Side effects

The Great Betrayal

Destroy their education. Destroy their jobs and their job prospects. Destroy their social life, their friendships, their mental health. Force them to work long hours at school or in physically demanding jobs in uncomfortable and breath-inhibiting face masks. This is what our country has done to our young people in the past 16 months.

Why? In an attempt (and not a very successful one) to protect a small minority of mostly elderly folk who are particularly vulnerable to one disease while we wait in limbo to develop a vaccine and roll it out to the vulnerable population.

Then do we give them back their freedom? Not at all. Then we move the goalposts, making freedom conditional on more and more people getting the vaccine. Until we make it to so-called ‘Freedom Day’, a month later than originally planned, and Boris Johnson chooses then to tell young people that their freedom to do the things they enjoy will be dependent on receiving a vaccine.

A vaccine that uses experimental technology and was rushed through trials without waiting for the full safety data (trials which will never now conclude as the control groups have been vaccinated). A vaccine, or rather vaccines, which the authorities now acknowledge increase the risk of dangerous blood clotting and heart conditions, particularly in younger people. Vaccines for which there are now more reports of fatalities in the U.S. than all other vaccines put together for the past 30 years.

Lancet Study Shows Real World Patients Are up to 400% More Likely to Suffer Adverse Events Than Drug Trials Show

Dr Sebastian Rushworth has written today about the serious problem of the underestimation of side-effects in drug trials, which he says should “shake the very foundations of evidence based medicine”.

His article reports on the results of a study recently published in the Lancet Healthy Longevity, funded by the UK Medical Research Council and the Wellcome Trust, which seeks to establish the extent to which drug trials underestimate side-effects by comparing trial data to real world data. The study focuses in particular on blood pressure drugs known as RAAS blockers, which Dr Rushworth explains were chosen because of the number of trials that have been done by different companies. There is no reason the results should not apply equally to other drugs, he says, including Covid vaccines (for which there have been an unprecedented number of adverse event reports despite the trials showing them to be safe).

The results are shocking. The difference was not marginal but out by a factor of three or four.

The real world patients were between 300% and 400% more likely to experience a serious event than the participants in the trials! That is in spite of the fact that the trials, as mentioned above, were using a broader definition of what constituted a serious event. If the trials were representative of reality, then they should have a higher rate of events than is seen in the real world data. Instead they have a rate that is several times lower!

The difference was just as large in trials specifically involving older people, so age differences can’t be the full explanation, he says (though he allows part of it may be that participants in the trials of older people may be healthier and younger than real world patients).

His main explanation, however, is darker. Are the drug companies simply under-reporting adverse events, both in the drug and placebo treatment groups?

Man Dies from Blood Clot after Taking Moderna Covid Vaccine

Cases of blood clotting after vaccination have mainly been associated with the AstraZeneca Covid vaccine over recent months, but an American man, aged 65, has now died 12 days after his second dose of the Moderna vaccine in what is being reported as the first known death from blood clotting linked to this vaccine. The Sun has the story.

After getting the coronavirus jab, the man experienced pain in both legs, difficulty breathing and was diagnosed with thrombosis with thrombocytopenia syndrome (TTS) two days before he died.

Three days into his stay at Allegheny Health Network in Pittsburgh, Pennsylvania, the man developed cerebral venous sinus thrombosis, according to a report published on the Annals of Internal Medicine website.

This is a rare type of blood clot blocking the brain’s sinus channels of draining blood, which could lead to hemorrhages. 

Doctors searched to identify other causes behind his TTS including Covid, other viruses or thrombotic thrombocytopenia purport, a rare disorder that causes blood clots throughout the body.

The man had chronic underlying conditions including high blood pressure and hyperlipidemia, which presents itself when high levels of fat particles are in the blood.

Despite “rapid and exhaustive” treatment eliminating all other options, a solution could not be found leaving investigators believing the blood clots were caused by the vaccine.

Previously, research showed that the “rare but life-threatening” condition only occurred in individuals who received Johnson & Johnson or AstraZeneca vaccines.

