COVID-19 Vaccines With 'Minor Side Effects' Could Still Be Pretty Bad (wired.com) 243
"The risk of nasty side effects in the Moderna and Oxford trials should be made clear now, before it ends up as fodder for the skeptics," argues Hilda Bastian, a former consumer health care advocate and a Ph.D. student at Bond University who studies evidence-based medicine. An anonymous reader shares an excerpt from her article via Wired: On Monday, vaccine researchers from Oxford University and the pharmaceutical company AstraZeneca announced results from a "Phase 1/2 trial," suggesting their product might be able to generate immunity without causing serious harm. Similar, but smaller-scale results, were posted just last week for another candidate vaccine produced by the biotech firm Moderna, in collaboration with the U.S. National Institutes of Health. [...] Back in May, a CNN report described the Oxford group as being "the most aggressive in painting the rosiest picture" of its product, so let's start with them. Just how rosy is the Oxford picture really? It's certainly true that this week's news shows the vaccine has the potential to provide protection from Covid-19. But there are flies in the ointment. After the first clinical trial for this vaccine began in April, for example, the researchers added new study arms in which people got acetaminophen every six hours for 24 hours after the injection. That's not featured in their marketing, of course, and I saw no discussion of this unusual step in media coverage in early summer. Newspapers only said the vaccine had been proven "safe with rhesus monkeys," and did not cause any adverse effects in those animal tests. It was a worrying signal though: How rough a ride were people having with this vaccine? Was the acetaminophen meant to keep down fever, headaches, malaise -- or all of the above?
The press release for Monday's publication of results from the Oxford vaccine trials described an increased frequency of "minor side effects" among participants. A look at the actual paper, though, reveals this to be a marketing spin that has since been parroted in media reports. Yes, mild reactions were far more common than worse ones. But moderate or severe harms -- defined as being bad enough to interfere with daily life or needing medical care -- were common, too. Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness. Close to 10 percent had a fever of at least 100.4 degrees and just over one-fourth developed moderate or severe muscle aches. That's a lot, in a young and healthy group of people -- and the acetaminophen didn't help much for most of those problems. The paper's authors designated the vaccine as "acceptable" and "tolerated," but we don't yet know how acceptable this will be to most people.
There is another red flag. Clinical trials for other Covid-19 vaccines have placebo groups, where participants receive saline injections. Only one of the Oxford vaccine trials is taking this approach, however; the others instead compare the experimental treatment to an injected meningococcal vaccine. There can be good reasons to do this: Non-placebo injections may mimic telltale signs that you've received an active vaccine, such as a skin reaction, making the trial more truly "blind." But their use also opens the door to doubt-sowing claims that any harms of the new vaccine are getting buried among the harms already caused by the control-group, "old" vaccines.What about the Moderna vaccine? "According to the press release from May, there were no serious adverse events for the people in that particular dosage group," reports Wired. "But last week's paper shows the full results: By the time they'd had two doses, every single one was showing signs of headaches, chills or fatigue; and for at least 80 percent this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community -- and there could be a lot of people who are reluctant to get the second injection."
UPDATE 7/27/20: Slashdot interviewed Oxford Vaccine Trial participant Jennifer Riggins and asked what her reaction was to Wired's article. Riggins is an American technology journalist and marketer who's self-employed in London. Here's what she said:
"I think the article is a poorly written, poorly researched opinion piece. It says offering acetaminophen or paracetamol is unusual with vaccines. I'm a working mom with a three-year-old, and you are told to give them acetaminophen or paracetamol before all live vaccines as they can cause discomfort and fever for the first 24 to 48 hours.
"I'm actually surprised this article was in Wired that tends to be reputable. It seems to be written by a vaccine skeptic at best who knows little about them. This is a dangerous message because we most likely won't have a widely distributed vaccine til 2021 at earliest. Even longer if you consider, like the chicken pox vaccine, it needs a booster for efficacy. This flu season is going to be awful and then combined with this coronavirus. Add to that less kids are getting vaccinated or at least are delayed during the pandemic. Any antivaxxer message is incredibly dangerous. We won't be able to have herd immunity for Covid-19 by winter but we could for the flu which will save so many lives."
The press release for Monday's publication of results from the Oxford vaccine trials described an increased frequency of "minor side effects" among participants. A look at the actual paper, though, reveals this to be a marketing spin that has since been parroted in media reports. Yes, mild reactions were far more common than worse ones. But moderate or severe harms -- defined as being bad enough to interfere with daily life or needing medical care -- were common, too. Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness. Close to 10 percent had a fever of at least 100.4 degrees and just over one-fourth developed moderate or severe muscle aches. That's a lot, in a young and healthy group of people -- and the acetaminophen didn't help much for most of those problems. The paper's authors designated the vaccine as "acceptable" and "tolerated," but we don't yet know how acceptable this will be to most people.
There is another red flag. Clinical trials for other Covid-19 vaccines have placebo groups, where participants receive saline injections. Only one of the Oxford vaccine trials is taking this approach, however; the others instead compare the experimental treatment to an injected meningococcal vaccine. There can be good reasons to do this: Non-placebo injections may mimic telltale signs that you've received an active vaccine, such as a skin reaction, making the trial more truly "blind." But their use also opens the door to doubt-sowing claims that any harms of the new vaccine are getting buried among the harms already caused by the control-group, "old" vaccines.What about the Moderna vaccine? "According to the press release from May, there were no serious adverse events for the people in that particular dosage group," reports Wired. "But last week's paper shows the full results: By the time they'd had two doses, every single one was showing signs of headaches, chills or fatigue; and for at least 80 percent this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community -- and there could be a lot of people who are reluctant to get the second injection."
