> As is common with new vaccines the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination, after two people with a history of significant allergic reactions responded adversely yesterday,
> They are understood to have had an anaphylactoid reaction, which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure. This is not the same as anaphylaxis which can be fatal.
Anaphylactoid reactions can kill you just as well as anaphylaxis.
"Anaphylactoid reactions are defined as those reactions that produce the same clinical picture with anaphylaxis but are not IgE mediated, occur through a direct nonimmune-mediated release of mediators from mast cells and/or basophils or result from direct complement activation"
Good bet that it's treatable with just antihistamines, going by my experience with systemic (non-anaphylactic) food allergy reactions, which display similar symptoms.
The Pfizer vaccine - and the Moderna one - both use a polyethylene glycol (PEG) copolymer in them as a nanocarrier. PEG in injections is a known allergen, and these very serious effects are known. Whether or not it showed up in the trials is irrelevant, it didn't have to.
Note that the Pfizer trial at least (and IIRC Moderna as well) excluded people with a history of severe allergies. Which IMO makes sense: why put those people at risk of a relatively common complication when you don't even know yet if the vaccine is effective? Testing for allergy safety in that small population is something you can do later.
How hard would it be to mass test people if they are allergic?
Because current polls show you probably won't reach heard immunity with voluntarily vaccination. But can you do mandatory vaccination, when you know some people may face serious problems?
Those two people seem to recover, but who knows with other people?
I'm very interested to see how this sort of situation will align with the increasing number of countries/airlines/music venues/hotels/theme parks that are stating they will only admit people who have been vaccinated.
It will probably take careful legislation to prevent those who can't be vaccinated from being relegated to second class citizens alongside those who won't get vaccinated. At the end of the day both groups still pose an infection risk.
My expectation is that most businesses will have some official policy of "you must be vaccinated to enter" but they won't actually enforce it. This decreases their liability on both sides (Don't want to be seen inviting outbreaks, but don't want to deal with HIPAA / privacy laws).
I was surprised to learn that the US already has a list of required vaccines for legal immigration[1]. I think its very likely the Covid-19 vaccine makes the list, considering even the flu vaccine is required.
Many countries already mandate some vaccinations before permitting entry (yellow fever comes to mind). Which requires a certificate as proof. I don't know how those countries handle people who can't get vaccinated, but I suspect that there are lessons to be learnt there.
In theory, people who can’t be vaccinated and people who can buy choose not to be will both need to be excluded from large crowds until the virus is no longer a significant risk factor.
In practice, given all that has happened since the last election, I expect the current UK government solution to show all the skill of a bored teenager mimicking Jackson Pollock in a school art class.
This is highly unlikely. These companies need the income. The last thing they'd want to do is add on further restrictions to their struggling industries.
>they will only admit people who have been vaccinated
Is any country issuing a proof of vaccination document? If they don't have a system already in place to issue these, I think it's unlikely they will be able to roll it out at this point.
Basically, I'll believe it when I see it. To me it seems like a very hard thing to enforce and implement. I suspect the companies are more interested in "security theater" to facilitate normal business operations as soon as possible than actually excluding people who haven't been vaccinated.
I think the problem is this is not government controlled, but will be individually implemented by each private org. Without central administration, they're likely to rely on the vaccination card they give patients to track when their next shot/brand of shot will be. If you're excluded for valid medical reasons, you might not get a card... but as of now, an exclusion card doesn't seem to exist.
Most healthy young people won't be vaccinated in the long run, I suspect. Those most at risk, the health workers and those who are most likely to spread it will get it, but everyone else will be kind of optional.
That companies are advocating for "passports" is more than likely an expression against anti vaccination sentiments and a desire to open for business whatever the costs.
Those claims are bullshit.
The people most likely to travel are last in line to receive the vaccine and supply is limited so you cannot just go to your GP and get the shots.
> Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.
I would doubt that inject into people with known allergies will ever pass the ethics committee. It sounds like `let's do a thing that is known harmful to people in experiment`. Should a normal people allow that experiment to proceed?