Both vaccines combine genetic material taken from the coronavirus and genes of the adenovirus, producing an immune response.

The findings show that the side effects can also occur when someone gets a vaccine that has messenger RNA (mRNA).

Because blood clots do occur after vaccinations, the report claims, “it should not dissuade people from getting the Covid jab”.

Earlier this month, the U.S. Food and Drug Administration announced that it would add a warning to the Moderna vaccine – as well as the Pfizer vaccine – after the Centers for Disease Control and Prevention said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults.

The Sun report is worth reading in full.

“The Vaccines Kill Two People for Every Three Lives They Save”, Says Peer-Reviewed Vaccine Study

A review of efficacy and safety data for the COVID-19 vaccines by three scientists has been published in the peer-reviewed journal Vaccines and comes to the disturbing conclusion that for every three deaths the vaccines prevent, two people die from an adverse reaction, while another four suffer serious side effects. The authors conclude: “This lack of clear benefit should cause governments to rethink their vaccination policy.”

Here is the abstract:

Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. 

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. 

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9,000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11 per 100,000 vaccinations. For three deaths prevented by vaccination, we have to accept two inflicted by vaccination. 

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

The authors note this conclusion is based on the reported adverse reactions, whereas the true number of adverse reactions may be considerably more.

Finally, we note that from experience with reporting side effects from other drugs, only a small fraction of side effects is reported to adverse events databases. The median underreporting can be as high as 95%. Given this fact and the high number of serious side effects already reported, the current political trend to vaccinate children who are at very low risk of suffering from COVID-19 in the first place must be reconsidered.

They note that the “risks and benefits” of the vaccines are “on the same order of magnitude” and suggest: “Perhaps it might be necessary to dampen the enthusiasm by sober facts?”

U.S. Medicines Regulator to Add Warning to Pfizer and Moderna Vaccines Over Link to Heart Inflammation

The U.S. Food and Drug Administration (FDA) is set to add a warning to the Covid vaccines made by Pfizer and Moderna after the Centers for Disease Control and Prevention (CDC) said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults. The MailOnline has the story.

The CDC made the announcement Wednesday during a presentation. 

The Covid Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of heart inflammation, known as myocarditis, in vaccinated adults under the age of 30.

The group of doctors said the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males  

It comes as the Advisory Committee on Immunisation Practices (ACIP) is set to meet this week to assess the possibility of a link between the heart condition and the mRNA vaccines. 

The Moderna and Pfizer vaccines use mRNA technology, while the Johnson & Johnson vaccine uses the more traditional virus-based technology. 

According to the presentation, there have been 484 preliminary reports of myocarditis or pericarditis in young people under age 30 as of June 11th.

So far, 323 have been confirmed by CDC and 148 are still under review.

In total, 309 patients were hospitalized, of which 295 were discharged and 79% have since recovered.

Nine patients are still hospitalized with two in intensive care units. There was no data available for five patients. 

Males were much more likely to report heart inflammation after receiving a second dose than women.

As of June 11th, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.

What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.

Ang [among] males, rates were 56.3 per million for the 18-to-24 age group and 20.4 per million in the 25-to-29 group.

In Australia, the AstraZeneca Covid vaccine is facing further criticism over its links to a variety of side effects. The vaccine will have been almost completely phased out of the country’s roll-out by October.

Worth reading in full.

Thousands of Women Suffering Period Problems Following Covid Vaccination

Britain’s medicines regulator has received reports from almost 4,000 women, mostly aged between 30 and 49, who have suffered period problems after taking a Covid vaccine. Reports were gathered until the middle of May – before the vaccine rollout opened for the whole adult population – so more up-to-date figures could show a much lower age range for period problems. The Sunday Times has the story.

Official data, obtained by the Sunday Times, show that the Medicines and Healthcare products Regulatory Agency (MHRA) received 2,734 reports of period problems linked to the AstraZeneca vaccine, 1,158 related to the Pfizer jab, and 66 linked to the Moderna vaccine up to May 17th.

The issue, typically involving “heavier than usual” bleeding, could have affected many more women who would not have thought to report their experience. The majority of issues were reported in women aged between 30 and 49.

