COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

speckle

There are many reasons more than nut allerygs to potentially have an epipen etc. Please consult beforehand with your medical professionals/specialists first... and have information, whether you are allowed to get it or not or even one of the other types later on.. so as not to waste time/resources and so that those giving it to you know your history.

foods – including nuts, milk, fish, shellfish, eggs and some fruits
medicines – including some antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin
insect stings – particularly wasp and bee stings
general anaesthetic
contrast agents – dyes used in some medical tests to help certain areas of your body show up better on scans
latex – a type of rubber found in some rubber gloves and condoms
(Not a full comprehensive list)

In some cases, there's no obvious trigger. This is known as idiopathic anaphylaxis.

Not all of the above may end up being contraindicated. ie not exclude you from making your choice.

Good luck and good health to all no matter were you fall on the spectrum.

funnydoggy

I just fear for the day that woman who got the first jab (outside of trials) dies. They'll blame it on the vaccine, despite her being at a very advanced age.

(not trivialising it)

joseywhales

Is nobody else concerned about the testing that was done during the trials?
I recently heard Fauci compare pfizer v astra zenca, where he opined , who would we give 70% efficacy vaccine v a 90% efficacy.

I was surprised by this, since he is an eminently intelligent man, he would know that in the astra zeneca trial they regularly swabbed participants for the virus, in the other trials they discouraged testing for mild symptoms because they said that the side effects may cause some mild symptoms and they left testing to the discretion of the participants' physician, who is by definition biased.

Now given that the majority of cases are asymptomatic, to compare 70%v 90% is nonsensical, they are completely different numbers.

We don't know which vaccine is more effective?

Am I missing something?

nommm

joseywhales wrote: »

Is nobody else concerned about the testing that was done during the trials?
I recently heard Fauci compare pfizer v astra zenca, where he opined , who would we give 70% efficacy vaccine v a 90% efficacy.

I was surprised by this, since he is an eminently intelligent man, he would know that in the astra zeneca trial they regularly swabbed participants for the virus, in the other trials they discouraged testing for mild symptoms because they said that the side effects may cause some mild symptoms and they left testing to the discretion of the participants' physician, who is by definition biased.

Now given that the majority of cases are asymptomatic, to compare 70%v 90% is nonsensical, they are completely different numbers.

We don't know which vaccine is more effective?

Am I missing something?

That narrative has gained a lot of popularity online but it is incorrect. Asymptomatic cases were not included in Oxfords 70% efficacy so he is right in what he is saying.
Details are in recent Lancet paper.

hmmm

joseywhales wrote: »

Now given that the majority of cases are asymptomatic, to compare 70%v 90% is nonsensical, they are completely different numbers.

Both of those numbers are percentages who caught the disease, Covid-19. It's an Apples for Apples comparison.

Astra Zeneca were doing a separate study for evidence of the virus (2019-nCoV). You're correct Pfizer weren't doing this. These Astra Zeneca numbers haven't been released (I think).

Hmmzis

hmmm wrote: »

Both of those are for numbers who caught the disease, Covid. It's an Apples for Apples comparison.

Astra Zeneca were doing a separate study for evidence of the virus. You're correct Pfizer weren't doing this. These Astra Zeneca numbers haven't been released (I think).

The asymptomatic infection results are in table 2 of the published paper. The point estimate is 58.9% for the LD/SD group but the CI is very wide. For the SD/SD group there is no difference in the positive swabs.

tom1ie

seamus wrote: »

Obviously we cannot know if anything will appear within 12/24/48 months for this particular vaccine, but that's not to say we've never done anything like this before. Long-term effects can also be extrapolated from the short-term data and outcomes from similar vaccines.

Most drugs do not have a long-term "testing" element. The long-term portion is the bit where it's approved for general use and the outcomes are monitored.

This is not known. It requires a specific kind of test where people are vaccinated and then deliberately infected to determine what happens next. It's ethically fraught.

Strictly speaking vaccination doesn't prevent an pathogen from getting into your body, it just trains your body kill it when it does.