This is why it's so critical that multiple vaccines were and are being developed. So that whatever subset of people can't get vaccine X, well they can get vaccine Y and Z. And hopefully, this means everyone has at least one vaccine they can take.
It also highlights the need for everyone to get vaccinated as quickly as possible. Don't procrastinate when the opportunity arises, because there are people around you who can't be vaccinated or can't be vaccinated with vaccines available to them. You being vaccinated cuts off one more path the virus can take to them.
I have one question regarding the current Pfizer data (it would be great if anyone with experience in statistics could help out):
UK healthcare professionals received this information called "REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS" [1]
It states that the "efficacy of COVID-19 mRNA Vaccine BNT162b2 [for 75 years of age and older] was [...] 100% (two-sided 95% confidence interval of -13.1% to 100.0%)"
What does this mean? With my very minimal university statistics knowledge I would say that they are 95% sure that the efficacy lies between -13.1% and 100.0% for age >=75. And that means: We simply do not know (probably due to lack of data in this cohort). Where am I making an error?
You being vaccinated only cuts off the path that the virus can take to somebody if the vaccine gives you sterilising immunity - otherwise, it may just prevent you experiencing disease symptoms, but not stop you being infectious.
There isn't enough evidence yet to understand whether the leading vaccines induce sterilising immunity yet. As such, we can't rely on these vaccines to give us herd immunity.
No thanks, the pre alpha test can do other people. On top of it you still have to wear the mask it doesn't stop you spreading the virus. It just reduces the severity for the people vaccinated.
> It also highlights the need for everyone to get vaccinated as quickly as possible. Don't procrastinate when the opportunity arises, because there are people around you who can't be vaccinated or can't be vaccinated with vaccines available to them. You being vaccinated cuts off one more path the virus can take to them.
I would consider this faulty logic. I'm going to avoid taking a coronavirus vaccine until we have some actual data on the effects. Why would you rush to risk unknown consequences to your own health, and thus your ability to care for your loved ones if they get sick?
Any time i have gotten the flu shot they ask all sorts of questions about allegeries, and even though i answer no to all of them, they still make me sit there for 15 minutes after "just in case".
Yes, it's non news dressed up as news because it feeds into fear. Ideally people would read the story, come to the same logical conclusion you did, and disregard if they aren't in the small group of people who know they have this issue.
Expect similar scary headlines when news outlets realize that they're not recommending it for pregnant or nursing mothers or children (because they haven't had chance to study the effects and effectiveness).
It makes complete sense to exclude people with severe allergies from the trials if you believe severe allergies are likely to affect the health and safety of the vaccine. This is fairly common for vaccines. It's not cutting corners either. If you expect severe allergies to adversely affect outcomes, you don't gain anything from having them in your general trial population, because unless you make sure your data gather and trial protocols are designed to test for the difference, you're unlikely to be able to form a robust opinion on the safety of the drug for allergy sensitive people, but are highly likely to taint your understanding of how it affects "normal" people. (that is, you could probably observe risk fairly easily, but you wouldn't be sure to confirm its safe for them if nothing showed up)
There might be something about being conservative to avoid what happened to these people without notice, but in the scheme of things its a pretty small pain point.
1 in 1,000 people in the UK have died after contracting COVID (this number is rising).
2 people out of thousands vaccinated yesterday had an allergic reaction that they recovered from (both people carry EpiPens and have a history of allergic reactions).
Monitoring systems mean we know about this, so bottom line is everything is going well so far. We will obviously want to continue to monitor.
1 in 1000 deaths is of the entire U.K. population, not just of those who have contracted the virus. The death rate is roughly 1 in 28 for those who caught it.
> We know from the very extensive clinical trials that this wasn't a feature...
Not a feature, no kidding!?! The latter portion of that read like something for devs to understand...I had never heard of language like that in the medical/pharma world...then again, I've been removed from that industry for almost 14 years now. My dark sense of humor wants to really laugh at this, if it didn't deal with such somber subject matter.
