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

First fly in the ointment.... to be expected due to not completing thorough testing.

https://www.theguardian.com/world/2020/dec/09/pfizer-covid-vaccine-nhs-extreme-allergy-sufferers-regulators-reaction?CMP=Share_iOSApp_Other

funnydoggy

lawrencesummers wrote: »

First fly in the ointment.... to be expected due to not completing thorough testing.

https://www.theguardian.com/world/2020/dec/09/pfizer-covid-vaccine-nhs-extreme-allergy-sufferers-regulators-reaction?CMP=Share_iOSApp_Other

EVERY vaccine carries this warning. Nothing at all got to do with testing.

Irish Stones wrote: »

Is it right to say that during the trials with the volunteers, no allergic reactions were observed?
If so, why are they showing up now when the vaccine is going to be approved?
And, will these reactions put the EU approval on hold?

Is it possible that the trials were only conducted with healthy people and nobody with allergies was included?

ACitizenErased

Irish Stones wrote: »

Is it right to say that during the trials with the volunteers, no allergic reactions were observed?
If so, why are they showing up now when the vaccine is going to be approved?
And, will these reactions put the EU approval on hold?

why would you enter a vaccine trial with previous allergic reactions?

There's 1 of 2 (or even both) things happening here:
1) The 2 NHS nurses are idiots who 'forgot' they've had reactions before
2) The NHS are idiots who didn't ask about allergic reactions.

funnydoggy wrote: »

EVERY vaccine carries this warning. Nothing at all got to do with testing.

That’s simply wrong.

This vaccine didn’t for instance, but it does now! Fair play to the UK for providing the first set of test subjects to this mass population
trial.
People with nut allergies get vaccinated, coeliacs, lactose allergies etc etc (because it’s been tested and proven safe).

ACitizenErased

lawrencesummers wrote: »

That’s simply wrong.

This vaccine didn’t for instance, but it does now! Fair play to the UK for providing the first set of test subjects to this mass population
trial.
People with nut allergies get vaccinated, coeliacs, lactose allergies etc etc (because it’s been tested and proven safe).

Fair play?
This is quite clearly a **** up by the NHS.

ACitizenErased wrote: »

why would you enter a vaccine trial with previous allergic reactions?

There's 1 of 2 (or even both) things happening here:
1) The 2 NHS nurses are idiots who 'forgot' they've had reactions before
2) The NHS are idiots who didn't ask about allergic reactions.

Or three the NHS were not informed that they needed to not give this vaccines to those people.

But truth be told you and I don’t know.

ACitizenErased

lawrencesummers wrote: »

Or three the NHS were not informed that they needed to not give this vaccines to those people.

But truth be told you and I don’t know.

Ah yeah I forgot we've never ever vaccinated anyone for anything ever.

awec

lawrencesummers wrote: »

Is it possible that the trials were only conducted with healthy people and nobody with allergies was included?

Is it possible?

Of course people who experience severe allergic reactions to vaccines do not take part in vaccine trials. Do you think people who are allergic to nuts help KP out in taste testing their latest flavours?

lawrencesummers wrote: »

That’s simply wrong.

This vaccine didn’t for instance, but it does now! Fair play to the UK for providing the first set of test subjects to this mass population
trial.
People with nut allergies get vaccinated, coeliacs, lactose allergies etc etc (because it’s been tested and proven safe).

We are not talking about people with your common allergies here. We are talking about people who experience severe reactions to vaccines specifically. This is exceptionally rare. It's like 1 in a million people or something.

lawrencesummers wrote: »

That’s simply wrong.

This vaccine didn’t for instance, but it does now! Fair play to the UK for providing the first set of test subjects to this mass population
trial.
People with nut allergies get vaccinated, coeliacs, lactose allergies etc etc (because it’s been tested and proven safe).

Every vaccine in the Republic of Ireland requires you to provide allergy history before vaccination.

So not fair play to the UK, they just proved why you need to ask these questions which we already do.

These aren't exactly your bog standard allergies, they were carrying EPI pens, that should have been the first thing flagged before getting the vaccine. That NHS fcuk up wouldn't have even had the chance to get off the ground here once someone provided their history

Micky 32

Maybe it’s me but it seems there’s a certain misery cohort that would love to see this vaccine fail to prevent life going back to normal for whatever their agenda is.

lawrencesummers wrote: »

Or three the NHS were not informed that they needed to not give this vaccines to those people.