UPDATE 7/27/20: Slashdot interviewed Oxford Vaccine Trial participant Jennifer Riggins and asked what her reaction was to Wired's article. Riggins is an American technology journalist and marketer who's self-employed in London. Here's what she said:
"I think the article is a poorly written, poorly researched opinion piece. It says offering acetaminophen or paracetamol is unusual with vaccines. I'm a working mom with a three-year-old, and you are told to give them acetaminophen or paracetamol before all live vaccines as they can cause discomfort and fever for the first 24 to 48 hours.
"I'm actually surprised this article was in Wired that tends to be reputable. It seems to be written by a vaccine skeptic at best who knows little about them. This is a dangerous message because we most likely won't have a widely distributed vaccine til 2021 at earliest. Even longer if you consider, like the chicken pox vaccine, it needs a booster for efficacy. This flu season is going to be awful and then combined with this coronavirus. Add to that less kids are getting vaccinated or at least are delayed during the pandemic. Any antivaxxer message is incredibly dangerous. We won't be able to have herd immunity for Covid-19 by winter but we could for the flu which will save so many lives."
Anything might be bad (Score:5, Insightful)
Good thing there's a bunch of different vaccines in development then. If one of them isn't good, there's a bunch more.
Re: Anything might be bad (Score:4, Interesting)
Re: Anything might be bad (Score:5, Insightful)
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The problem is it will create yet another divide between the vaccinated and the unvaccinated. Say you can't have the vaccine your particular country decided to buy for some medical reason. Everyone else can get back to normal, go back to the office, but you are stuck at home isolating now all the protections like masks and social distancing are gone.
At least many countries are making the vaccine free, in countries where you have to pay for it there will be an economic divide too, especially if you need one
Re: Anything might be bad (Score:4, Insightful)
IF the vaccine is made freely available so that everyone medically able gets one, then there will be herd immunity that will allow the few who can't have it to be reasonably safe.
If economic status becomes a factor, coverage will likely be insufficient for that and the divide between haves and have-nots will grow and the medically disqualified will become have-nots.
Re: Anything might be bad (Score:5, Insightful)
> There won't be 7.6 billion doses available on day 1 anyways.
Good thing most people are unaffected anyways. Otherwise people would care.
Most people were unaffected by malaria and polio that didn't stop them from lining up to get their vaccines.
Re: Anything might be bad (Score:3)
I know an 80 year old woman who is breathing portable oxygen because of COPD. She caught and recovered from COVID-19 without even knowing. Her 80 year old husband thought he had a bad flu for two weeks. Both are now fine.
Yes, this pandemic is serious and the real deal, but anecdotal stories, like mine above, are worthless. What isn't worthless is hard core math and science.
There seems to be more to immunity than antibodies, which is very interesting:
https://www.bbc.com/future/art... [bbc.com]
Re: Anything might be bad (Score:5, Informative)
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So fucking a lot of people won't take the vaccine and we won't reach herd immunity.
Re: Anything might be bad (Score:2)
Are they cutting corners or is this normal? Could somebody with a vested interest already be trying to smear one of trials?
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That means if this vaccine truly helped 70% of the human population while not helping or even harming the other 30%, they would "cut corners" to approve it.
I don't understand why you think anybody would approve or take a vaccine with a 30% 'harm' rate to ward off a virus with a rate far, far lower than that, especially if you are under 50.
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If the "harm" is you get a fever and a headache for a few hours, that is quite disproportionate to the potential "harm" of getting COVID.
> a virus with a rate far, far lower than that, especially if you are under 50.
Are you from the future? You're able to put to rest all those nasty reports of even young people suffering long term damage to organs and blood vessels then? So it clears up and is gone from the body completely with no harm done in what, a year? 2?
Re:Anything might be bad (Score:5, Insightful)
The side effects are mild fever and bit of muscle ache.
I'll take that over dying.
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If the vaccine is designed well, then the bodily reaction is to a harmless substance, the chills or muscle are there when the immune system goes into action, but no damage was done. The vaccine doesn't invade bodily cells.
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The current virus candidates do invade cells. The Oxford one specifically is a live virus that's had its DNA removed and replaced with some that codes for a coronavirus spike protein.
The difference is that the vaccine virus can't reproduce and invade *more* cells.
Re:Anything might be bad (Score:5, Insightful)
Mild fever and some muscle aches that are treatable with Tylenol is a lot better than being on a ventilator and having all your life's savings wind up paying medical bills. This isn't the flu where people can get the virus, be sick for a few days and be out and about. Just look at all the refrigerator trucks in sunbelt states.
I personally have signed up for any trial in the area. Same reason why I always get a flu shot and keep my immunizations up to date. Not that I get sick, but so I don't pass it onto others.
Re:Anything might be bad (Score:5, Insightful)
The side effects are mild fever and bit of muscle ache.
I'll take that over dying.
And you expect that. It's no surprise.
(As I understand it) the Oxford vaccine is:
- A live virus
- that's had the SARS-CoV-2 spike protein transplanted into it
- but is missing a piece of its replication machinery, one that also isn't present in human cells. (It is grown in cell cultures that DO have the missing piece, but can't finish its life cycle in the human body.)
So it infects some of your cells and makes them start presenting the spike protein - but can't go the whole way and make them produce more virus. The converted cells annoy your body until it attacks and destroys them all - and thus ends up with immune system memory cells for making both free antibodies and T cells that attack the spike protein.
(Some subjects didn't produce much immune response after one dose but all that had two doses built up both the free antibody and T-cell reaction. Free antibody immunity tends to fade after a few months, T-cell immunity tends to last a lot longer but may increase the chances of cytokine storms.)