It's really hard to tell from the wording of all of this what exactly this applies to. It talks about medicine and food allergies, but also says those who carry an an adrenaline autoinjector. Does that mean those that carry the adrenaline autoinjector for medicine and food allergies? Or anyone who carries one AT ALL? For example, someone who has one for bee stings - should they avoid the vaccine?
Moreover my sister reacted badly to one specific vaccine... Should she skip this based on that or assume it's fine based on the lack of reaction to most vaccines.
This is dangerous guidance because it ignores the risk of COVID. Both of these people turned out fine, so if anything this seems like an endorsement of this vaccine for people with severe allergies. There is no guarantee any of the vaccines won't have issues. Its much better to say: "If you commonly get allergic reactions to medicines, you might get one here. Use your judgement or speak to your doctor about the risks of remaining unvaccinated versus taking this particular vaccine."
Let people make their own risk decisions. Banning the vaccine is how we got into this mess to begin with.
[+] [-] m-i-l|5 years ago|reply
[0] https://www.bbc.co.uk/news/health-55244122
[+] [-] rsynnott|5 years ago|reply
> As is common with new vaccines the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination, after two people with a history of significant allergic reactions responded adversely yesterday,
It's kind of understated, tho
[+] [-] rubatuga|5 years ago|reply
[+] [-] mcintyre1994|5 years ago|reply
From the BBC article: https://www.bbc.co.uk/news/health-55244122
As someone who carries an epi-pen after experiencing anaphylaxis that distinction makes a big difference to what we're talking about here.
[+] [-] Panoramix|5 years ago|reply
"Anaphylactoid reactions are defined as those reactions that produce the same clinical picture with anaphylaxis but are not IgE mediated, occur through a direct nonimmune-mediated release of mediators from mast cells and/or basophils or result from direct complement activation"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209676/
[+] [-] TillE|5 years ago|reply
[+] [-] hammock|5 years ago|reply
[+] [-] petertodd|5 years ago|reply
[+] [-] hutzlibu|5 years ago|reply
Because current polls show you probably won't reach heard immunity with voluntarily vaccination. But can you do mandatory vaccination, when you know some people may face serious problems?
Those two people seem to recover, but who knows with other people?
[+] [-] Bombthecat|5 years ago|reply
[+] [-] bb123|5 years ago|reply
It will probably take careful legislation to prevent those who can't be vaccinated from being relegated to second class citizens alongside those who won't get vaccinated. At the end of the day both groups still pose an infection risk.
[+] [-] dahfizz|5 years ago|reply
My expectation is that most businesses will have some official policy of "you must be vaccinated to enter" but they won't actually enforce it. This decreases their liability on both sides (Don't want to be seen inviting outbreaks, but don't want to deal with HIPAA / privacy laws).
I was surprised to learn that the US already has a list of required vaccines for legal immigration[1]. I think its very likely the Covid-19 vaccine makes the list, considering even the flu vaccine is required.
[1] https://www.uscis.gov/policy-manual/volume-8-part-b-chapter-...
[+] [-] elric|5 years ago|reply
[+] [-] ben_w|5 years ago|reply
In practice, given all that has happened since the last election, I expect the current UK government solution to show all the skill of a bored teenager mimicking Jackson Pollock in a school art class.
[+] [-] rcstank|5 years ago|reply
[+] [-] 99_00|5 years ago|reply
Is any country issuing a proof of vaccination document? If they don't have a system already in place to issue these, I think it's unlikely they will be able to roll it out at this point.
Basically, I'll believe it when I see it. To me it seems like a very hard thing to enforce and implement. I suspect the companies are more interested in "security theater" to facilitate normal business operations as soon as possible than actually excluding people who haven't been vaccinated.
[+] [-] swalsh|5 years ago|reply
[+] [-] thinkingemote|5 years ago|reply
That companies are advocating for "passports" is more than likely an expression against anti vaccination sentiments and a desire to open for business whatever the costs.
