So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?
No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
The UK versus FDA Thalidomide experience is at least one good reason.
The FDA approved phen-fen, vioxx, des, the opiod disaster.. the hold up on AZ is not because they have magic time machine insight into why AZ should be delayed.
Here, we're targeting the actively-circulating virus. The match should be better, but getting enough into arms is the obvious problem.
I'll take the first vaccine that becomes available to me, and I highly doubt they'd give me a choice at the clinic anyway.
There are plenty of people in the lower-risk categories who would prefer to get a >60% effective vaccine now, rather than wait months for their turn in line for vaccines with the highest efficacy.
These are pretty extraordinary claims.
If this isn't true, then you should delete this immediately.
??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.
The AZ vaccine seems to be the best candidate as it can be distributed at fridge temperature. It looks like the novavax vaccine (protein + adjuvant design) may actually prevent invection. The goal of the 1st generation of vaccines is to prevent severe illness.
When I’m eligible, I still may take the nRNA, but my preference is on older tech at this point.
I fully acknowledge that the nRNA is extremely likely to be safe, but it’s just my preference
There is no such thing as long term issues that *suddenly appear after months or years". It simply can't happen because they don't have pharmacodynamics and you don't take them that regularly. They are not the same thing as medication.
Long term side effects like after the polio vaccine in the 70s always occur IMMEDIATELY after vaccination. Hours to days, maybe a week. These vaccines are in your body for a short period of time before they produce the spike protein from the mRNA instruction. All effects happen very fast. If you get vaccinated you might feel ill within the day.
So why did we only notice some effects of vaccines much later, for example narcolepsy in swine flu? Answer: it's all statistics. Some side effects have a chance of only 1:60.000 or even much less. Do you know how long it usually takes to vaccinate enough people to find something that occurs only in one out of 60.000 times? The answer is months or years.
But for COVID we have already vaccinated millions of people in multiple countries with multiple political systems and ideologies in power. No serious issues whatsoever. I know people who did get pretty sick for 2-3 days (basically bad cold) from the mRNA vaccine but that's GOOD. They are not infected, it's just a short term immune reaction that will disperse without causing serious harm and it shows the vaccine does what it is designed for: invoke an immune response.
And 2 days of symptoms are much better than 3 weeks with symptoms including hospitalization and long term effects due to an active virus in your body.
Have there been any long term double blind studies (e.g. 20+ years) to actually verify that this is the case? Or is this all based on the current models of how vaccines and their components behave in the body and what effects they have?
Sure, but this is different. Suppose a target cell happens to be expressing a retrotransposon that by chance binds to the mrna vaccine and integrates it into host dna in an inopportune spot, could cause elevated risk of cancer years from now. I think it's highly unlikely, and plan on getting an mrna vaccine myself but there are whole classes of side effects we can't simply rule out because "traditional vaccines show immediate effects"
> mRNA technology is new, but not unknown. They have been studied for more than a decade. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person. mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person's DNA.
https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basic...
It should say almost never. It's low enough for the risk to be worth it, but posting actually wrong absolute statements risks causing a backlash, the last year should have taught us all this basic condition of humanity
By contrast, the mRNA vaccines do the same thing in the end - get your cells to appear infected & emit the target spike proteins – in the narrowest possible way, via a subset of the changes an Adenovirus infection causes.
The complication with the adenovirus carrier is that you immune system may attack the carrier so effectively that you don't get enough exposure to the coronavirus protein that it is carrying, and hence don't develop a strong enough immune response to it. This causes problems determining how people will respond to varied treatment schedules (delay of the booster shot, mixing of vaccines, etc).[2][3]
The mRNA vaccines do not get your cells to 'appear infected'. See https://www.youtube.com/watch?v=LcTEmHlvY10
[1] https://www.sciencemag.org/news/2020/12/suspicions-grow-nano... [2] https://www.sciencedirect.com/science/article/pii/S152500160... [3] https://blogs.sciencemag.org/pipeline/archives/2020/12/02/ta...
I'm pretty sure they're attacked & destroyed by the immune system for their emission of foreign proteins - that is, they "appear infected". And, some time after the mRNA was introduced – days? weeks? – it's all used up, because unlike a full viral vector, it doesn't code for more invasive genetic material, only proteins. And, the cells it hijacked are in some combination, destroyed by the immune system or revert back to normal, non-threatening operation.
