MHRA

“Safe and Effective”: MHRA Approves Moderna Covid Vaccine for Six to 11 Year-Olds and Valneva Vaccine

The U.K. medicines regulator, the MHRA, has approved the Moderna Covid vaccine for six to 11 year olds, describing it as “safe and effective”.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an update to the current U.K. approval of the Moderna COVID-19 Vaccine, or ‘Spikevax’, that allows its use in Great Britain (GB) in six to 11 year-olds.

This approval takes into account the extension to use in children aged six to 11 years already approved by the European Medicines Agency on March 2nd 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision.

Spikevax is authorised in children aged six to 11 in Northern Ireland under the update granted by the European Medicines Agency on March 2nd.

Dr June Raine, MHRA Chief Executive, said:

Vaccine Safety Update

This is the 30th of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 29th one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This was done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr. Tess Lawrie in June wrote an open letter to Dr. June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • The first batch of documents from the Pfizer vaccine trial released by the U.S. FDA on March 1st includes a nine-page list of 1,291 different types of adverse event reported post-authorisation.
  • An additional Pfizer trial document released separately shows immunosuppression in the first seven days following vaccination and evidence supporting natural immunity.
  • A study suggests the Pfizer vaccine can damage brain cells and the immune system.
  • U.S. army doctor Pete Chambers gave an informed consent briefing to 3,000 soldiers, setting out in full the risks and benefits of the vaccine, following which 99.8% declined to get vaccinated. Dr. Chambers was subsequently dismissed.
  • Data from Rambam hospital in Haifa, Israel reveal a stillbirth, miscarriage and abortion (SBMA) rate of 6% among women who never received a COVID-19 vaccine, compared to 8% among women who were.
  • Case report in journal Brain Hemorrhages of intracerebral bleeding following vaccination.
  • A study shows that more than two-thirds of adolescents with COVID-19 vaccine-related myopericarditis had persistent heart abnormalities months after their initial diagnosis.
  • The Miami Open tennis tournament saw 15 withdrawals or retirements. While all players were required to be vaccinated to enter the U.S., it’s not clear how many of the withdrawals were vaccine related.
  • Eudravigilance – the European version of the Yellow Card Reporting system – as of April 3rd has reported 4,039,333 reactions from 1,670,823 reports of which 1,862,987 were deemed as serious. 42,782 fatal reactions were reported with an approximate actual number of deaths being 14,438. This is due to a 2.96 reporting rate in fatalities across multiple reactions. Of these reports, 30,764 injuries have been recorded in the 0-17 years age group. 
  • VAERS – the American version of the Yellow Card reporting system – as of March 25th reports a total of 1,205,755 reports of adverse events following Covid vaccines, including 26,396 deaths and 214,521 serious injuries.
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to March 22nd) 118,035 reports of adverse events, including 809 deaths.
  • Children (Under 18) Adverse Events U.K. – up to March 23rd, the MHRA reports a total of 3,674 adverse event reports, comprising 3,366 Pfizer, 262 AstraZeneca, 24 Moderna and 22 unspecified from 3,314,700 children vaccinated. This includes 70 reported cases with Pfizer of myocarditis/pericarditis, suggesting a current reported risk of 14 cases per million first doses and 12 per million second doses for this age group.
  • Booster Doses – 47,418 adverse events have been reported across all vaccines up to March 23rd from 38,701,747 people vaccinated, suggesting a reporting rate of one adverse event per 816 doses.

Summary of Adverse Events in the U.K.

According to an updated report, as of March 23rd the MHRA Yellow Card reporting system has recorded a total of 1,475,298 events based on 450,567 reports. The total number of fatalities reported is 2,075.