The question is about how far the virus gets before being eliminated by the immune system. We know that it reduces the severity of any infection, which by implication suggests that it limits the propagation of the virus within the body.
One can then deduce that if someone's viral load is lower, their infectiousness is also lower.

But that's supposition and cannot be known.

If they're classed as immunocompromised, then vaccination is not advised. Other family members should still get vaccinated as this will still limit the compromised person's risk of exposure.

Anyone who had never taken a vaccine before is not going to take this one, that's kind of a given.

It is so unlikely that it's basically impossible that someone could get to adulthood and be unaware of a severe allergy to the ingredients. They will have received multiple vaccinations as a child, but will also have been exposed to them through food or the environment.

If someone *can't* get the vaccine, then their employer can't do anything about it. If vaccination is important to their work, then they will be prioritised.

Thanks very informative.
However I see a major problem here.
If myself and my wife get vaccinated we could still become infected with the virus (but not know it) and spread that to our kids who won’t be getting the virus (one of which has a low white blood cell count).

So if we get the vaccine pressure mounts on the government to get rid of restrictions.

At least 25% of the population won’t be getting the vaccine (that’s the population of kids in Ireland under 16).

So adding this 25% to the people who are immune compromised and the people who won’t get it, that could mean 40% of the population not vaccinated.

When restrictions lift that means the virus can spread via people that are vaccinated (approx 60%) to people who aren’t.
The people who aren’t vaccinated being kids and immune compromised, and to a lesser extent the people who don’t wanna get it.

So do we have to keep restrictions eve n with this vaccine or am I way off the mark here?

tom1ie

polesheep wrote: »

If 20% don't take it, it will be spun as 80% taking it. A fantastic uptake that, if replicated across society, would be a resounding success.

It can’t be though.
25% of the population are under 16 which can’t take the vaccine. That doesn’t include immuno compromised people and people that just won’t take it.

Leftwaffe

Wait until mass vaccinations occur. If you observe a group of say 1 million people for a set period of time, naturally enough you’re bound to get some freak deaths, like people dropping dead, dying in their sleep, etc.

Now vaccinate a million people and observe the results, you’re bound to get these same types of deaths yet they’ll be attributed to the vaccine somehow. If someone dies say within 24 hours of getting the shot it will make headlines.

Fear sells.

tom1ie

Stheno wrote: »

Same here, had to fill out a pre screening form and wait for 15 minutes after the injection in case of a reaction

Yep me too.
Media not really helping by not explaining the allergy thing being fairly normal.

dublinman1990

I heard the news about the allergic reactions from the Pfizer vaccine a short time ago.

This is bad news for me because I have had an allergy to nuts as I have had eczema since birth. I also get hayfever in the summer time as well. I get allergies from wearing non-powdered latex gloves. I'm also allergic to minocycline oral tablets which are used to treat acne. This could mean that my GP could say to me that I'm not allowed to receive this vaccine at all because that instruction could apply to people who have allergies of any kind including food & other allergies from medicine. I don't like the idea of fearing through an ordeal of getting a potential anaphylactic shock in my own body from the Pfizer vaccine whatsoever. I rather just wait it out a little bit longer until I get word of either a safe Oxford, Moderna or Johnson & Johnson Covid vaccine becomes available from the GP instead.

I do take the seasonal flu vaccine once a year & the pneumonia vaccine every few years. The only problem that I get from them is a sore arm.

expectationlost

Irish Stones wrote: »

OK, but what if one has no known history because simply they have never taken a vaccine before?
One could be allergic and still not know that.

find me a person (in Ireland) who hasn't taken a vaccine before _and_ also is not aware that they maybe allergic or immune-compromised?

expectationlost

dublinman1990 wrote: »

I heard the news about the allergic reactions from the Pfizer vaccine a short time ago.

