The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.
Naomi Wolf graduated from Yale in 1984 and was a Rhodes scholar at New College, Oxford University. She is the author of the bestselling feminist books, “The Beauty Myth”, “Fire with Fire”, “Promiscuities” and “Misconceptions”. The New York Times called “The Beauty Myth” one of the 70 most significant books of the century. More recently, Naomi has written books critiquing the establishment’s advances in censorship, Covid-19 vaccinations and many more issues which she addresses with James.
Note: Title editorialised.
[Ms. Spit] is part of a very small, little-discussed community of pandemic victims: those who have suffered—or had family or loved ones suffer—from rare but serious vaccine side effects recognized by doctors, regulators and researchers. They say they feel lost in wider Covid-19 statistics, which have shown vaccines to be extremely safe and effective for most of the population.
Faced with the gravest health crisis in memory, governments deployed newly developed vaccines in record time. Many countries indemnified pharmaceutical companies that made the shots, with some governments promising to consider compensation for suspected Covid-19 vaccine-related injuries.
Now governments, including the U.S. and U.K., are trying to live up to that pledge. They are in the very early stages of applying existing vaccine-injury programs to hundreds of claims of injury alleged from Covid-19 shots.
…The U.K.’s National Health Service has received more than 720 claims requesting Covid-19 vaccine-related compensation. The country’s vaccine-injury compensation program entails a one-size-fits-all cash payment of £120,000, equivalent to around $163,000. The volume of Covid-related claims has grown by about 20 a week, toward a projected 1,500 to 1,800 new claims this year, according to U.K. government projections.
ASTRAZENECA, now referred to as Vaxzevria by the Medicines and Healthcare Regulatory Agency (MHRA), has been associated with cases of transverse myelitis – i.e. inflammation of the spinal cord.
As of Wednesday, January 26, transverse myelitis has officially been added to the “warnings and precautions [of] neurological events” section given to healthcare professionals. The MHRA has assured that cases are “extremely rare” but the reaction can lead to: muscle weakness, localised or radiating back pain, and bladder issues. Furthermore, transverse myelitis can lead to bowel symptoms and changes in sensations.
Early Covid-19 symptoms mirror vaccine side effects, according to a recent study that warns people who suffer headaches, fatigue, or fever after being jabbed to assume they have been infected, get tested, and isolate themselves.
The findings, published last week in the eClinical Medicine journal, show there is no way to tell if the symptoms are from the disease or an adverse reaction to the shot unless a screening test is taken. Researchers at King’s College London have raised concerns that the recently vaccinated could be inadvertently spreading the virus, thinking their symptoms were from the jab.
A professional musician died after suffering a brain haemorrhage ‘induced by his first dose of the AstraZeneca Covid vaccine’, an inquest has heard.
Matthew Dibble, 40, suffered a ‘catastrophic’ episode just two days after he self-presented at St Thomas’ Hospital in central London complaining of a headache on May 8.
Arguments to vaccinate children as young as five against Covid are ‘scientifically weak’, British experts claimed today after the US moved closer to jabbing infants.
…Professor David Livermore, a medical microbiologist at the University of East Anglia told MailOnline: ‘Vaccinating children to protect adults via herd immunity is ethically dubious and is scientifically weak.’
…Professor Russell Viner, a pediatrician and member of the UK Government’s scientific advisory group SAGE, said it was crucial the UK does not ‘rush to a decision’ in the wake of the announcement in the US.
A 3-part series by Simon Elmer from Architects for Social Housing.
- Part 1: Adverse Drug Reactions and Deaths (archive)
- Part 2: Virtue and Terror (archive)
- Part 3: Resistance (archive)
It’s been nine months now since, in my article Lies, Damned Lies and Statistics: Manufacturing the Crisis, I analysed the statistics on official ‘COVID-19 deaths’ published by the institutions responsible for justifying the regulations and programmes of the UK biosecurity state. These include the Office for National Statistics, the National Health Service and Public Health England. Together with concerned reports from medical bodies, including Cancer Research UK, the British Heart Foundation and the Alzheimer’s Society, these statistics strongly suggested that at least half the 80,000 deaths attributed to COVID-19 in 2020 resulted from the withdrawal of medical diagnosis, treatment and care under lockdown restrictions. However, this is a conservative estimate, and doesn’t include the 20,000 excess deaths in care homes last year swept under the COVID-19 carpet. I’m pleased to relate that my article has been visited over 57,000 times on our website, which shows, if nothing else, that there is a continued desire among the public to know what is actually going on, and an ongoing refusal to accept the increasingly transparent lies we continue to be told by those awarding themselves increasing power and authority over our lives.