Vaccine Safety Update

This is the 29th of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 28th one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This was done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr. Tess Lawrie in June wrote an open letter to Dr. June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • The U.K. Children’s Covid Vaccines Advisory Group (CCVAG) has warned there is no benefit and all risk in vaccinating children.
  • Pfizer’s informed consent documents show potential concerns regarding Covid vaccine side-effects, including myocarditis, original antigenic sin and birth defects.
  • Dr. Jessica Rose notes that no genotoxicity or carcinogenicity studies were done on the Covid mRNA vaccines because the World Health Organisation did not consider them necessary.
  • Over two million vaccine injuries have now been reported via VAERS in America.
  • Yorkshire Examiner reports on the death of 18 year-old Kasey Turner from a blood clot caused by the AstraZeneca vaccine. Kasey was training to be a paramedic and had received her Covid jab early, which meant that she was given the AstraZeneca jab.
  • The Mail reports on the death of 45 year-old Nicola Weideling of a stroke caused by the AstraZeneca vaccine.
  • BBC News reports on the death of 34 year-old Kim Lockwood of a “catastrophic” bleed on the brain caused by the AstraZeneca vaccine.
  • VAERS – the American version of the Yellow Card reporting system – as of March 11th reports a total of 1,183,495 reports of adverse events following Covid vaccines, including 25,461 deaths and 208,209 serious injuries.
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to March 11th) 115,851 reports of adverse events, including 796 deaths.
  • Children (Under 18) Adverse Events U.K. – up to March 9th, the MHRA reports a total of 3,569 adverse event reports, comprising 3,275 Pfizer, 248 AstraZeneca, 24 Moderna and 22 unspecified from 3,314,700 children vaccinated. This includes 68 reported cases with Pfizer of myocarditis/pericarditis, suggesting a current risk of 15 cases per million first doses and 11 per million second doses for this age group.
  • Booster Doses – 46,943 adverse events have been reported across all vaccines up to March 9th from 38,437,814 people vaccinated, suggesting a reporting rate of one adverse event per 819 doses.

Summary of Adverse Events in the U.K.

According to an updated report, as of March 9th the MHRA Yellow Card reporting system has recorded a total of 1,471,106 events based on 449,324 reports. The total number of fatalities reported is 2,061.

Of Course Vaccines Still in Phase 3 Clinical Trials Are ‘Experimental’

‘Fact check’ website Lead Stories (which Facebook and others rely on to guide censorship) has published an article by journalist Ed Payne claiming to ‘fact-check’ a recent Daily Sceptic article by retired Pharmaceutical Researcher Dr. John D. Flack. The ‘fact check’ is headlined: “Covid Vaccines are NOT Experimental Gene Technology – they ARE Fully Authorised.” Here Dr. Flack responds.

I think Mr. Payne and I are jousting around semantics – none of which addresses my fundamental concerns as to whether appropriate preclinical regulatory test protocols were conducted prior to MHRA/FDA/EMA approval of these novel gene-based ‘vaccines’. In his own admission, “they’re still under trial for about three years after being given the OK”. Under the emergency powers these gene-based ‘vaccines’ were authorised by the Government health regulatory bodies during the clinical trial phase of medicine development. Many products that have yielded promising results in early clinical trials with limited patient numbers have failed in the ‘field’ when larger patient numbers are involved. Therefore, to those practised in the art of pharmaceutical development, an experiment is still being conducted until the trials are fully completed and reported. To date, only interim analysis of the Phase 3 study results has been published, meaning the Phase 3 studies are ongoing (and are now unblinded so the quality of any final results is questionable). Will the product meet or fail to meet the agreed clinical end points? These are very large clinical trials of products however one wants to describe them.

I did make a mistake in saying: “Under the emergency laws surrounding the pandemic, these new injections were not approved but licensed as experimental medicines so there is no transparency as to the regulatory toxicology studies conducted.” Mea culpa. I should have said: “Under the emergency laws surrounding the pandemic, these new injections were approved as experimental medicines and not as licensed medicines.” (This has now been amended.) The MHRA in its statement says its authorisation was given “following a review of safety, quality and efficacy information from the clinical trials”. This begs the question – which is the main thesis of my article – of what preclinical studies were conducted to identify the toxicological profile of the both the gene sequence in the injection and the spike protein that it induces? I think we should know. Frankly, a ‘trust me’ statement that “there is sufficient evidence to demonstrate the safety, quality and effectiveness of the vaccine” is not good enough.

Vaccine Safety Update

This is the 24th of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 23rd one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This was done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr. Tess Lawrie in June wrote an open letter to Dr. June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

Summary of Adverse Events in the U.K.

According to an updated report published on January 20th, the MHRA Yellow Card reporting system has recorded a total of 1,429,071 events based on 436,173 reports. The total number of fatalities reported is 1,954.

  • Pfizer (25.5 million first doses, 22.2 million second doses) now has one Yellow Card in 160 people vaccinated. Deaths: 1 in 36,638 people vaccinated (696).
  • AstraZeneca (24.9 million first doses, 24.2 million second doses) has one Yellow Card in 103 people vaccinated. Deaths: 1 in 20,924 people vaccinated (1,190).
  • Moderna (1.6 million first doses, 1.4 million second doses) has one Yellow Card in 48 people vaccinated. Deaths: 1 in 53,333 people vaccinated (30).

