Covid Pfizer vaccine: What we know about jab’s safety

The head of the UK’s medicines regulator says “no corners have been cut” in checking the safety of the Pfizer coronavirus vaccine which could be injected into patients as soon as next week.

The announcement that the Medicines and Healthcare products Regulatory Agency (MHRA) had approved the vaccine for use was made by press release from the Department of Health and Social Care at 7am on Tuesday.

No detailed information was made available alongside it.

The full safety data and clinical trial results have still not been published by Pfizer and neither has any technical analysis by the MHRA. Its chief executive June Raine told a Downing Street press conference that the public could be confident there had been an “extremely thorough and scientifically rigorous review”.

It would be far better if Pfizer, the government and the MHRA adopted more of a “show not tell” approach.

The Department of Health confirmed to The Independent it has given Pfizer an indemnity from being sued by patients and that the jab has been authorised under emergency regulations, specifically regulation 174 of the Human Medicine Regulations 2012.

This allows a rapid roll out of unlicensed medicines to tackle a public health emergency such as a pandemic.

But ministers recently changed this law so that the regulations now, for the first time, protect pharmaceutical companies like Pfizer from civil liability in the event of any complications a result of their vaccine being used.

So what do we really know about the safety of the Pfizer/BioNTech vaccine?

In terms of the clinical trial results we only have what Pfizer has announced in corporate press releases. It’s important to note none of the safety data has been published.

It used around 43,000 people in its trials with more than 20,000 getting the vaccine and only mild side-effects were reported. It was 95 per cent effective at stopping the disease.

While this would suggest that any dangerous side effects that could impact large numbers of people who get the vaccine can be ruled out, it does not mean there won’t be very rare side effects that emerge for a small number of people.

Such side effects can only realistically emerge once a vaccine is used at population-level involving hundreds of thousands of people which can never be replicated through a smaller clinical trial.

The MHRA has said it will be actively monitoring the roll out of the vaccine through its yellow card reporting system that allows anyone, including the public, to report side effects they believe were caused by the vaccine.

It will also be launching a random patient recall system to actively check on patients who have received the jab.

Vaccines are safe. They save millions of lives a year. But very rarely, complications do happen for some people and when they do, they can be devastating.

During the swine flu pandemic in 2009 the UK rushed into use a vaccine created by GlaxoSmithKline (GSK), Pandemrix, which had not gone through the normal testing process unlike the Pfizer vaccine which has. The GSK drug was linked to a small number of patients developing the debilitating condition narcolepsy.

The then Labour government indemnified GSK and subsequent legal action by more than a hundred people is believed to have cost taxpayers millions of pounds in compensation. One of the issues was whether patients had been given enough information to give informed consent when being vaccinated.

For example, much of the literature about the swine flu vaccine was misleading and didn’t inform people that the company had been given legal indemnity or tested in the usual way.

Should people suffer a permanent disability of harm as a result of a vaccine they can seek a one-off payment from the government under the Vaccine Damages Payments Act and the Department of Health has said ministers will add the Pfizer Covid vaccine to the list of vaccines covered by the law later this week.

That is a helpful step.

But the act only pays out £120,000 which could be of little help to someone who, as in the case of narcolepsy caused by the swine flu vaccine, loses their job and their livelihood.

Public confidence is important and making it harder for the minority of people who may suffer a debilitating side effect of the Covid vaccine to get justice seems an odd way of tackling vaccine sceptics.

Peter Todd, a partner at Hodge Jones and Allen, which represented Pandemrix claimants, told The Independent: “I think it would be much fairer if society just stood behind everybody because the chances are actually that the level of adverse reactions will be very very low. Therefore, it really won’t cost very much to make sure that everybody who has it is fully indemnified.

“I think that would have been a better way for the government to promote the vaccination than simply say, ‘You’re all on your own, it’s at your own risk.’ That’s a poor message really and encourages hesitancy which is not helpful in a pandemic.”

