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With AZ double jab, my risk of symptomatic illness is as follows.
Original variant, R around 3. No vaccination/protection. 100%
Delta variant, (alpha 60% more transmissible than original, delta, 40% more transmissible than alpha).
Risk without vaccination now 224%.
AZ double jab giving me 60% protection on this 224%.
So my risk as a double jabee is now 89% of that for the original variant without vaccination.
Very grateful for it, but that puts me only about 11% ahead.
Risks for hospitalisation and death are far better, which is the bigger issue. Don't see any data available for long covid risk yet.
So I will carry on being careful however much Boris tries to paint a very rosy picture of vaccine efficacy.
Feeling cross that government propaganda is painting too rosy a picture of how safe we are after being double jabbed. I am able to make my own decisions, but I know a lot of people, some vulnerable who think if Boris says it is allowed that means it is safe to do! Think they need to sever that link!
The original variant had a natural R value of around 3.
For herd immunity in a population you need 1-(1/R) as a percentage of immune people for infections to fade out.
We have heard that alpha was 60% more transmissible than the original, and delta 40% more transmissible than alpha. This tallies with my hearing that delta has a natural R value of around 7. This means that 1-(1/R) requires around 84% immunity in the population for infections to fade.
Astra Zeneca appears to give 60% protection against symptomatic infection of the delta variant. So even if everyone, including all children were vaccinated we would still be 24% short of the 84% needed for herd immunity and for delta to stop circulating. Some have had Pfizer which seems better and there is some immunity from previous infections, but still not enough the way rates are rising.
So, a lot more infections are inevitable. I suspect the government see these figures and think we might as well get on with it and get there sooner rather than later. When 'freedom day' arrives I will be letting the herd get on with it. I think it is completely irresponsible that government rhetoric is not making the situation clear to people.
I am very grateful for my vaccinations and very positive is the reduction in hospitalizations an deaths, but having let the delta variant spread here vaccinations are great but not a miracle. Please government, stop misleading people on their risks, including of long covid when expecting them to take responsibility for themselves, rather than trusting government planning to look after them!
From the full year results RNS (12th May) it said:
Synairgen's global Phase III "SPRINTER" clinical trial in hospitalized COVID-19 patients, SG018, is a randomised, placebo-controlled study being conducted in 17 countries enrolling a total of 610 COVID-19 patients who require supplemental oxygen (ie they are by definition more likely to have marked or severe breathlessness). After reporting the results for the primary and secondary endpoints of the study, enrolled patients will continue to be assessed for Long COVID symptoms.
So it looks like data for the follow up until 35 days will be unblinded and reported, but they will continue follow up at 60 and 90 days after unblinding. Hopefully this will still give us data readout in September or even end of August and we won't need to wait for the full 90 days follow up before unblinding.
Some of this has been said already, sorry if repeating..
The hospital arm of the P2 completed recruitment on 27h May 2020, so now is the one year follow up of those patients. RM has said that at the 28 day follow up point the SNG hospitalised patients were still doing markedly better than the placebo group. We have not seen their data beyong 28 day follow up. So, question is, did the placebo group catch up over a longer (long covid) time, or did the SNG mean that long term disability was prevented.
True, the 'not very ill' group from the home trial may not show much. Possible they recovered to an ultimately better level, but unlikely. There are the breathless patients in that group though, who have now been followed to beyond the 90 day readout.
So, in the interview last Friday RM said this data is now being analysed. Could be another important strand to the SNG story, and readout probably in the next few weeks.
Jenny Harries was on the Andrew Marr show this morning.
She now seems to be in charge of future pandemic preparedness.
Asked about the new Yorkshire variant she said that it had identified mutations which might:
1) Alter transmissability
2) Alter ability to counter the immune response we would normally produce.
Sounds like she gets the interferon side of Covid. If she is in charge of stockpiling for future pandemics perhaps this is promising.
Interesting that the business model seems to be:
In discussion with governments regarding:
1) Use as a Covid treatment
2) Stockpiling
SNG can meet demands for these applications.
They would need a big pharma partner (and there is interest) for:
3) Use as a broad spectrum antiviral for other respiratory viruses.
This is stunning. Profit margins for covid treatments without a big pharma partner would not need to be shared and must be great for shareholders. Presumably government are able to make orders and organise distribution for covid treatments as they are doing for vaccines. Brilliant news.
Regarding cashflow, I assume any government orders/pre-orders would have enough cash deposits to oil the wheels of production, so don't see further fundraising as necessary.
Hope we get some positive news from Activ-2 soon and possibly use of combined data from HT to get us EUA rather than waiting for the P3 readout.
Astonishing the share price is not responding better to this great news!
The home trial was for people in their own homes with clinical input via a zoom call.
Scinv, do you have any idea how unlikely collection of sputum samples is even on a busy hospital ward.
How likely is it that people at home could collect sputum samples then return them to Synairgen when they were ill and isolating/unable to leave home.
Have some sense before you make unreasonable criticisms of a trial which was a remarkable achievement.
Well...
Dr Penny Ward seems to get that showing statistical significance in small number studies where only a subset of the group are 'vulnerable' and their signal drowned out by the 'not vulnerable' group is a challenge. She also cautiously gets how good this treatment might be.
Dr Peter English (retired) says he would like to understand the mechanism of action of SNG. If he is so utterly out of touch with the enormous literature on IFN mechanisms and Covid (even BBC news would have informed him) he is embarrassing himself by posting in public on this topic!
Slowly sinking in more and more how important this finding is.