If that's the case then it's a result of the MHRA's decision to not review all of the data, skip the normal review process and rush through the approval of the vaccine.

One way or another, it's a cock-up of the UK's making. And people now panicking over this allergic reaction is exactly why the EMA crticised the MHRA for rushing their approval process.

Micky 32 wrote: »

Maybe it’s me but it seems there’s a certain misery cohort that would love to see this vaccine fail to prevent life going back to normal for whatever their agenda is.

There sure are. And they'll spend the next six months posting opinion pieces that say the vaccine won't work long-term and we're going to have to start from scratch.

Hmmzis

This one kind of kept going on in background and now came out equally quietly (now fully licensed in the UAE):

https://www.wam.ae/en/details/1395302893589

This is the Chinese Sinopharm inactivated whole virus vaccine (there is another from Sinovac that's still to report). The 86% efficacy is excellent, especially given the somewhat meager antibody responses in phase 1 and 2. The press release also states that it prevents all moderate and severe disease cases which is very welcome news.

[Deleted User]

speaking on the news last night there was a doctor speaking of incidences with patients developing bells palsy too,

https://www.wionews.com/world/four-trial-volunteers-who-got-pfizers-covid-19-vaccine-developed-bells-palsy-348547

awec wrote: »

Is it possible?

Of course people who experience severe allergic reactions to vaccines do not take part in vaccine trials. Do you think people who are allergic to nuts help KP out in taste testing their latest flavours?

We are not talking about people with your common allergies here. We are talking about people who experience severe reactions to vaccines specifically. This is exceptionally rare. It's like 1 in a million people or something.

The people who reacted are not “1 in a million” they are people who carry epi pens because they can die from some certain common things that exist.

Epi pens are widely held in Ireland by people. I know a few. Until today there was no mention that they shouldn’t get this vaccine, that’s now changing but the question becomes what specific allergies exclude people, and that’s not known yet.

It’s inevitable that more people will be excluded from this vaccine as information becomes available, such as people currently taking medication for certain diseases etc.

Hmmzis

rusty cole wrote: »

speaking on the news last night there was a doctor speaking of incidences with patients developing bells palsy too,

https://www.wionews.com/world/four-trial-volunteers-who-got-pfizers-covid-19-vaccine-developed-bells-palsy-348547

... at the same rate it occurs in the general population (1.5-3.0 per 10000).

The odd bit is that nobody in the placebo group got it, which is unusual from a numbers point of view.

stephenjmcd wrote: »

Every vaccine in the Republic of Ireland requires you to provide allergy history before vaccination.

So not fair play to the UK, they just proved why you need to ask these questions which we already do.

These aren't exactly your bog standard allergies, they were carrying EPI pens, that should have been the first thing flagged before getting the vaccine. That NHS fcuk up wouldn't have even had the chance to get off the ground here once someone provided their history

Your applying hindsight to foresight.

As of yesterday what people were excluded in Ireland from taking this vaccine?

I will wager than nobody was on that list, but in time it will grow. That the nature of emergency approval. Simply put they don’t know because it’s not been fully tested

rusty cole wrote: »

speaking on the news last night there was a doctor speaking of incidences with patients developing bells palsy too,

https://www.wionews.com/world/four-trial-volunteers-who-got-pfizers-covid-19-vaccine-developed-bells-palsy-348547

If you take 50,000 random people, you'd expect about ten of them to develop Bell's Palsy spontaneously in any given year.

In drug and vaccine trials, all adverse events have to be recorded and reported.

The existence of adverse events doesn't mean they were caused by the vaccine.

We're going to see a lot of this nonsense appear in the coming months.

seamus wrote: »

If you take 50,000 random people, you'd expect about ten of them to develop Bell's Palsy spontaneously in any given year.

In drug and vaccine trials, all adverse events have to be recorded and reported.

The existence of adverse events doesn't mean they were caused by the vaccine.

We're going to see a lot of this nonsense appear in the coming months.

Nonsense? People reporting adverse reaction to a medicine is nonsense?

lawrencesummers wrote: »

Nonsense? People reporting adverse reaction to a medicine is nonsense?

