Safety

Vaccine Safety Update

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

  • Norway has announced vaccine injury compensation for at least three claims following AstraZeneca vaccination. An Oxford man has called for a review of U.K. Government vaccine injury compensation after he developed Guillain-Barré Syndrome following AstraZeneca vaccination. 
  • A 16 year old boy in Singapore suffered a cardiac arrest when exercising after his Pfizer vaccination.  
  • Some new medical reports exploring endocrine issues following Pfizer vaccination: one looking at a case of necrotising pancreatitis following the second dose of vaccine, and two looking at the development of Graves’ disease in two health care workers in Mexico.
  • The U.K. VITT Organ Donor Study Group has published a report of an analysis of organ donation and transplantation from U.K. donors with VITT (blood clots) to understand the implications. It concludes that transplantation from VITT donors should only proceed with caution due to a variety of possible complications in multiple organs. 
  • The Daily Mail reports that the MHRA has quietly added warnings on Moderna and Pfizer vaccines that they can cause heart damage in rare cases.
  • The Government has uploaded its Technical Briefing for Variants of Concern Number 18, which continues to show that despite rising cases the Delta variant is not currently causing as many fatalities or hospitalisations as the Alpha variant (case fatality rate 0.2% vs 1.9%).
  • Following a FOI request to the MHRA for all vaccine associated deaths between 2010 and 2020, the Daily Expose reports that deaths from Covid vaccines are 407% higher than all cumulative previously reported deaths from other vaccines.
  • ‘Breakthrough’ cases are being reported in Las Vegas, Wales and aboard HMS Queen ElizabethMyLondon reports that London Hospitals are refusing to provide this data.  
  • The Daily Mail reports that Johnson & Johnson and AstraZeneca are both seeking to modify their vaccines to reduce the incidence of life-threatening blood clots. 
  • VAERS – the American version of the Yellow Card reporting system – released new data bringing the total to 463,457 reports of adverse events following Covid vaccines, including 10,991 deaths and 48,385 serious injuries between December 14th 2020 and July 9th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Kent radio host Jules Serkin and Anthony Shingler (57).

Summary of Adverse Events in the U.K.

According to an updated report published on July 16th (covering the period up to July 7th), the MHRA Yellow Card reporting system has recorded a total of 1,059,307 events based on 314,043 reports. The total number of fatalities reported is 1,470.

  • Pfizer (19.7 million first doses, 11.6 million second doses) now has one Yellow Card in 357 doses, 2.8 adverse reactions per card. Deaths: 1 in 68,640 (456 deaths)
  • AstraZeneca (24.7 million first doses, 22.3 million second doses) has one Yellow Card in 214 doses, 3.6 adverse reactions per card. Deaths: 1 in 47,813 (983 deaths)
  • Moderna (1.1 million first doses) has one Yellow Card in 123 doses, 2.9 adverse reactions per card. Deaths: 1 in 157,143 (7 deaths). (This is a high rate of Yellow Card reports but lower fatal reports compared to the other two vaccines.)

Vaccine Safety Update

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

  • Correspondence in the BMJ from nurse Marco T. Suadoni calculating that, as far as vaccinating the under-25s is concerned, “for every single prevention of a hospital admission, at least 22 to 23 individuals will experience at least one serious adverse event”.
  • Article in the Telegraph quoting JCVI member Professor Robert Dingwall suggesting that it is safer to let children catch COVID-19 than vaccinate them.
  • UKMFA has written an open letter requesting that informed consent be properly addressed at vaccination centres.
  • The peer-reviewed paper in Vaccines that we mentioned recently claiming that two deaths result from COVID-19 vaccinations for every three deaths prevented has been retracted by the journal, citing serious concerns with the use of adverse event data. The paper’s authors have issued a statement in which they say: “The true reason seems to have been pressure on the part of some editors of the journal,” and “The timeline suggests that the journal was not really interested in our response and that our response was irrelevant to the retraction”.
  • Report of a blood clotting death following Moderna vaccination.
  • Newsweek reports that the CDC is investigating the death of a 13 year-old Michigan boy in his sleep days after receiving the second dose of the Pfizer vaccine.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 16,535 people have died and 1,750,275 have suffered injuries following receipt of the Covid vaccines in the EU.
  • VAERS – the American version of the Yellow Card reporting system – released new data bringing the total to 441,931 reports of adverse events following Covid vaccines, including 6,985 deaths and 34,065 serious injuries between December 14th 2020 and June 25th 2021.

