The U.K. regulator may decide on whether Covid vaccines should be approved for British babies before Christmas. The Mail has the story.
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in the U.K., told MailOnline it is currently reviewing data on Moderna’s vaccine.
The pharmaceutical firm has submitted evidence in the hope of getting its jab approved for children aged six months and older, as it is in the EU and U.S. Only over-fives can currently get Covid vaccines in the U.K.
Any approval of jabs for babies would cause huge controversy. British authorities have so far held out on approving jabs for infants despite massive pressure, due to concerns that the benefits do not outweigh any potential risks. Children rarely get seriously ill with Covid and the majority are thought to have already been infected.
Experts said today that, even if approved, the jab must not be rolled out “en masse” to healthy infants.
Dr. Laura Squire, the MHRA’s Chief Healthcare Quality and Access Officer, revealed the regulator was processing an application from Moderna. But she added the mRNA jab, which works in a similar way to Pfizer’s, would only be approved if it met strict safety and efficacy standards.
She said: “We have received an application from the company to extend the approval of Moderna to those aged six months to five years. No extension to the vaccine will be approved unless it meets our stringent standards of safety, quality and effectiveness.”
Moderna’s jab application was submitted in mid-September, meaning it has already gone through weeks of analysis. The MHRA declined to detail the timeframe for its expected decision. But it took health chiefs two months to consider the evidence before approving the first Covid jab in December 2020. Moderna’s application is for its existing jab to be rolled out to other groups, rather than for a new drug. Dr. Squire also confirmed rival vaccine maker Pfizer has not yet applied to have its jab approved for use in the youngest children.
Professor David Livermore, a microbiologist at East Anglia University, said giving the jab to the very limited numbers of children with specific conditions might be wise.
He said: “The tiny minorities of children with severe underlying health problems may benefit from vaccination against Covid.”
But he added that a large-scale jab campaign for children should be off the cards. “There should be absolutely no question of mass vaccination of healthy children, for whom the benefits don’t outweigh the risks,” the professor said. “Over 80% of children have now had Covid and have developed natural immunity. This lasts longer than vaccine-induced immunity and is broader in respect of covering variants. Vaccines offer nothing useful to this very large majority.”
Professor Livermore said the risks of vaccine-related harm, while tiny, do not clearly outweigh the very minor benefits for the vast majority of children.
“This is acceptable for elderly vulnerable populations at risk from severe Covid,’ he said. “It’s not acceptable for healthy children, who are at minuscule risk of developing severe Covid.”
He added that he would like Britain to follow Denmark’s lead and stop vaccinating children against Covid unless recommended by a specialist paediatrician.
Worth reading in full.
Moderna has now published the results of its trial in the under-fives. The study population was very small – too small to get meaningful efficacy results and efficacy was “inferred” from “neutralising antibody concentrations”:
The efficacy of mRNA-1273 was inferred on the basis of having met prespecified criteria for immunobridging, the approach used for authorisation and approval in COVID-19 vaccine studies involving adolescents and older children.
In the supplementary appendix (Table S28 and S29) vaccine effectiveness estimates are given which, while the confidence intervals are wide, are all below 51% and one is even negative.
Among children 6-23 months of age, eight serious adverse events occurred in the vaccine group and none in the placebo group. The data in the supplementary appendix consistently show the vaccinated with adverse events of grade 3 (prevents carrying out daily tasks) and grade 4 (hospitalisation) many times higher than either a placebo or lower dose cohort.
Medically attended unsolicited adverse events (Table S26) were two to three times higher in the vaccine cohort than the placebo:
- 1% vaccinated vs 0.3% placebo in 2-5 years
- 1.5% vaccinated vs 0.8% placebo in 6-23 months
- 1.2% vaccinated vs 0.5% placebo in 6 months-5 years
This indicates that 0.7% of the vaccinated or 1 in 143 had an unsolicited side-effect of the vaccine that required medical attention.
Alex Berenson spotted that in the appendix Moderna disclosed a case of new-onset Type 1 diabetes in a one-year-old girl that its investigators found was vaccine-related. This is Moderna admitting that its vaccine can give children diabetes. El Gato Malo points out that this does not appear to have been disclosed ahead of the approval of the vaccine in the U.S.
A German retrospective study found a hospitalisation rate from the (lower dose) Pfizer vaccine in under-fives of around one in 500.
Why are regulators even considering approving these vaccines for small children?
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I’m going to stick my neck out and bet that they will get approved for this age group but that the government won’t advise tots this young get them, in the same way several other countries are doing. Mind you, I could be being a bit overly optimistic here given the limited options you guys have for your next PM..
Cradle to grave marketing and shortening the time in between.
Oh, that’s class.
Cradle to Grave drug pushing and addiction. MHRA et al are in the drugs-profits business. Not health.