The stage where your body contains some converted cells IS a "mild cold" of limited duration (because the virus can't reproduce in you, but you ended up with some infected cells that your body had to clear out). Most of the symptoms of a "cold" are really your body clearing out infected cells and other debris of battle. So, yeah, "cold" side-effects up the wazoo.
Re:Anything might be bad (Score:4, Insightful)
Re:Anything might be bad (Score:5, Informative)
A large percentage of COVID-19 patients get permanent damage to their lungs. A somewhat smaller percentage suffer permanent damage to their heart. Then there is the high rate of blood clots that can cause permanent brain damage, destroy your kidneys etc. I would absolutely put up with a day or two of muscle aches from a vaccine in order to prevent even a tiny chance of debilitating injury. That's no different from the vaccines that protect me against a host of other dangerous diseases.
Re:Anything might be bad (Score:4, Interesting)
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> For the young testers? Sounds just like getting the real thing then for that age and so older people could die.
Except for the percentage of young people who also ended up on ventilators, had strokes, organ failure, etc. But you know, you're PROBABLY not going to be one of those people so just go take a chance, what could happen?
https://www.ibtimes.com/minnesota-reports-first-child-death-covid-19-amid-states-highest-day-coronavirus-3014749
https://www.medscape.com/viewarticle/927196
"20% of US COVID-19 D
Re:Anything might be bad (Score:5, Insightful)
Comment removed (Score:5, Insightful)
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>"The side effects are mild fever and bit of muscle ache. I'll take that over dying."
I think you mean you will take that over a 0.26% chance of dying if infected (unless you are under 50, then it is a 0.0325% chance).
Still a valid motivation, but let's not be overly dramatic about it.
What's over-dramatic is the article acting like a short regimen of acetominaphen is some kind of deal-breaker. (I won't go in to the death stats because I pay no attention to them, and neither should you until all the medical Bigshots working their jaws begin to converge with their data. This is Science they're doing, not fucking Economics. Their data should begin tightly agreeing on this. 2+2 still equals 4 in any universe that matters to humans.) Just because it was time, I got the first of two shingles i
Re:Anything might be bad (Score:4, Funny)
Where do you sign up to be one of the asymptomatic ones?
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Good thing there's a bunch of different vaccines in development then. If one of them isn't good, there's a bunch more.
You remember how I mentioned a couple of months ago that I was very badly hoping for the microneedle skin vaccine to be first to market, because it seemed least likely to cause serious harm? This right here is exactly what I was afraid of.
I'm hoping that not all the traditional vaccines do this, but there's a very real possibility that they will. And the real question is whether these vaccines will have a nonzero CFR when given hundreds of millions or billions of times. We'll know more when the larger-sc
Re:Anything might be bad (Score:4, Interesting)
And the real question is whether these vaccines will have a nonzero CFR when given hundreds of millions or billions of times. We'll know more when the larger-scale studies are finished.
According to my father (a doctor who has studied public health), the real dangerous side effects of a vaccine don't really come out until you seriously scale things up because they have a rate of 1 in 100,000.
Thankfully this problem is global enough that most of us don't really have to worry about taking a vaccine until its already been given to millions of other people.
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Exactly. The larger the trial, the more likely you are to find the outliers.
That said, the coronavirus has a CFR even among young people of a couple of tenths of a percent, so if the bad effects are anywhere near as bad as the actual virus, there's a decent chance of detecting it even in trials of even single-digit thousands of people.
Of course, IMO, the more critical analysis won't be the trial itself, but rather the six-month follow-up, when they determine whether the vaccine resulted in actual immunity
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According to my father (a doctor who has studied public health), the real dangerous side effects of a vaccine don't really come out until you seriously scale things up because they have a rate of 1 in 100,000.
Thankfully this problem is global enough that most of us don't really have to worry about taking a vaccine until its already been given to millions of other people.
Absolutely agree that it is very possible that rare side effects may not be found out until it was deployed in large scale. However, assuming you are an American, then you better think twice about not having to worry about it until millions other have already had it.
Currently [worldometers.info], the US, Brazil and India are the countries with most confirmed cases. (Russia is the 4th but the daily new cases were much lower by far.) There is practically no hope for these 3 countries to be able to contain the virus by lockdow
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Good thing there's a bunch of different vaccines in development then. If one of them isn't good, there's a bunch more.
So - just like cars or donuts or cleaning fluids then. Try one, and if it kills you or cripples you, no sweat - just try another.
And so on until you have ranked all 200 or whatever.
Big deal, it wouldn't be the first (Score:5, Informative)
I'm in my late 50s, so my doctor recommended I get the shingles vaccine (Shingrix).
Now what they generally don't tell you about the shingles vaccine is - it absolutely clobbers some people for 1-2 days. It hit me fairly hard - I felt like I had the flu, with severe body aches and a temp of 101.5 for roughly a day. Since it's a two-part vaccine - you get two shots a few months apart - you can plan on this happening twice.
But so what? Sure, I felt like crap... but it wasn't the end of the world. Getting shingles would likely be much worse - as would getting COVID-19.
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Exactly. A nasty headache and fever for a day or two is nothing compared to pneumonia, which hurts as hell.
Re:Big deal, it wouldn't be the first (Score:4, Interesting)
It would rule the vaccine candidates out if the likelihood of getting COVID19 was low or it the seriousness the illness, after catching it was low. On the latter point there is a slight chance of this happening. Viruses have a tendency to evolve towards being less pathogenic over time, and it is hypothesised that this is what happened in relation to the 1918 influenza pandemic. Even though viruses are not technically alive, the less pathogenic ones are 'fitter' candidates for propagation, as the host is not dead or incapacitated. It is a long-shot though, especially given that, if my understanding is correct, H1N1 is able to evolve faster than COVID19.
