What's wrong with this picture?

Let me start by saying that I'm not a medical professional, but rather a senior computer consultant with decades of experience debugging problems, of all sorts. Given that let me address some of the issues that immediately come to mind with these scheme.

1) The test group doesn't match the at risk group. So even if it works for the test group there is no guarantee that it will work for the at risk group.

2) This mismatch is true for all phases of the trial. So after the trials are completed it's unclear if the at risk group could tolerate the vaccine or if it will be effective.

3) There are plenty of at risk people in care facilities that would likely chose to participate, give the horrific death toll see there so far.

4) Since the response to Covid-19 seems to cover such a wide spectrum, with 5/6 of people tolerating it well, is there a way to identify those who would not be at risk and infect them to achieve herd immunity (~80% infection rate)?

"Should we...?" The article begins with the unfounded assumption that there is some "we" who will (must!) make a final decision for everybody. There are more than 100 sovereign states deems itself competent to make its own decision, not to mention millions of individuals. Since this is a discussion of ethics, it begs the question to assert "it is unethical to [whatever]". It is very much elitist to assume that some authority must make a universal decision instead of the actual people affected. It is outrageous to assert that the US's FDA should do so, given its horrible history. The one-day-sooner people have the start of a good idea: ask for volunteers (having given them the best available information. If there are not enough volunteers, offer pay! Still not enough? Offer MORE pay. SO -- is it ethical to offer people (mere) money to take risks? For that answer, ask the thousands who work as fishermen, loggers, roofers, truck drivers, and the many others who take provably risky jobs already.

I don't care about whether this vaccine works or doesn't work. I don't care about whether polio saved millions of people or killed millions of people (or maimed half amillion indians). Well, that bothers me a little bit. What I do care about is how the masses are clamoring for a cure and how the politicians are gonna fall for the scam and I really care about my choice whether to vaccinate or not. Informed or not.

Let me start by saying I am a medical professional, and as far as choice goes - to vaccinate or not - there is little choice involved, only a lack of knowledge. Vaccines are artificial means of exposing or bodies immune systems (or our most vulnerable - our children's immune systems) to illnesses that carry severe consequences. Believe Wakefield and fake science all you want, you watch one child die of measles and unless you go by the sign in "ChairmanLMAO", you understand that as a compassionate human, the choice is already made. If you are a "CharimanLMAO", you just decide and if you have condemned thousands to misery, you squelch the discourse!

The system of vaccination trials - like medication trials - is not like programming. You must start with a cohort that you have a low likelihood of harming - the military aged, low income college students who are reasonably healthy and willing to be guinea-pigs. Tremendous stamina for such studies. If you consider both genders - which many researchers are just now becoming tuned to - you will TEST a group of HUMANS who represent a SEGMENT of the total cohort. THEN you move to the expanded trial with a wider age group and wider range of health conditions but you generally omit the pre-existing conditions that predispose a subject to greater side effect response or a null response - NO COMPROMISED iMMUNE SYSTEMS or subjects with biologics on board. Otherwise you get a Phase II failure of massive side effects when the dose is appropriate for the full cohort (but these people exhibiting the side effects may benefit from lower, repeated dosing regimen, and so forth). When you get to Phase III, the cohort is supposed to be the complete and reasonably healthy range of all humans. That is the exact groups at risk for the disease. So your line mjr1007 is inaccurate: "2) This mismatch is true for all phases of the trial." For example, Phase III trials attempt to include all ages that this vaccine will be recommended to so that the response and the side effect profiles can be verified statistically in a larger, more varied cohort - but they still try to eliminate the kidney failure, liver diseased, heart failure or current immunocompromised/cancer therapy patients so that the statistics do not include non-vaccine caused deaths but rather, vaccine on board deaths where several other causes of death might be present. They do set an age limit for volunteers, but with the Herd Immunity, you can omit the newborns and the 70+ patients during phase III.