British health chiefs have quietly released a warning that Pfizer and Moderna’s Covid vaccines may cause heart damage, MailOnline can reveal.
Fears about the mRNA jabs’ links to myocarditis have grown in recent weeks, following a string of cases in young adults and children in Israel and the US.
THE CENTERS for Disease Control and Prevention’s safety committee has provided an update on the association between Pfizer-BioNTech and Moderna COVID-19 vaccines and heart inflammation.
On 23 June the US Centers for Disease Control and Prevention’s safety committee said there was a “likely association” between the Pfizer-BioNTech and Moderna COVID-19 vaccines and myocarditis (the medical term for heart inflammation) and pericarditis (inflammation of the tissue that surrounds the heart) in some young adults. The CDC’s Advisory Committee on Immunization Practices said there was a higher than expected number of reports of heart inflammation in people aged 16-24 who had received the mRNA vaccines but that the benefits of vaccination still clearly outweighed the risks.
Covid testing in schools is hugely disruptive and should be suspended, experts have said, as it emerged that up to 60 per cent of “positive” tests a week are coming back negative when checked.
Under plans to keep schools open, more than 50 million lateral flow tests have been carried out on youngsters, leading to thousands of pupils and their social bubbles being forced to self-isolate for 10 days.
Manufacturers have been granted exemption from liability for any resulting harm. Ruud Dobber, a member of AstraZeneca’s senior executive team, said: “This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects.” (The government has taken on the liability and has an insurance scheme in place.)
Innova tests’ performance not proven and they should be returned to manufacturer or thrown in bin, says FDA
The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass testing programme.
In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.
…In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.
Published 15 December 2017
MHRA today announced a partnership worth over £980,000 to improve the safety monitoring of medicines in low and middle-income countries.
Doctors are now being told to look out for signs of the most common type of stroke following the Oxford coronavirus vaccine, after three British patients were admitted to hospital and one died.
Two women in their 30s and a man in his 40s suffered ischaemic strokes after having the vaccine.
Previous reports of rare blood clots from the jab have specifically involved cerebral venous thrombosis – a rare form of stroke caused by the blockage of specific veins.
Resources use inappropriate emotional pressure
The Human Medicines Regulations 2012 (the ‘Regulations’) apply to anything ‘designed to promote the … supply … or use of that [medicinal] product’, which according to the regulations amounts to an advertisement. As the materials do not properly encourage critical thinking and present information as fact without substantiation, it is entirely possible that the teaching materials and lessons delivering those materials amount to an advertisement and may constitute an offence.
However well meaning these materials might be, it appears that they have at least the potential to put emotional pressure on children and — potentially — coercively control children’s decisions in relation to the vaccine. The materials are therefore incompatible with the NC and the government’s advice on Teachers’ Prevent Duty, which are there to help protect children.
The Government is facing a backlash over plans to extend the vaccine rollout to children, with some experts questioning the benefits of the proposed move.
Dozens of medics, doctors and scientists have written to the Medicines and Healthcare products Regulatory Agency (MHRA) to express their “grave concern” over the proposals.
In a joint letter, they warned it is “irresponsible, unethical and unnecessary” to jab children and urged the medicines watchdog not to “repeat mistakes from history”.
All under-40s are to be offered an alternative to the Oxford-AstraZeneca coronavirus vaccine as a precaution.
Schools back mass vaccinations for children, with headteachers saying that “peer pressure” will boost take up.
Education leaders would be willing to help facilitate a vaccine roll-out at schools around the country, according to Geoff Barton, general secretary of the Association of School and College Leaders (ASCL), the largest union for secondary school heads.
…“I think there will be a sense of schools wanting to step up and play their part and explain to children why having the vaccine is important during assemblies and in tutor time.”
…He explained that vaccinating children at school could result in higher take-up because pupils would not want to feel socially isolated by refusing to have the jab.
…“The peer pressure of seeing that your friends are lining up to do it is likely to make the overall numbers taking up the vaccine higher,” he said. Some scientists have argued that if Covid rates rose significantly it would be a priority to vaccinate children to prevent any more disruption or closures of schools during the next academic year.
The UK’s healthcare regulator has expressed concern to the government that its multibillion-pound mass testing programme is “a stretch” of the authorised use of rapid tests, the Guardian has learned.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the lateral flow devices to be used to find coronavirus cases but not to act as a “green light” for people who test negative to enjoy greater freedoms.
The regulator is concerned that people who test negative will be given false reassurance by their result and will let down their guard if they believe they are Covid-free.
There is very little data to show how well the Innova lateral flow devices detect the virus when used as a self-test by someone who has no symptoms. They are being used by millions of people a week in England under the government’s universal testing programme.