Since the start of the pandemic, the biggest question has been why many people have no symptoms/mild disease and do not require treatment. Yet, a small percentage get severe disease and many die. Because of the sheer numbers of infections the small percentage who die means a large number of deaths. A way of predicting who to treat early and a way to treat them has been a bit of a holy grail. It would never be reasonable to treat all cases when they will recover on their own. We may have found that holy grail, but statistical significant will only fall out by using the correct protocol for patient selection.
There has been an avalanche of evidence that IFN difficulties (antibodies or genetics) underlie the vulnerability to severe disease, but never reasonable to use research test on the world population to predict who to treat.
We now have an easy clinical guideline, able to be used across the world with no technology/advance needed, of 'breathlessness' early in the onset of illness to make this prediction. For this group we also have an easy to administer treatment (even at home) to specifically target this group with seemingly excellent efficacy.
I understand the P3 trial protocol can be amended. I would be shocked if ACTIV2 do not run with this and get the extra data needed to get this to EUA. The people running ACTIV2 do understand the IFN message and will understand the implications of this finding even if the concept is not easy to grasp or easy to show statistical significance unless you target the protocol correctly.
I think the ACTIV2 protocol can be amended for their P3 arm.
Assuming we get there, if inclusion criteria are amended to 'breathless', SNG may be exactly what ACTIV2 are looking for to keep people out of hospital.
That also goes for the UK home treatment venture.
1) A bit disappointing if we need to wait another 4-6 months for the P3 data, but positive results from the hospital arm are now further derisked. Application after that will be for full approval, not just EUA.
2) Armed with this information, Activ2 may still have legs in getting us EUA.
a) of the breathless patients who benefitted from treatment, 20% of them were in the home group. Not to be ignored as a potential treatment group.
b) Activ 2 are looking for a treatment to keep people out of hospital. They have mabs, camostat and SNG.
c) mabs are not very practical for home use as they need i/v infusion, are expensive, limited in supply and as shown would need to be given to very large numbers to save one hospital admission. As far as I know they do not have selection guidance to improve on this. Moving ACTIV2 to new countries they may be less effective in the face of new variants.
d) Camostat unknown, may not work, may not be available yet.
e) SNG - armned now with the selection criteria of 'breathlessness' may be the only treatment they have which will be useful to keep people out of hospital. If they can limit treatments to this group, the cost benefits may be far greater in terms of number to treat to save a hospital admission.
So, having slept on this new information, the at home treatment EUA may still arrive. Also, in India and soon to be other countries where the hospital system is overwhelmed, home treatments for sick/breathless patients may be a game changer.
In summary, we may have good news to come long before 4-6 months for the P3 data readout.
RNS a bit of a let down compared to what we might have hoped for!
However,
1) More support and derisk for SNG working very well in the sickest and most vulnerable section of the population.
2) Clarifies that 'breathlessness' is a good marker of who will benefit. This is a real advance on Scinvs suggestion that obscure research assays are needed to screen people.
3) Target areas are hospital patients, the breathless people in the car park in India who can't get a hospital bed or oxygen, but could use SNG at home, people who are breathless but not hypoxic at home to hopefully avoid need for hospital.
4) This a still a drug to change the face of covid deaths/overwhelming of inpatient services.
5) The potential demand for SNG will be far greater than supply for a long time to come.
6) It is a step forward that target patients are now easily identified. This target will also help with a pricing level when limited to the most at risk patients.
8) If only the world could start to use it. Hope India does the right thing and gives it a EUA.
Prion, the paper I remember had a test for, I think, 5 genetic markers which they said would predict a large percentage of severe cases. I may have bookmarked the link, so will see if I can find it. That would be amazing as a tool, but is very much a lab based thing at the moment and would need a long period of testing before it got in to clinical use.
However, when countries don't have oxygen or hospital beds to treat the scale of their patients, suggesting that research based screening assays should be routinely used just isn't a point worth making. Even in UK hospitals anything like that would need a lot of development and testing before it got into routine clinical use. It would need as much development and validation as a drug to be accepted and we know how long that takes.
1) Scinv is making a good point that 13% of severe covid cases have interferon antibodies and if tested they would be in a group predicted to have most benefit from SNG.
2) However, a recent paper showed that a group of 63 genetic markers predicted over 90% of severe covid cases. Many of these were interferon related genetic markers. Probably most if not all of this group would also benefit greatly from SNG.
3) While having a scientific base, these tests are currently obscure research tools. They will not be widely available clinical tools even in the most high tech centres. Where they could be available, the time taken to get results would probably mean your patient was recovered or dead in actual clinical use.
4) So, perhaps the most pragmatic option to target the most high risk group and treat them quickly would be for SNG to be a hospital treatment. The hospital group may have already self selected for interferon antibodies and the other 63 genetic markers predicting severe disease. This option would not require research based screening assays and could actually be achieved in a clinical setting.
5) Scinv does make a good point that treating people earlier at home would mean treating a lot of people who would not get severe disease and would recover on their own. However, we have not yet seen whether there are benefits in terms of long Covid for early home treatment.
My impression when they mention repurposing of existing drugs is that it will be for drugs already approved after a phase 3 trial and safety data in their existing formulation. This could be existing inhalers or tablets in approved for a different condition. (eg, budesonide/asprin).
Interferon is an approved drug, but not so far in nebulised form.
I am very happy we are in the ACTIV 2 trial. I don't see any mention that ACTIV 6 will take over from ACTIV 2.
During discussion interviews after the P2 hospital trial results there was mention of retrospective longer term follow up of the hospital patients over a longer time window to look at long covid. The long covid follow up would have been introduced for the home arm of the combined P2 study at that time.
This change was a long time before unblinding and should not be seen as having any implications for the HT results.