Then those medical professionals who have 85 year old vibrant multiple concern patients who might benefit from this fully released vaccine will help their patient and patient families make a decision about receiving the vaccine - at which the FULL COHORT will be monitored. We report adverse outcomes without pointing the finger to any single cause of the adverse outcome. My geriatric patient falls and breaks a hip 7 days after the vaccine - only gets reported if they vaccine side effects list muscle weakness or rhabdomyolysis OR the patient received a vaccine injection in the same hip. In other words, we are all undergoing PHASE IV TRIALS anytime we take a medication, so isn't this THE RISK GROUP?

Lastly - as a medical professional in his 60's, I'd volunteer for a Phase II trial or even Phase III trial with the possibility of being exposed to aerosolized virus if it helps with the efficacy and safety profile. I do not have kidney disease, heart disease, liver dysfunction, and only mild lung disease from "farmers' lung" so I represent even a smoking cohort (I'm a non-smoker). But I have been - as have most everyone reading these articles - a phase IV participant.

We will determine a way to limit the severity of the SARS-CoV2 virus, it may be with an antiviral regimen when exposed, or it may be a partially effective vaccine that needs to be repeated every 5 years or so. But we will figure a way. mrj1007 - I do appreciate your thoughtful analysis, while I find it flawed reasoning, I applaud you for applying your knowledge to medicine. EVERYONE OF MY PATIENTS SHOULD DO THE SAME! I only recommend and treat, I do not dictate and command! It is up to each patient to care for themselves and see me when their knowledge base is either failing them or they want a 'second opinion'. And if they don't like my recommendations - there are other opinions out there they may follow for themselves. Peace, and keep breathing!

It seems to me that the question is moot. Health people have been infected by the millions, because of a choice made by Boris Johnson, to let the virus run wild through the population, and going for troop (I refuse to say "herd"... we primates are not herd animals, we live in troops.) immunity in the general population.

I'd even suggest that's what Trump is doing, by ignoring the problem for almost three whole months... but he isn't smart enough to come up with that idea on his own... he once asked Bill Gates, twice, what the difference was between the H.I.V. and H.P.V. viruses. I'll bet it's what Putin told him to do.

I think it's sad that in 2020 we are still so vulnerable.

The article is a pretty good perspective of how to produce the vaccine. The previous 3 responders all make good points: about whether a vaccine resulting from this process would actually benefit those at risk (we won't know until it is used), if there are higher risk groups who might benefit from the trial itself as well as speed up the process (sounds like there are), and who decides how to use the proposed vaccine (should people be forced to get immunity from being vaccinated as opposed to getting it from surviving an infection). That last question is the one without a good answer, because we don't usually force people to take risks in order to benefit other people, which is what a vaccination program is. In our society, the majority usually decides by voting. So if you want all of the benefits of living in our society, then that's how it works. Fortunately, there is also the option of withdrawing from society completely.

We must learn more about this virus before we deviate from the standard procedures and requirements for developing a reliable vaccine. One latest discovery is the virus may revive in those recovered. It may mutate. Before infecting healthy humans for vaccine, can we ensure that we won't create something more dangerous? No Frankenstein, no new virus in reaction to the trials, etc.

Laurence Lee's "That last question is the one without a good answer, because we don't usually force people to take risks in order to benefit other people" I question. Thinking of the military, police, firefighters and medical staff who through the very nature of their chosen professions are forced to take risks to keep the rest of us safe.
If some of the younger generations are asked to volunteer to test a vaccine then so be it. Think back to the sacrifices made by previous generations during WWI, WWII, Korea and Vietnam etc. The men and women who were killed or maimed or scared for life did their duty at great personal risk and sacrifice so that future generations could live free. Asking people to take the risk of maybe getting sick for a while is not such a large request.

As a member of the at risk group, over 70, certainly hope for a vaccine so I and many like me who are healthy and self sufficient can continue with what little remains of our lives.

Ask your doctor if this medication is right for you. Then talk to your local class action lawyer to file a claim. Remember, this medication will cause severe side effects and possible death. Make sure your will is recorded. If you can't afford the medication, AstraZeneca may be able to help. Meanwhile, back at the ranch.....