Graham wrote:
The AZ design is far more scientifically robust.
Since when is “scientific robustness” a criteria for trial design ? ;-)
Just kidding – but we know the industry: Trial design has for many years been optimized for easy approval, broad label (as least as broad as you want to have it) and creating a dossier that demonstrates additional value over existing standard(at least for Germany). Everything else is a nice to have. Don’t know if it has been by design or just luck – but having endpoints that allow to demonstrate “some high percentages” is obviously quite helpful in a category that is so publicly discussed.
On a different topic:
I get a lot of story from medical staff that already got first shots. At least the impression is that the AZ vaccine has a worse adverse effect profile than the Biontec one. It feels like much more people (young and healthy ones) report AEs like tiredness, joint pain, etc. the day after the shot with AZ than with Pfizer – obviously all of that is not really medically relevant (haven’t heard of any serious AEs yet) and might also be driven by placebo effect (or by biassed communication). It just feels that way.
Not every Oxford/AZ participant was swabbed weekly, only those in COV002 (the UK cohort), and overall efficacy was predictably lower with the asymptomatics included.
From the Feb 01 preprint (my bold):
The primary outcome was symptomatic COVID-19 disease defined as a NAAT+ swab combined
with at least one qualifying symptom (fever ≥ 37.8 o C; cough; shortness of breath; anosmia
or ageusia). The primary analysis was of cases occurring more than 14 days after the second
dose, with a secondary analysis of cases occurring more than 21 days after the first dose. In all
studies, participants were asked to contact the study site if they had symptoms of COVID-19,
and were then invited to attend for clinical review and a swab. Additionally, in the UK,
asymptomatic infections were measured by means of weekly self-administered nose and throat
swabs using kits provided by the Department of Health and Social Care. All endpoints were
adjudicated for inclusion in the analysis by an independent blinded endpoint review committee.
In any event, real-life data seems to be encouraging
Pim5 wrote:
Say country A has approved the Russian or China one for use on its population but the UK for example has not
What is going to be the status of an individual from county A fully vax’d according to their home country’s reg when wanting to enter the UK in this example.
Are they going to be regarded as an approved individual for entry despite their vax not being authroised in the UK – or are they not and are to be subject to some restrictive quarantine process?
There seems to be a misunderstanding: Drug approval is to the by far largest extend driven by safety. The core question at approval is if the vaccine is likely to kill you. How much it protects against the disease is only secondary. Accordingly the lack of approval of Sputnik or CoronaVac in EU is mainly due to missing safety data. If you survived your Sputnik shots, there is little reason to believe that you are protected worse than with AZ or Moderna…
DavidS wrote:
Not every Oxford/AZ participant was swabbed weekly, only those in COV002 (the UK cohort), and overall efficacy was predictably lower with the asymptomatics included.
From the Feb 01 preprint (my bold):The primary outcome was symptomatic COVID-19 disease defined as a NAAT+ swab combined
with at least one qualifying symptom (fever ≥ 37.8 o C; cough; shortness of breath; anosmia
or ageusia). The primary analysis was of cases occurring more than 14 days after the second
dose, with a secondary analysis of cases occurring more than 21 days after the first dose. In all
studies, participants were asked to contact the study site if they had symptoms of COVID-19,
and were then invited to attend for clinical review and a swab. Additionally, in the UK,
asymptomatic infections were measured by means of weekly self-administered nose and throat
swabs using kits provided by the Department of Health and Social Care. All endpoints were
adjudicated for inclusion in the analysis by an independent blinded endpoint review committee.In any event, real-life data seems to be encouraging
That differs from the protocol I read. That looks like an add-on of some sort – population testing of some sort.
The one I read (my focus tends to be on the schedule of assessments) showed Covid-19 swab tests at the start and several more times throughout as part of core study procedures. Not weekly, but a handful of times from start to end – enough that not many infections would slip the net.
Malibuflyer wrote:
There seems to be a misunderstanding: Drug approval is to the by far largest extend driven by safety. The core question at approval is if the vaccine is likely to kill you. How much it protects against the disease is only secondary. Accordingly the lack of approval of Sputnik or CoronaVac in EU is mainly due to missing safety data. If you survived your Sputnik shots, there is little reason to believe that you are protected worse than with AZ or Moderna…
Indeed. Inter-country recognition of a person’s vaccinated status (‘vaccine passports’) is – in theory at least – likely to concern itself with efficacy. After all it is not the safety of the individual concerned that the receiving country is bothered about.