Why would anyone think that this was something worth considering? I have just done a word search and the words, futile gesture, ineffective, pointless, meaningless and ineffectual come up when thinking whether there is any benefit to human health in doing this. But of course it is worse than this because these potions are causing harms. It is also the case that, despite the fact that alternative and maybe safer vaccines like Valneva are approved; the only game in town is the mRNA potion.
And so we must ask what is driving this? as far as I can see it is a sinister and monstrous move to hook the whole human race up to a lifetime of dependency on mRNA potions. The prize for big pharma is enormous, the totalitarian control of the population has our fascist politicians drooling with joy.
Where will we find a politician or a leader to save us from descending down these circles of hell?
One just has to wonder what type of parent allows their tiny baby to be used as a guinea pig.
Because science – sorry THE science
‘The $cience.’
There can be only one science Frodo. One science to rule them all….
The late, incomparable US Supreme Court Justice Antonin Scalia, a devout traditionalist Catholic, said he believed the Devil was a real being, an actual individual. Perhaps he’d actually met him working at Moderna.
What is the matter with this guy?In the whole of 2020-2021, Only 1 child died (aged 1-15) of covid-19 alone. Out of over 7 million population. No children died between the age of 1-10.
Even MHRA have reported 8 child deaths from the toxic jab. And we know that is likely to be a factor of at least 10 too low.
Here is last week’s VAERS data for child deaths in the USA. 162 jab deaths – 2 deaths under 6 months old!
I note that VAERS has not updated this week. The date has changed but the results are the same as last week. Also, the OWID jabs data for the USA stopped on 11th October.
Unreal
Safe and Effective. SIDS – bad breast milk we are told. Or too much porridge syndrome….
The Yanks are on the way to approving it for infants 15-0 the vote apparently + pushing to get it as a school requirement, This will all absolve the Jabbers of any litigation forever !!!
They had the second vote yesterday and approved that it be added to the schedule. No one dissented. The regulations should not allow an emergency use medicine to be put on a routine injection schedule. It has not happened before and should not have happened this time either.
There must be a lot of money changing hands.
These were authorised for use on the basis that there was a life threatening emergency. There is no emergency, the jabs do not stop transmission and children are not at risk. There is zero justification for these still to be available to anyone far less to children who will have a far higher risk of serious adverse effects. No genotoxity studies or carcenogenicity studies have been done, the spike protein has been shown to remain in the body for periods of at least 12 months.
Why would anyone expose children to this risk unless for malevolent intent?
It raises the question of what should be done when they admit that there is no longer an “Emergency” to authorise it’s use. How can they complete a conventional process for new drugs now? After all, it’s early days, but there is a lot of evidence (probably incomplete) that could be used in a proper assessment. So much so that they want to brush it under the carpet.
“U.K. Regulator Mulls.”
There is a sickness right there.
“the mRNA jab, which works in a similar way to Pfizer’s, would only be approved if it met strict safety and efficacy standards”.
That’s right, just like the jabs for adult and older children.
I am yet to hear a public health official anywhere in the world describe any of the jabs as anything other than “safe and effective”.
“Why are regulators even considering approving these vaccines for small children?”
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Its all about the liability, innit? Doesn’t matter how toxic and dangerous it is, once on the US child jab schedule there’s no pharma liability for anyone forever. The UK govt gave upfront liability indemnity in 2020 for the EUA, and with more adults are getting a bit twitchy about it these days, kids are a logical target regardless of need or the risks. If parental concerns can be sufficiently ‘nudged’ to get it into as many kiddie arms as possible then damn the consequences, lives don’t matter when there’s profit to be made. Pfizer, Moderna, J&J & BioNTech share prices all rose markedly after the VCIP decision. Cristian Terhes and colleagues of the Special EU Committee had some choice words to say about it recently: https://www.youtube.com/watch?v=2jTgDj7uiX8
That is….unless fraud is proven. And it will be sooner or later
Is this just about profits, though? If so, then the adverse effects must just be down to faulty design, rather than being an intended consequence.
I find it hard to get my mind round, but I suspect the motivation / objective is a combination of profit (including payments to enablers), intent to damage health and establishment of a regular vaccine schedule which can later be used to inject dubious ingredients (including electronic chips?) into human bodies.
“Why are regulators even considering approving these vaccines for small children?”
Why? Money
Big Pharma’s indemnity against harm caused by their experimental vaccines will continue indefinitely if they can get it approved for use on children.
85% of MHRA’s funding comes from Big Pharma and the Gates Foundation.
This is the disgusting corruption that has already killed hundreds of children in the western world already.
Why are our gov’ts and health authorities so eager to kill our children with unsafe and ineffective covid vaccines? Let’s all insist every relative of every politician get in line first to receive these poisons. You will see an immediate halt to this injection madness. Just say NO
Vaccinating infants provides great protection. For the Pharma companies, against law suits for vaccine injuries.
What parent would allow their child to be in a trial like this?