Will you take an approved COVID-19 vaccine?

hmmm

PhantomHat wrote: »

If you are considering taking this new generation vaccine, PLEASE look at this. It's published 3 days ago and it's published on the UK Governments website, so it ain't conspiracy stuff. In the link for Heathcare Professionals, please look at 4.6 and 4.7

4.6 says it hasn't been tested on pregnant women and shouldn't be given to them. 4.7 advises against driving if you're feeling side effects after receiving the vaccine.

This is all very normal stuff.

PhantomHat

hmmm wrote: »

4.6 says it hasn't been tested on pregnant women and shouldn't be given to them. 4.7 advises against driving if you're feeling side effects after receiving the vaccine.

This is all very normal stuff.

I don't know if you haven't read all of it or you're deliberately omitting an important part.

I shall quote the text

Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

Johnboy1951

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941452/Information_for_healthcare_professionals.pdf

In 4.8 ..... I quote

Demographic characteristics were generally similar with regard to age, gender, race and ethnicity
among participants who received COVID-19 mRNA Vaccine and those who received placebo.
Overall, among the participants who received COVID-19 mRNA Vaccine BNT162b2, 51.5% were
male and 48.5% were female, 82.1% were White, 9.6% were Black or African American, 26.1% were
Hispanic/Latino, 4.3% were Asian and 0.7% were Native American/Alaskan native.

Those percentages appear to add up to 122.8%

Could someone explain this please?

cgc5483

PhantomHat wrote: »

I don't know if you haven't read all of it or you're deliberately omitting an important part.

I shall quote the text

Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

Standard text in this type of document. Nothing unusual or out of the ordinary.

ceegee

Johnboy1951 wrote: »

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941452/Information_for_healthcare_professionals.pdf

In 4.8 ..... I quote



Those percentages appear to add up to 122.8%

Could someone explain this please?

Being Hispanic/Latino is not defined by skin colour. So you will have people ticking multiple boxes

PhantomHat

cgc5483 wrote: »

Standard text in this type of document. Nothing unusual or out of the ordinary.

I as much as you hope this vaccine is a success.

They have yet to collate useful data such as fertility implications on this as there is no long term data. You cannot substitute for this.

AFAIK no time machines have been used in the trials to date

Johnboy1951

ceegee wrote: »

Being Hispanic/Latino is not defined by skin colour. So you will have people ticking multiple boxes

Giving breakdown percentages of participants which adds up to more than 100% is ridiculous in the extreme and is not in any way scientific ........ at least not without proper explanation of how it happened.

In addition, as this vaccine is initially to be administered to the 'vulnerable' I have (so far) not found any breakdown for age or underlying medical problems.

If this has not been done then there is a lack of information about its efficacy for different ages and underlying medical conditions.

IF that is the case then to administer first to those vulnerable in our society seems to be the opposite of what should be done.

drunkmonkey

Johnboy1951 wrote: »

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941452/Information_for_healthcare_professionals.pdf

In 4.8 ..... I quote



Those percentages appear to add up to 122.8%

Could someone explain this please?

You can't add those percentages the way they're presented.

ceegee

Johnboy1951 wrote: »

Giving breakdown percentages of participants which adds up to more than 100% is ridiculous in the extreme and is not in any way scientific ........ at least not without proper explanation of how it happened.

In addition, as this vaccine is initially to be administered to the 'vulnerable' I have (so far) not found any breakdown for age or underlying medical problems.

If this has not been done then there is a lack of information about its efficacy for different ages and underlying medical conditions.

IF that is the case then to administer first to those vulnerable in our society seems to be the opposite of what should be done.

Regarding ages: For those who received the vaccine in study 2:
57.2% were aged
16-55 years, 42.6% were aged > 55 years and 21.8% were ≥ 65 years.

It is worth noting that this document is intended for healthcare professionals. The fact that a breakdown of race and ethnicity adds up to over 100% should not be in any way confusing to someone familiar with this type of data.

cgc5483

PhantomHat wrote: »

I as much as you hope this vaccine is a success.

They have yet to collate useful data such as fertility implications on this as there is no long term data. You cannot substitute for this.

AFAIK no time machines have been used in the trials to date

You suggested that the previous poster have deliberately omitted this part as if it is some significant data gap. I will reiterate this is a standard statement which exactly reflects your point that there is not enough data but in no way suggests that this is an issue.

eagle eye

cgc5483 wrote:

You suggested that the previous poster have deliberately omitted this part as if it is some significant data gap. I will reiterate this is a standard statement which exactly reflects your point that there is not enough data but in no way suggests that this is an issue.

