The state of the vaccines

What 113 people died in the US after having the Pfizer vaccine? Source? If you mean people died of cancer, heart attacks, etc. etc. etc. after having the Pfizer vaccine, do realize that the Pfizer vaccine only protects against Covid-19, not against cancer, heart attacks, etc. etc. etc. and given that it started deploying for very old people, of course people will continue to die at the usual rates after getting the shot. I am entirely unaware of 113 people dying of conditions attributed to the Pfizer vaccine itself in the US, and I'm following this VERY closely. Unlikely that I'd have missed it. But if I did, source, please.

I don't see it as a "concerted effort" to attack the AstraZeneca vaccine. I see it as valid medical research after post-market experience revealed a new and concerning side effect (although rare). The issue did indeed warrant investigation. It's been investigated extremely fast and a cause and treatment have been found (as per post #624), which is quite remarkable. Calling it a concerted effort to discredit the AZ vaccine sounds like a conspiracy theory to me.

So what would you have preferred? That a cause, diagnostic tools, and treatment had not been designed???

 

A lot of new information there. Thanks.

I don’t think the fact Sputnik V uses adenovirus as a vector is evidence this particular “strain” of adenovirus can’t be causing the problem from previous exposure. The adenovirus vectors are different and we know even slight differences in viruses can affect people quite differently (for example the 1918 H1N1 vs the 2009 H1N1 influenza virus strains).

Another bit of perhaps pertinent information is young people typically having higher antibody titers to cold viruses than older demographics.

I’m not saying I think this is definitely the case, I’m saying ruling out this possibility without some hard evidence would be a mistake.

What if the Russians used two different adenovirus vectors (one for first dose and another for second dose) for a reason besides increased efficacy?

 

I'm not disputing what you're saying, just introducing more info. AstraZeneca uses chimp adenovirus that can't cause human disease; but of course it can trigger antibodies.
The Russians have previously said that they used two strains precisely to avoid the second dose being hindered by anti-adenovirus antibodies.
Young people and stronger AB production: true.
I think the hard evidence is the blood-clotting auto-antibodies the German and Norwegian researchers have found.

 

Just remember to wear your seatbelt on the way to get your vaccination as the odds are that you are more likely to be injured in a road traffic accident than by any of the available vaccines.
The UK is acting as a large test bed for the AZ vaccination with nearly half of our 26m jabs administered so far being the Oxford one. With problems in the supply of the Pfizer vaccine this ratio is likely to increase. So far we have had fewer cases of clots reported than Germany and other European nations and only one death. You can't rule out that this is a result of different reporting procedures I suppose but if you look at the rates of deaths from the virus itself and the figures on new cases the importance of taking any vaccination is put into perspective.
Germany has administered a first jab to around 2% of the population, has daily deaths in excess of 200 a day and rising with new cases rising by a worrying 49% over the last 7 days.
The UK has administered first jabs to around 30% of the population (over 50% of the adult population), has daily deaths below 100 and falling and new cases dropping by 2%.
The populations of the two countries are broadly similar with Germany having around 84 million and the UK having around 68 million. So Germany has 20% more people but twice the daily deaths and rising.

Take the vaccine, even if it's the Oxford Astra Zeneca you are offered.

 

Don't know who you're talking to (my Ignore list doesn't stop growing) but if it's an American, remember, the AZ shot is not even approved in America. We have purchased enough Pfizer, Moderna, and Janssen to vaccinate our entire adult population, twice (and I mean twice, with both doses for the ones that are 2-dose). We don't need the AZ doses we contracted for, and should be sending them to Mexico, Canada, Brazil, etc. - we did send 4 million to Mexico and Canada, this week.

 

Understood. It’s a fascinating subject. I haven’t had the bandwidth lately to keep up with all the details so I appreciate you continuing to update us all.

 

I wasn't responding to any post in particular just giving my personal opinion on the importance of getting a vaccine of any type as soon as it is offered to you.
Europe has not procured sufficient vaccines so rejections of the perfectly safe, according to all major health authorities, Astra Zeneca vaccine is particularly disturbing.

 

That is a difficult question to answer. People always think about Germany as one culture/people, which it is not. You got this overlaying system which came from Prussia. The organization, pragmatism, militarism, discipline and so on. Prussia was the dominate Country when the German Empire united again, 1870. This is were all that comes from.
It depends were you are in Germany. The North a little bit more stiff, the South more easy going. In between, you have everything.
Take my State Hesse, the South is rather easy going, Frankfurt area, than go to the north, 150 miles, were I am from. Hard headed, moody, clannish, crappy weather, forest, nasty falls, crappy winters and lousy springs, shapes people and traditions.

I am sorry to hear that you did not have good hosts, which is not our tradition.

