Vaccine for 5+

[NotTheBaby]

It’s on sky news now. Leaked document stating 5 year olds and above to be vaccinated from spring. I’m so hesitant to get my children done, when I couldn’t wait for mine. Why is this so much harder than it should be? Or am I just overthinking it?

Many more doses of this vaccine have been given but when kids stand to benefit little from the vaccine those are pretty scary numbers to dismiss.

Controlling for the total number of doses given is extremely important @Hotcoffee10, it can't just be waved away and "scary numbers" of adverse effects shouted about.

If 90 developed (for example) heart failure after vaccination, this would be a grave concern if it was out of a total of 100 doses, and not so much if it was out of 2 billion.

Take miscarriage. Many people extremely concerned about the number of reported miscarriages in the yellow card data, stating there shouldn't be any.

This is ignoring the fact that sadly, there is general underlying rate of miscarriage in pregnant women - 1/4 pregnancies. If no women miscarried after vaccination, this would suggest that vaccination was somehow protective and preventing miscarriage from happening.

Instead of looking at raw figures, you must compare to a comprable, unvaccinated cohort of people. And to do this, you must consider the total number of people involved in the numbers - in this case for the yellow card data it is millions.

[quote DayKay]@Barbie222 you’re partly correct

From Gov.uk -

The assessment by the Joint Committee on Vaccination and Immunisation (JCVI) is that the health benefits from vaccination are marginally greater than the potential known harms. However, the margin of benefit is considered too small to support universal vaccination of healthy 12 to 15 year olds at this time.[/quote]
Yes - it's not worth spending the money, in other words. As a parent, I don't care!

It would be lovely to compare to a placebo group but there is none. They were all vaccinated after 4 months. That is why we should have had longer trials.

Nor can I find rates of ADRs per 100000 doses given despite the fact it seems like this would be a sensible way to present the data.

When you have a brand new drug that has a mechanism never before used in humans you need to be extremely careful and alert to safety signals. This is it, there is no other safety monitoring. Just adverse event reporting 100s of times higher than ever seen in the UK before.

There have been statistically significant rises in miscarriage and stillbirth. www.heraldscotland.com/news/19726487.investigation-launched-abnormal-spike-newborn-baby-deaths-scotland/

I think it is due to the effect of restrictions on antenatal care rather than vaccines most likely but I hope it will investigated with an open mind. If it’s due to covid we should have seen this last year not this year.

I should clarify I still think at risk groups should get the vaccine. But for healthy under 40s and for children the picture is far more nuanced.

So that’s a ‘no’ on weighted data (adults more likely to notice side effects and attribute to vaccine), and ‘no’ on comparative ratio to vaccine doses over the same time period? And measuring increased awareness of yellow card over the last 12 months from a November 2020 baseline?

Without all that it’s fairly hard to draw conclusions on safety or determine whether the numbers are ‘scary’ or not.
MHRA says the reporting is 3-6 per thousand; I’ve not seen comparators yet so grateful if you can share any. They also say:

For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.

We’re in the midst of the most publicised vaccine rollout in history, involving huge numbers of people who don’t usually have any vaccines. Awareness of Yellow Card will have increased if only through news media reporting of Yellow Card events.

Some people will ascribe entirely incidental events to their vaccines, because as humans we look for patterns and reasons for things. There will have been a large number of strokes this year within a month of people having a vaccine, for example, because there are always large numbers of strokes and when you’re vaccinating millions a month there will be some that fall near a vaccination.

There have been statistically significant rises in miscarriage and stillbirth. www.heraldscotland.com/news/19726487.investigation-launched-abnormal-spike-newborn-baby-deaths-scotland/

I commented on this on another thread @Hotcoffee10

Firstly, this is not "statistically significant" increases in stillbirth or micarriage. Have you read the article?

This is about a specific region in Scotland, where there has numbers of neonatal deaths have breached what are considered normal (as far as that term can be used) levels. This has occured in conjuntion with increased rates of RSV in the same period, leading to the hypothesis that this is the most likely factor.

Other factors considered are poorer maternal care, maternal COVID infection in pregnancy, and preterm birth. Nowhere in the article is vaccination mentioned.

The more you post the more it does seem like you have a specific agenda when it comes to offering vaccination - you've moved on from children/teens to suggesting it isn't safe for pregnant women? @Hotcoffee10

I don’t know about pregnant women. I don’t think there is enough data to say for sure it’s safe but pregnant women are at high risk for Covid so it’s a difficult call. Pregnant women should get vaccinated for their own safety but more research should be done as a matter of urgency is what I think.

Healthy kids are very low risk so it should be a very easy call. Not till there is more long term data.

I think the public dialogue related to the vaccines is wrong. Any concerns about safety and whether vax passports are the right thing to do is absolutely shouted down.

I did find the data per 100000 doses not on Public health England website, someone else has worked it out. ukfreedomproject.org/covid-19-vaccines-yellow-card-analysis/

For Pfizer vaccine the risk of death per dose appears to be 1 in 67000 doses given.

Yellow card usually under reports. That seems low but consider adverse reactions seem more common in younger age groups. Very low risk of dying of Covid in kids remember.

Would you take your child to Wembley (90000) capacity if you knew 1 person there was going to be killed at random?

If the safety data is useless as you asset because not corrected for reporting rates and ages than why do you think it is acceptable to use it at all? You said we had lots of data from adults and kids in other countries and >12 years. This is it.

@Hotcoffee10

Here is the Pfizer press release www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results As you can see 4500 kids - so not enough for adverse events, and the outcome was immune response not hospitalisation or death.

4500 in a study is certainly enough to test for adverse events. And presumably having hospitalisation as an endpoint would be problematic given the relatively small number of children who are hospitalised with COVID.

