MHRA

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.

Health Experts Express “Grave Concerns” over Proposals to Vaccinate Children Against Covid

Over 40 health experts have expressed their “grave concerns regarding all proposals to administer Covid vaccines to children” in an open letter sent to the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). The letter was organised by Dr Ros Jones, a member of the Health Advisory and Recovery Team (HART), and warns against a “repeat of any past tragedies which have occurred especially when vaccines are rushed to market”. The Telegraph has more.

In a joint letter, [the health experts] warned it is “irresponsible, unethical and unnecessary” to jab children and urged the medicines watchdog not to “repeat mistakes from history”.

Their intervention came as Matt Hancock announced that Britain had bought enough Pfizer vaccines to inoculate all children over the age of 12.

The Health Secretary said the Government would be “very, very careful and sensitive” about whether to roll out the vaccination programme to children, but stressed that research showed the jabs were safe. 

He told MPs on Monday that a decision was likely to be taken within the next two months while the rollout continued through younger age groups.

[The letter reads:] “Extreme caution has been exercised over many aspects of the pandemic, but surely now is the most important time to exercise true caution.

“We must not be the generation of adults that, through unnecessary haste and fear, risks the health of children.”

The letter has been signed by over 40 medics, scientists and doctors including Professor Karol Sikora, Dean of Medicine at Buckingham University, and Lord Moonie, a former consultant in Public Health Medicine.

It argues that while there are clear benefits of a vaccine for the elderly and vulnerable, the balance of benefit and risk for youngsters is “quite different” since healthy children are at “almost no risk” from Covid.

The letter goes on to say that children do not need the vaccination to support herd immunity, adding that recent modelling suggests the U.K. has now achieved the herd immunity threshold.

“All medical interventions carry a risk of harm, so we have a duty to act with caution and proportionality,” it says.

“This is particularly the case when considering mass intervention in a healthy population, in which situation there must be firm evidence of benefits far greater than harms”.

A new petition, flagged up in today’s News Round Up, says that children should not be given Covid vaccines until Phase Three trials are complete.

The Telegraph report is worth reading in full.

Britain’s Regulator Missed Early Blood Clot Cases Linked to AstraZeneca Vaccine

By the time cases of blood clotting in patients who had received the AstraZeneca vaccine had begun to emerge on the Continent (in March), Britain had already administered 11 million doses (the first ones having been given in January). No such adverse events had been reported publicly in Britain, but not for a lack of cases, according to the findings of a new investigation. Clotting cases were recorded in the UK’s Yellow Card database (a website for reporting adverse drug reactions) in January but were missed at first by the Medicines and Healthcare products Regulatory Agency (MHRA) – possibly due to the algorithms it uses to interrogate UK data. The Telegraph has the story.

On March 11th, the MHRA put out a statement saying it could see no evidence of a problem…

But the MHRA was, it appears, wrong. An investigation by the Telegraph has established that signals had been firing unnoticed in the UK’s Yellow Card database for at least a month, perhaps longer.

In January, a patient suffered a brain clot following their first dose of the AstraZeneca jab… Then in early February, two similar cases followed, including a death and a life-changing CVST clot in a young adult. All had low platelets and all were reported into the Yellow Card system.

On Friday, the MHRA told the Telegraph: “We are aware of thromboembolic events that occurred in January, however, our first report was received in the week commencing February 8th…. we cannot disclose information about individual cases to protect patient and reporter confidentiality.”

… The MHRA faces serious questions as to why it did not detect the signals sooner. The issue is not that it has been left looking flatfooted or even that earlier detection would necessarily have altered its advice, but that the delay left it unable to shape international policy and confidence in what remains a vital vaccine in the fight against Covid for the world.

Professor Stephan Lewandowsky, a psychologist at the University of Bristol studying the rollout of Covid vaccines, told the Financial Times on Friday: “The MHRA was slow in responding to the emergence of a specific constellation of symptoms associated with the AstraZeneca vaccine and slow to communicate what they were finding – and I am not the only one who thinks so.”

This slow repose was caused, it is said, by algorithms which were not as sensitive as the ones used by European health agencies to sift through data.

From January 4th to March 14th, a total of 532 “blood system events”, including 20 deaths, came through the UK’s Yellow Card system relating to the AstraZeneca jab, according to an analysis of published MHRA data by Dr Hamid Merchant, a pharmaceutical scientist at the University of Huddersfield. There were thousands of non-blood-related reports besides.

Of the thrombotic events recorded, four related to CVST (but no deaths were recorded), 55 were non-site specific and there were clusters of 64 and 66 cases in the lungs and deep veins respectively. There were then 267 general bleeding events and six deaths, three of which resulted from cerebral haemorrhage. Finally, there were 60 cases of thrombocytopenia, including two deaths.

To sift such data, regulators build algorithms that must balance “sensitivity” against leg-work. The more sensitive the algorithm, the more warning signals it will throw up to investigate – and many of those labour-intensive investigations will prove fruitless.