Asked why the problems had not been added to the official list of possible side effects of the Covid vaccines, the MHRA said a review with experts had found that there was no need to do so. The “current evidence” did not suggest an “increased risk” of period problems after the jab, it said, but it had published information on reports of menstrual disorders in its weekly report on adverse reactions.

Victoria Male, a Reproductive Immunologist at Imperial College London, said more women were likely to have been affected than the number of case reports. “It’s definitely true that not everyone will be reporting any menstrual changes they have noticed to Yellow Card [the MHRA’s scheme for people to report suspected side effects] simply because not everyone knows that it exists and that they can file a report,” she said.

Although a clear link between the Covid jab and menstrual disorders had not been established, “lots of people have contacted me to tell me about changes that they have noticed in their periods following vaccination”, Male said. “The kinds of things they are telling me about, mostly periods that are heavier or later than usual, are very similar to the reports we are seeing in Yellow Card.”

Angharad Planells, 34, from Cheltenham, said her period had been 11 days late after her second dose of the AstraZeneca vaccine. “My whole life I’ve been pretty regular and I track my period on an app. It was super late,” she said. “When it did start, it was one of – if not the – most painful periods I’ve ever had, to the point where I felt a bit nauseous.”

Planells, who reported the suspected adverse reaction to the MHRA, added: “I would still have the vaccine again. I have had family members die from Covid. It’s just the lack of information out there.”

Worth reading in full.

AstraZeneca Covid Vaccine Recommended Only for Australians Aged 60 and Over

The Australian medicines regulator has recommended that the AstraZeneca Covid vaccine is only used in those aged 60 years and over amid further reports of blood clotting following vaccination, as well as reports of a link between the AZ vaccine and an illness that can leave patients paralysed.

Five out of the 12 confirmed and probable new cases of blood clotting following vaccination are actually in people over the age of 60, according to the Australian Therapeutic Goods Administration (TGA). A further four cases are in people less than five years away from turning 60. All remaining cases are in people above the age of 50.

The Guardian has more.

Pfizer will be the preferred vaccine for eligible people under 60 following a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI). However, people who have had their first shot of AstraZeneca will be advised to have their second shot of the same vaccine.

The Health Minister, Greg Hunt, said the opening of Pfizer to people aged 50 to 59 would mean that the 2.1 million people in this cohort who have yet to have the AstraZeneca shot will receive the Pfizer vaccine instead.

The TGA reported on Thursday there were a further 12 reports of blood clots and low blood platelets assessed to be confirmed or probable cases of thrombosis with thrombocytopenia syndrome (TTS) linked to the AstraZeneca vaccine in the past week.

The new cases include three confirmed in 55 and 65 year-old women from Victoria and a 53 year-old woman from NSW. The nine new probable cases include: a 54 year-old man from the Northern Territory, a 65 year-old woman from Tasmania, 50 and 56 year old men and a 69 year-old woman from Victoria, a 58 year-old woman from South Australia, 59 and 80 year-old men from Queensland, and a 67 year-old woman from NSW.

It takes the total of Australian reports of TTS following the AstraZeneca vaccine to 37 confirmed and 23 probable.

The estimated risk of TTS following the first dose is 3.1 per 100,000 for people under 50, 2.7 for people between 50 and 59, 1.4 for people between 60 and 69, 1.8 for people 70 to 79, and 1.9 for people over 80 years of age.

The Chief Medical Officer, Professor Paul Kelly, said the new cases had “changed the rate” for those between 50 and 59, changing the risk profile more in line with those under 50. There have been two deaths in Australia linked to TTS, and Kelly stressed it remains a very rare condition.

“Remember this remains a very rare but sometimes serious event; we’re picking it up much more commonly than other countries because we’re looking more fully,” he said. 

“For most people, they’ve been diagnosed early, there was a large proportion of those with a less severe form of this rare syndrome, and most of those have been discharged from hospital already.”

Last week, the Italian Government also restricted the use of the AZ vaccine to people over the age of 60 after the death of a teenager with blood clots following vaccination.