He added that patients needed to be given enough information to be able to make informed consent.

“I’d be interested to know why the government have given an indemnity [to Pfizer]. I can only assume it’s because without it, the pharmaceutical company would have been reluctant to actually supply the vaccine.

“I think that people ought to be aware of that because people have got to make a choice about whether they’re vaccinated, or not, they ought to be given good advice and good information in order that they can make the right choices.

“It undermines giving informed consent if you’re not given all the relevant information to make a decision at the time.”

Doubts and questions about the vaccine remain. It appears safe for the majority of people based on the information that has been published to date from the clinical trials and the MHRA’s assessment.

The UK death toll from coronavirus now exceeds 60,000 deaths. With those sorts of numbers it is clear the risk-benefit analysis of having the vaccine is hugely in favour of getting the jab.

It is essential to save lives and get the country back to normal.

Health correspondent Shaun Lintern for the Independent

High Court Ruling: Children under the age of 16, must convince a judge they understand the immediate and long-term consequences of taking puberty blockers

Children under 16 who want to undergo gender reassignment must now convince a judge they understand the “immediate and long-term consequences” of the process before taking puberty blockers, a landmark ruling said today.
The High Court has decided a child must be able to “understand, retain, and weigh” the factors involved in the process, including the implications of surgery and loss of fertility which may follow in the future.
Three top judges, Dame Victoria Sharp – sitting with Lord Justice Lewis and Mrs Justice Lieven said the courts must weigh up whether the child can go ahead with the treatment, but said it is “very doubtful” 14 and 15-year olds will now be able to give consent and “highly unlikely” 13-year-olds could satisfy the test.
The ruling comes after a legal challenge by Keira Bell, a 23-year-old woman who began taking puberty blockers when she was 16 before “detransitioning”, and the mother of a 16-year-old autistic girl who is currently on the waiting list for treatment.
The case was brought against Tavistock and Portman NHS Trust,
which said it was “disappointed” but immediately suspended such referrals for under-16s.

The NHS said it “welcomed the clarity” the ruling would bring.
One of the claimants, Keira Bell, said she was “delighted” by the judgment.

Birmingham church leader’s fury at police over ‘intimidating’ Covid swoop

The bishop of a popular black church has launched a furious broadside at police after officers turned up at a service to check on Covid rule breaking.

Bishop Jonathan Jackson could barely contain his anger in a Facebook post over what he called police ‘disrespect’ and ‘intimidation’ at the New Testament Church of God at Spring Hill, known as The Rock, in Hockley.

He claimed plain clothes officers turned up and accused the church of flouting the rules by letting in too many worshippers – wrongly, say the church, as the number inside was well within assessed limits.

West Midlands Police said uniformed officers had visited the church following a call from a member of the public about a ‘large number’ of vehicles at the site. It said no issues or breaches were found.

In his video message, the bishop said: “I am so annoyed today that the police can just roll up and start intimidating like this is Southern America.

“You must be mad when people are out there getting killed and getting massacred and all you can do is walk around looking for churches to find out if they are breaching rules.

“This is the beginning of Black History Month and I am not taking this foolishness sitting down.

“We work hard day and night, I can’t sleep worrying about all of these changes….and the disrespectful police in Birmingham can do this in the middle of our service and can come in ready to drill us without even knowing the rules.

“Me for one is not closing my mouth on this until I get a formal apology from those undercover police.”

Bishop Jackson described the rules on worshippers as ‘draconian’, comparing them to the freedom that allowed people to still gather in pubs.

Bishop Jackson said the church had battled to ensure every worshipper was kept safe and every Covid rule is stringently followed before reopening its services last week.

Visitors to the church are temperature checked on entry, worshippers must sit in household groups and obey social distancing rules, while the church also has separate entrances and exits, hand sanitiser and strict cleaning regimes – all set out in line with guidance from the city’s public health team.

He said the church has worked with the city’s director of public health Dr Justin Varney to assess risks and meet every rule to keep people safe.