It is not known exactly what parameters the MHRA set but it is clear they were not as sensitive as those used by some regulators in Europe. 

Under-30s to Be Offered Alternative to AstraZeneca Vaccine Following MHRA Investigation

Britain’s vaccine rollout is to undergo a “course correction” that will see people below the age of 30 being offered alternatives to the AstraZeneca vaccine, following advice from the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA said there is a possible link between this vaccine and “extremely rare and unlikely to occur” blood clots. Government advisors have stopped short of restricting the use of the AZ jab in younger people altogether, despite considering doing so.

Up to March 31st, 79 people in the UK developed blood clots following their first AstraZeneca jab. Nineteen of these people have died. The Chief Executive of the MHRA said: “The risk [of getting blood clots after receiving the AZ vaccine] is four people in a million.” Sky News has the story.

Britons aged 18-29 will be offered an alternative to the AstraZeneca vaccine following 79 people developing blood clots after the jab, Government advisors have decided.

The MHRA concluded there is a possible link between the AZ vaccine and “extremely rare and unlikely to occur” blood clots with lowered platelets.

Younger people are much less likely to die from Covid so the Joint Committee on Vaccination and Immunisation (JCVI) has decided it is safer to advise that age group are offered a different jab, where possible. …

The advice is being given after a total of 79 people in the UK have had blood clots following their first AstraZeneca jab up to March 31st, Dr June Raine, chief executive of the MHRA said. More than 20 million people have been given the AZ vaccine.

Of those 70 people, 19 have died – three under the age of 30.

A total of 51 women and 28 men aged 18 to 79 were affected but Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said there is no evidence women have a predilection to develop blood clots after having the AZ jab.

“The risk is four people in a million,” Dr Raine added.

The UK is currently also rolling out the Pfizer Covid vaccine and, most recently, the Moderna vaccine, but people below the age of 30 will only be given these alternatives where possible.

JCVI chairman Professor Wei Shen Lim said: “We are advising a preference of one vaccine over another vaccine for a particular age group out of utmost caution rather than any serious safety concerns.”

He added that people who are just over 29 years-old should make their decision, but getting the vaccine is much safer than not getting it.

Worth reading in full.

Stop Press: A review by the European Medicines Agency has also concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the AstraZeneca vaccine.

Stop Press 2: In an article for the Spectator, Ross Clark asks whether the writing is on the wall for the AZ jab.

The Government has invested a huge amount of money and faith in the AstraZeneca vaccine, and has rightly been praised for its rapid rollout, which was based on the best evidence at the time. The AstraZeneca vaccine has been wrongfully attacked by President Macron among others, who declared it to be “quasi-ineffective” in the over-65s – without any evidence. It will take political courage to admit that the AstraZeneca vaccine is second-best, and should perhaps be phased out as other vaccines become available in substantial quantities. But it is beginning to look as if that might be the most likely outcome.

Very much worth reading in full.

UK Health Regulator May Restrict AstraZeneca Covid Vaccine for Younger People

The Prime Minister received his first dose of the AstraZeneca Covid vaccine last month and said that all Brits should get theirs when told to do so. But now, the UK’s medicines regulator is being urged to restrict the AZ jab for younger people because of fears over blood clotting.

At the end of March, Canada’s National Advisory Committee on Immunization (NACI) said that the risk of blood clots is greatest for women aged under 55. In response, both Canada and Germany limited their AstraZeneca vaccine rollouts to those over 55 and 60, respectively. Channel 4 News has revealed that Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) is also considering issuing similar advice. Reuters has the story.

Britain’s health regulator is considering a proposal to restrict the use of the AstraZeneca vaccine in younger people over concerns about very rare blood clots, Channel 4 News [has] reported…

“Two senior sources have told this programme that while the data is still unclear there are growing arguments to justify offering younger people – below the age of 30 at the very least – a different vaccine,” the broadcaster reported.

The UK’s regulator, the MHRA, has previously said the benefits of the vaccine in the prevention of Covid far outweigh any possible risk of blood clots.

The MHRA did not immediately respond to a comment on the Channel 4 report.

After receiving his first dose, Boris Johnson said: “The Oxford jab is safe… The thing that isn’t safe is catching Covid, which is why it is so important that we all get our jabs as soon as our turn comes.” Channel 4 News reports that authorities are now investigating whether the AstraZeneca vaccine might actually pose a greater risk for younger people – particularly young women – than Covid itself.

The UK [medicines] regulator, the MHRA, and the Joint Committee on Vaccination and Immunisation are urgently scrutinising whether younger people – particularly women – could be at greater risk of getting a potentially fatal blood clot after the AstraZeneca jab than they are of dying from Covid. In either case, though, the risk is very small.

Last month, the European Medicines Agency said the AZ Covid vaccine is “safe and effective” to use, but highlighted that it “cannot rule out definitively” a link to a rare clotting disorder.

Channel 4 News’s full report can be viewed here.