Authorisation has today been granted for a new presentation of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for use in infants and children aged 6 months to 4 years.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the vaccine in this new age group after it has been found to meet the UK regulator’s standards of safety, quality and effectiveness, with no new safety concerns identified. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.
This presentation is specially designed for this new age group and given at a lower dose compared to that used in individuals aged 5 to 11 years (3 micrograms compared with 10 micrograms). It is given as three injections in the upper arm, with the first two doses given 3 weeks apart, followed by a third dose given at least 8 weeks after the second dose.
In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 4,526 participants. The common, expected side effects (reactogenicity) were in-keeping with what can be anticipated from a vaccine in this age group.
It will be for the Joint Committee on Vaccination and Immunisation (JCVI) to determine if the vaccine will be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme.
Notes to editors:
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
This new line extension granted by the MHRA is valid in Great Britain only and was authorised via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the vaccine in this new age group after it has been found to meet the UK regulator’s standards of safety, quality and effectiveness, with no new safety concerns identified. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.
“Meets the standards… no new safety concerns…” -
That’s a flat lie. Raine’s bunch of criminals at the MHRA know damn’ well, unless they’ve been under stones full-time for the past two years, that the bloody poison-stabs kill, maim and injure people - by the goddamned scores of thousands, millions even. They must know this!
The bastards need to be in the Nurnberg 2 dock as soon as possible, on trial for their crimes. These were the scumbags who were laughing and joking about “breaking out the champagne” when they knew that stab-damaged - and stab-bereaved - people were actually listening in by zoom to their meetings.
Simple, incredible, wilful, blind - and outright criminal - irresponsibility. Technocrat dolts blinded by their own incredible brilliance! And on the take, natch…
At Prime Minister’s Questions this afternoon (7th December), Tory MP Andrew Bridgen told Prime Minister Rishi Sunak that the mRNA Covid jabs have caused more deaths and adverse events than have been caused by conventional jabs worldwide in the past 50 years.
Bridgen said:
“There have been more reported deaths and adverse reactions following mRNA vaccination in 18 months, than there has been from every conventional vaccine administered worldwide for the last 50 years.
And given the mRNA vaccines are not recommended for pregnant women or those who are breastfeeding, would my right honorable friend overturn the big-pharma funded MHRA recent recommendation that these experimental vaccines are administered to children as young as six months old?”
In response, Sunak said:
“Let me first say that I believe that covid vaccines are safe and effective.”
Followed by no press release from the MHRA (Medicines and Health Regulatory Agency). According to Dr Aseem Malhotra (a pro vaxer no converted to at least recognise the real dangers) on The Highwire, the MHRA is more than 80% funded by the private sector. Not an arm of government or the actual health services!!
Oh yes. The fool Raine has actually admitted that far from regulating Big Pharma gangsters, MHRA is about “enabling” them!
I begin to think of her as a thicko who’s been through a long period of indoctrination into technocrathood, and now thinks of herself as pretty well on top of of all The ScienceTM, and completely competent to regulate medicines. Twerp!
I don’t know exactly, Rich, but Debbie Evans, UKCnews’s Nursing Correspondent is keenly on to it, and urges people to attend the open-to-public meetings of the MHRA by zoom. UKC is the place to get more nitty-gritty.
Zoom is well known as one of the easiest video conferencing tools to hack. Apart from the usual spooks, any half decent hacker can get into Zoom meetings.
