UK approves Pfizer jab for use in 12-15-year-olds

[johnboy1975]

pavarotti1980 said:

BUG4LIFE said:

The argument is one is tried and tested, the other isn't. I haven't got a 12-18 year old [mine is only 2] so currently don't have to make a choice, but my original post was how a parent would feel if their child dies of the vaccine for protection against something that really doesn't effect them. I don't buy the 'to protect others' BS...if the vaccine works on the vulnerable, they've got nowt to worry about anyway.

Vaccines are not 100% effective and never have been.

How much "testing" do you want to happen in drugs?
The COVID vaccines have been through
i) Phase 1 - small cohorts of patients looking at safety; pharmacokinetics and pharmacodynamics
ii) Phase 2 - larger cohort of patients looking at efficacy; optimising doses
iii) Phase 3 - larger cohort looking at the safety and efficacy; confirmation of doses; identifying adverse events; compare against current treatments or a control group and now are part of

iv) Phase 4 - Ongoing monitoring of efficacy; monitoring of adverse events following widespread use. Usually this happens upon commercial release of the product.

From your stance you would never consent to receive any new/experimental drug or take part in a clinical trial yourself or on behalf your children?

Pre covid, I thought this was everyone's (or the vast majority's) default position? And then you could go off and volunteer for an experimental drug if you so chose (and get paid 3-4k for the privilege)

No?

Presumably Pandemrix (2009 swine flu vaccine) went through those testing stages you listed above? They missed the narcolepsy side effect. And I stand to be corrected, but didn't they miss the clotting issue with AZ this time round?

[robuk]

Got to love PH's anti-science pro-virus lot...

[pavarotti1980]

johnboy1975 said:

Pre covid, I thought this was everyone's (or the vast majority's) default position? And then you could go off and volunteer for an experimental drug if you so chose (and get paid 3-4k for the privilege)

No?

Presumably Pandemrix (2009 swine flu vaccine) went through those testing stages you listed above? They missed the narcolepsy side effect. And I stand to be corrected, but didn't they miss the clotting issue with AZ this time round?

You will only receive £3-4k for being part of the phase 1 studies and this wont happen in the phase 3's

They didn't miss the clotting, there were just no or virtually no reported incidences in the 20k phase 3 participants who received the vaccine in blinded study, hence the requirement for monitoring in widespread use

Yes Pamdemrix went through the same phases and neurological disorders were attributed as a very rare adverse event (1:10,000)

[johnboy1975]

pavarotti1980 said:

Yes Pamdemrix went through the same phases and neurological disorders were attributed as a very rare adverse event (1:10,000)

Would you (and anyone else commenting) take that result from jabbing 12-15 year olds with Pfizer? Or would that be unacceptable?

[pavarotti1980]

johnboy1975 said:

Would you (and anyone else commenting) take that result from jabbing 12-15 year olds with Pfizer? Or would that be unacceptable?

Thats the standard way of classifying adverse events in medicines to put them in the context of relative levels of incidence.

Unable to answer your question as you are using the adverse event profile for a different drug and attributing it to the Pfizer vaccine in terms of relartive risk, but I would consent for my 12 year old son to have the vaccine if it was available

[blackrabbit]

robuk said:

Got to love PH's anti-science pro-virus lot...

That's the normal "know better" woke response if anything is questioned. Would have been the same a few decades ago with thalidomide.

Government, SAGE, pharma, media, etc are not to be trusted on their Covid agendas nor their curated scientific reasoning which in reality is just cherry picked to suit their agenda. An under 18 year old has effectively zero chance of dying from Covid and anyone above 60 who has a tiny risk should take the vaccine if they are so concerned.

Smart people don't give young kids drugs they don't need that have been rushed into production given the choice. There is no way we can be sure of the impact of this vaccine on growing children's bodies.

[pavarotti1980]

blackrabbit said:

There is no way we can be sure of the impact of this vaccine on growing children's bodies.

Im sure the clinical trial currently underway in children will give plenty of indications

[BUG4LIFE]

pavarotti1980 said:

blackrabbit said:

There is no way we can be sure of the impact of this vaccine on growing children's bodies.