But than most Germans see US Americans as superficial. They say how are you, but do not mean it, don't care. Call everybody by first name, like friends and aren't it. Sounds easy going, but ain't.
The first name means friends, our language expresses it. You in englisch has not qualification. German has 2 qualification, Du the friend and Sie the stranger. It is not polite to use the Du if it is not offered. Between the Young not a problem, or Hippy Generation like me.
But than I know, when in Germany, how to use those 2 different addresses.
Lets say I go to a Bank, I will always address the employees with Sie, am I am in Bar Du, Restaurant Sie.
You are in a professional meeting, first names used, the you does not make any difference.
John could you please, hand that memo to me.
John could Sie hand that memo to me. John koennen Sie, mir das Memo geben. Strangers.
John could Du hand that memo to my. John kanst Du mir das Memo geben. Freunde.

I hope that helps

I did not leave Germany because I hate it. I wanted to see the world. Spent 10 years working in South and Central America and than ended up by accident in the US and if I can help it, will end up in Portugal, because of the weather and living cost, good food beautiful people, whine and what ever.
I am a globalist, but do not enjoy people to much. Three dogs, 2 pigs and a Bier, and my farming is all I need.
But than I am a Waldschratt.

Groeoeoeoeoeoeoeoeoehl

 

Thanks for your answer, gnoib. Very interesting. And yes, I'm familiar with the formal/familiar structures in a language, like the Vous and Tu in French.

 

As expected, confidence in the safety of the AZ vaccine has dropped sharply in Europe:

https://www.yahoo.com/news/european-trust-astrazeneca-covid-19-000958474.html

No spilling over of this effect to Pfizer and Moderna, fortunately.

 

AZ did not help itself with the sloppy Phase3 from the beginning. Its reputation was already low.
BioNtech has a rock solid reputation. It very much helped that they were very open, gave a lot of interviews.
Sahin is a first class spokes person for the vaccine, low key, straight forward.

 

We're still getting mixed messages from Europe about the AZ vaccine.
They are again threatening to withhold shipments of it to the UK from the manufacturer in the Netherlands.
Despite the reluctance of many in Europe to take it they seem desperate to procure doses even if it means breaking legally obtained contracts.
Make your bloody minds up Europe, do you want it or not?
The politics going on is costing lives.

 

AstraZeneca has finally released the preliminary results for their large Phase 3 trial in the US, this one done right, within the parameters dictated by the FDA. 32,000 subjects, with 2 of each 3 getting the shot, and 1 of each 3 getting the placebo. Significant elderly population.

Results: 79% efficacy against symptomatic infection. 100% efficacy against hospitalization and death. No major side effects. No thrombosis, no CVST. For the elderly, 80% efficacy against symptomatic infection.

I have only read their press release. The publication in a scientific journal, as usual, will be done later.

AZ will apply for FDA authorization. The way they will do it, it's likely that when/if they are granted it, we will already have all the Moderna, Pfizer, and Janssen shots that we need for our entire population and will likely not deploy the AZ shots, but for the company, after all the mess, it will be helpful to have the FDA's endorsement.

 

@CenterField, is AZ using the half dose or full dose? The most common reason for viral induced auto immune antibody production is lack of viral antigen in germinal centers. When viral antigen is only present in small isolated tissues, auto antibodies are more likely because the B cells are not being “proof read” for “self” in the germinal centers.

 

Full dose.

 

Incredible. What's wrong with AstraZeneca? Now, there was a report that the company's press release on Monday containing partial results of the American phase 3 trial was misleading. So, they seem to be doing all they can to undermine public confidence in their vaccine, which is already significantly shaken. The serial blunders this company is engaging in, are exasperating.

The FDA needs to take a hard look. If the real data are not consistent with what the company is saying, it would be appropriate for the FDA to deny the Emergency Use Authorization, on bases that the makers are not reliable and their data can't be trusted. Enough with AstraZeneca blunders. They need to learn a lesson. They are undermining the credibility of all Covid-19 vaccines, by association.

PS - I do not know what the inconsistencies are, between the press release and the data, since the source doesn't mention them, and the full data have not surfaced yet, in the form of a paper submitted to one of the major journals.

 

AstraZeneca’s U.S. vaccine trial data may have been ‘outdated,’ independent panel says
By Carolyn Y. Johnson, Laurie McGinley, William Booth and Erin Cunningham

 

That's behind a paywall. Can you post the relevant points please?

 

I found this one.

https://www.marketwatch.com/story/u...d-information-over-covid-19-trial-11616484192

 

Thank you.
So it appears to relate to a slight difference in the efficacy figures and have nothing at all to do with the safety of the vaccine.
That's reassuring.

 

You're welcome.

I'm not in the field so am no expert but that's how I read it as well.