In reality it’ll be a matter of international politics with a bit of point-scoring thrown in. Hopefully everyone will accept pretty much everything, but maybe some will enjoy setting ostensibly Covid-related rules to try and make a point with some other country they’d like to dictate terms to – rather like Macron’s little pre-Brexit deal border closure “because of the UK variant”.
Graham wrote:
The one I read (my focus tends to be on the schedule of assessments) showed Covid-19 swab tests at the start and several more times throughout as part of core study procedures. Not weekly, but a handful of times from start to end – enough that not many infections would slip the net.
I see, thanks.
I believe Astrazeneca have only ever quoted vaccine efficacies for symptomatic cases though, eg here
Separately, this is the Public Health Scotland preprint which has made the news, with VEs of up to 85% ,79%, and 81% in age groups 18-64, 65-79, and 80+ respectively. The phrase “up to”, used on its own, sets off every statistician’s internal fire alarm. Table 3 is ‘interesting’ in that respect as it shows the lowest VEs too: 43%, 8%, 77%, 21+ days after the jab. It’s also worth noting that their ‘VE’ is not the well defined ‘vaccine efficacy’ but a ‘vaccine effect’. A perfectly good case can be made for vaccination without resorting to this ‘spin’.
@malibuflyer If you are offered a AZ jab but dont want it, please sent it to me here in France, ’cause Ill happily have it. Im in my forties and at the rate france is going Ill be lucky to be offered a vaccine before next year…
Regards, SD..
Malibuflyer wrote:
In Germany you are informed beforehand which vaccine they will give you – and looks like many people decide not to take the vaccine if they are offered the AZ one. You don’t have the choice between vaccines – but you have the choice to take the one offered to you or not.
I am not sure this is correct. I suspect a little like here, this is the impression given. However, if you refuse a particular vaccine, you can make your way back a week or two later, and so on. Government’s are trying to ensure everyone who wants the vaccine will get it, so no one wants a list of those who do want it, but have refused a particular make. Of course so far as Germnay is concerned I may be wrong, but were are you then placed on the list? Clearly the idea is still to vaccinate you and some point, because you have not said I will not have it, and even those who do say this are encouraged to change their opinion.
Personally I think it is the most incredibly selfish decision for someone to make.
Fuji_Abound wrote:
Personally I think it is the most incredibly selfish decision for someone to make.
I’ve heard similar things from someone working in a vaccination center here, even between Moderna and Pfizer. However, anyone refusing a vaccine at the date will have to queue up from the back of the queue, which means in our country at least a 2 month wait.
In the very beginning due to that they had quite often some excess capacity at the end of the day and in order not to waste them used them on available health care workers. So some people got their shot early due to these guys.
By figures published today, Switzerland has so far received about 800k doses of Pfizer and Moderna of which 650k have been administered and the remaining are reserved for the 2nd shot. Translated into the double shot this means about 400k people were vaccined in the first lot. According to that news, there won’t be any vaccine available until mid March or possibly worse, April. There are no immediate outlooks to certify further vaccines.
skydriller wrote:
If you are offered a AZ jab but dont want it, please sent it to me here in France, ’cause Ill happily have it.
So sorry – but I’ll take it myself as soon as it is offered to me …
Fuji_Abound wrote:
Personally I think it is the most incredibly selfish decision for someone to make.
I don’t regard this as more selfish than not wearing a mask, mingling up with other people, queuing in front of s Skilift, etc. in the midst of a pandemic.
Unfortunately this pandemic has clearly shown that most people are extremely selfish and if there is no immediate benefit for themselves and not realistic punishment they fear, they are happy to kill other people even if what is ask from them is as little as wearing a mask.
Malibuflyer wrote:
Unfortunately this pandemic has clearly shown that most people are extremely selfish and if there is no immediate benefit for themselves and not realistic punishment they fear, they are happy to kill other people even if what is ask from them is as little as wearing a mask.
It’s not easy to judge on this but massive anti-vax and anti-mask campaigns influenced a lot such attitude and behaviour. It’s not easy to explain how here in Croatia at the same time we had selfishness of such kind and extreme solidarity and help for victims of devastating earthquake. Of course we had selfishness towards earthquake victims by church who sent only thoughts and prayers and asked money for itself pretending to be a victim as well.