Im sure the clinical trial currently underway in children will give plenty of indications

If that's all the answers you need to pump it into your 12 year old mate, good luck to you!

[johnboy1975]

pavarotti1980 said:

johnboy1975 said:

Would you (and anyone else commenting) take that result from jabbing 12-15 year olds with Pfizer? Or would that be unacceptable?

Thats the standard way of classifying adverse events in medicines to put them in the context of relative levels of incidence.

Unable to answer your question as you are using the adverse event profile for a different drug and attributing it to the Pfizer vaccine in terms of relartive risk, but I would consent for my 12 year old son to have the vaccine if it was available

I'm not attributing anything to the Pfizer vaccine. As it is an unknown. We can find out by monitoring millions of people who have taken it over the remaining time of the EUA (so until 2023 I believe?) or we can jab 10 million kids and hope for the best.

You seem to be in the latter camp. I'm in the former.

[pavarotti1980]

BUG4LIFE said:

If that's all the answers you need to pump it into your 12 year old mate, good luck to you!

Clinical trials, EPAR, SPC etc etc.

Oh hang on that's the same with all drugs.....

[Douglas Quaid]

pavarotti1980 said:

BUG4LIFE said:

A child shouldn't have to have the vaccine just in case they pass Covid on...crazy!

Why are they immunised against influenza as the risk of death is minute with that?

Edited by pavarotti1980 on Friday 4th June 13:38

Influenza is a real risk to young people. It does kill them and is far more dangerous than covid. Covid isn’t deadly for young people (barring those that have serious medical issues already) and doesn’t kill them. It makes sense to vaccinate children against diseases that are harmful to them but covid isn’t.

I’ve been jabbed but am in my 40s and the very small risk of me dying from the covid is slightly higher than the very small risk of me dying from the vaccine so I weighed it up and thought it made sense. However the risk profile changes for a 12 yr old. Zero risk from covid compared to a very small risk from the vaccine. What is the point of risking it unnecessarily? To protect adults? I thought adults were supposed to look after kids not the other way round?

[anonymous-user]

pavarotti1980 said:

Clinical trials, EPAR, SPC etc etc.

Oh hang on that's the same with all drugs.....

Normally the drug manufacturer would be liable for severe side effects though wouldn’t they? Why do these vaccine manufacturers need immunity from being sued if it’s the same as any other drug?

https://www.independent.co.uk/news/health/coronavi...

[rxe]

ElectricSoup said:

Of course there is not zero chance of this happening. However, healthy 12-18 year olds have died already across the world from Covid. This number will always be significantly higher than adverse reactions to a vaccine. And many more have passed it on to someone else, who has subsequently died or been hospitalised.

Nothing is risk free, but when presented with a choice, it's usually the better path to choose the lower risk where higher benfits accrue. Nobody wants to be in this situation, but we are where we are. A choice exists. Do nothing and risk (contracting and spreading) Covid, or vaccinate and risk adverse events. The benefits of taking the latter course outweigh its risks. Decision made for me.

I don't think there is much evidence to support your position.

At the start of this, anyone who was even slightly concerned about the vaccine was an "anti-vaxxer". Unfortunately, some of those concerns have turned out to be true. Hundreds of people have died of blood clots caused by the AZ vaccine. As a result, that vaccine is not recommended for people under 30, even in the UK.

How did we find this out? Well, we injected shed loads of people. We had no issues with the elderly, and carried on pushing down the age groups. Then overwhelming evidence started to appear that there was a problem. Then we started off saying it was just the stupid Germans who had a problem, but then we realised we had one too. Duh.

I have an 18 year old, and my advice to him is the same as the advice I've followed myself - get vaccinated, but be a long way from the front of the queue. His risk of covid is negligible. His risk from some vaccines (AZ) is greater than covid, but still negligible. I don't care if he doesn't have the vaccine quickly - I've been vaccinated, so has Mrs rxe, so we might get a bit of a cold. Who cares?

I really don't see the problem if everyone at risk of this disease has been offered a vaccine, and people who are not at (material) risk don't have the vaccine.

[pavarotti1980]

MrMan001 said:

Normally the drug manufacturer would be liable for severe side effects though wouldn’t they? Why do these vaccine manufacturers need immunity from being sued if it’s the same as any other drug?

https://www.independent.co.uk/news/health/coronavi...