Healthy kids are very low risk so it should be a very easy call. Not till there is more long term data.

I’m honestly curious. Long term data on what?

I did find the data per 100000 doses not on Public health England website, someone else has worked it out. ukfreedomproject.org/covid-19-vaccines-yellow-card-analysis/

I would be questioning the ability of anyone to analyse, interpret & report data in an unbiased manner with clangers such as these on their website @Hotcoffee10

Eighteen months into the pandemic, it is clear that children’s risk from COVID-19 is statistically zero.

The data on short term harms show worrying signs, including fatalities being reported at 28 times the rate seen on a per dose basis for influenza vaccines.

Not sure how you can trust anything from a website which is happy to propogate fake claims. As I've said before, how can anyone make an informed choice if they're saturated with anti-vaccine misinformation?

The UK Freedom Group, unsuprisingly, have links to FLCCC, who have spent a great deal of time misinforming the public over the past 18 months.

Not till there is more long term data.

Could you outline how a vaccine could cause side effects that only emerge in the long term @Hotcoffee10?

For Pfizer vaccine the risk of death per dose appears to be 1 in 67000 doses given.

No, it doesn’t, and even that website allows for that.

Yellow card usually under reports.

As I say, I don’t think you can extrapolate from normal yellow card activity to the vaccine rollout. There are so many confounding factors - hugely increased promotion of YC, greater publicity around possible side effects, mass vaccination of adults rather than kids, greater nerves around something that’s ‘new’ rather than just the annual flu jab that makes you feel rough, adults are more able to analyse and articulate their health and may be more likely to look for patterns - that ‘usual’ Yellow Card conditions can’t possibly apply.

I mean, how many of us reported with YC when our babies were grizzly or had a fever or slept loads after their vaccines - even if we talked to other people about it? I didn’t, and I was one of the 15-20% (oldish figure from 2014 but most recent I could find) who’d actually heard of it. According to the study most who knew about it worked in healthcare…

I shared the actual MHRA figure (it won’t be on UKHSA, formerly PHE, they don’t run Yellow Card.)

Can you explain why the claim of higher ADRs per dose as compared to flu vaccine is fake?

6 healthy children are reported to have died from Covid 19. Given the size of the UK population statistical risk approaches 0 for healthy children.

It would be nice if public health England reported the data of adverse events per 100000 on their website but the data breakdown is based on data they provide.

Long term data on safety and efficacy of the vaccine in at risk adults would enable a measured decision to be made on a longer larger trial in kids.

You are talking about the entire next generation. It’s a completely new drug, different to all previous childhood vaccines. What is the rush?

4500 is not enough to test for adverse events in a drug you are giving to a low risk healthy population. Would you give it if a 1 in 5000 risk of death? I seriously hope not.

4500 is not enough to test for adverse events in a drug you are giving to a low risk healthy population. Would you give it if a 1 in 5000 risk of death? I seriously hope not.

Luckily there have been about a billion doses given so we don’t have this straw man to contend with, distracting as he might be waving about over there.

@JassyRadlett if yellow card data isn’t reliable what safety data for rare but serious adverse events is there? You say there is data from other age groups - this is it.

And again how do we know how many of the billion doses have resulted in a serious adverse reaction. We know it’s not 0, how many then?

@JassyRadlett

4500 is not enough to test for adverse events in a drug you are giving to a low risk healthy population. Would you give it if a 1 in 5000 risk of death? I seriously hope not.

Luckily there have been about a billion doses given so we don’t have this straw man to contend with, distracting as he might be waving about over there.

[quote Hotcoffee10]@JassyRadlett if yellow card data isn’t reliable what safety data for rare but serious adverse events is there? You say there is data from other age groups - this is it.[/quote]
No one is saying it isn't reliable, it just shouldn't be used in the way you're attempting to.

Very common tactic from the anti-vaccine groups though.

It's used to identify signals which need further investigation - such as menstrual related symptoms.

You are talking about the entire next generation. It’s a completely new drug, different to all previous childhood vaccines. What is the rush?

Let’s turn it around: We’re talking about the next generation. This an entirely new disease, different from anything we’ve encountered. The long term data on its impact on children is completely lacking. It causes heart symptoms in a small minority of children who get it. So does the vaccine, but not to as many. There have been widespread reports of other long term impacts on children who have been ill, though these haven’t been picked up much by the medical community and may well be overplayed by worried parents or those with an agenda to push. Regardless, we don’t have certainty on what an infection will do to kids a few years down the track. Hopefully nothing! We also have the possibility that this disease mutates to something that is more dangerous to children, so it would be good to minimise the chances of that happening.

Do you see?

(It’s not a drug, they’re different from vaccines - they work entirely differently.)

I will also admit that I’m not entirely confident that every single entry on YC and VAERS is genuine.

So MHRA say 3-6 yellow card reports per 1000 doses. Can you provide breakdown of how serious those ADRs are and how that compares to for example the flu vaccine or other childhood vaccines. Because it seems on an order of magnitudes much higher to me.

It’s not me whose got the straw man argument. You say it’s safe because billions of doses have been given. I say there have been higher reports of adverse events than any other vaccine. You say those reports are unreliable.

Well how exactly do we know it’s safe enough to give our children then? If the only safety reporting system doesn’t work doesn’t that mean we have no reliable data on rare but serious adverse events? And isn’t that a pretty big issue, no?

And again the vaccine won’t stop kids getting Covid. It might even mean they develop less robust long term immunity. Most kids have been exposed already in the UK so they will have some immunity.

And again how do we know how many of the billion doses have resulted in a serious adverse reaction. We know it’s not 0, how many then?

Because we have schemes like YC that enable reports to be considered in closer detail, and because this is frankly the most scrutinised pharmaceutical rollout in history.