If you have a more specific reference that denies the mRNA-altered cells are attacked-as-if-infected, I'd appreciate seeing it. But that video doesn't make that claim, and in fat the reference to 'cytotoxic T-cells' implies the opposite.
(Also, as the sibling response elaborates, the problems with Adenovirus-vectors are not limited to PEG reactions.)
https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vect...
For example, famously, one Ad-based HIV vaccine was found to increase the chances of getting HIV. People still theorize that it might be due to the vector itself:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
(that said, these platforms are certainly better validated than the mRNA-based vaccines. There's an approved rabies virus vaccine based on adenovirus.)
Of course if you made an mRNA virus to produce some sort of toxic cellular protein then safety would be an issue - which is what the phase 1 and 2 trials are about. Phase 4 is about finding the one in a million adverse reactions.
1. get injected with some vaccine soon, expose your body to a controlled amount of slightly noxious chemicals and hope your body learns how to eliminate them before they degrade on their own
2. contract COVID-19 soon, expose your body to those same noxious chemicals, plus a bunch of others that help it spread throughout your body and cause damage and linger, possibly for weeks or sometimes until you die
(excluding extreme options, like living alone for the next 5 years far from other humans, or dying of a mundane cause sooner)
Your statement makes it sound like everyone that gets it will die when that is absolutely not true.
In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?
> In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Over 10,000 people under age 70 have died from covid, why does it matter if they have underlying symptoms?
So, basically, if you are healthy, your chances are absolutely tiny that you will die if you catch it.
So, yeah, it matters a whole lot actually.
Healthy is subjective but when you say it like that then, yes, everyone has something.
However, there are a bunch of things that will greatly increase your chances of dying from COVID: diabetes, obesity, cancer, immune-related illnesses so this is what I am referring to. It's fair to say that people with one or more of those (not an exhaustive list) are "unhealthy".
So, it's not misleading: it's people who are vulnerable either due to age or health reasons that are at risk of dying, no one else.
It was even raised by an MP recently and he asked Boris Johnston why we're getting locked down when only 400 or so people with no underlying conditions have died... everyone else had underlying conditions related to poor health that made them susceptible so they should have been locked down and the rest of us left to get on with things.
This seems wildly expensive and impractical. Who's going to take care of all those people? Where are you going to house them (many of them live with people without those conditions)? Do you know how many people have diabetes, just to grab the first item off your list?
34.2 million people in the US are estimated have diabetes and you're proposing housing all of them (and a bunch of other people) in isolation for a year or two while everyone else goes about their business.
That's a lot of housing to find somewhere, food to provide, etc. Now try to do it in, say, six months.
At it's peak, unemployment from COVID shutdowns in the US looks like they were around 20-30M last summer. So in terms of making sure those people still have income, the number of people isn't too dissimilar, but that number has declined and we also didn't have to find new, isolated, housing, food, and other services for that group.
It's also a lot of people suddenly pulled out of their existing jobs and out of the regular in-person retail market, which means you're still not going to avoid some of the shocks we're seeing anyway.
Cancer, Chronic kidney disease, COPD (chronic obstructive pulmonary disease), Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies, Immunocompromised state (weakened immune system) from solid organ transplant, Overweight (BMI > 25 kg/m2, but < 30 kg/m2), Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2), Severe Obesity (BMI ≥ 40 kg/m2), Pregnancy, Sickle cell disease, Down Syndrome, Smoking/Vaping (more than 20 days a month), Type 2 diabetes mellitus, Asthma (moderate-to-severe), Cerebrovascular disease (affects blood vessels and blood supply to the brain), Cystic fibrosis, Hypertension or high blood pressure, Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines, Neurologic conditions, such as dementia, Liver disease, Pulmonary fibrosis (having damaged or scarred lung tissues), Thalassemia (a type of blood disorder), Type 1 diabetes mellitus, Down Syndrome
Now, include the people who live with anyone with those conditions or the people who care or regularly interact with people with these conditions. We end up with a large percentage of the population. The proposal to lockdown/isolate only people with higher risk conditions is completely impractical.