The church can normally hold up to 500 people – under Covid rules this is limited to up to 150 people for congregational worship only.

Rev Dr Desmond Jaddoo, who chairs the West Midlands faith in action group, wrote in support of Bishop Jackson to police Chief Constable Dave Thompson after being informed of the issue.

In his email he wrote: “It is with the utmost of regret that I have to write to you regarding the actions of your officers in visiting black churches; some which have just reopened, following months of closure.

“It is concerning that today Bishop Jonathan Jackson of the New Testament Church of God at Spring Hill known as The Rock has reported that plainclothes officers visited his church today telling them that they are not allowed to have any more than 50 people in the church.

“This is not in line with the advice from Dr Justin Varney, director of public health for Birmingham.

“The advice given to churches is that providing it is regular worship, the churches will be allowed to have as many people as it can socially distance 2 metres apart, with households sitting in bubbles and everyone wearing face masks, with no singing.

“Furthermore, churches have risk assessments in place, track and trace systems and also sanitisation along with entry and exit procedures.

“Why is it at the beginning of Black History Month have your officers visited churches, advising they have a list of churches to visit, which is reminiscent of the southern United States of America in the 1960s.

“There are so many issues on the streets of our city right now and your Officers are now seeking to intervene with our worship. What next?”

He said he would be raising the issue at the next meeting of West Midlands Faith in Action, which meets regularly with the police.

https://www.birminghammail.co.uk/news/midlands-news/birmingham-church-leaders-fury-police-19049031

Christian school worker takes her dismissal fight to tribunal

A Christian school assistant who was sacked for posting on Facebook about plans to teach LGBT relationships in primary schools is taking her case to an employment tribunal.

Kristie Higgs, 44, was dismissed for gross misconduct by Farmor’s School in Fairford, Gloucestershire last year.

The mother-of-two shared and commented on Facebook posts which raised concerns about relationship education at her son’s Church of England primary school.

Mrs Higgs, who was posting on Facebook under her maiden name, shared two posts in October 2018.

In one Facebook post, Mrs Higgs urged people to sign an online petition against making relationships education mandatory.

In another she shared an article about the rise of transgender ideology in children’s books in American schools.

The Christian Legal Centre is supporting Mrs Higgs’s case at the employment tribunal, which is starting in Bristol on Monday.

Lawyers representing Mrs Higgs will argue that her sacking breached her freedom of speech and freedom of religion.

Ahead of the hearing, Mrs Higgs said: “Nothing could have prepared me for what happened. I was told that the reasons behind my sacking were nothing to do with my Christian beliefs – it had everything to do with my Christian beliefs.

“The whole experience broke my heart. I have been punished for sharing concerns about relationships and sex education.

“My number one concern has always been the effect that learning about sex and gender in school will have on children at such a young age. I have not discriminated against anyone.

“Through my case I want there to be renewed freedom for others, especially Christians, to express their beliefs and opinions without fear of losing their jobs.”

by Rod Minchin

RSE Victory for Parental Rights – for now

Roger Kiska on the government’s announcement that schools can delay their introduction of Relationships and Sex Education
September 2020 is just around the corner, at which time the government’s new regulations on Relationships Education and Relationships and Sex Education (RSE) will take force. If you are not yet familiar with the new regulations, Christian Concern has put together this video to guide you through what will be taught and what may be taught. The regulations will apply to all schools in England, regardless of whether your child’s school is maintained or independent.
However, one of the fundamental statutory requirements put in place under the regulations to safeguard parental rights is that schools must consult parents when drafting their school’s RSE policy, which includes informing parents of what is to be taught their children. To be clear, while the Department for Education, in guidance it released in October 2019 refers to this process as ‘parental engagement’, the law could not be any more clear that no less than consultation should take place. This means that your ability to give feedback should be robust and that the school must give due regard to the views of parents during the consultation process. Anything less would be a breach of the school’s statutory duty towards your rights.
Department for Education Delays Start of RSE
In a victory for parental rights, the Department for Education has now announced that while the new regulations making RSE compulsory will still take effect from September 2020, schools will nevertheless be able to delay introducing it into their pupils until Summer term 2021. The Department made their decision because of the impact of the coronavirus restrictions on education and how it has hampered the ability of schools to consult parents about their RSE policies.
We therefore encourage parents to write their children’s schools asking when those consultations will take place; letting them know that you support a delayed roll out of RSE given the short time frame between now and September.
The team at the Christian Legal Centre has put together the following draft letter to assist parents in engaging with their schools:

Dear [Headteacher Name],
I write this letter on behalf of my son/daughter, [child’s name], in Year [R-6].
I understand that from September 2020, new regulations requiring that relationships education be taught in the school will take force but that schools may delay beginning RSE until the summer term of 2021 as per the announcement of the Department for Education on 04 June 2020.
I am also aware that as a statutory pre-condition to relationships education being taught my child, the school must consult with parents as to the contents of the school’s RSE policy and what it intends to teach my child.
Would you please let me know when that consultation will be taking place and what materials will be used as part of the teaching of relationships education?
I am aware that time is of the essence because of how close we are to September 2020. Given the potential impact of how and what will be taught as part of relationships education on the manner in which I choose to raise my child in accordance with my Christian faith, I would urge the school to take the extension granted by the Department for Education to fully assess the needs of parents and ensure a robust consultation process.
Kind regards,
[Parent(s) name]

There is strength in numbers! Please act now for the benefit of our children.
Know Your Rights
As a helpful guide about your rights, it is important to note that schools do not have unfettered discretion in deciding on the content of RSE classes. In fact, schools are bound by numerous statutory requirements governing what and how they select material to be presented as part of RSE:
The material must be age appropriate [Section 34(3) of the Children and Social Welfare Act 2017];
The material must have due regard for the religious background of the pupils [also Section 34(3) of the Children and Social Welfare Act 2017];
The process in which the material is chosen and taught must respect the manner in which parents wish to raise their children in accordance with their own religious and philosophical convictions [Protocol 1, Article 2, European Convention on Human Rights];
The material cannot indoctrinate as to sensitive moral issues; i.e. any material chosen and the manner in which it is taught must be critical, objective and pluralistic [Kjeldsen, Busk Madsen and Pedersen v Denmark, Judgment, Merits, App No 5095/71 (A/23), [1976] ECHR 6, IHRL 15 (ECHR 1976), 7th December 1976, European Court of Human Rights [ECtHR]];
The material, and the way it is selected must have due regard to the school’s public sector equality duty to promote good relations among those with different protected characteristics, meaning that the school must have due regard not to cause offense or discord to parents of a faith background [Section 149(1)(c) Equality Act 2010];
Schools must consult with parents when drafting and amending their RSE policies [Section 80B(3) Education Act 2002; Section 2A(f) Education (Independent School Standards) Regulations 2014];
Regard must be given to the principle that pupils are to be educated in accordance with their parents’ wishes [Section 9, Education Act 1996];
The pursuit or promotion of partisan political views in the teaching of any subject is forbidden [Section 406, Education Act 1996].
LGBT elements are not required to be taught as part of Primary school Relationships Education [Nick Gibb, Minister for School Standards, Parliamentary Question Period 25 June 2019].

Christian Concern

Relationship Sex Education lessons in primary schools are being reviewed amid complaints.

There are growing concerns with guidance given for Relationship Sex Education “RSE”.
Kent and Barnsley councils are withdrawing on transgender issues in schools. In an email exchange with a concerned citizen, TEP’s Gille Heath said:
“In response to questions raised as to the legality of the Guidance, this was taken down on 15 May and is now under review.”