No, media reporting benign data in such a way as to imply danger and to sow doubt about vaccines.

lawrencesummers wrote: »

Your applying hindsight to foresight.

As of yesterday what people were excluded in Ireland from taking this vaccine?

I will wager than nobody was on that list, but in time it will grow. That the nature of emergency approval. Simply put they don’t know because it’s not been fully tested

As of yesterday nobody because we don't have an approved vaccine.

This is why the UK approval process was criticised by the EMA, they rushed into approving it. The EMA process is much more in depth.

You suggest it hasn't been fully tested. Can you point to what part of a normal trial hasn't been completed please ? Where have safety standards differed from other vaccines ?

I'm not bothered going round and round as to how the trials were able to progess quicker, its well documented but if your going to say its not tested then please address the above compared to a trial for any other vaccine.

stephenjmcd wrote: »

As of yesterday nobody because we don't have an approved vaccine.

This is why the UK approval process was criticised by the EMA, they rushed into approving it. The EMA process is much more in depth.

You suggest it hasn't been fully tested. Can you point to what part of a normal trial hasn't been completed please ? Where have safety standards differed from other vaccines ?

I'm not bothered going round and round as to how the trials were able to progess quicker, its well documented.

Yep....

Pregnancy
There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.
5

Breast-feeding
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.
Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Paddygreen

Micky 32 wrote: »

Maybe it’s me but it seems there’s a certain misery cohort that would love to see this vaccine fail to prevent life going back to normal for whatever their agenda is.

Our bi-annual vaccine won’t fail but we will need to still do whatever Mr Tony says and keep all the restrictions going forward, wash your hands, better safe than sorry. Masks will have to be forever, that’s what our experts will command, the consensus is nearly carved in stone.

seamus wrote: »

No, media reporting benign data in such a way as to imply danger and to sow doubt about vaccines.

So somebody needing adrenaline after taking medication shouldn’t be reported in case it implys a danger?

People need to realise that this vaccine while needed and welcome has not been fully tested. It’s as simple as this, mass testing is going hand in hand with mass inoculation.

lawrencesummers wrote: »

Yep....

Pregnancy
There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.
5

Breast-feeding
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.
Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Pregnant and breastfeeding women are generally excluded from normal trials. There are considerable ethical issues that manufacturers would rather avoid if at all possible.

Virtually every medicine in existence, even over-the-counter stuff, advises that pregnant/breastfeeding women should either consult their doctor first, or just not take it at all.

Paracetemol is about the only thing allowed, and that's because we inadvertently proved it was safe by letting pregnant women take it. It wasn't formally tested on them.

lawrencesummers wrote: »

So somebody needing adrenaline after taking medication shouldn’t be reported in case it implys a danger?

Someone with known severe allergies, having an allergic reaction, is not news. It's as useful as reporting that grass is green. The purpose of reporting something is to imply that it's new or unknown. If it's reported by media, people assume that it's unexpected and a danger. It was not at all unexpected, it was an error by the NHS (and the people who received it, presumably).

People need to realise that this vaccine while needed and welcome has not been fully tested.

In what way has it not been fully tested? What has been skipped?

seamus wrote: »

Pregnant and breastfeeding women are generally excluded from normal trials.

Virtually every medicine in existence, even over-the-counter stuff, advises that pregnant/breastfeeding women should either consult their doctor first, or just not take it at all.

Paracetemol is about the only thing allowed, and that's because we inadvertently proved it was safe by letting pregnant women take it. It wasn't formally tested on them.

Fair play to you for replying Seamus because I wasn't bothered. It would be like talking to a brick wall.

The question I asked was "Can you point to what part of a normal trial hasn't been completed please ? Where have safety standards differed from other vaccines "

So I'd love to know what part has been skipped but I suspect I won't get an answer.

And I got back pregnant women etc which as you say in every vaccine or medicine always contains a warning for, rarely if ever tested on that cohort.

dominatinMC

Interesting to observe the volume and ferocity of posts from certain posters on here once a bit of (perceived) bad news on the vaccine is announced. Those same posters are conspicuous by the absence the remainder of the time.

Jim_Hodge

Don't know if this piece from this morning's news has been posted.

UK regulators have issued a warning that people who have a history of "significant" allergic reactions should not currently receive the Pfizer/BioNTech Covid-19 vaccine after two people who had the jab yesterday had allergic reactions.