 

It is about the sloppy paperwork they produce

 

Yes, the issue is not safety. The issue is, it seems like the AstraZeneca company claimed 79% efficacy when the data only support between 69% and 74%.

Seems like a small difference, splitting hairs? Well, it isn't, because the issue is trust.

The Data and Safety Monitoring Board is taking the very unusual stance of accusing the company, in a 2-page scathing letter, of cherry-picking the data to make the vaccine look better.

Still ANOTHER blunder by AstraZeneca. I'm sick and tired of them. The board wrote, "decisions like this are what erode public trust in the scientific process." The NIH's NIAID followed up by issuing a statement too, and making the issue public.

A DSMB berating a drug maker for a trial it is overseeing, like this, is almost unheard of.

AstraZeneca, when they released the partial results, did not count newly found Covid-19 cases in their volunteers. The Board had spent days repeatedly asking for updated figures. The company, instead, went ahead and released the outdated results, with not a peep about them being outdated. That is also highly unusual. Usually the company will only release the information after the DSMB has been through it all and has sent back to the company the endorsement of the data. That's exactly what Pfizer did, and that's why Pfizer never released anything before the DSMB spoke (and they resisted the White House's pressure to release info earlier precisely because they didn't want to taint the process).

By now, as a proud American and a proud American scientist, I'll say this, even under the risk of sounding nationalistic:

In the matter of reliability, trust, and bioethics, at least as far as these Covid-19 vaccines go (I mean, Pharma companies are no angels and even ours have misbehaved in the past, too):

American company Pfizer > British/Swedish company AstraZeneca
American company Moderna > British/Swedish company AstraZeneca
American company Johnson and Johnson > British/Swedish company AstraZeneca

I'm very mad at AstraZeneca. Like I said, I think that the appropriate response is for the FDA to deny the Emergency Use Authorization, on grounds that we can't trust what this company is putting forward; if they are willing to repeatedly mislead, how do we know that they even conducted the trials appropriately? By now, AstraZeneca looks to me like a Russian or Chinese operation, from which, data frequently are tainted by a cloud of suspicion.

That is NOT the first time that AstraZeneca manipulates data. They lumped together half-dose, full-dose and failed to initially inform that the half-dose was a mistake. They lumped together results of trials in different countries without acknowledging that they had different end points and different methodology, including, variable intervals between first and second doses.

They didn't even seem to know how to put together a decent phase 3 trial, to the point that the FDA had to step in and say, "if you want to get our approval, you need to run a phase 3 trial by the books, no more blunders; these are our requirements; and do it here in the USA; do it right this time, then we'll consider your product." OK, they obeyed (knowing that FDA approval is a hugely important seal of quality for their already controversial product)... but then, couldn't refrain from AGAIN trying to mislead the public with their data??? WTF???

I wonder how the #1 university in the world, Oxford, associated themselves with these idiots. They (Oxford) are world-class scientists. They must be cringing by now, and thinking "we picked the wrong partners." I mean, they should have picked, say, Merck, who had the courage of giving up when their own vaccine candidate appeared to be unconvincing. Merck would not have done what AstraZeneca did. Merck is one of the world's most reliable and most experienced vaccine makers (they are the makers of the BCG, MMR, HPV vaccine, Hep A, Hep B, Pneumococcus, Meningococcus, Varicella, Shingles, Ebola, Diphtheria-Tetanus-Pertussis vaccines, among others).

And they are American... haha.

Now, for humanitarian reasons, the FDA will likely forgive AstraZeneca and still endorse their vaccine given that at worst, it is still above the 50% efficacy threshold established for approval. The FDA knows that denying the AstraZeneca shot will have ripple effects around the world, undermining even more the confidence in a shot that is cheap, doesn't need freezers, and will be important for under-developed countries, so people will die if the FDA says "no." Not to forget, the lack of trust will spill over other, worthier shots and makers.

So, UNFORTUNATELY AstraZeneca is unlikely to get punished for their blunders and their intentionally (I bet) misleading cherry-picking.

But frankly, speaking emotionally more than rationally, I'd like to see an approval being denied. They'd have a lesson to learn. Next time they'd behave more ethically. You know, the more you overlook bad behavior, the more it perpetuates.

And think that we allocated a huge grant to them, from our Operation Warp Speed. They did not deserve the help we extended to them.

At this point I think that here in our domestic market, we should only use vaccines made by our own makers, Pfizer, Moderna, Johnson and Johnson, and soon, Novavax. F.... AstraZeneca.

 

I think it's worse than sloppy. I think it's intentionally misleading.

 

Sounds fair but failing to approve a safe and effective vaccine would cost lives. As a doctor I'm sure you don't really want them to do it.
Let's hope it only undermines faith in Astra Zeneca themselves and not their vaccine.