ExpatExp

Agreed. No doubt most mistakes or accidents in medicine have horrible results. Also, mistakes or accidents have led to advances in medicine on occasion. Perhaps this will be one of those occasions

radonc1

The alterations in the statistical analysis would be significant if you had a large cohort of your randomized group now excluded from analysis. It probably took the study statisticians little time to determine that the entire study would have to undergo major rewriting if that cohort was excluded. Furthermore, the study is huge so that a small cohort of ineligible patients would not alter the final analysis. Thus, the study proceeded as planned.

Every study has exclusion criteria. In most of those that I deal with, immunocompromised people are excluded.
If you are really interested, look up the study, which will have the exclusion criteria in it

There are a slew of questions we will have to answer, but for now, we need a good general purpose effective vaccine that will cover a relatively healthy populus. That would include the usual groups such as elderly and those with chronic illness such as hypertension, obesity and heart disease.

cockpitvisit

The tricky part here is that they chose to keep the initial group in the study after having got the first results (namely, that there were less adverse reactions to the vaccine among this group). So I am not sure why they are permitted to include this group's results in the whole tally.

Just imagine the opposite: by technical mistake, the initial group would have received 2x the dose with bad side effects and less efficacy. After having noticed and corrected the mistake, would they have included this group in the final tally? Of course not.

So the reason why the initial group counts (and thus pushes the efficacy from 62% to 70%) is because they knew it produced favorable results. This is cherry picking to me, and it slightly invalidates the whole result.

chococat

My understanding (with the caveat that we don't know a lot about a lot of stuff when it comes to COVID-19 vaccines) is that the concern about using live attenuated vaccine in the immunocompromised is that the attenuated pathogen could revert back to an active pathogen (which has happened with the polio vaccine). However, none of the current COVID-19 vaccines would be considered live, attenuated vaccines in this sense since none of the formulations contain encoded information for a complete pathogen (just an antigenic surface protein), and it is biochemically impossible for an active COVID-19 infection to develop from any of the vaccines (we don't use the word "impossible" a lot in science, but it really applies here).

This could be a little confusing because the AZ vaccine uses a live adenovirus vector to deliver DNA, but the adenovirus strain is considered to be non-pathogenic. I'm not exactly sure how the (Pfizer, Moderna) mRNA gets delivered (lipophilic transfection reagent?) but similarly, no complete SARS-CoV2 pathogen is involved at any stage in the vaccine production process.

At this point, I'd guess (just a guess) that any of the vaccines in development would be considered SAFE for people on immunomodulatory mABs since there's zero chance of developing disease from the vaccine (the side effects can be a bit bothersome though). There is a live non-pathogenic component to the AZ vaccine, but not believed to be problem in the immunocompromised. Whether or not a person on any sort of immunomodulator (or the very young or very old) will have an adequate immune response to be protective is a separate question.

corporate-wage-slave

The UK regulator has approved the Pfizer vaccine today for general use in Britain and dependencies. I would expect the Oxford AZN vaccine to get approval in the next few days.

Dan1113

But under the 1-1 or 0.5-1 dosage?

corporate-wage-slave

I don't know, the head of the MHRA is just about to do a data briefing, which will be covered by BBC News, so we may find out more. But logically both approaches would be approved since they are both over 50%.

GUWonder

Assuming the UK approves both dosage vaccination regimens for the AstraZ vaccine, who determines which of the two dosage regimens is ideal for any given individual?

corporate-wage-slave

The UK's approach to vaccination is through 3 channels
- hospital hubs - looking after patients (many high priority anyway) and staff (front line staff are high priority)
- vaccination centres in the major cities - sports stadia and airport car parks for example, for those for are fully mobile
- NHS Primary Care Networks, typically a group of up to a dozen GP surgeries covering about 40,000 residents between them.

I imagine that a standard guideline will be set by the Joint Committee, but for those in the last group, which would be better suited for the AZN vaccine logistically, your GP could prescribe the dose.

8420PR

It seems a quick way to find out if you had the vaccine or the placebo is to start a gofundme for 'vaccine caused' foot blisters.

https://www.independent.co.uk/news/w...-b1768644.htmlPfizer stated she received the salt water placebo. Also it's a little bit click-bait as she only raised USD$5k on gofundme.

LondonElite

Even if the vaccine had caused her foot blisters, wouldn't Pfizer have covered her treatment?

radonc1

In general, patients on studies are covered by insurance. Most studies in the US will only enroll patients if their insurance will allow it (so the patient will get certified for protocol coverage prior to enrollment and if denied, will not get enrolled and just receive standard of care therapy.).

Patients on Medicare or Medicaid usually are not an issue unless they are also on a simultaneous Advantage plan which can limit participation in trials. Some studies will pick up copay expense, and if the study has experimental drugs (such as vaccines), those of course are provided gratis.

Post study complications will almost always be covered by insurance.

However, one of the biggest impediments to enrolling people on study (besides the usual concern about studies in general) is the inability to get their insurance company to permit experimental treatment. Very sad

hugolover

Has the US government offered these firms an indemnity like in the UK, forcing anyone who suffers ill effects months/years down the line to seek compensation in some kind of Vaccine Court?

I thought when I read that, why didn't Boeing think of it for the MAX!

I'm quite impressed that Bibi will be the first in Israel to have the vaccine. That really shows faith when the political leadership are willing to be first. Never mind pensioners.

rustykettel

Yes,

https://www.hrsa.gov/cicp

News article discussing CICP and it's track record of limited payouts with higher threshold than the VICP.

https://www.insurancejournal.com/new.../14/579150.htm

hugolover

This is very clever. But it’s not an issue as the “science” says the vaccines are 100% safe.