Last week, Shropshire County Council withdrew its own controversial guidance on transgenderism for schools and colleges and asked them to stop using the advice.
The document, ‘Guidance for schools and colleges on transgender and supporting transgender pupils’, said that pupils should have the “right” to use the toilets which match their so-called gender identity,
and should be allowed to access the changing rooms of the opposite sex.

Earlier this month, Oxfordshire Council’s ‘Trans Inclusion Toolkit for Schools 2019’ was also withdrawn amid pressure from parents and an impending court case.
In March, lawyers representing Warwickshire County Council told The Christian Institute that it was dropping its explicit and misleading All About Me programme following the Institute’s threat of legal action.

The Minister for Equalites and Women, Elizabeth Truss, Speaks

The Minister for Women and Equalities has confirmed that single-sex spaces will be protected when any changes are made to gender recognition law.

Liz Truss MP was responding to a letter from Baroness Nicholson of Winterbourne, who had raised concerns about the distortion of the “traditional rights to privacy, dignity, personal identity and honour” of women and girls.
The Equalities Office is set to outline its plans for changes to the law in the summer, following a consultation which took place in 2018 but it has faced a number of delays because it has proven “divisive”.

‘Clear message’
In her response, Truss wrote: “I am grateful to you for raising your concerns. I have made my commitment to protecting single sex spaces for women and girls clear.
“As part of this work I will ensure that Government guidance gives a clear message to service providers, schools and others, putting their ability to provide single sex spaces beyond doubt.
“I will be able to say more about this important issue when I publish the Government’s response to the Gender Recognition Act consultation in the summer.”

Irreversible treatments
Last month, Truss announced several changes to gender law, including restricting irreversible treatments for under-18s, to mixed response.
She suggested that under-18s may soon be prevented from having sex-change surgery, that single-sex spaces would be protected, and that transgender adults should be free “to lead their lives as they see fit”, but did not provide any detail on how the Government would proceed.

Maya Forstater: Woman loses tribunal over transgender tweets

A woman who lost her job after saying that people cannot change their biological sex has lost an employment tribunal.

Maya Forstater, 45, did not have her contract renewed after posting a series of tweets questioning government plans to let people declare their own gender.

Ms Forstater believes trans women holding certificates that recognise their transgender identity cannot describe themselves as women.

But that view is “not worthy of respect in a democratic society”, a judge said.

Ms Forstater, who had worked as a tax expert at the think tank Center for Global Development, was not entitled to ignore the rights of a transgender person and the “enormous pain that can be caused by misgendering”, employment judge James Tayler said. He concluded in a 26 page judgement.

“It is a core component of her belief that she will refer to a person by the sex she considered appropriate even if it violates their dignity and/or creates an intimidating, hostile, degrading, humiliating or offensive environment,” he continued.

“The approach is not worthy of respect in a democratic society.”

Ms Forstater had argued “framing the question of transgender inclusion as an argument that male people should be allowed into women’s spaces discounts women’s rights to privacy and is fundamentally illiberal (it is like forcing Jewish people to eat pork)”.

Author JK Rowling is among people who have come out in support of Ms Forstater.

10-year-old girl suspended for asking to be exempted from LGBT school lesson

Kaysey

LONDON, July 1, 2019 (LifeSiteNews) — A 10-year-old who was suspended from school for a week after asking her teacher permission to be excused from participating in a “Pride Month” LGBT lesson has gone on the record to explain the real dangers of the invasion of LGBT ideology in her school.

“Before anybody knew what LGBT meant, everybody knew what gender they were,” explained Kaysey, who, along with her classmate, Farrell, was suspended from the Heavers Farmer Primary School, located in Croydon, South London.

“But now people are confused,” continued the precocious 10-year-old, “and they’re saying that they’re bisexual and trans because they’re confused.”

“Before this happened, they were completely confident of who they were but now they’re not,” she added.

“It’s really affecting other kids,” explained Kaysey, “because now they’re losing confidence in [them]selves and looking at [them]selves and asking, ‘Why am I this person? Why can’t I be someone else?’”