A scientist friend has said that he is worried about the Oxford ChAdOx1 candidate - it is based on a modified adenovirus, which hasn't been done before, and according to him, the middle of a pandemic is not the time to try. He's worried about 'off-target editing'.
Western media rarely talks about the Sinovac candidate - developed between Canada and China. Currently being tested on China's own military personnel. Lucky them - their definition of 'fighting for country' is broader!
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It looks like your scientist friend was mis-informed. ChAdOx1 doesn't do any editing so there's no chance for off-target editing. Adenoviruses might be used for gene therapy (and then off-target editing is of concern) but this is *not* what vaccine does.
Re:Big deal, it wouldn't be the first (Score:4, Informative)
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Re:Big deal, it wouldn't be the first (Score:5, Informative)
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Re:Big deal, it wouldn't be the first (Score:4, Insightful)
Now what they generally don't tell you ...
If your doctor isn't generally honest with patients, perhaps you should find a new doctor.
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I travel a lot, to interesting places, so I've been vaccinated for a lot of different things. Right before I got a yellow fever vaccine the doctor told me this one was famous for stinging quite a bit. A little kid walked by the open door right as she started injecting. I think the look on my face might have scared that kid off travel vaccinations.
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That's funny - the pharmacist at Walgreens who administered my shingles vaccine(s) went through a 5-minute explanation of possible side effects, and indicated each one with a highlighter in the patient information insert as she described them. Maybe you need a different provider?
Re:Big deal, it wouldn't be the first (Score:5, Interesting)
Dude, I'm 70, and I HAVE Shingles. Consider yourself LUCKY that your pains were only a few days each for a couple of sessions ! ! !
My initial symptoms were buried in my spinal/back damage pains, and I lived with it for over a decade. Unfortunately, by that time the neuropathic damage was permanent - and it really sucks.
Every day, every night, burning nerve channel pains down the left leg - and even opiates don't do more than dull this pain.
Yeah, sometimes the remedy has a seriously disabling (temporarily) side effect - everywhere. BUT, IF the issue is serious enough - like nerve channel pains for life - you'll deal with it. The medical community just has to be up-front about the issues.
Now, IF the Covid-19 vaccine grants long term immunity it just MIGHT be worth it - BUT if it's an annual dick-in-the-dirt pain for inoculations - EVERY YEAR, then KEEP SEARCHING ! ! !
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ONE BIG THING that jumped out at me, being a chronic pain sufferer, is the AMOUNT of acetaminophen administered - which is 4 GRAMS in 24 HOURS - OVER the medically recommended safe level of 3 grams in 24 hours.
- https://www.webmd.com/a-to-z-g... [webmd.com]
McNeil Consumer Healthcare (the maker of Tylenol) lowered their recommended maximum daily dose to 3,000 mg
- https://www.healthline.com/hea... [healthline.com]
Adults should not take more than 3,000 mg of single-ingredient acetaminophen a day
- https://medlineplus.gov/ency/a... [medlineplus.gov]
The recommended maximum dose per day has dropped from 4000 mg to 3000 mg
- https://www.emedicinehealth.co... [emedicinehealth.com]
Acetaminophen Poisoning (Tylenol Overdose) Symptoms, Causes, Treatments, and Recovery
Remember folks - most of the docs on this medication are from the BIG PHARMA guys, and it IS a proven liver killer. Why is Tylenol still allowed when less toxic alternatives are available - duh - $$$$$$$
Hell, the only real reason it was allowed on the market was because of the complications from Reye's Syndrome.
Aspirin has been linked with Reye's syndrome, so use caution when giving aspirin to children or teenagers for fever or pain. Though aspirin is approved for use in children older than age 3, children and teenagers recovering from chickenpox or flu-like symptoms should never take aspirin.
- https://www.mayoclinic.org/dis... [mayoclinic.org]
These are healthy, young adults in this test.
What is going to happen to the general population of less-healthy, obese, older, clinically/medically weakened couch potatoes who get this and chug down 4 grams of acetaminophen to slam into their alcohol (and/or drug) abused livers - and they turn orange from Jaundice ? ? ?
cheers
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most of the docs on this medication are from the BIG PHARMA guys, and it IS a proven liver killer. Why is Tylenol still allowed when less toxic alternatives are available - duh - $$$$$$$
What are you talking about? The patents for acetaminophen/paracetamol expired decades ago and it's ridiculously cheap; over here (Netherlands), white-label pills (500 mg) cost 2 eurocents a piece: 12 cents per day for the standard maximum daily dose.
It's only a proven liver killer on large overdoses. The maximum 3000 mg per day is a one-size-fits-all number for children above 12 and adults that include a safety margin. If one takes into account body weight, health status, and other medicine use and the pati
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Acetaminophen's safety margin is very low for an over-the-counter medication.
Re:Big deal, it wouldn't be the first (Score:4, Informative)
I'm a physician, but this isn't my field of study. That being said...
Acetaminophen has been generic for decades. Nobody's making big bucks over it.
Admittedly, the safety margin for acetaminophen isn't great. But the 4 grams/day dose only causes liver damage over a prolonged period ... and the liver continually regenerates!
Also, the studies that look at the 4gram/day dose consider toxicity any transient increase in AST or ALT (enzymes created in the liver), rather than permanent liver failure.
Another thing: One of the reasons the toxic dose of acetaminophen was decreased from 4 grams/day to 3 grams/day was because of the realization that there are many medications that include acetaminophen as part of them. So individuals taking a pain killer and a decongestant and a sleep aid were likely taking a much higher dose of the chemical, spread over multiple different branded meds.