The Guardian report is worth reading in full.

CDC to Hold Emergency Meeting Over 226 Cases of Heart Inflammation in American Teens Who Have Had Pfizer or Moderna Vaccines

The U.S. Centers for Disease Control is set to hold an emergency meeting over a greater than expected number of cases of heart inflammation among young Americans who have received two doses of either the Pfizer or Moderna Covid vaccine. The MailOnline has the story.

[CDC leaders] will gather on June 18th to discuss 226 plausible cases of heart inflammation in young people – mainly affecting teenage boys and young men – after they have received their second doses of the vaccines. 

CDC bosses said Thursday the number of cases is higher than expected, although still rare.

[CNBC reports that, according to the CDC, scientists expected only between 10-102 cases of myocarditis or pericarditis.]

A total of 226 cases have been reported that may meet the CDC’s “working case definition” of myocarditis and pericarditis following the shots, the agency said. 

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart.

Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest – 167 – have recovered.  

It is not clear if either condition is caused by the shots and the reports of cases are extremely rare. 

The CDC continues to urge everyone aged 12 and older to get vaccinated.

These types of heart inflammation can be caused by a variety of infections, including a bout of Covid, as well as certain medications…

Cases are reported through the U.S. Vaccine Adverse Event Reporting System (VAERS).

The system accepts reports from everyone regardless of the plausibility of the vaccine causing the symptom.

In total, VAERS received 573 reports of myocarditis and pericarditis after the patient had received their second dose. 

A total of 372 reports were from people who had the Pfizer vaccine, while the remaining 201 had Moderna.

Another 216 cases of the heart inflammation were also reported after dose one of the vaccines. 

More than half of the cases reported after people had received their second dose were in people between the ages of 12 and 24, the CDC said.  

This group accounts for less than nine per cent of doses administered.  

Almost four-fifths of cases were in males. 

The overwhelming majority of the cases have occurred within a week of vaccination. 

Symptoms included chest pain and breathing difficulties. 

This comes just one day after Moderna asked the U.S. Food and Drug Administration to extend the emergency use of its Covid vaccine to American children aged 12 and over.

The U.K. Medicines and Healthcare products Regulatory Agency approved the use of the Pfizer vaccine in British children aged 12-15 earlier this month, though the Joint Committee on Vaccination and Immunisation said that the decision on whether or not to vaccinate children against Covid is down to the Government given that it is a “political” matter. So far, the petition on the Gov.uk website against the vaccination of children has been signed by over 50,000 people.

Worth reading in full.

Stop Press: Watch Tucker Carlson react to this news.

We Shouldn’t Vaccinate Children as a Matter of Principle Because of the Side Effects, Says Government Vaccine Adviser

Adam Finn, Professor of Paediatrics at the University of Bristol and a member of the Government’s Joint Committee on Vaccination and Immunisation (JCVI), was on BBC Radio 4’s Today programme this morning (around the 50 minute mark) taking a surprisingly strong line against vaccinating children because of the “side effects”. Here’s an edited transcript of what he said:

The main priority at the moment is to try and immunise as many people as possible who are at risk of getting really sick with this virus, because that’s the one thing we want avoid is another big surge of hospitalisations and deaths, and that isn’t going to happen in children. … Children are very rarely seriously affected by this infection. …

The evidence we’ve got with children, particularly young children, is that they are not very infectious to each other or to adults around them and that the majority of the transmission of the infection is in the adult population in fact. …

There is a certain amount of transmission going in secondary schools, so in teenagers, but in fact we’ve been surprised about how little transmission we’ve picked up in schools and of course this time around there’s been a lot more testing and awareness of what’s going in schools. …

In normal times, just as in pandemic times, we simply wouldn’t want to immunise anybody without needing to. It’s an invasive thing to do, it costs money, and it causes a certain amount of discomfort, and vaccines have side effects. So if we can control this virus without immunising children we shouldn’t immunise children as a matter of principle. …

I’m optimistic that we in particular in the U.K., with the high coverage we’re achieving and the extremely effective vaccine we’ve got, that we can achieve population immunity and I’m afraid it’s an open question as to whether we need to immunise any children at all and if we do how many children we need to immunise.