And that is in large part thanks to the government and its public health experts, who we are now, I guess, supposed to believe have our interests in mind, even though, by letting 40% of the population become obese, when there are plain and simple steps they could have taken to prevent it, they have irrefutably demonstrated they do not actually care about the health of the population.
"letting" seems like a strong verb. I'm all for empathy for those who struggle with maintaining a healthy weight—imagine being addicted to something that you must consume about 3 times a day to stay alive—but it seems a stretch to lay the blame of obesity on the feet of public health experts. Are they also responsible for alcoholics? Other drug addicts?
Of course some in shape people will become fat as adults, but almost all fat adolescents stay fat until they die.
That's >40% of US adults[1] and ~30% of UK adults[2] covered already.
[1] https://www.cdc.gov/obesity/data/adult.html
[2] https://digital.nhs.uk/data-and-information/publications/sta...
People at risk include people with diabetes and asthma.
In Scotland, the most hospital beds have been occupied by the 45 - 64 age group. Not sure about other parts of the UK.
It still doesn't negate the argument that it only affects the vulnerable.
And those in the hospital beds: what were their conditions while in there? What were their underlying health issues (if any)? Did they recover?
I'm not saying people don't get sick, I'm saying the cure is worse than the disease especially when the ones dying are a tiny fraction of the population.
Edit: I live in Scotland - we have had the "sick man of Europe" title for a long time and we have an obesity crisis here [0]
[0] - https://www.obesityactionscotland.org/media/1026/obesityfact...
This is worth some inconvenience and higher taxes to me. I guess some people have no vulnerable relatives and no co-morbidities, or maybe value things like going to the pub above their gran. Personally I would rather have my 80 year old dad and 76 year old mum around for another few years than spend a week in Tenerife this year.
I live in the UK and we have the NHS so their job is to look after people when they get sick (and, to a certain extent, use preventative measure like education where appropriate).
But the UK governments largest spend is the NHS. We pay a fortune every year for it. So if they can't do their job then heads should roll among politicians and NHS brass.
My argument is that the death rate does not justify the measures that are being taken: by all means protect the vulnerable (my parents are in that class) but the rest of us have been locked down when the stats absolutely do not justify it.
I haven't even mentioned the economic cataclysm we are facing... that's another story!
Here in New Zealand we isolate new arrivals in hotels and they are strictly monitored. There are only a few thousand people there at any given time, and despite the huge effort, covid still escapes into the community every so often.
Then why do the numbers keep going up despite locking down everyone? Why didn't governments institute a policy that keeps people away from those in vulnerable groups with a £1000 fine for breaches? Mandated masks etc. That would have been just as manageable. Lockdowns do not work, the figures clearly show that yet people still mandate for more lockdowns? I don't get it.
> and despite the huge effort, covid still escapes into the community every so often.
yes, but who is dying from it? It's the old and vulnerable, not the young and non-vulnerable: the vast majority of people will not die from this!
The cure is worse than the disease.
What figures show that lockdown doesn’t work? I’m in New Zealand. We had community covid multiple times and have eradicated it (with lockdowns initially).
Keep in mind that our initial lockdown was very strict, particularly compared to UK style lockdowns.
In the UK the cases are falling fast, why do you say otherwise? There are less new cases each day.
No one is dying from covid here and hasn’t for a long time, touch wood, hopefully that continues.
Hi, Victoria, Australia here. Today, our state is at 24 days of zero community transmission of covid, managed largely via a small lockdown after a small outbreak from interstate.
Before that small outbreak, we were up to 80-ish days of zero community transmission of covid, after a much much larger outbreak which was brought under control by a robust lockdown which began in March and continued into December.
Lockdowns work, if people obey them. And we’re proof of that.
So let's re-phrase: you had one of the longest lockdowns in the world (110 days), spanning the fall, winter and spring...and then it came back in the summer, and you had to do it again. And you're in an isolated island nation with almost no international travel.
Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
If everyone did it, we would have a solution.
What Victoria achieved looked an impossible task for a while there, and shows that a severe outbreak can be corrected. That’s an achievement that can’t be underestimated.
Why anyone in Australia or NZ would want to travel internationally for anything other than absolutely essential travel is baffling to me - outside of travel, we have achieved normality. Rampant covid and freedom of movement is not the freedom I want.