Basically, the 4grams/day dose for 2-3 days is safe for just about anyone who doesn't have a chronic liver disease. Physicians that prescribe acetaminophen for pain relief (just about all of them) know that. Also, patients with chronic liver disease are usually well informed about taking ANY pain killers, since the ones that don't contain acetaminophen usually contain other things that can thin the blood (which is potentially dangerous for those with chronic liver disease). The few pain killers they can take are controlled substances.
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Better than shingles brother, believe me.
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Now what they generally don't tell you about the shingles vaccine is - it absolutely clobbers some people for 1-2 days. It hit me fairly hard - I felt like I had the flu, with severe body aches and a temp of 101.5 for roughly a day. Since it's a two-part vaccine - you get two shots a few months apart - you can plan on this happening twice.
But so what? Sure, I felt like crap... but it wasn't the end of the world. Getting shingles would likely be much worse - as would getting COVID-19.
Having had shingles a co
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I suspect there will be a push from both sides of this argument to conflate the risks of proven vaccines (MMR) and new vaccines for covid. The anti-vaxxers will want to use the inevitable deaths from a fast-tracked vaccine as proof for their cause. On the other side of the coin their opponents will try to downplay the side effects.
Just because the decades-old MMR vaccine is safe does not mean we should assume that the as-yet-unfinished covid vaccine will or won't be.
We live in interesting times.
Bad is relative (Score:5, Insightful)
But also, coronavirus precautions are really disruptive. We're talking trillions of dollars here. If a mild fever for a couple days is what it costs me to be immune from contracting or spreading the virus for a few months or more, and be free to live normally again, I'd take that bargain.
Death a bit more Disruptive (Score:2)
But also, coronavirus precautions are really disruptive.
Forget the precautions, catching COVID-19 comes with a ~0.5-1% chance of death which tends to permanently disrupt your life. I'll happily take a risk of 1-2 days of fever and chills vs 2-3 weeks of fever, chills, headaches and the risk of death.
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I think we're missing the point of the article (surprise!) - not that the side effects are a deal-breaker, but that by not covering them as we go, we risk feeding the antivaxers (see other response to the parent below) and increasing fear and resistance to it. Also, that the feel-good press releases for a vaccine that is likely more than a year off seem more geared to pump-and-dump stock trading than anything else. She doesn't mention the massive government investments going into preproducing something that
Side effects (Score:4, Informative)
Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness.
And the most common side effect of acetaminophen is also fever (presumably in people taking it for analgesia). Go figure. It has a bunch of others as well, though they are described as rare.
https://www.drugs.com/sfx/acet... [drugs.com]
You're were looking for a drug with none? Sorry, you are gonna die.
acetaminophen (Score:5, Interesting)
>"and the acetaminophen didn't help much for most of those problems. "
In my personal experience, acetaminophen doesn't help for anything, EVER. Ibuprofen, however, is great. Same with my mom and several of my friends. I don't know why acetaminophen is even used anymore.
Anyway, it is a bit troubling to hear such feedback about these early COVID-19 vaccines. I get a flu vaccine every year, and have for something like 20 years, and the only reaction I have ever had about 50% of the time was moderate muscle pain at the injection site, lasting a few days. Asked lots of people, and I could never find anyone that had anything worse than that.
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In my personal experience, acetaminophen doesn't help for anything, EVER. Ibuprofen, however, is great. Same with my mom and several of my friends. I don't know why acetaminophen is even used anymore.
In my personal experience, it works wonders for fever and migraine, and reduces inflammation. Ibuprofen does nothing for me, except give me a nasty stomach ache. If I need an NSAID, I get diclofenac which *does* work very well.
It's almost as if medication works different for different people :)
As for the flu shot, it works fine. Never had the flue again since I'm getting those, and I used to have it every year, more than once, to the point where I was getting lasting damage (influenza does that). It's a sor
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I take it as a good sign. Symptoms like this from a vaccination mean your body is taking it seriously and responding. Especially with these new style vaccines, the big danger is that they don't produce much of an immune response.
All the trials have a bunch of dose groups for a reason. You can pick the lowest dose that gives you a decent response. If none of them do, you're back to square one.
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Agreed - I question whether acetaminophen would pass a double-blind trial by modern standards.
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In my personal experience, acetaminophen doesn't help for anything, EVER. Ibuprofen, however, is great. Same with my mom and several of my friends. I don't know why acetaminophen is even used anymore.
Neither one does anything noticeable for me. I've given up taking them.
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Acetominophen is worthless to me. Ibuprofen works a little bit. Aleve works well, eventually. I used to take Orudis KT for major headaches, and it worked better than anything, but apparently it was killing people or something.
Re: acetaminophen (Score:2)
I think the main problem was that 12.5mg just wasn't enough of a dose to work. To be literally equivalent to 400mg of ibuprofen, you needed ~100mg of ketoprofen, at which point the gastric irritation was mostly indistinguishable FROM ibuprofen.
If a single 12.5mg Orudis KT was enough, half of a 200mg ibupbofen tablet probably would have been, too... and enormously cheaper. Ketoprofen's real market is, "people who need 1600-3200mg doses of ibuprofen, but would have bleeding ulcers if they actually took that m
Re: acetaminophen (Score:2)
Naproxen does wonders for nerve pain in your back. I have a herniated disk at the L4/L5 area and for a while pounding naproxen was the only thing that kept me going. Of course, I think I took so much one time I screwed up my kidneys, looked like I was peeing coke. Had kidney issues ever since, but as long as I stay hydrated its under control.
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In my personal experience, acetaminophen doesn't help for anything, EVER. Ibuprofen, however, is great.
It depends what it's for. As a painkiller it does nothing for me, but to reduce a fever it's fine. Ibuprofen is better re pain relief, but still not all that effective.