[+] [-] vmception|5 years ago|reply
[+] [-] bt1a|5 years ago|reply
Also, you raise an interesting dichotomy between those who can't VS those who won't that I hadn't considered.
[+] [-] ichbinwiederda|5 years ago|reply
[+] [-] f311a|5 years ago|reply
[+] [-] noja|5 years ago|reply
[+] [-] OscarCunningham|5 years ago|reply
[+] [-] unknown|5 years ago|reply
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[+] [-] mmis1000|5 years ago|reply
[+] [-] unknown|5 years ago|reply
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[+] [-] mabbo|5 years ago|reply
It also highlights the need for everyone to get vaccinated as quickly as possible. Don't procrastinate when the opportunity arises, because there are people around you who can't be vaccinated or can't be vaccinated with vaccines available to them. You being vaccinated cuts off one more path the virus can take to them.
[+] [-] pepperberg|5 years ago|reply
UK healthcare professionals received this information called "REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS" [1] It states that the "efficacy of COVID-19 mRNA Vaccine BNT162b2 [for 75 years of age and older] was [...] 100% (two-sided 95% confidence interval of -13.1% to 100.0%)"
What does this mean? With my very minimal university statistics knowledge I would say that they are 95% sure that the efficacy lies between -13.1% and 100.0% for age >=75. And that means: We simply do not know (probably due to lack of data in this cohort). Where am I making an error?
Thank you in advance!
[1] https://assets.publishing.service.gov.uk/government/uploads/...
[+] [-] ultrafez|5 years ago|reply
There isn't enough evidence yet to understand whether the leading vaccines induce sterilising immunity yet. As such, we can't rely on these vaccines to give us herd immunity.
[+] [-] _up|5 years ago|reply
[+] [-] silicon2401|5 years ago|reply
I would consider this faulty logic. I'm going to avoid taking a coronavirus vaccine until we have some actual data on the effects. Why would you rush to risk unknown consequences to your own health, and thus your ability to care for your loved ones if they get sick?
[+] [-] bawolff|5 years ago|reply
Any time i have gotten the flu shot they ask all sorts of questions about allegeries, and even though i answer no to all of them, they still make me sit there for 15 minutes after "just in case".
[+] [-] Exmoor|5 years ago|reply
Expect similar scary headlines when news outlets realize that they're not recommending it for pregnant or nursing mothers or children (because they haven't had chance to study the effects and effectiveness).
[+] [-] klmadfejno|5 years ago|reply
There might be something about being conservative to avoid what happened to these people without notice, but in the scheme of things its a pretty small pain point.
[+] [-] scraft|5 years ago|reply
2 people out of thousands vaccinated yesterday had an allergic reaction that they recovered from (both people carry EpiPens and have a history of allergic reactions).
Monitoring systems mean we know about this, so bottom line is everything is going well so far. We will obviously want to continue to monitor.
[+] [-] ben_w|5 years ago|reply
https://en.wikipedia.org/wiki/Template:COVID-19_pandemic_dat...
Which uses as a reference:
* https://coronavirus.data.gov.uk/details/cases
* https://coronavirus.data.gov.uk/details/deaths
[+] [-] burnthrow|5 years ago|reply
[+] [-] mxuribe|5 years ago|reply
Not a feature, no kidding!?! The latter portion of that read like something for devs to understand...I had never heard of language like that in the medical/pharma world...then again, I've been removed from that industry for almost 14 years now. My dark sense of humor wants to really laugh at this, if it didn't deal with such somber subject matter.
[+] [-] joekrill|5 years ago|reply
[+] [-] gpm|5 years ago|reply
The guidance here is really lacking.
[+] [-] mchusma|5 years ago|reply
Let people make their own risk decisions. Banning the vaccine is how we got into this mess to begin with.
[+] [-] unknown|5 years ago|reply
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[+] [-] fred_is_fred|5 years ago|reply
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[+] [-] neals|5 years ago|reply