> Why anyone in Australia or NZ would want to travel internationally for anything other than absolutely essential travel is baffling to me
"If it wasn't for other people, my plan would be perfect!"
I laughed.
The plan is good, it belongs to Dr Ashley Bloomfield and The Ministry of Health here in NZ. I was using ‘we’ in a global sense, but unfortunately Bloomfield has no jurisdiction out there.
If you want to be precise, there was one lockdown in April->May, and then the major one in July->November that we’ve been talking about. It was 112 days for that second lockdown, the severe one. (note that the exact restrictions changed over that period, but 112 days was the period for which there were any restrictions around when you were allowed to leave your home)
> spanning the fall, winter and spring
No, that would require around 270 days. The 112-day lockdown included the second half of winter and most of spring, but didn’t include any of Fall (which is March->May here in Australia, and also we call it Autumn).
The first (much less severe) lockdown did take place in part of Fall, though. But that wasn’t part of the 112 day period that you were talking about.
> and then it came back in the summer, and you had to do it again
It was a small handful of cases in a corner of the state and we just backed up one step in the scheduled reduction of restrictions to make sure things didn’t get out of control; it lasted about three weeks before the government was satisfied that it was contained and restrictions resumed easing.
It absolutely wasn’t a case of “do it all again”.
> And you're in an isolated island nation with almost no international travel.
Note that “almost no international travel” is because it was shut down by the government, to protect against the spread of Covid. That’s another option that’s available to other countries.
It might also interest you to know that we’re holding the Australian Open here in about a week, with folks arriving from all over the world. They’re apparently expecting to have 30,000 spectators attending per day, in person.
> Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
Oh, it’s absolutely tenuous. Absolutely. Everyone has to be working together for it to effectively bring cases down to zero, as has happened here in Australia and in New Zealand. One bad apple or one selfish person in the wrong place can undo the sacrifices of thousands of people who are doing the right thing.
But what’s the alternative? Just stand around and watch the corpses pile up? (3500 covid deaths yesterday in the USA, for example)
I would take the lockdown over that, personally. In fact, I did. And today, after the lockdown has ended, I went to work in an office. And I took public transport to get there.
0 locally acquired cases, for the 24th day in a row.
https://www.usatoday.com/story/news/factcheck/2021/01/26/fac...
There are things that can make living quite uncomfortable. So while yes not everyone will be hospitalized and die, there is still a lot of reasons to get any decently effective vaccine.
Edit:
"Bankhead-Kendall, who has treated thousands of patients since the pandemic began last March, says patients who had COVID-19 symptoms show a severe chest X-ray every time, and those who were asymptomatic show a severe chest X-ray 80 percent of the time."
With a sample size of what? That's a nonsense statement that can't be scrutinised.
Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50
82 people over the age of 50. It also doesn't mention how healthy these people were.
This is typical of pretty much all media coverage: very little facts but also very little to throw back at them...
Nothing like back to back cases of bad pneumonia 19 years ago to make me take this whole thing seriously.
My understanding is the hospitalization rate even for young and healthy (20-44) is around 10%. 1 in 10 odds for something happening is really a quite good chance of that thing happening.
Hospitalisation rate says nothing other than they were in hospital. It could have been because they were feeling a bit rough but utterly terrified due to all the scaremongering that's going around. Or they may have been close to deaths door. No way to tell.
The figures don't lie: There are vulnerable groups that can be severely symptomatic and even die from this but they make up a tiny tiny fraction of the population.
What are you pushing for? There are places we can look to where covid ran free, it isn’t pretty.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2...
Assess your actual chances of catching and suffering from covid. Then balance it against the risk of a rushed experimental gene therapy still in initial trials.
Edit: Remember that none of the media and government published figures show recovery rates - this is hugely important.
You can't link to the exact thing, but choose "Coronavirus Risk Perceptions" and split by age.
People under 40 believe that their risk of dying from the virus is over 10% on average. The actual risk for that age group is somewhere around 0.02%, which means they're overestimating their risk of dying by a factor of 500.
Five hundred! It's mindboggling how wrong people are.
But once you see those numbers, it becomes clear why there is such widespread support for strict lockdowns.
