Germany says Astrazeneca's vaccine is not for ... - CLL Support

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Germany says Astrazeneca's vaccine is not for over 65s, European regulator statement due tomorrow.

bennevisplace profile image

The German vaccination authority is reported to have blocked the use of AZ's vaccine in people age over 65, because, they say, its efficacy in older people has not been demonstrated. ft.com/content/0190dae8-f75...

Reports surfacing 3 days ago drew these "expert" reactions from the UK sciencemediacentre.org/expe...

The German decision does not appear to be related to the row between the EU and AZ regarding the current shortfall in supply of vaccine.

The European Medicines Agency, which has been considering regulatory approval of AZ's vaccine in the EU, is due to hold a press conference at 15:00 hrs CET tomorrow. Whatever the EMA says will not directly affect the use of the vaccine in the UK, where it is already approved for use in all adults.

28 Replies
Newdawn profile image
NewdawnAdministrator

The claim is highly disputed however.

Newdawn

This is today's report from the FT. It does run counter to their story of 26/27 January, reporting that the German health ministry refuted it. Tomorrow's press statement by the EMA will be interesting.

Newdawn profile image
NewdawnAdministrator in reply to bennevisplace

It will. Sadly these scare stories undermine confidence at a time when there’s difficulty reassuring the elderly, BAME (Black, Asian and Minority Ethnic) population to take up the vaccine in the U.K. Sadly they are in one of the highest risk groups too.

Newdawn

Agree with you, we don't need scare stories. The EMA is rigorous, will not be influenced by external discussion, and I hope they will soon approve the drug for all adults.

I think we have to distinguish between two different reports.

The older story, which everyone now seems to have refuted, is that the vaccine has low (8%) efficacy in over 65s.

Today's report is that a decision has been taken based on there being insufficient evidence for efficay in over 65s. The evidence may come soon and the German decision be reversed. What's more interesting is what the EMA has to say tomorrow.

Newdawn profile image
NewdawnAdministrator in reply to bennevisplace

My concern is that any already sceptical elderly people hearing of any report, will feel their reasons for reluctance are being confirmed. Once the seed of doubt is planted, it becomes difficult to refute to the satisfaction of some.

Shame that we are starting to see such a competitive element being introduced into what is a global problem.

Newdawn

Edited: to show the issue is still open and does not affect use of the AZ vaccine in the UK.

I would encourage everyone to get vaccinated unless their doctor has categorically advised not to.

Been dismissed by other authorities.

Hope that is found to be untrue as just had Astra Zenica 30 mins ago

I wouldn't be too worried. The allegation that trial data showed AZ's vaccine to be ineffective in older folk is untrue. Apparently it was based on someone's silly confusion of certain figures in the data.

The report that the German vaccination authority has blocked the AZ vaccine's use in older folk may be true, or it could be an unfounded leak - this was the top story on BBC Radio 4's 5pm news bulletin this evening, and they were still not sure which.

I would expect Germany to use the AZ vaccine in line with its authorisation by the EMA, which is expected tomorrow. The EMA and the UK equivalent, the MHRA, are independent of each other and they are entitled to come up with different interpretations of statistical data. If the EMA is not convinced at this point, they may say wait for AZ to provide more data on older folks, which AZ is compiling in ongoing clinical trials.

If tomorrow it turns out that the EMA decides to be a bit more cautious than the MHRA, I still don't think it's cause for concern.

Well I hope it's OK, my wife & I are due to have it tomorrow.

On the news last night it stated that Germany had independently of the other EU Nations purchased 400 million doses of another vaccine anyway so they are just looking after their own at the end of the day. I had my AZ on Monday and I guess if the 8 per cent margin should be true at least I have some protection !

Summary of story: The studies of the ‘Oxford’ AZ vaccine was not best designed.. for age group over 65 there was too little data to draw any statistically significant conclusions..

Tests do show older people develop antibodies after AZ vaccine.

We here are CLLers with compromised immune systems.. and we are a very heterogeneous group: our specific health condition/immune system varies.. and, over time, our treatment history varies..

It is unlikely that any (early) study will look at us specifically.. thus, at this time, we really don’t have solid statistics for how we will respond to any of the COVID19 vaccines.

What can we do?

Stay safe. Be very aware of indoor air in share spaces.. attempt to use multiple virus transmission mitigations (ventilation, air filters, face masks..)

..and we should get vaccinated in the hope that we get some beneficial vaccine response.

SofiaDeo profile image
SofiaDeo in reply to Shedman

Hear, hear! It will be a looong time before we have the high numbers needed to say with a high degree of certainty to what extent it works...plus there's all those pesky cofounders to the data like nutritional status, comorbidities, etc. I can totally see someone not responding well to the vaccine if their nutritional state isn't optimal.

For example, my FIL who was diagnosed with PRP (pityriasis rubris pilaris) was doing well on Humira and an optimal diet; he was too ill at one point to reject what was fed him. Now he got much better, and started refusing the extra protein/vitamins and unsurprisingly (to me, anyway) his skin has gotten worse. The docs are talking switching meds, but my take on it is.... he needs to go back to healthy eating with the extra protein, veggies, etc. instead of ice cream, sodas, cookies, & other junk.

Justasheet1 profile image
Justasheet1 in reply to SofiaDeo

Sofia,

Can he have both? No junk? 😢

Jeff

LeoPa profile image
LeoPa in reply to Shedman

My thoughts exactly. Even the other vaccines have different effects on different people. My wife developed few antibodies nearly 3 weeks after her first Pfizer shot. Colleagues who are older and in worse shape developed 3 times as many. We will see 2 weeks after the second shot. I think the differences will still be significant from person to person.