This is quite a change of tune for Professor Finn, who last month told BBC Breakfast that children had been “left behind” in vaccination and vaccine trials, saying: “We’re impatient now to get on and do the necessary trials in children so that these vaccines can start to be used, and actually circumstances are holding us back so it’s a very frustrating situation to be in.”

He did add, though, that side-effects appeared to be worse in younger people: “There is evidence for more or less all of the vaccines against Covid that the side-effect rate, the reactogenicity that we see, basically goes up the younger you are.”

At the time of these earlier comments the AstraZeneca trials in children were paused while the MHRA investigated blood clot links. What has Professor Finn seen since then that persuaded him that maybe vaccinating children isn’t so pressing after all? Is this a sign that the side-effects, at least in the young, are beginning to be taken seriously by the Government?

Major Study Finds “Abundance of Patients Admitted to Hospital With Covid Within Seven Days of Vaccination”

A new study of Covid hospital patients has found once again a spike in infections post-vaccination – what the authors call “an abundance of patients admitted to hospital within seven days of vaccination”.

The ISARIC4C consortium’s COVID-19 Clinical Information Network (CO-CIN) enrolled 52,280 Covid patients who were admitted to hospital between December 8th and April 10th. Of these, 3,842 had received at least their first vaccine dose, which is 7.3% or one in 14.

The researchers found that the median time between receiving a first jab and the onset of Covid symptoms was nine days. Since the median time from infection to symptom onset is five days, this suggests the majority contracted the disease in the days after vaccination.

The graph above shows how many of the vaccinated Covid patients experienced symptom onset on each day since vaccination. Note the massive spike on the day of vaccination and the three days afterwards. Although the authors do not say it in so many words, clearly the vaccines here are bringing on the symptoms. Why else would the frequency of symptom onset increase by 400% from the day before vaccination to the day of vaccination and in the following days?

The authors offer a few potential explanations. They suggest elderly and vulnerable people who had been shielding may have become infected through the exposure involved in the vaccination programme. Or perhaps they stopped shielding or being careful as soon as they got vaccinated, wrongly assuming they were immune.

The authors also raise the possibility that recent asymptomatic or mild COVID-19 could be triggered by vaccination into “symptoms likened to COVID-19 symptoms including fever”.

The study’s co-lead Dr Calum Semple, Professor in Child Health and Outbreak Medicine at the University of Liverpool, was clear where he stood on this, saying that the spike indicated “people are letting their guard down because they’ve been vaccinated. There is evidence here that people are unfortunately assuming that they’re protected very quickly after vaccination and that’s not the case.”

Such behavioural change was likewise blamed by Michael Day writing in the BMJ in March. Dr Clare Craig wrote a thorough riposte in the same journal, pointing to ONS data showing that the vaccinated did not increase their social contact and asking how it would explain similar spikes in care homes. She suggested other explanations were more likely, such as a drop in white blood cells in the days after vaccination as observed in the Pfizer trial, which may temporarily suppress immunity.

The spike in symptomatic Covid from day zero plainly cannot be explained by behaviour change, and as the authors suggest looks very much like the vaccine somehow re-triggering an old or existing Covid infection.

The good news from the study is that the vaccinated did not make up a large proportion of those hospitalised with Covid during December and January, though by late February and March (when all the over-65s were vaccinated) they made up a sizeable chunk of a much reduced total.

The authors note that the first dose of the vaccine doesn’t appear to reduce death among the high-risk hospitalised, saying “mortality appears to remain high for people in high-risk vaccination tiers who are admitted to hospital with symptomatic SARS-CoV-2 infection (COVID-19) despite vaccination 21 days or more previously”. It is not clear if this is a temporary effect owing to adverse effects of the vaccine or a permanent gap in the protection it offers.

How much longer can governments and scientists ignore the evidence of the post-vaccine spike in infections, found in study after study? When will they stop lazily blaming people for getting themselves infected and commit to investigate it properly?