This is bad news for me because I have had an allergy to nuts as I have had eczema since birth. I also get hayfever in the summer time as well. I get allergies from wearing non-powdered latex gloves. I'm also allergic to minocycline oral tablets which are used to treat acne. This could mean that my GP could say to me that I'm not allowed to receive this vaccine at all because that instruction could apply to people who have allergies of any kind including food & other allergies from medicine. I don't like the idea of fearing through an ordeal of getting a potential anaphylactic shock in my own body from the Pfizer vaccine whatsoever. I rather just wait it out a little bit longer until I get word of either a safe Oxford, Moderna or Johnson & Johnson Covid vaccine becomes available from the GP instead.

I do take the seasonal flu vaccine once a year & the pneumonia vaccine every few years. The only problem that I get from them is a sore arm.

you don't think all those other vaccines don't have the same warnings?

stephenjmcd

dublinman1990 wrote: »

I heard the news about the allergic reactions from the Pfizer vaccine a short time ago.

This is bad news for me because I have had an allergy to nuts as I have had eczema since birth. I also get hayfever in the summer time as well. I get allergies from wearing non-powdered latex gloves. I'm also allergic to minocycline oral tablets which are used to treat acne. This could mean that my GP could say to me that I'm not allowed to receive this vaccine at all because that instruction could apply to people who have allergies of any kind including food & other allergies from medicine. I don't like the idea of fearing through an ordeal of getting a potential anaphylactic shock in my own body from the Pfizer vaccine whatsoever. I rather just wait it out a little bit longer until I get word of either a safe Oxford, Moderna or Johnson & Johnson Covid vaccine becomes available from the GP instead.

I do take the seasonal flu vaccine once a year & the pneumonia vaccine every few years. The only problem that I get from them is a sore arm.

The other vaccines you've mentioned all come with the same warnings. Your asked the same questions for allergies in terms of food and past vaccines.

No offence but you wont get the option of picking which vaccine is for you. If a clinical decsion is made that this is the one for you then you've 2 options get it or don't.

schmoo2k

yosemitesam1 wrote: »

The trials can't answer how much of an impact on hospitalisations or deaths the vaccine will make. Severe covid is far too rare for them to be able to do that.
We are hoping that it will make a substantial impact and we are also hoping it will be possible for it to reduce the circulation of the virus

Their trials did answer that very question.

scooby77

Business media, including FT, reporting Johnson & Johnson cutting number of participants in USA trial from 60,000 to 40,000 due to prevalence of Covid there. Single dose vaccine.Expecting results end January, need 154 infections. Hoping apply FDA emergency approval February.

tom1ie

tom1ie wrote: »

Thanks very informative.
However I see a major problem here.
If myself and my wife get vaccinated we could still become infected with the virus (but not know it) and spread that to our kids who won’t be getting the virus (one of which has a low white blood cell count).

So if we get the vaccine pressure mounts on the government to get rid of restrictions.

At least 25% of the population won’t be getting the vaccine (that’s the population of kids in Ireland under 16).

So adding this 25% to the people who are immune compromised and the people who won’t get it, that could mean 40% of the population not vaccinated.

When restrictions lift that means the virus can spread via people that are vaccinated (approx 60%) to people who aren’t.
The people who aren’t vaccinated being kids and immune compromised, and to a lesser extent the people who don’t wanna get it.

So do we have to keep restrictions eve n with this vaccine or am I way off the mark here?

Anyone care to take a bash at this?

Water John

Listening the Dr. Fauci, he was saying it would be mid summer before the vaccination programme would have a significant effect on the Covid numbers. So masks and social distancing I presume until then makes sense.
He said main roll out would be April. Also 30% vaccinated would have some effect but the 70% would be md summer.

Hmmzis

tom1ie wrote: »

Anyone care to take a bash at this?

The only data points we have about infection prevention is from the Oxford trial in the UK. Even the full/full dosage gets some small benefit to resucing infections outright, while the half/full looks much better at it. The confidence inteevals are huge, so more data is needed to tell for sure how big that effect is, but it's unlikely to be zero. There is no reason to think that the other vaccines would perform any worse in this regard while having greater efficacy on disease prevention.

