Agree the more people vaccinated the better. But Moderna is saying having the vaccine will reduce the severity ('100% success rate in reducing severity'.). That's all my elderly parents and elderly relatives need. They can accept the risk from there on.
Whichever definition of lockdown... 'light' or 'severe', I'm not a supporter of a two-tiered system where some can party while others can't go to the RSL to see their mates.
Last week I posted (on one of the AFF threads) the CMO saying that they were not testing the severity of the outcomes but he 'hoped' it would decrease it.
The maths
The news is definitely good but not exceptional, not even wonderful really. As the ABC's Norman Swan said; "This isn't the beginning of the end for CV, but the end of the beginning." A great third step, as it were, of a long journey.
The 'emergency use authorisation' absolves Big Pharma of ANY liability for adverse impacts from taking the vaccine whether currently known or unknown. So, if for example it has an unfortunate (serious) side effect such as making people sterile (global warming solved!) - then the drug company cannot be sued as long as at the date of approval it did not
conclusively know of it.
Australia (luckily) does not have such a 'free pass' mechanism.
The emergency approval of the Pfizer vaccine is based on the Phase 3 trial which began on July 27th, the results used for the 'emergency use authorisation' are based on the first 3.5 months for the very first participants, and less than a couple of days for the last 5,000:
- Out of the planned total Phase III trials involving over 43,000 participants (appears around 2,500 were ruled out after reviewing Nov 9 interim analysis but for some reason Pfizer does not mention why), around 41,000 (+5,000 net increase after elimination of the above mentioned 2,500 on a week earlier) had received their 2nd dose (of either vaccine or placebo).
- Just 170 of these 41,000 caught CV - so 0.41% of these particpants
- Placebo 162 & vaccine 8
- Serious CV cases 10: 9 placebo & 1 vaccine
- Efficacy = 1 - (8 / 162) = 95.06% which to their credit Pfizer called 95% (unlike Moderna who used a 4th decimal place to round up, if they'd used 3rd decimal place it would have gone down)
Using a 'media spin' approach then you could have the headline that '
Vaccine more than doubles risk of severe CV cases' as 12.5% of all +ve vaccinated cases are serious vs 5.6% of placebo cases.
Statistically that statement is not as valid as the 95% efficacy statement - but it is only around 1 standard deviation less valid!
Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group Efficacy was consistent across age, gender, race and...
www.pfizer.com
None of the media, that I've come across, have looked to see whether over this time period (since July 27th to Nov 13th) did participants catch CV at the same, greater than or at a lesser rate than the wider population? Being the pedant I got out the calculator & found that the
participants caught CV at a significantly lower rate than non-participants over that period in the US or UK. This is a more statistically significant result than the efficacy result BTW - but totally spurious, or is it?
Just how much higher was the infection rate for non-participants? 5%, 10%, 40%, 100%, 200%, 300%, 1,000%?
For the UK the number of people testing positive (should be a much lower proportion as unlike the trials - everyone in the UK is not getting contacted weekly/monthly so misses out the asymptomatic cases who don't notice), between those dates was just over 1,000,000. Strictly speaking I should deduct all those who had previously tested positive from the UK pop'n figure but if you won't tell...
1,000,000 out of UK pop'n of 68 million = 1.5%, vs trial particpants at 0.4%.
Don't shoot me BUT perhaps an immediate campaign should be launched telling the UK or US public to take part in a vaccine trial, give them the same literature/briefings given to the participants of this trial - and the UK/US may see a 70+% drop in CV cases!
Does anyone wonder why the Worldometer site does not provide the set of graphs for either the US or any US state? Makes it much harder to do the calculations.
That's the risk of 'emergency use authorisations' - the UK has come down on the side that the known risks (people dying from CV) are greater than the possible unknown side effects. A typical Phase 3 study will monitor participants for 3 to 5 years after last dose to determine what possible medium to long term side effects may emerge. Side effects that take longer to appear (such as with statins) are missed.
This is not being a naysayer but being scientific vs spin doctoring.
The figures for Moderna are:
- 196 particpants testing positive out of 30,000 enrolled 100% in the US, just under 26K had received their 2nd dose
- 185 with the placebo & 11 with the vaccine (after 2 doses, those who caught it after the first dose are excluded, not stated by Pfizer included/excluded that I could find)
- Efficacy = 1 - (11 / 185) = 1 - .0595 = 94.05%, claimed as 94.1%
The Moderna preliminary data saw the efficacy fall from 94.5% (in their media release but do the numbers yourself & get 94.4%) when 95 participants tested positive to 94.1 with 196 particpants testing positive. After the AZ/Oxford 'issues', here's the efficacy for the next 101 to test positive (cases # 96 to 196)
= 1 - (6 / 95) = 1 - .0632 = 93.7% efficacy.
Excluding those who had the 1st dose but not the second & caught CV in the meantime overstates the efficacy.
Meanwhile the figures for short term side effects of the Moderna vaccine are mutliples of what Pfizer revealed.
First interim analysis included 95 participants with confirmed cases of COVID-19 Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p
investors.modernatx.com
The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived.
The Moderna trial only completed its 'enrollment' of participants on October 22nd, that does not appear to mean they'd received their first injection though, 25,564 had received their 2nd dose. They do not state when the trials began though.
"immediately contacting the study physician if they are experiencing symptoms of COVID-19."
Everything you want to know about the Moderna trial....
www.modernatx.com
Moderna are seeking 'Emergency use authorisation' within 5 weeks of signing up their last participants and before those have had their 2nd injection. To me, this helps explain Faucci's comments in the US last night about 'rushing'. 5 weeks vs previously 3 to 5 years pre-CV does seem akin to 'Fools rush in where angels fear to tread!
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Whilst wanting (& actually needing) to go overseas - after delving with a bit more rigour than many commentators, I am happier for the rollout of vaccinations in Australia & international flying opening up to be more delayed than I was previously.
Some vaccines I will not touch with a barge pole (AZ/Oxford despite being 'old tech'), and the for the others I am not in such a rush. This is purely my opinion and I can be totally wrong in the conclusions I am drawing. If I was able to travel & the need was higher than my current situation (reassessed cost vs benefit - no point being the richest person in the graveyard) then I would prefer to pay the 14 day quarantine hotel cost on return vs be an early vaccination candidate (assuming could be).
Whether they realise it or not - the UK is being volunteered as non-clinical guinea pigs.
I really hope all goes well.