcing, or changing the laws allowing parenting of traits.

Progress is being made.
https://www.oilseedandgrain.com/sin...nting-generic-gmos-as-monsanto-patents-expire

Do you have evidence consumers in Europe oppose GMO’s because you can’t save seed without breaking the law, and not because of the technology itself? I’m very open to reconsidering, but the news we get here is that the technology itself is rejected, not patentability.

 

No, the consumers are mostly ignorant of the patent situation. It's the farmers who would resist the copyrighting of seed production etc. Most consumers just label GMOs as Frankenstein foods and want nothing to do with them.