Btw. A lot of immune compromised people can be vaccinated just fine, they can't take live virus vaccines that are replication competent. None of the current approved ones and candidates are of that type.

marno21

Water John wrote: »

Listening the Dr. Fauci, he was saying it would be mid summer before the vaccination programme would have a significant effect on the Covid numbers. So masks and social distancing I presume until then makes sense.
He said main roll out would be April. Also 30% vaccinated would have some effect but the 70% would be md summer.

Fauci has been very conservative to date. Plus the U.S. is a completely different ball game - they're not taking it as seriously as us to begin with.

IMO, when Ireland gets back to normal depends on how the Oxford/AstraZeneca and J&J trials go. If we have both of these by the end of February, with minimal logistics and single dose in the case of J&J, there's no reason why John Doe can't ring his doctor and book a vaccination appointment should he want to. If enough people do this in March/April, we'll have an immune herd in no time. Plus by then the vulnerable will be vaccinated in droves.

larchielads

If other vaccines are available later in the year can we pick which vaccine to take??

Irish Stones

expectationlost wrote: »

find me a person (in Ireland) who hasn't take a vaccine before _and_ also is not aware that they maybe allergic or immune-compromised?

I don't know if such a person exists, we will never know.
Anyway, allergies may develop later in life. Today I'm fine, in ten years I might get allergic to nuts, aspirine, or something else, and I won't know that until I try.

brisan

larchielads wrote: »

If other vaccines are available later in the year can we pick which vaccine to take??

That maybe a decision best left to a healthcare professional

CIARAN_BOYLE

larchielads wrote: »

If other vaccines are available later in the year can we pick which vaccine to take??

Most likely medical professionals might make the decision as to which vaccine is most suitable. If there is no suitability difference you will most likely be given whatever's available.

There may be lower efficacy vaccines that are offered to people lower on the priority list before people higher up the list are offered a vaccine.

seamus

Water John wrote: »

Listening the Dr. Fauci, he was saying it would be mid summer before the vaccination programme would have a significant effect on the Covid numbers. So masks and social distancing I presume until then makes sense.
He said main roll out would be April. Also 30% vaccinated would have some effect but the 70% would be md summer.

We definitely can't use commentary from the states to inform us on what will happen in Ireland or even the EU.

While the US is planning to provide the vaccine for free, there will definitely be large corporate interests who will purchase supplies of the vaccine and will provide it through private health insurance or otherwise for profit.

This will allow people to jump the list and will hamper the general vaccination programme.

The US healthcare system is also not at all primed for a large free vaccine rollout. Socialised system like in Europe are well rehearsed and well prepared for mass public health programmes, we do them year in and year out. But these are rarer in the US. The government will be heavily reliant on military personnel and private hospitals, which will take time to ramp up so delay proper implementation.

And that's before you get to the enclaves of "muh freedoms" lunatics who might blockade any vaccine programmes arriving into their town.

This is probably why Fauci is thinking April before the programme is in full swing. Whereas Europe is ready to go today.

brisan

CIARAN_BOYLE wrote: »

Most likely medical professionals might make the decision as to which vaccine is most suitable. If there is no suitability difference you will most likely be given whatever's available.

There may be lower efficacy vaccines that are offered to people lower on the priority list before people higher up the list are offered a vaccine.

On that point
Assuming you are low risk and a given a 70% effective vaccine because they are on plentiful supply and 95% vaccines are being kept for higher risks groups .
Could you in the future get the 95% vaccine when the pressure comes off the system

Hmmzis

brisan wrote: »

On that point
Assuming you are low risk and a given a 70% effective vaccine because they are on plentiful supply and 95% vaccines are being kept for higher risks groups .
Could you in the future get the 95% vaccine when the pressure comes off the system

Most likely, yes. Mix n' match of vaccines has been done before, even with flu shots.

funnydoggy

Dad is allergic to penicillin (anaphylactic shock) and he's unaware of the last time he's had a vaccine. This is scaring him now which is annoying as all he needs to do is listen to his doctor but he's listening to facebook fearmongers.