Because it is currently a drug without a marketing authorisation due to its emergency approval. Therefore due to Human Medicines Regulations 2012 https://www.legislation.gov.uk/uksi/2012/1916/regu... the pharmaceutical manufacturer can not be liable as the use was recommended by the licensing authority (MHRA) in response to a pathogen (COVID-19).

Here is the legislation which covers it all

Immunity from civil liability
345.—(1) This regulation applies where the licensing authority makes a recommendation or requirement to which paragraph (2) applies in response to the suspected or confirmed spread of—

(a)pathogenic agents;
(b)toxins;
(c)chemical agents; or
(d)nuclear radiation,
which may cause harm to human beings.

(2) This paragraph applies to a recommendation or requirement—

(a)for the use of a medicinal product without an authorisation; or
(b)for the use of a medicinal product with an authorisation, but for a therapeutic indication that is not permitted under the authorisation.
(3) None of the following are to be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement—

(a)any holder of an authorisation for the product;
[F1(aa)if there is no holder of an authorisation for the product but the sale or supply of the product is authorised by the licensing authority on a temporary basis under regulation 174, the person responsible for placing the product on the market in the United Kingdom;]
(b)any manufacturer of the product;
(c)any officer, servant, employee or agent of a person within [F2sub-paragraph (a), (aa) or (b);]
(d)any health care professional[F3; or]
[F4(e)any person, not being a health care professional, who administers the product in accordance with a protocol of the type mentioned in regulation 247A.]
(4) This regulation does not apply in relation to liability under section 2 (liability for defective products) of the Consumer Protection Act 1987M1 or article 5 of the Consumer Protection (Northern Ireland) Order 1987M2.

(5) In this regulation “authorisation” means a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation.

[jinba-ittai]

rxe said:

ElectricSoup said:

Of course there is not zero chance of this happening. However, healthy 12-18 year olds have died already across the world from Covid. This number will always be significantly higher than adverse reactions to a vaccine. And many more have passed it on to someone else, who has subsequently died or been hospitalised.

Nothing is risk free, but when presented with a choice, it's usually the better path to choose the lower risk where higher benfits accrue. Nobody wants to be in this situation, but we are where we are. A choice exists. Do nothing and risk (contracting and spreading) Covid, or vaccinate and risk adverse events. The benefits of taking the latter course outweigh its risks. Decision made for me.

I don't think there is much evidence to support your position.

At the start of this, anyone who was even slightly concerned about the vaccine was an "anti-vaxxer". Unfortunately, some of those concerns have turned out to be true. Hundreds of people have died of blood clots caused by the AZ vaccine. As a result, that vaccine is not recommended for people under 30, even in the UK.

How did we find this out? Well, we injected shed loads of people. We had no issues with the elderly, and carried on pushing down the age groups. Then overwhelming evidence started to appear that there was a problem. Then we started off saying it was just the stupid Germans who had a problem, but then we realised we had one too. Duh.

I have an 18 year old, and my advice to him is the same as the advice I've followed myself - get vaccinated, but be a long way from the front of the queue. His risk of covid is negligible. His risk from some vaccines (AZ) is greater than covid, but still negligible. I don't care if he doesn't have the vaccine quickly - I've been vaccinated, so has Mrs rxe, so we might get a bit of a cold. Who cares?

I really don't see the problem if everyone at risk of this disease has been offered a vaccine, and people who are not at (material) risk don't have the vaccine.

Where's your source for hundreds of deaths from the AZ vaccine? (not saying it isn't true, just seems much higher than I'd seen quoted previously)

[blackrabbit]

pavarotti1980 said:

blackrabbit said:

There is no way we can be sure of the impact of this vaccine on growing children's bodies.

Im sure the clinical trial currently underway in children will give plenty of indications

Some of these bad outcomes can take many years to manifest in kids whose bodies are changing. This vaccine is being rushed into production (along with tracking apps) in the hope that people will take/accept it quickly while the "threat" of Covid is still being hyped. Its a window of opportunity for more profit and control that is rapidly closing. Drug companies and government know each passing week more and more people are realising they do not need this vaccine for kids who are not impacted by Covid.

