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?

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.

Posters on mumsnet love to say “link some peer reviewed research” and then when you do they say you can’t possibly understand it??? Obviously I have a scientific background as many on this forum do. I actually think public engagement with science is really important and I absolutely reject the idea engaging with important ideas and asking questions is only for people with university positions or whatever your definition of expert is.

Ok, I think I see where you’ve got confused. There’s a difference between a study’s primary endpoint and everything it looks at.

For example the Pfizer study found that apart from immune response from the smaller dose, it was 90.7% effective in preventing Covid. It also looked at safety measures.

Hospitalisation levels in children are so low that they would be difficult to capture in an RCT but prevention of infection is a useful proxy.

Where does it say 90% protection against infection? Genuinely curious, I have only read the press release (don’t think they published all the data) but if it was 90% protection against (symptomatic?) Covid I would have thought that would have been the first thing they shouted about?

(And you’re entirely right that the primary goal was to compare immunobridging criteria in this cohort, with this dose, to 16-25 year olds. That is, does it elicit the same immune response as produces the impacts we’ve seen in older people. It does, which feeds into actual disease prevention. It will be interesting to see duration of immunity over time - you would expect these younger cohorts to potentially mount a more durable immune response.)

It looked at safety. Do you think the numbers of children are adequate to detect rare but serious adverse events? The FDA did not.

Do you think the duration is long enough to make any statements on long term immune response?

To be justification for vaccinating the entire population of healthy children this trial needed to be much bigger, much longer and have some proper hard end points. (If hospitalisation is so low we can’t measure it why would we vaccinate anyway!?)

It looked at safety. Do you think the numbers of children are adequate to detect rare but serious adverse events? The FDA did not.

The FDA thought it’s safety profile was sufficient to license, with ongoing monitoring for rare events - just like for any other new pharmaceutical. (I’ve shared a few times recently my story of being part of officially adding a new side effect for an antibiotic 40 years after it was licensed…)

Do you think the duration is long enough to make any statements on long term immune response?

I’ve responded to that. The answer is the same as for every other age cohort.

To be justification for vaccinating the entire population of healthy children this trial needed to be much bigger, much longer and have some proper hard end points. (If hospitalisation is so low we can’t measure it why would we vaccinate anyway!?)

Why do you think there is a higher standard of evidence required for this vaccine than for many we already give to children and babies?

@Hotcoffee10

Posters on mumsnet love to say “link some peer reviewed research” and then when you do they say you can’t possibly understand it??? Obviously I have a scientific background as many on this forum do. I actually think public engagement with science is really important and I absolutely reject the idea engaging with important ideas and asking questions is only for people with university positions or whatever your definition of expert is.

Again, you're putting words in my mouth - that isn't what I said in the slightest

Reading, engaging, improving understanding, asking questions obviously important and people don't do enough of it.

Using this, and not acknowledging the idea that you're probably not infallible, to make definitive arguments (which tend towards the anti-vaccine in your posts) is an entirely different thing

Please tell me what other vaccine added to the UK schedule for routine inms with this little data in so small a group and with so short a follow up.

Again I do not claim to be infallible. I have made suggestions only and been clear these are not things I know the answer to. I am deeply concerned about the safety of this vaccine for children. I think we need much more evidence on long term immune responses in adults before we even think about vaccinating children and we should have much larger scale trials before giving them to entire population.

I am sad to say I doubt the integrity of the FDA when they made that decision.

I am deeply concerned about the safety of this vaccine for children.

I'm deeply concerned about effect of covid on children. So, it's a good thing if we have a choice, isn't it? You can decide not to vaccinate your children, some parents decide to vaccinate their children.

Parental choice is an argument to an extent @rainrainraincamedowndowndown but usually before a vaccine is licensed there must be clear evidence of benefit for kids not just parental concern.

Your concerns about the health effects of Covid on kids are not based on the available data which is that covid it is a mild often asymptomatic illness in kids.

I fear parental choice will not last long. Look at what has happened with adult vax. It seems like a short journey from it being recommended to required for normal life - in Scotland we already have vax pass. I believe in the US vaccine mandates for schools are already in place in some areas. Where is parental choice then?

Please tell me what other vaccine added to the UK schedule for routine inms with this little data in so small a group and with so short a follow up.

I mean, billions of doses have been given. Millions to under 18s as young as 12.

There isn’t a magic switch that is triggered between 11 years 11 months and 12. This isn’t a brand new study with no associated data. The safety profile hasn’t shown up anything unexpected compared to older cohorts. They’ll keep monitoring, as they do for all new pharmaceuticals

We had much less data on Bexsero, for example, when it was licensed and introduced - not least because of the low levels of MenB circulating. There were longer follow up times but - as expected from vaccine history - no effects after 8 weeks. Because that’s how vaccines work (I’ve shared information and links on this. We probably already have more data on Pfizer in children than we do on Bexsero even now - and in the UK parents will be able to draw on what’s going on elsewhere to make the decision for their own children, I hope.

I fear parental choice will not last long. Look at what has happened with adult vax.

The UK has long resisted the path taken by other countries to mandate vaccines for school entry, childcare etc - preferring measles and whooping cough outbreaks, for example.

They’ve already said there would be no compulsion for children.