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Some people are allergic to ibuprofen...
Yep... (Score:2)
Similar to shingles vaccine (Score:4)
The reported side effects from all 4 trials that have published results have been pretty similar to the side effects of the shingles vaccine. I happened to experience exactly the middle range of effects of that vaccine as described in the patient insert. It was unpleasant and the worst reaction to a vaccine I have had in my adult life, but not anything that stopped me from taking the 2nd dose even knowing I might go to the high range the second time (3 of the 4 tested COVID vaccines are 2-dose as well). I can't see that being a stopping point for a COVID vaccine. YMMV.
Vaccine Injury Compensation Fund (Score:2, Insightful)
Do not forget the group dosage level! (Score:2)
In the trial, the group with the highest level of dose had more severe symptoms. The groups with a medium dosage had a good response and less severe symptoms. The groups with a low dose had mild symptoms, but also a low level of antibodies, lower than
Re: (Score:2)
It stands to reason that a higher dose of a live virus leads to worse symptoms. In fact, we were talking about this here just yesterday [slashdot.org]. :-)
That said, I doubt the antibody numbers are going to be the only deciding factor on dosage. If the side effects are bad enough, they might well go with a much smaller dose and do multiple booster injections instead. Or they might try using a different delivery mechanism, weakening the virus differently, etc. in hopes of getting a similar antibody reaction without su
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Or they might try using a different delivery mechanism, weakening the virus differently, etc. in hopes of getting a similar antibody reaction without such severe symptoms.
If they go that route, it will delay the development of the vaccine by another half year: develop he production process with quality control, do in-vitro tests, get the approval for human trials, etc.
Side effects may include ... (Score:5, Insightful)
.. your body activating it's immune response and therefore reacting as if it is defending itself against a virus. That's what happens when you get sick. It's kind of an odd misunderstanding we hold on to, that these symptoms are simply "bad", when in fact they're just an indication that our body is doing it's job and effectively fighting off an illness. And that's exactly the response you want to get with a vaccine. It's not universal but it's a total furphy that feeling any kind of side effect is an indication that something is going "wrong".
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that these symptoms are simply "bad", when in fact they're just an indication that our body is doing it's job and effectively fighting off an illness.
Unless the vaccine triggers an excessive response that actually does more harm than good.
https://www.ncbi.nlm.nih.gov/p... [nih.gov]
And:
Early efforts to make SARS vaccines, using whole, killed viruses or viral proteins, seemed promising. The vaccine candidates rapidly induced antibodies that, in cell culture, neutralised the virus. When vaccinated animals were exposed to SARS, the virus didnâ(TM)t replicate in their lungs. But several labs noticed that the animals still experienced a lung inflammation resembling a severe allergy.
This rang alarm bells. Experimental vaccines for animal coronaviruses have had this effect, and it has also been seen with viruses from other families. Most notoriously, it occurred in the 1960s with vaccines for measles and respiratory syncytial virus (RSV), a common infection in babies. Vaccines containing killed viruses were tested in children and appeared safe, but when the children encountered live measles or RSV, they got sicker than unvaccinated children. Both vaccines were abandoned, and developers have been wary of the effect ever since.
(https://www.newscientist.com/article/dn23563-threatwatch-could-a-mers-vaccine-make-people-sicker/)
Side Effects (Score:3)
Medicine is awesome.
However, side effects can actually cause more harm than good and those side effects aren't always obvious right away.
I've recently become rather experienced in one of them so here's that story.
About a year ago, my doctors were not happy with my cholesterol levels so they started me on a medication called Rosuvastatin ( Crestor ).
It seemed to work very well according to test results to check my levels a few months later, so I didn't give it a second thought.
Fast forward a year.
I wake up and put my glasses on and note that I am unable to see anything clearly beyond five or six feet. The next day I get hit with a thirst
you cannot quench and an hourly run to the bathroom. Didn't take long to figure out the symptoms were high blood sugar although I had never
had an issue with it when I get my physical done every year.
Bought a meter, strips, lancets, etc. and started checking my glucose levels anyway.
After fasting for fifteen hours, my first check returned a result of 285. ( Corresponds to an a1C of ~11.5 which is well into the holy shit side of things )
Immediately stopped all medications regardless of what they were or what they were for as I needed a clean slate to figure out the cause.
Did more research.
Turns out, Crestor ( like all statins ) has this rare side effect of INDUCING Type II Diabetes in some folks. Fan-fucking-tastic :|
In three weeks, my blood sugar went from holy shit levels back to normal. The eye docs are happy I caught it quickly as diabetes has a tendency to wreak havoc on the blood vessels in your eyes. ( My vision returned to normal as well ) Haven't taken the medication since and my glucose levels remain where they should be.
The takeaway from this is the side effects of medications are not always immediately obvious, even in a fully certified and FDA approved drug and can take weeks, months and even years to manifest.
It is very likely we won't know the full extent of the side-effects of any vaccine for years and the folks who elect to get it sooner rather than later are basically going to be pharmaceutical guinea pigs for everyone else. You can bet your ass I will PH.D level research the shit out of anything the Docs try to give me from now on before I agree to it.
As a result of my fun filled experience with what is considered a " safe " statin drug, I think I'll wait on v2.0 or even v3.0+ on any Covid vaccine once it hits the market. I got lucky that my issues were reversible.
Some side effects don't give you that option at all.
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Did more research. Turns out, Crestor ( like all statins ) has this rare side effect of ...
Here in the Netherlands, the patient leaflets that come with medication usually list side effects, grouped by categories (common, uncommon, rare, very rare). Was this side effect too rare to be listed, or does it work differently where you live?
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I am very glad to hear that you caught this serious side effect early and took immediate action to address it. Not everyone who takes medications is as self-aware about such things.