If you read it carefully it just says there's not enough info for them to make a decision on how effective it is but only 2 pple in the trial group of old pple of 670 or so got covid and none of those died. There's no evidence it doesn't work and 100% produced antibodies after the 2nd shot. Sounds good enough for me. It may not be perfect but I don't want to wait until I can afford a rolls royce - I'll get a honda in the meantime. It'll do the job good enough and I can get it now. Anyway, Astrazeneca may be a Rolls Royce but just hasn't gone through the testing. Most of Europe are doing a lousy job rolling out vaccine jabs because of precisely this sort of delay. Imagine holding up getting a jab by a month to do efficacy trials in a group and the number of old pple who could catch covid in the meantime. Altho they claim to be unbiased, pple rarely are and it seems the Germans/Europeans aren't too keen on AstraZeneca at the moment as they complain they can't get enough of their vaccine. Somehow I doubt this would have come up if they had all the doses they want and they be rolling out to all the 100 year olds....

Shedman profile image
Shedman in reply to Research123

Please? Let us not do mind-reading, and let us not wade in to guessing the scientific approvals process.. there are an awful lot of professional health/virological/epidemiological/statistical/medical scientists involved in making any such assessments and decisions.. You will also see newspaper articles on “Why the EU made such a decision/recommendation..”

No country is going to be sufficiently vaccinated any time very soon.

Those following the wisest strategy will become clearer in a year or two..

Meanwhile, the virus continues mutating.

Data difficulty: elderly neighbour of elderly friend.. he is in the Oxford *trial* — does not know if he got vaccine or placebo.. he is ‘blinded’ .. it means: he is not going to find out.. not until the trial ends.. this to ensure the research data gives genuinely unbiased results.

If I were him? I’d be ultra cautious.. does such behaviour likely expose him to the virus? Living alone? No.

I suspect that the EU may be wise.. that the correct strategy to maximise the impact of early vaccine supplies is to give them to the most exposed / frontline people:

Medics, carers, shop staff, pharmacists, bus drivers, teachers, police, fire service, food processing, essential govt administrators, next of kin to vulnerable folk (mostly elderly, CLLers, etc), ..and all of these peoples’ next of kin..

We simply need to remain calm and wise:

- get vaccinated

- behave cautiously, as though the vaccine provides limited if any protection

- behave somewhat more cautiously in this time of the new virus variants..

- work to stay in touch with friends and family, offer them support and listening, as much as hope for that ourselves.. look after our emotional health.. sometimes, switch off from the trigger of endless ‘news’ and social media..

- stay attuned to our Watch and Wait health alertness, to our symptoms..

[looking back a couple of months, my doctors and I should have caught my recent skin cancer much earlier.. was it an itchy spot? why wasn’t it healing? = classic symptoms.. too busy worrying about everything else..! It is removed now. ]

Stay safe everyone. One day at a time.

We are all in this together.

Shedman, re: "Data difficulty: elderly neighbour of elderly friend.. he is in the Oxford *trial* — does not know if he got vaccine or placebo.. he is ‘blinded’ .. it means: he is not going to find out.. not until the trial ends.. this to ensure the research data gives genuinely unbiased results".

For ethical reasons, trial participants can ask to be unblinded when they are offered vaccination (which in this case may have happened), so there's no need to carry on in the dark until the trial ends. I'm in a different trial but have the same option, and I will do the obvious - if I find out I have had placebo I will get vaccinated.

telegraph.co.uk/global-heal...

Yes. I know. He knows. He volunteered “for the science research” — he opted to continue being ‘blinded’ *for the science* - he is a generous fellow..However.. *IF I WERE HIM* I would be taking zero chances..

..which might still somewhat prejudice the results..

..at least, might see very very few infections from which to draw conclusions about the benefit of this vaccine.

Big_Dee profile image
Big_Dee in reply to Shedman

Hello Shedman

I agree with your post. Having been on several ISO Technical Advisory Groups, they can be overly cautious and many times try to "out expert the other experts". Your call to take safety precautions is justified. I do the same, wash hands, use sanitizer, avoid crowds and wear masks. Covid is not the only thing we can catch and we still have cancer of the immune system at the end of the day. I went to see my CLL Specialist yesterday and asked him about covid shots. He suggested I get the shots, however said my response may not be good. Sounds to ne just like the flue shot.

The European Medicines Agency will start a press briefing on its recommendation for COVID-19 Vaccine AstraZeneca at 16:30 hrs CET (15:30 GMT) today, that's about half an hour from now ema.europa.eu/en/events/pre...

OK the EMA has authorised AZ's vaccine for ALL ADULTS, one could say all ages from 18 to180.

The EMA is also happy with the extended dose interval of up to 12 weeks.

Astrazeneca should be happy, you should be happy, I'm happy. Let's hope the supply situation can be sorted pdq.

A video of the press briefing, the meat starts at 11m 45s youtu.be/oQNtvAMWdrY

Recommended.. but the earlier science statement still applies: there simply is not the trial data to give definitive, reliable, conclusions.

— we need to keep being very cautious for quite a while yet.. face masks; avoid crowded indoor spaces; etc. :)

Yes sound advice to all CLLers. Even 3 weeks after the 2nd vaccination stay vigilant.

Some are talking about antibody tests to measure their response to vaccine. But is there a scientific basis to interpret the result? Would you stake your life on a qualitative test that doesn't distinguish neutralising antibodies?

My “instinct “ - totally uninformed, is that there is more politics than science in this.

Fortunately the two regulators have kept politics out of their processes and have independently reached the same conclusion, that despite shortcomings in data collection they approve use of this vaccine for all adults.

The German vax authority is out of step and the losers could be their elderly and vulnerable. Can you imagine the outcry here if the JCVI had made a similar decision?

Thanks for the update. I hope all this testing gives confidence that we can trust science and scientists.

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