“Before all this happened, people knew who they were,” said Kaysey. “School children are now facing the choice of what gender they are by the age of four.”

Teacher reported to school authorities

Susan Papas, the head of Heavers Farmer Primary School, Croydon, South London, who banned the children from the school for five days for alleged anti-LGBT comments, has been reported to the local authorities for what amounts to an unlawful act.

Christian Concern, an advocacy group seeking to restore the United Kingdom to the Christian faith, recounts the incident that led to the two students’ suspension:

On June 20, Farrell, sitting next to his friend Kaysey in class, asked his year 5 class teacher, “Sir, please may I not take part in this lesson?” when the teacher handed out LGBT material for colouring. The teacher refused permission saying that the LGBT lesson was part of the curriculum.

After class, the form teacher is said to have accused Farrell of using “homophobic language” for allegedly saying, “LGBT sucks and LGBT’s dumb,” which the child denies.

Farrell, who was sitting with female pupil Kasey says he is a Christian and told a “visitor teacher” he did not “accept LGBT” because of his religion.

The teacher asked the two children, “Do you want them to die?” “We said no,” Farrell replied. If, however, they went back to their countries, they would be punished for being gay, Farrell told the teacher.

The teacher asked Farrell where he was from. Farrell said he was of “African Jamaican” heritage, and because there “everybody is Christian and Catholic, so they don’t accept LGBT.”

Later, Ms Papas shouted at the two children in front of the class, according to Kaysey. “How dare you? You are a disappointment to the school,” Papas told the two children outside the classroom.

Papas then put the children in different rooms and asked Kasey [sic]: “How dare you say that you want to kill LGBT people?” Kasey [sic] replied: “I didn’t say kill.” Papas then shouted at her and said, “Yes, you did, and don’t lie.”

Kaysey, a pentecostal Christian, says she was kept in detention for five hours from 10am to 3pm.

Kaysey’s and Farrell’s version of the story, which differs widely from what their teacher and the head of their school alleged, has been corroborated by their classmates.

Court banned me from teaching son basic rules for boys’ – father of 7yo slated for transition

Jeff Younger

Jeff Younger, who is locked in a court battle with his ex-wife over whether their son should undergo transition to a girl, says a court order bans him from discussing things like religion or the need to be respectful to girls.

Jeff and his former spouse Anne Georgulas are trying to resolve a parental dispute over their son, James. Anne insists that James identifies as a girl, calls him Luna, and envisions hormone therapy and eventually sex-change surgery in the future. Jeff rejects the idea and says his son is perfectly comfortable being a boy in his presence. The pair are fighting a legal battle, with a court temporarily ordering Jeff not to impose a male identity on the child.

The order forbids Jeff from calling his son James in front of anyone who knows him as a girl, and this significantly limits what they can do together, he told RT’s Sophie Shevardnadze.

“Basically I can’t go to a school. I keep him away from any friends he might have at school that know him as a girl, and at my home he’s known as James and I use male pronouns. What I’m prohibited from doing right now is trying to convince him that he’s actually a boy,” he said.

The court’s ruling means that Jeff, who is a religious Orthodox Christian, has to be careful when discussing his faith with his son, he said. He is also cautious about teaching James how to behave decently, so that his words cannot be interpreted as imposing a male gender identity.

“I’m even a little trepidatious about reading the Book of Genesis as we go through our Bible readings after Pascha,” he said. “So, I’ve had a lot of trouble communicating with him on religious issues and on basic things that you’d have to teach boys, issues around self-control: how they should deal with women, older women, being respectful to females of their peer group.”

It’s very difficult for me to figure out how to do this without violating that order.

Jeff said James was misdiagnosed with gender dysphoria and simply wants the approval of both his parents.

“The court asked us to take them to social services and let the boys express their preferences,” Jeff said. “And what James said was: he wants to be a girl at his mom’s home and a boy at his dad’s home. He basically wants both his parents to love him.”

Watch the full video here