Deenie78

funnydoggy wrote: »

Dad is allergic to penicillin (anaphylactic shock) and he's unaware of the last time he's had a vaccine. This is scaring him now which is annoying as all he needs to do is listen to his doctor but he's listening to facebook fearmongers.

I hear you, my dad's allergic to penicillin too but it's my sister who's raising the question (he'll do whatever the doctor tells him). I've had to remind her that he gets the flu vaccine every year and that vaccines always come with a word of warning. As others have previously posted, all medicines and treatments come with warnings and most don't read or pass any heed on them but any little thing with this vaccine is going to cause hesitation and fear.
Hopefully your Dad's concerns will be put to rest as things move along.

CIARAN_BOYLE

brisan wrote: »

On that point
Assuming you are low risk and a given a 70% effective vaccine because they are on plentiful supply and 95% vaccines are being kept for higher risks groups .
Could you in the future get the 95% vaccine when the pressure comes off the system

Not really sure. My uneducated opinion would be not to take a second vaccine for a period of at least a few months after the first one.

timsey tiger

Any updates on the EMA approval process? I think that they are appearing before some committee today, but I can't recall the detail (didn't hear it from an Irish jurno that's for sure).

I looked for info on RTE, but that was fruitless. They are running around like headless chickens about two people who are actually fine now, ffs.

I really don't understand all the panic about two people who apparently are allergic to practically everything having a turn after getting the vaccine. We have loads of people to be vaccinated, before worring about people with hypersensitivity or are immunocompromised.

schmoo2k

brisan wrote: »

On that point
Assuming you are low risk and a given a 70% effective vaccine because they are on plentiful supply and 95% vaccines are being kept for higher risks groups .
Could you in the future get the 95% vaccine when the pressure comes off the system

No point - your in a low risk group to start with and by the time you get your vaccine we will be approaching herd immunity.

Also even at 70% efficacy if you did get Covid you would still have reduced symptoms.

stephenjmcd

timsey tiger wrote: »

Any updates on the EMA approval process? I think that they are appearing before some committee today, but I can't recall the detail (didn't hear it from an Irish jurno that's for sure).

I looked for info on RTE, but that was fruitless. They are running around like headless chickens about two people who are actually fine now, ffs.

I really don't understand all the panic about two people who apparently are allergic to practically everything having a turn after getting the vaccine. We have loads of people to be vaccinated, before worring about people with hypersensitivity or are immunocompromised.

That would be the Independent body to the FDA meeting today. Its a public session, will literally do a deep dive into the data and then they'll make a recommendation to the FDA

https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-could-get-fda-committee-nod-n1250537

stephenjmcd

Moderna has begun trials in the age 12-18 group.

"Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," - Chief Executive Officer Stéphane Bancel.

timsey tiger

stephenjmcd wrote: »

That would be the Independent body to the FDA meeting today. Its a public session, will literally do a deep dive into the data and then they'll make a recommendation to the FDA

https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-could-get-fda-committee-nod-n1250537

That is the FDA, I was asking about the EMA, which for obvious reasons should be more interesting to us, though you wouldn't know it from RTE, IT etc.

I got the day wrong, it is tomorrow.

stephenjmcd

timsey tiger wrote: »

That is the FDA, I was asking about the EMA, which for obvious reasons should be more interesting to us, though you wouldn't know it from RTE, IT etc.

I got the day wrong, it is tomorrow.

Yes but there won't be an update per say on the approval process for Pfizer & BioNTech tomorrow or technical details. This is more of a laying out the process to the public how the approval process works, what they look for etc.

Your original question sounded alot more like what the FDA was doing today.

Anyway fingers crossed we should hear something on approval from the EMA in around 2 weeks.

iamwhoiam

funnydoggy wrote: »

Dad is allergic to penicillin (anaphylactic shock) and he's unaware of the last time he's had a vaccine. This is scaring him now which is annoying as all he needs to do is listen to his doctor but he's listening to facebook fearmongers.