You are absolutely correct that FDA approval of a drug or biologic does not ensure safety. In many cases, it doesn't even ensure efficacy! The thing to understand is that it's impossible to develop a treatment that works for everyone and is safe for everyone in the indicated population. While drug companies and the FDA genera
I work in drug development (Score:5, Informative)
And here's my take based on what I've seen so far. Bear in mind that as the science progresses, the situation may change and the opinions I present may need updating.
Having years of expertise in applying biostatistical principles to clinical trial data in support of approval of novel therapeutics, I have been paying close attention to the recent early phase studies of the nCoV-2 vaccines currently being investigated. The first thing to understand is that to date, no confirmatory trials have been completed. All data that have been presented thus far have been from preliminary, hypothesis-generating/dose-finding studies.
Under the current accelerated approval pathway for these vaccines, it is entirely possible that a suboptimal dose may be approved for use, given our ongoing lack of understanding of how strong an immune response is needed to confer protective benefit. In other words, the earliest vaccines approved to prevent COVID-19 infection may be stronger than what is required to protect the individual while minimizing adverse events.
Second, only through large-scale confirmatory studies will we have a better understanding of the safety profile as well as the efficacy. Currently, I would say that the adverse events reported so far are generally a tolerability concern, not a safety issue. Having a fever or injection site pain, as long as these do not require hospitalization and do not generate long-term adverse health effects, would most likely be considered acceptable. The main safety concerns for any compound would be things like toxicity or organ injury. In this case, we would want to pay special attention to hypersensitivity reactions leading to injury. This is because there is evidence of a correlation between COVID-19 mortality and immune system hyperstimulation--the so-called "cytokine storm" that is treated with immunosuppressants to avoid damage to healthy tissues. And the high fevers that are reported as a result of vaccination is a possible sign of such a reaction, as well as potential evidence of efficacy.
Third, we have yet to determine the posology of these vaccines in relation to risk of infection, duration of response, and safety/tolerability. For example, some vaccines need "boosters," such as the HPV vaccine. Some are reformulated for each strain that becomes prevalent in a given season, such as for influenza. Some are administered once and that's enough to confer lifelong or nearly lifelong protection. Then the dosing of each injection is not finalized. Given that natural immunity arising from actual infection and recovery is likely to wane over a time scale that is measured in months and not years or decades, it is more likely that any successful vaccine will need to be administered multiple times in order to have sustained benefit.
I personally believe--and this is without any hard evidence--that an effective vaccine will not only cause adverse events such as fever, pain, and fatigue, but will need to do so, because these are signs of elicitation of an adequate immune response. Thus, the correct dosing and administration will only be determined with time. My main concern is that vaccine efficacy could be compromised as a result of incomplete adherence, noncompliance, and/or incomplete protection resulting in selection pressure for the virus to mutate. We have evidence that nCoV-2 is more easily transmissible than other respiratory diseases such as influenza; moreover, the existence of asymptomatic infection is another reason for concern for long-term control of COVID-19 through vaccination.
The bottom line is that it is still too early to be worried about the reported safety profiles from these small trials, because too much is still unknown, there isn't enough subject-years of exposure, and there isn't yet conclusive evidence of clinical benefit in the form of reduced risk of infection. We don't even have an estimate of the reduction in risk. The only efficacy data we have is antibody levels, and that is a surrogate for the real efficacy endpoint, which is the reduction in risk of infection as measured by a time-to-event analysis.
Is she really qualified? (Score:2)
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I know I can find actual doctors to talk about this, why can't Wired?
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apples to apples (Score:2)
> any harms of the new vaccine are getting buried among the harms already caused by the control-group, "old" vaccines.
If this is true, and harm caused by the new vaccines are getting buried by a control group using vaccines already approved and in circulation for use by the general public, without issue, then the new vaccines also are without issue.
This article is just fear-mongering by a university student.
Fairly standard (Score:4, Informative)
I just had a Shingrix vaccine last year. Two doses. Both times fever, headaches etc. Bad enough to call in sick.
Worth it to avoid painful neuralgia. In the case of Covid it's definite worth being able to function normally again without worrying about being infected.
The sceptics will soon change their minds when countries or airlines start requiring vaccinations.
Pointless (Score:2, Insightful)
Re:Pointless (Score:4, Informative)
Forty to sixty percent of people are already immune and the death rate is near zero.
Coronavirus immunity has been identified as short lived: https://www.medrxiv.org/conten... [medrxiv.org]
The daily death rate is trending up slightly and has been for the past several months. Even the initial spike saw a peak daily death rate only 30% higher than what we're getting now, which is to say people are dying in the thousands every day.
1119 people died yesterday from the virus in the country with the self proclaimed world's best health system. The statistics seem to indicate that this number is on the conservative side.
Even if you ignore the brain damage it can cause https://www.businessinsider.co... [businessinsider.com], or the ability to permanently damage the heart https://www.hopkinsmedicine.or... [hopkinsmedicine.org], or the lung damage that outlives the virus https://www.hopkinsmedicine.or... [hopkinsmedicine.org], simply ignoring the thousands that die daily is enough to make you a horrible person.
Re:Pointless (Score:4, Interesting)
Not immune, have T cells that can recognise the virus - that's a different thing. This may be where the asymptomatic cases are coming from. People get infected, are briefly infectious, and then the T cells clear up the infection without significant symptoms. These people can still spread the disease. A vaccine will prevent spread.
We've had months of a positive death anomaly. Of course that's going to be followed by a negative period - all of the vulnerable people who would have passed away peacefully surrounded by their families have suffered nasty deaths alone already.