Is it standard or is it a case that there's a rush to get this to market?
Like isn't it normally the case that drug authorities wait at least two years for results and stats on vaccines before approval?

PhantomHat

cgc5483 wrote: »

You suggested that the previous poster have deliberately omitted this part as if it is some significant data gap. I will reiterate this is a standard statement which exactly reflects your point that there is not enough data but in no way suggests that this is an issue.

This is effectively a previously untried and relatively limited tested technology/ vaccine. it is only fair that one should question its long term safety. This has to be taken very seriously.

The companies will be collecting further data based on the population that receive it. Nothing unusual about that you might say but we are effectively being implemented into a long term safety investigation.

The results of which we all hope will be ok.

Johnboy1951

ceegee wrote: »

Regarding ages: For those who received the vaccine in study 2:
57.2% were aged
16-55 years, 42.6% were aged > 55 years and 21.8% were ≥ 65 years.

It is worth noting that this document is intended for healthcare professionals. The fact that a breakdown of race and ethnicity adds up to over 100% should not be in any way confusing to someone familiar with this type of data.

Thanks.
That information is of great interest to those of us not familiar with this type of data, but I have not found it in a more accessible form.

So this is the breakdown by age apparently

57.2% 16 - 55
20.8% 56 - 64
21.8% 65 +

So what about the 12 - 16 year olds who do not seem to be included in those numbers. Is there some reason for them not to be included in the age breakdown?

In Study 2, approximately 44,000 participants 12 years of age and older were randomised equally

That is particularly 'interesting' in light of this

Children and adolescents
COVID-19 mRNA Vaccine BNT162b2 is not recommended for children under 16 years.

ceegee

Johnboy1951 wrote: »

Thanks.
That information is of great interest to those of us not familiar with this type of data, but I have not found it in a more accessible form.

So this is the breakdown by age apparently

57.2% 16 - 55
20.8% 56 - 64
21.8% 65 +

So what about the 12 - 16 year olds who do not seem to be included in those numbers. Is there some reason for them not to be included in the age breakdown?



That is particularly 'interesting' in light of this

It looks as though 0.2% of people were 12-15 (other ages add up to 99.8%)
That works out at about 35 in each of the vaccine and placebo group. At a guess, its possible that not enough people in this age group were symptomatic for them to show the vaccine works. Or that not enough people in this age category could be recruited for the data to be useful.

ceegee

Johnboy1951 wrote: »

Giving breakdown percentages of participants which adds up to more than 100% is ridiculous in the extreme and is not in any way scientific ........ at least not without proper explanation of how it happened.

In addition, as this vaccine is initially to be administered to the 'vulnerable' I have (so far) not found any breakdown for age or underlying medical problems.

If this has not been done then there is a lack of information about its efficacy for different ages and underlying medical conditions.

IF that is the case then to administer first to those vulnerable in our society seems to be the opposite of what should be done.

Regarding underlying conditions:
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at
risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk
of severe COVID-19 disease (e.g. asthma, BMI ≥ 30 kg/m2
, chronic pulmonary disease, diabetes
mellitus, hypertension).

hmmm

All the vaccine producers are writing peer reviewed papers which will be published. These take time to prepare.

The detailed information on the trials from the independent safety boards has gone to the regulators for review.

It's all very well calling for more information, but it's obvious just from this thread that many people will deliberately or inadvertently misinterpret data they don't understand. The safest thing for everyone is to let the independent regulators who are experts in this area look at the data and decide whether they are satisfied with what they have been given.

hmmm

Johnboy1951 wrote: »

So what about the 12 - 16 year olds who do not seem to be included in those numbers. Is there some reason for them not to be included in the age breakdown?

Only a very small number of under 18s were included in trials. The vaccine is not going to be authorised for use in children as part of the emergency authorisation.

There are separate larger trials planned for next year where 12 to 18s will be included.

hmmm

eagle eye wrote: »

Is it standard or is it a case that there's a rush to get this to market?
Like isn't it normally the case that drug authorities wait at least two years for results and stats on vaccines before approval?

The vast majority of side-effects in previous vaccine trials were detected within a few weeks.

We're in a pandemic with 30,000 a week dying in Europe alone. We can't wait 2 years and let Covid rip through the world for that extra 1% of assurance. Vaccines have been rapidly developed in the past where needed (e.g. the Ebola vaccine which helped stop the Ebola outbreak which had killed 11,000 people).

The vaccine will be rolled out to those most at risk initially. There will be millions of high-risk people vaccinated before it is ever authorised for use by younger people.

eagle eye

hmmm wrote:

The vast majority of side-effects in previous vaccine trials were detected within a few weeks.