However, even with the accurate numbers, I would still say the case for the mRNA vaccines is strong. I think you are exaggerating the risks of the mRNA vaccines, in the same way that regular people are exaggerating the risks of the virus.
What specific policy are you suggesting? The more <40 year olds that get the virus, the more virus there is. The more virus there is, the more people who are spreading the virus, the more people who can get the virus, including people at very high risk of dying or being disabled from it.
As far as I'm aware no place has let the virus spread uncontrollably, think everything was fine, and not lock down at some point. The policy clearly has to be somewhere in between fully locked down and fully opened up, and I'm not sure discriminating by age and health is going to be some magical solution.
I think the biggest problem is the hyper-focus on a single cause of death. People look at the covid-19 death numbers, and have no idea how many people actually die in a normal year.
And this causes people to focus on ensuring nobody dies of covid-19 to the exclusion of everything else. Yes, it absolutely sucks that a lot of vulnerable people in elder care facilities have died of it, but it's equally tragic that a lot of them have died of cognitive decline due to not being allowed to see their family and friends, or not being allowed to see each other.
Or that people are dying or going to die because hospitals and patients alike are postponing care and checkups and routine surgeries, because they're afraid of hospitals being overrun with covid-19 patients, or because they're afraid hospitals will increase spread.
I belong to the privileged class of people who can work from home, I've done it for years, and I live far away from friends and family, so I've been doing weekly video calls for years. The effect for me, personally, is pretty much zero. A lot of people who drive policy are like me, and therefore think lockdowns are no big deal.
But lockdowns are absolutely miserable for a large amount of people. There's a very good reason that we're seeing violent anti-lockdown protests in several countries, because a lot of people are completely fed up with the restrictions.
So, in terms of specific policy, I want governments to encourage and enable people to isolate and distance and keep themselves safe, but I don't want them to enforce it. People have to be allowed to make their own choices, their own risk analysis, and live with the consequences. As we already do for a lot of things.
One example of encouragement is to have good sickpay policies in place, so that no-one feels they "have to" get to work even though they're sick or possibly infected, either out of social obligation or financial necessity.
> and I'm not sure discriminating by age and health is going to be some magical solution.
It's too hard to lock down and isolate a fraction of the population, therefore the solution is to lock down the entire population, except "essential" workers? This argument doesn't make sense to me.
This is how covid has been eradicated in NZ and Australia. Locking down part of the population doesn’t work - isolating the vulnerable from those that are less likely to die isn’t possible.
> People have to be allowed to make their own choices, their own risk analysis, and live with the consequences.
And where has this worked? A portion of people refuse to listen to advice, refuse to wear masks and refuse to isolate. People go out while sick, they congregate in groups. Why should the vulnerable have to be exposed to this? If everyone follows the rules, you get back to normal faster.
An approach based on evidence is the way to get results.
A forecast, but with data up to November 2020, which means it's probably not gonna change substantially when we have the full year data:
https://www.statista.com/statistics/1102546/coronavirus-euro...
So, Sweden is third least affected country in that list. It's missing Norway and Finland, though, but a quick google shows Norway at -3.5% and Finland at -4.0%, both worse than Sweden.
At the same time, the covid-19 deaths in Sweden is pretty close to the EU average, now, after the winter surge:
https://ourworldindata.org/coronavirus-data-explorer?zoomToS...
The obvious conclusion of that data is that lockdowns destroy your economy, but don't actually save lives.
I think that first sentence sounds like a great strategy, and it's perfectly in line with what I suggested. Coincidentally, that's exactly what Sweden did as part of its strategy. So I'm not so sure how Sweden is an example of the opposite?
> guess what, it turns out people don't want to go out and risk dying.
If people are voluntarily doing that, what's the point of having the government enforce the lockdown?
> So if your economy is doing to have mass unemployment, you may as well do that and avoid the death and injury.
Again, lockdowns aren't 100% free. They also cause death, injury, and misery. Suicides are up, domestic violence is up, cancer screenings are down, drug overdoses are up, alcoholism is up, depression is way up. Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition now.
I have a friend who was sick with covid for months, and she's got a long way to recovery. I have a friend who just got out of the ICU after having been there a couple of weeks, he's in shit shape, but alive. That sucks. But I also have friends who were close to suicide because they were unemployed, isolated, and really depressed. That also sucks.