Moderna Covid Vaccine Approved for Use in 12 to 17 Year-Olds by U.K. Regulator

The Medicines and Healthcare products Regulatory Agency says the Moderna Covid vaccine is safe for use in U.K. children aged 12 to 17 years. It is now up to the Joint Committee on Vaccination and Immunisation (JCVI) to advise the Government on whether the Moderna jab should be rolled out to children in this age group. Reuters has the story.

Moderna’s vaccine was recommended for use in adolescents by European regulators in July and is awaiting U.S. authorisation. It is already approved for people over the age of 18 in the U.K.

Britain’s JCVI gave the go ahead on August 4th for 16 and 17 year-olds to get their first dose of Pfizer’s Covid vaccine ahead of the reopening of schools for the new education year in September.

JCVI will make a decision on whether 12-17 year olds should be vaccinated with the shot made by Moderna as part of its deployment programme.

The MHRA said it did not identify any new side effects with the vaccine and that the safety data was comparable with that for young adults, with adverse events being mostly mild and moderate and including sore arms or fatigue. …

The vaccine developed by Pfizer… got MHRA’s nod for use in children aged 12 to 15 on June 4th.

Worth reading in full.

All U.K. Children Could Be Offered Covid Vaccines by the End of the Year

The Government will announce its plans for the vaccination of children against Covid later today and is expected to say that only clinically vulnerable children and those living with vulnerable adults will be included in the national roll-out – for now. It hasn’t taken long for reports to emerge suggesting that all children could be offered a vaccine by the end of the year. The argument is that it will be difficult to reach herd immunity if children remain unvaccinated. The Telegraph has the story.

The Joint Committee on Vaccination and Immunisation (JCVI) is expected to announce that only vulnerable youngsters between the ages of 12 and 15, and 17 year-olds within three months of their 18th birthday, will be offered a jab amid concerns there is too little data on safety and efficacy in young people.

But the JCVI is expected to leave the door open for more children to be vaccinated once trials conclude later this year, the Telegraph understands.

In June, the Medicines and Healthcare products Regulatory Agency approved the Pfizer jab for 12 to 15 year-olds in Britain following early trial results in teenagers, but there is still no data for younger children. 

Pfizer is expected to release results on trials for five to 11 year-olds in September and two to five year-olds by November, with the company expecting regulator approval within a month of releasing positive data. AstraZeneca is also conducting trials in children aged six to 17, with the British team likely to release results before the end of the year.

On Sunday, experts warned that it may be difficult to reach herd immunity in Britain if children are not vaccinated. Nearly one in five people in the U.K. are under 16 and, despite everyone being offered a vaccine, around 12% of adults have not had a first jab.

Professor Neil Ferguson, of Imperial College, a member of SAGE, told the BBC: “In the absence of vaccinating it’s inevitable that we’re going to have very high numbers of cases in teenagers, and we will not be able to reach herd immunity without significant immunity in people under 18.”

The JCVI is expected to keep the situation under review and will be watching the results from trials closely. 

Scientists are particularly concerned that vaccination may damage the developing immune system of younger children. Different age groups may require different doses, further complicating the roll-out, and companies must show it will not make children who get Covid more ill – which has happened with other vaccines in the past. 

Experts are also worried that the benefits to children may not outweigh the risks, making vaccination ethically dubious and leaving the Government vulnerable to legal challenges.

A Department of Health spokesman said: “The Government will continue to be guided by the advice of the JCVI, and no decisions have been made by ministers on whether people aged 12 to 17 should be routinely offered Covid vaccines.”

Worth reading in full.

Thousands More Women Report Changes to Periods After Covid Vaccination

By late June, Britain’s medicines regulator had received reports from almost 4,000 women who have suffered period problems after taking a Covid vaccine. Since then, around 9,000 more women have reported changes, according to Sky News.

The Medicines and Healthcare products Regulatory Agency has so far received more than 13,000 reports from women across the country who have experienced changes to their period after having the vaccine.

Experts say there is no evidence to believe the coronavirus vaccine affects fertility, but there are reports that some women are refusing to get the jab.

Dr Viki Male, a Reproductive Immunologist at Imperial College London, said women should feel confident getting the jab and that reports of changes are not unexpected, as similar reactions have been observed with the flu vaccine.