[anonymous-user]

pavarotti1980 said:

Because it is currently a drug without a marketing authorisation due to its emergency approval. Therefore due to Human Medicines Regulations 2012 https://www.legislation.gov.uk/uksi/2012/1916/regu... the pharmaceutical manufacturer can not be liable as the use was recommended by the licensing authority (MHRA) in response to a pathogen (COVID-19).

Here is the legislation which covers it all

Immunity from civil liability
345.—(1) This regulation applies where the licensing authority makes a recommendation or requirement to which paragraph (2) applies in response to the suspected or confirmed spread of—

(a)pathogenic agents;
(b)toxins;
(c)chemical agents; or
(d)nuclear radiation,
which may cause harm to human beings.

(2) This paragraph applies to a recommendation or requirement—

(a)for the use of a medicinal product without an authorisation; or
(b)for the use of a medicinal product with an authorisation, but for a therapeutic indication that is not permitted under the authorisation.
(3) None of the following are to be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement—

(a)any holder of an authorisation for the product;
[F1(aa)if there is no holder of an authorisation for the product but the sale or supply of the product is authorised by the licensing authority on a temporary basis under regulation 174, the person responsible for placing the product on the market in the United Kingdom;]
(b)any manufacturer of the product;
(c)any officer, servant, employee or agent of a person within [F2sub-paragraph (a), (aa) or (b);]
(d)any health care professional[F3; or]
[F4(e)any person, not being a health care professional, who administers the product in accordance with a protocol of the type mentioned in regulation 247A.]
(4) This regulation does not apply in relation to liability under section 2 (liability for defective products) of the Consumer Protection Act 1987M1 or article 5 of the Consumer Protection (Northern Ireland) Order 1987M2.

(5) In this regulation “authorisation” means a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation.

Does this not imply that there is a lower confidence in the safety of the drug? Else why would they be concerned about liability. The UK legislation used isn’t really relevant as the immunity/indemnity is being used globally. As far as I know vaccine manufacturers won’t ship the drug to governments that won’t grant them indemnity or immunity to damages caused.

[pavarotti1980]

MrMan001 said:

Does this not imply that there is a lower confidence in the safety of the drug? Else why would they be concerned about liability. The UK legislation used isn’t really relevant as the immunity/indemnity is being used globally. As far as I know vaccine manufacturers won’t ship the drug to governments that won’t grant them indemnity or immunity to damages caused.

No it doesn't imply anything. As MHRA have not given them a marketing authorisation (product license) and instead given emergency approval to use it they cannot insist on the liability being carried by the pharmaceutical company as they have insisted on its use as per the legislation.

This legislation does not just apply to COVID vaccines

blackrabbit said:

Some of these bad outcomes can take many years to manifest in kids whose bodies are changing. This vaccine is being rushed into production (along with tracking apps) in the hope that people will take/accept it quickly while the "threat" of Covid is still being hyped. Its a window of opportunity for more profit and control that is rapidly closing. Drug companies and government know each passing week more and more people are realising they do not need this vaccine for kids who are not impacted by Covid.

Ok

[anonymous-user]

pavarotti1980 said:

MHRA stuff

The MHRA’s position is only relevant to the UK, the vaccine manufacturers have immunity or indemnity in (almost?) every country. It also seems to be at the insistence of the manufacturer, as the quotes in my earlier link show. They say that they can’t absorb the risk.

Edit for source: https://www.reuters.com/article/us-astrazeneca-res...

Edited by anonymous-user on Friday 4th June 16:37

[andy ted]

blackrabbit said:

robuk said:

Got to love PH's anti-science pro-virus lot...

That's the normal "know better" woke response if anything is questioned. Would have been the same a few decades ago with thalidomide.

Government, SAGE, pharma, media, etc are not to be trusted on their Covid agendas nor their curated scientific reasoning which in reality is just cherry picked to suit their agenda. An under 18 year old has effectively zero chance of dying from Covid and anyone above 60 who has a tiny risk should take the vaccine if they are so concerned.

Smart people don't give young kids drugs they don't need that have been rushed into production given the choice. There is no way we can be sure of the impact of this vaccine on growing children's bodies.

Can you say who you do trust on this then?