I have had an anaphylactic shock to a certain medication ,. I had the flu vaccine four times now .I bring two anapens and make the pharmacist aware .I will take this vaccine too( unless they wont give it to me ) and will have no problem doing so . I will bring four anapens this time and take the risk

expectationlost

Irish Stones wrote: »

I don't know if such a person exists, we will never know.
Anyway, allergies may develop later in life. Today I'm fine, in ten years I might get allergic to nuts, aspirine, or something else, and I won't know that until I try.

presumably they would have had a vaccine then?

Water John

seamus wrote: »

We definitely can't use commentary from the states to inform us on what will happen in Ireland or even the EU.

While the US is planning to provide the vaccine for free, there will definitely be large corporate interests who will purchase supplies of the vaccine and will provide it through private health insurance or otherwise for profit.

This will allow people to jump the list and will hamper the general vaccination programme.

The US healthcare system is also not at all primed for a large free vaccine rollout. Socialised system like in Europe are well rehearsed and well prepared for mass public health programmes, we do them year in and year out. But these are rarer in the US. The government will be heavily reliant on military personnel and private hospitals, which will take time to ramp up so delay proper implementation.

And that's before you get to the enclaves of "muh freedoms" lunatics who might blockade any vaccine programmes arriving into their town.

This is probably why Fauci is thinking April before the programme is in full swing. Whereas Europe is ready to go today.

Missing the point, maybe I wasn't that clear. The main rollout to the rest of the general public after the risk groups are vaccinated is what I'm referring to.
It will be midsummer before all will be vaccinated.

ACitizenErased

Not sure if anyone posted this but:

The European Medicines Agency has suffered a major cyber attack. Pfizer/BioNTech vaccine documents were accessed but the EMA says that the timelines remain the same.

Micky 32

“Data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates is "very robust", according to its executive director.”


"We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy," Emer Cooke said at a European Parliament committee meeting.“

“The agency is expected to complete reviews by 29 December for the Pfizer/BioNTech vaccine and 12 January for the Moderna vaccine at the latest.”

"We cannot guarantee there will be a positive outcome," Ms Cooke said.“

GeorgeBailey

Micky 32 wrote: »

“Data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates is "very robust", according to its executive director.”


"We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy," Emer Cooke said at a European Parliament committee meeting.“

“The agency is expected to complete reviews by 29 December for the Pfizer/BioNTech vaccine and 12 January for the Moderna vaccine at the latest.”

"We cannot guarantee there will be a positive outcome," Ms Cooke said.“

Equals a headline of "EMA Approval Now In Doubt"

hmmm

Pfizer peer reviewed data now out.
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

100% effectiveness in the over 75s Albeit with a small sample of about 1500 in total - 5 Covid cases in the Placebo group.

Micky 32

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

I’d say very unlikely that it won’t be approved.

stephenjmcd

Micky 32 wrote: »

I’d say very unlikely that it won’t be approved.

Oh absolutely, however it just can't be seen to be open and closed with them going into the review with a pre judged outcome

is_that_so

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

That's just an EMA version of a CMO statement!

daydorunrun

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

Micky 32 wrote: »

I’d say very unlikely that it won’t be approved.

I think George is referring to what headlines our National media will conjure up for a few clicks.

GeorgeBailey

daydorunrun wrote: »

I think George is referring to what headlines our National media will conjure up for a few clicks.

Exactly that

seamus

EMA has the right idea tbh. They know the pressure to approve is enormous. No end of public and private interests who want them to just push it through without proper review.

So they give a date that's way out there to avoid having to deliver an approval before they're good and ready.

If they go all the way to 29th December, I'll eat my hat.

stephenjmcd

seamus wrote: »

EMA has the right idea tbh. They know the pressure to approve is enormous. No end of public and private interests who want them to just push it through without proper review.

So they give a date that's way out there to avoid having to deliver an approval before they're good and ready.

If they go all the way to 29th December, I'll eat my hat.

Likewise. I'd be surprised if we didn't hear next week or early Christmas week, 21st /22nd, they'll go shortly after FDA is my guess.

Moderna to follow first week or new year I'd say