So, another reason to extend lockdown? (Score:3)
First it was to flatten the curve, then until vaccine is developed, now it seems 'until we have vaccine with no side effects', let's see what new standard will there be once we have that, maybe until every single person is vaccinated, or until COVID-19 has been eliminated world-wide? And then another 70 years past that just to be sure?
A lot of constitutional rights have been blatantly violated and courts upheld the unconstitutional rulings 'because pandemic'. It seems maintaining the state of emergency is very desired by some.
But potentially great for high risk groups (Score:3)
TLDR: probably not for everyone, but a boon for many people in the high risk groups who can start living again.
Say the first vaccines do turn out to have really nasty side effects. Maybe it will not be a vaccine I should take as a generally healthy middle aged person, and maybe it would not be right to do mass vaccinations with those particular vaccines.
But for my friend in the high risk group who has had parts of his lungs removed, who needs to breathe extra oxygen for moderate physical activity, and who has been diagnosed with a terminal worsening lung condition which means he needs a transplant within the next ~5 years? And who is pretty much imprisoned at home despite our country Norway currently being in the low risk zone? Absolutely, I am 99.99% sure he would jump on this immediately, happily accepting a minor risk of nasty side effects, and being eager to spend a few tough days in bed in return for getting back into society.
If lots of people in high risk group make similar trade-offs and choose to take such a vaccine (assuming older people can also tolerate the side effects of taking the vaccine), this would also easily benefit society as a whole - as those are the people who will fill up emergency rooms and occupy ventilators.
A vaccine does not have to be perfect to be useful. Yes, we should hope for and work towards "the perfect vaccine" - and if the current emerging vaccines suffer from the effects summarized in the article, they do not sound not good enough for mass vaccinations. That does not mean they are "bad". Also, developing a few versions of less than optimal vaccines is probably a necessary step to figure out how to make a better one, kind of like the SpaceX fail fast philosophy. We should embrace such partial failure.
I see a lot of negative comments here about the vaccines based on the article - and I could easily have taken a step into the bubble as I hate the corrupt pharma industry as much as the next guy, as well as marketing departments putting extra shine and perfume on stuff which got turd on it. But at least there are some people out there trying to make a vaccine, which is more than we can say about most of us who are just sitting around couch surfing waiting for someone else to do the job.
Wait, we're supposed to believe some student... (Score:3)
...over the actual explanations from actual scientists and real doctors?
Dear slashdot and wired: this is why anti-vaxxers have so much power over the country: you give them a large audience they never deserved.
Yeah, side effects should be discussed, but not through inflammatory posts that are clearly already written by an anti-vaxxer, and a damn student at that, with no real credentials whatsoever.
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Two big reasons:
1. Back then there was no incentive to make a cold vaccine. The investment required was too high and so was the chance of failure. Think about it, people won't buy a lottery ticket unless the payoff is millions of times higher than the investment. Would you put a million dollars in something if there was a fairly high chance you'd lose it?
2. The common cold is caused by a hundred or more different strains of viruses, mainly rhinovirus strains -- more so than coronavirus. So would you make a
Re:Coronavirus vaccines are not going to happen (Score:4, Interesting)
There's also the minor point that a cold vaccine would not pass the risk/benefit test, because even infants have a very very low death rate from colds. Therefore the risk of severe side-effect from the vaccine outweighs the benefit of avoiding a cold.
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...it's just a matter of time before we develop broader spectrum or personalized vaccines, gene therapies, and antivirals that can protect the rich and powerful from multiple virus strains.
FTFY, since you obviously forgot about human greed that helps kill millions every year.
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By now I think we've spotted the antivaxer.
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By now I think we've spotted the antivaxer.
No, actually we've simply spotted the one who assumes. My arm has seen more shots than most travelers. I have no fear of them.
You should simply learn to respect and fear human greed. It's certainly more deadly than any vaccine, and history validates my correction far easier than your assumption.
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I'm getting a little tired of correcting this misunderstanding. The vast majority of colds are caused by strains of rhinovirus, not coronavirus. There are 160 different strains of rhinovirus that affect humans. If you wanted to vaccinate against them all, you would have to get 160 different vaccines. And give it a year, and there will be at least a few more. If you wanted to vaccinate against all the viruses that can cause colds, you
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Just to clarify, viral vaccines mostly involve weakened viruses that still at least to some degree behave like viruses. A few are inactivated, but still contain genetic material. I don't think you can do anything even approaching a pure polysaccharide vaccine with a virus, because it's either the genetic material or the cytokines produced by dying cells that your immune system reacts to, not the viral capsid itself, typically. That said, I could be wrong about that.
Also, I doubt an inactivated virus wil
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The inability to vaccinate against the common cold has absolutely nothing to do with it sometimes being caused by a coronavirus.
I'd say the inability to vaccinate against the common cold has more to do with stupid humans attacking that problem with 200 vaccines rather than accepting the fact that we must attack that problem in a completely different way.
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True. In some cases there might be certain surface structures that are conserved across multiple strains, in which case it might be possible to create vaccines that cut across a bunch of those strains. That said, my impression is that a least with the rhinovirus strains the capsids are wildly different, so although the optimal number might be considerably less than 200, my guess is that it probably wouldn't be anywhere close to a single-digit number.
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Well, I admit I had to do a Google search for the numbers, but no, that was pretty much off the top of my head.
Also there actually was a common cold vaccine many decades ago. At first glance, it appeared to not work, but when folks went back and analyzed the data, they found that it actually did work; it just only worked against the one strain that they vaccinated against (a rhinovirus strain, I think, but I can't find a reference for it right now, so I may be remembering wrong).
Re:Coronavirus vaccines are not going to happen (Score:4, Funny)
But someone is wrong on the Internet.