Mandatory vaccines for certain jobs have existed previously.

Parental choice is an argument to an extent @rainrainraincamedowndowndown but usually before a vaccine is licensed there must be clear evidence of benefit for kids not just parental concern.

The FDA and CDC felt there was sufficient evidence of benefit - the CDC presentation and papers are clear on this point.

The MHRA licensed for 12-17 year olds. Our own JCVI (they don’t license) found evidence of a small individual benefit despite some questionable inclusions/exclusions from the data and categories they were considering.

@dementedpixie

No, I already put a link above saying the dose is about ⅓rd of the adult dose

I didn't realise this, do you know why? I'm assuming it's not being based on bodyweight alone since there can be over 100kg difference amongst adults, certainly I know a fair few parents who's children are heavier than them too. I'm assuming maybe less of the vaccine is safer but then surely also won't work as well. Or maybe children don't need as much to get the same immune response due to their immune system being quite different from adults, as in they have much more red bone marrow and are capable of producing many more antibodies than us? Maybe a full dose would over stimulate the immune system?
Hmm, I'd certainly like to learn more about this.

[quote Toty]@dementedpixie

No, I already put a link above saying the dose is about ⅓rd of the adult dose

I didn't realise this, do you know why? I'm assuming it's not being based on bodyweight alone since there can be over 100kg difference amongst adults, certainly I know a fair few parents who's children are heavier than them too. I'm assuming maybe less of the vaccine is safer but then surely also won't work as well. Or maybe children don't need as much to get the same immune response due to their immune system being quite different from adults, as in they have much more red bone marrow and are capable of producing many more antibodies than us? Maybe a full dose would over stimulate the immune system?
Hmm, I'd certainly like to learn more about this.[/quote]
I believe Pfizer’s trials considered three different dosing schedules and this was considered optimal in terms of reaching the same immune response as the reference group (16-25s).

Vaccines don’t work like medications - they don’t need to accumulate to a certain concentration in the body to be effective. In vaccines, the body’s own cells carry the immune information around the body from the cells near the vaccination site that are ‘trained’ by the vaccine before it’s broken down and expelled.

That means weight isn’t generally a factor in vaccine doses. In fact there are some vaccines where adults receive a smaller dose of active ingredient than children, because they tolerated it less well and had greater side effects. (This blew my mind a bit when I first learned about it.)

Men B vaccine was tested on nearly 3 times the number of children for a longer time period. It is not a novel vaccine technology never before licensed for use in humans. There is data from other similar vaccines indicating a long term immune response is likely. Meningococcal disease is a rare but serious threat to children, much greater than covid.

The doses of covid vaccine given to adults are showing a safety and side effect profile never before seen in any vaccine licensed in terms of reported adverse events on the VAERs data in US and yellow card in UK. Many many times worse than any other vaccine. How many say the publicity around these vaccines is causing over reporting of adverse events which could be true. Some say the adverse events are underreported. We don’t know about the true safety profile because there is no control group the trials in adults were only 4 months long.

The two are not comparable.

@JassyRadlett
Thanks for the explanation. Makes sense. I didn't realise they'd tried different doses in trials

Men B vaccine was tested on nearly 3 times the number of children for a longer time period.

That’s not what I said. I said data - even with a larger trial cohort for Bexsero we still have a better safety profile on this one when it comes to rare side effects than we did on MenB, given the numbers who have already had it.

Very rare side effects aren’t much more likely to show up in a cohort of 15,000 rather than 5,000 (made up numbers.) The millions of teenagers who’ve already had this vaccine - and the data we get out of other countries who are deploying to their 5-11s already - will give us far superior data.

Unbothered by the ‘extended time period’ for the reasons I’ve mentioned.

Interesting on the VAERS data. Can you share the relative numbers against doses given, weighted for age and likelihood to report demographic data? Thanks!

These vaccines weren’t even recommended for over 12s. The JCVI said the benefits didn’t outweigh the risks for them.

@Sumsencosrshit

These vaccines weren’t even recommended for over 12s. The JCVI said the benefits didn’t outweigh the risks for them.

No, you're wrong - they said the benefits outweighed the disadvantages for this age group (as they do in every age group, it now transpires)

@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.

@JassyRadlett (like the username by the way) VAERs data is here.

openvaers.com/covid-data/mortality

Yellow card is here on page 10 of this report.

assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1034810/Coronavirus_vaccine_-_summary_of_Yellow_Card_reporting_10.11.2021_Cleared.pdf

And an FOI here of all vaccine reactions reported in previous years via yellow card. P4 of this report.

www.whatdotheyknow.com/request/690857/response/1653809/attach/4/JCVI%202018.pdf?cookie_passthrough=1

TLDR the total adverse events reported to yellow card in UK related to Pfizer vaccine alone is over 120000. (AZ and moderna another 220000)

Yellow card scheme is usually believed to be an under report rather than over report.

Previous years ADRs related to all vaccines in the UK are around 3000 total.

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.

Oh and the safety monitoring you refer to - this is it. So if you are going to dismiss it as biased then how would you suggest we monitor vaccine safety.

In terms of adverse reactions weighted for age and likelihood to report. Nobody has that data. I agree it would be a very good idea to collect it.