There are no easy choices in this mess, and yet lockdowns are sold as an easy choice by people for whom it is easy, and failure to lock down is portrayed as some sort of moral failing, which is horrifying to me.
In NZ the suicide rate dropped, despite a lockdown that was considerably more severe than done in many places. Possibly making this misleading, NZs suicide rate is atrocious to begin with.
Yes, there was a hell of a lot of grim news and poor stats - but the below seems a little hard to to believe. They will lose years of life?
> Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition
https://www.mentalhealth.org.nz/assets/Suicide/Chief-Coroner...
But if you are really sick, you'd be at home, in your bed taking it easy anyway especially if your symptoms are as severe as some of the COVID reports suggest.
And it's not balanced reporting I want either, it's accurate reporting with facts that can be challenged or verified: most articles are incredibly vague when it comes to COVID and some have incredibly low numbers that, at first glance, look damning but are still tiny numbers.
Edit: deleted the 100,000 sentece - In response to that number, yes it may be a large number but there is no breakdown of the cases. For all you know, they were all 90+ years old with previous underlying conditions. All the figures we see have very little behind them that can substantiate the measures taken, while at the same time trigger responses in all of us that make them hard to argue against without coming across as callous but the numbers are not there to justify the lockdowns.
https://observer.com/2021/01/covid-long-term-health-impacts-...
It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.
If said leadership wanted people that would take the clear and simple steps needed to solve the obesity crisis to be in charge of that problem, then the obesity crisis would have been solved. The obesity crisis has not been solved, so we can only conclude that the leadership does not want the right people to be involved. Yet presumably we should also believe that said leadership has our best interests in mind now that there's a new virus going around, when they have already irrefutably demonstrated that they don't?
I do not even think an argument can be made that their failure is due to incompetence.
And if you would like to become educated on the government's role in fighting obesity, and its recommendations, you can go to https://www.cdc.gov/obesity/strategies/index.html
How about requiring every high school student to spend two hours per day doing strenuous physical exercise in order to graduate? How about considering it a failure for a student to graduate without being in excellent athletic form, on par with the student being unable to do algebra?
If the people in charge wanted to make that happen, they could do it by spending a tiny fraction of the public money at their disposal on propaganda, but all indications are that they don't want a population that's in great physical shape, even though it would obviously be good for them.
People who are in great shape when they graduate high school might still become fat, but people who graduate from high school fat will almost certainly spend their lives that way.
They could also regulate extremely sugary foods like how tobacco, which is less harmful, is regulated, where you have to be 18 to buy it and have to ask for the cashier to get it for you, rather than having it in your face at the checkout aisle.
Whining about how hard it is on their website is exactly the sort of reason why they have no credibility. They're not really trying, and pretty much everyone can sense that, even if they don't have it spelled out for them.
What is a "severe chest X-ray"? This story was debated on Twitter[1].
I agree with the (unforgiving) statements put there.
[1] https://twitter.com/Craig_1_1_7/status/1351203220878716928
And if it would actually end the pandemic and let me go into a store without a %$@#&#@ mask, I'd gladly swallow the syringe whole, sideways.
As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this?
All of these drugs were approved by the FDA's "process".
https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded.
You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.
I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy.
I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example:
Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.
Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.
The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.
Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
If we had started releasing the vaccine in August of last year we probably could have saved 100,000 lives.
Also the FDA doesn't regulate medicine. Only drugs. All the rest of medicine doesn't fall under FDA regulation (like surgeries).
For example: the otherwise promising and effective candidate from QUT accidentally causes you to test positive for HIV on the common/cheap/simple assays, which would make effective HIV testing vastly more expensive in the population and cause a huge anti-vax movement. I think we are happy that this side effect is constrained the the small trials group.
Maybe this needs to be explained in computer terms: would you be upset if Apple rushed out a security patch and that caused every iphone to reboot randomly during odd numbered months, and was unpatchable?
Or from drugs not being researched or approved because it's too expensive to do an fda trial?
Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless."
If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs.
Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.
You forgot a critical distinction: safely every time
However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
I have no idea how the FDA can hold back these vaccines in good conscience while peoples are dying by the thousands on a daily basis.