She told Sky News that 25% of women who contract Covid also see changes to their period.

“We know that sex hormones affect the immune system and the immune system affects sex hormones and we have some evidence that the flu vaccine, given a certain time in your cycle, can slightly dampen the amount of progesterone you have, and it’s the balance between oestrogen and progesterone that builds up and breaks down the lining of your uterus.

“So if these get slightly out of whack then we might expect to get a heavier period or a later period,” she said. …

Experts are concerned that increasing numbers of young women are hesitant about the vaccine or refusing to have it altogether, putting pressure on the Government’s plan to unlock the country as it relies heavily on high numbers getting vaccinated.

Dr Male said there is no scientific link between the vaccination and fertility issues and warned that women can be more susceptible to problems during pregnancy if they contract Covid.

Worth reading in full.

School Leaders Say Children Should Be Vaccinated before the Start of the Summer Holidays

Following the approval of the use of the Pfizer vaccine in those aged 12-15 by the U.K. medicines regulator, school leaders have called on the Government to vaccinate schoolchildren against Covid before the start of the summer holidays. Their hope is that pupils will be fully vaccinated before returning to the classroom in September. The MailOnline has the story.

Ministers have asked the Joint Committee on Vaccination and Immunisation (JCVI) whether to give the jab to teenagers – the current rollout is set to stop at age 18 except for children with serious health conditions. 

The JCVI – which normally rules who should get a vaccine – is expected to tell Number 10 that jabbing children is a “political” decision and will leave the ball in ministers’ court. 

Teaching unions and school leaders today said starting vaccinating children soon could ensure they have had both jabs by the time they start the school year in September.

But vaccinating children against the virus is a controversial issue because youngsters only have a tiny risk of getting seriously ill and their immunity would likely only protect older adults. 

More than 100 cross-party MPs and the World Health Organisation have said the priority should be to get vaccine doses abroad to poorer countries where vulnerable people still haven’t been jabbed before giving them to low-risk children.

Hamid Patel, Chief Executive of the Star Academies school trust based in Blackburn – the area of the country with the most cases of the Covid Indian variant – said schoolchildren should be vaccinated as a matter of priority.

He said there would be a much higher uptake if children were given the jab during term time before the school holidays…

And Patrick Roach, General Secretary of the NASUWT teaching union, also urged the JCVI to consider expanding the rollout to teenagers.

He said offering them the vaccine would “protect the wider adult population who are at greater risk from Covid”.

There are “ethical dilemmas” to be considered when it comes to the decision on whether or not to vaccinate children against Covid, an expert has said.

Professor Anthony Harnden, Deputy Chairman of the JCVI, said while a “very small minority” of children have been severely affected by the virus, children “in the main” do not get severe illness.

He told BBC Breakfast: “I think the vast majority of benefit won’t be to children, it will be an indirect benefit to adults in terms of preventing transmission and protecting adults who haven’t been immunised, for whatever reason haven’t responded to the vaccine and therefore that presents quite a lot of ethical dilemmas as to whether you should vaccinate children to protect adults.”

He added: “We need to be absolutely sure that the benefits to them (children) and potentially to society far outweigh any risks.”

Worth reading in full.

Stop Press: Health Secretary Matt Hancock says vaccinating children in the U.K. against Covid will take priority over donating doses to other countries.

U.K. Medicines Regulator Approves Pfizer Vaccine for Use in Children Aged 12-15

The U.K. has moved a step closer to vaccinating children against Covid today, with the medicines regulator having approved the use of the Pfizer vaccine in those aged 12-15. This comes in spite of the warning from Adam Finn, Professor of Paediatrics at the University of Bristol and a member of the Government’s Joint Committee on Vaccination and Immunisation (JCVI), that children should not be given Covid vaccines because of the “side effects“. The Guardian has the story.

“We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer-BioNTech Covid vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk,” said Dr June Raine, the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA).

She added it would be up to the JCVI to decide whether this age group would come under the vaccine deployment programme.

More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer vaccine, the Chair of the Commission on Human Medicines, Professor Sir Munir Pirmohamed, said. “We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side-effects.

“We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk. The MHRA will continue to scrutinise all of the suspected side effects data received through the rigorous surveillance programme in place through the yellow card scheme and other safety surveillance measures for all of the Covid vaccines used in the U.K.”

Worth reading in full.

Stop Press: There is a petition on the Gov.uk website opposing the vaccination of children against Covid until Phase Three trials are complete which can be found here.