We're in a pandemic with 30,000 a week dying in Europe alone. We can't wait 2 years and let Covid rip through the world for that extra 1% of assurance. Vaccines have been rapidly developed in the past where needed (e.g. the Ebola vaccine which helped stop the Ebola outbreak which had killed 11,000 people).

The vaccine will be rolled out to those most at risk initially. There will be millions of high-risk people vaccinated before it is ever authorised for use by younger people.

I'm not in disagreement with you on that it needs to be rushed.
I'm asking if it's the norm to have all these unknowns. A poster said it was.

hmmm

eagle eye wrote: »

I'm not in disagreement with you on that it needs to be rushed.
I'm asking if it's the norm to have all these unknowns. A poster said it was.

It's normal for many drugs to not be tested on pregnant women yes, and the drug information will say this. Similarly testing on children is done with lots of extra care and only after considering whether it is really necessary. It's an ethical question and generates a lot of debate - what's important is that the information is clear.

eagle eye

hmmm wrote:

It's normal for many drugs to not be tested on pregnant women yes, and the drug information will say this. Similarly testing on children is done with lots of extra care and only after considering whether it is really necessary. It's an ethical question and generates a lot of debate - what's important is that the information is clear.

You still didn't answer the question. Acura or no answer will suffice. Is it normal to have this many unknowns with an approved vaccine?

hmmm

eagle eye wrote: »

You still didn't answer the question. Acura or no answer will suffice. Is it normal to have this many unknowns with an approved vaccine?

You're not explaining yourself. What unknowns are you talking about?

The vaccines have gone through 3 phases of trials since March, and each have been tested on 30,000 adults.

eagle eye

hmmm wrote:

You're not explaining yourself. What unknowns are you talking about?

There's a whole host of unknowns in the linked document.

hmmm

eagle eye wrote: »

There's a whole host of unknowns in the linked document.

The document (which is for medical practitioners only) tells them which groups the vaccines have been tested on, and which groups they haven't. Yes it's unknown how it affects pregnant women because it hasn't been tested on them, so the instructions are not to give it to pregnant women. That's all very normal.

schmoo2k

PhantomHat wrote: »

I don't know if you haven't read all of it or you're deliberately omitting an important part.

I shall quote the text

Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

Not an issue for a lot of the venerable folks (the older ones).

schmoo2k

eagle eye wrote: »

You still didn't answer the question. Acura or no answer will suffice. Is it normal to have this many unknowns with an approved vaccine?

Yes - and the important thing is that you are very clear about what is known and what is not, especially when it comes to who you can administer it to. This is why they put it specifically in this document.

Doc07

eagle eye wrote: »

Is it standard or is it a case that there's a rush to get this to market?
Like isn't it normally the case that drug authorities wait at least two years for results and stats on vaccines before approval?

Reasonable question but it is absolutely NOT normally the case to wait at least 2 years before approval. Most regulators will expect to see 6 weeks follow up safety data after the final dose (in this case 2nd dose)
These are new vaccines but they stimulate the immune system like other vaccines and the vast,vast,vast majority of adverse effects from previous experience with vaccines become apparent within 6-8 weeks. So waiting 2 years may only pick up a tiny amount (or none) of additional information and denies at risk groups an effective protective vaccine for almost another 2 years.
What will happen is that the people who were part of the trials will be followed (as many as possible) for 2 years to get any additional information on safety and efficacy of the vaccine by comparing the placebo and vaccinated groups and if it is important it will be added to the known information

speckle

ceegee wrote: »

Regarding underlying conditions:
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at
risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk
of severe COVID-19 disease (e.g. asthma, BMI ≥ 30 kg/m2
, chronic pulmonary disease, diabetes
mellitus, hypertension).

I wonder is there a breakdown regarding asthma types aswell as mild moderate and especially severe of the participants as the drug regimes change depending on how severe.. as some may be on immunosupressants/modulators separate to their inhalers etc.

ILoveYourVibes

Yes ..and i think most Irish will do so too rather than face another year of lockdown.
The choice is clear ..take the vaccine ..or lose another year of your life.

I would rather take the vaccine. I think most will feel the same.

eagle eye

ILoveYourVibes wrote:

Yes ..and i think most Irish will do so too rather than face another year of lockdown. The choice is clear ..take the vaccine ..or lose another year of your life.

I would rather take the vaccine. I think most will feel the same.

I think it's about 50/50 right now. We need some respected people to take it to bring the numbers up.
The likes of Michael D Higgins, Mary Robinson, Bono, Conor McGregor, Miriam O'Callaghan, Katie Taylor, random respected gaa stars, newer pop stars etc. should help bring the numbers up significantly.
It's the time for influencers to step forward and get counted.