Summary of Adverse Events in the U.K.

According to an updated report published on July 1st (covering the period up to June 23rd), the MHRA Yellow Card reporting system has recorded a total of 1,007,253 events, based on 298,081 reports. The total number of fatalities reported is 1,403.

  • Pfizer: 18 million first doses, 11 million second doses.
  • AstraZeneca: 24.5 million first doses, 20.7 million second doses.
  • Moderna: 0.88 million first doses.

Vaccine Safety Update

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

  • An article in the peer-reviewed journal Vaccines discusses the balance of benefits and risks of COVID-19 vaccines. Based on analysis of data from Israel and Europe, the study finds that for every three Covid deaths vaccines prevent they cause two deaths through adverse reactions, leading the authors to question the lack of clear benefit of the current vaccination policy. The journal has subsequently published an “expression of concern” about the paper to notify readers that it is reviewing the numerous complaints it has received about the article.
  • A preliminary review of VAERS reports (the U.S. equivalent of Yellow Card reports) has found that 86% of the first 250 deaths reviewed were correctly reported as involving an adverse reaction to the vaccine.
  • There have been reports of “breakthrough” infections among the fully vaccinated in a Cornwall care home, though all were reportedly asymptomatic. Massachusetts has reported 4,000 infections among the fully vaccinated, also said to be mainly asymptomatic or mild with a low viral load. Half of Israelis in the most recent outbreak are also reported to have been fully vaccinated.
  • Further reports of Guillain-Barré syndrome linked with the vaccines, particularly AstraZeneca, in India and the UK.
  • The American Journal of Ophthalmology Case Reports has released a study that looks at “acute-onset central serous retinopathy after immunisation with COVID-19 mRNA vaccine”, finding that there may be a causal link in a 33 year-old male case study. 
  • Reuters reports on the recent decision of the FDA to add warnings of possible heart inflammation following vaccination with Pfizer and Moderna Vaccines and JAMA reports on 23 cases of heart inflammation among members of the U.S. military following vaccination with mRNA vaccines, which was “higher than expected among male military members after a second vaccine dose”.
  • The Mirror reports on a case of a 48 year-old male writer and filmmaker who died of blood clots associated with the AstraZeneca vaccine, raising questions over access to the Vaccine Damage Payment Scheme for the families of victims of vaccine injury who have died as a result of the vaccine.
  • Suspected adverse events in the U.K. as reported in the media: the latest victim is Lucy Taberer, a 47 year-old mum of three.

Summary of Adverse Events in the U.K.

According to an updated report published on June 24th (covering the period up to June 16th), the MHRA Yellow Card reporting system has recorded a total of 970,696 events, based on 285,219 reports. The total number of fatalities reported is 1,356.

  • Pfizer (16.8 million first doses, 10.9 million second doses) now has one Yellow Card in 375 doses, 2.8 adverse reactions per card. 
  • AstraZeneca (24.6 million first doses, 19.6 million second doses) has one Yellow Card in 196 doses, 3.6 adverse reactions per card.
  • Moderna (0.73 million first doses) has one Yellow Card in 140 doses, 2.8 adverse reactions per card. (It’s possible the continuing very high rate of Yellow Cards with Moderna is to do with skin reactions.)

“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?”

Vaccine Safety Update

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

  • Dr Robert Malone, the inventor of mRNA and DNA vaccine technology, has expressed concern about the safety profile of the current Covid vaccines and the censorship of discussing the issues, and called for them to be properly investigated as a matter of urgency. See also his appearance on Bret Weinstein’s podcast (deleted from YouTube) along with Steve Kirsch, who has written of his concerns about the vaccines here.
  • The UKMFA has written an open letter objecting to a report on BBC Newsround (a children’s television news programme) by Professor Devi Sridhar, Chair of Global Public Health at the University of Edinburgh, about vaccine efficacy and safety.
  • Researchers at RCSI have published a study in the Journal of Thrombosis and Haemostasis in which they show that COVID-19 patients had higher levels of pro-clotting VWF molecules and lower levels of the anti-clotting ADAMTS13. This has yet to be applied to clots in vaccinated patients but may have implications.
  • A study in the British Journal of Ophthalmology noted the occurrence of corneal transplant rejection after vaccination with COVID-19 mRNA vaccines.  
  • In Public Health England’s latest Variants of Concern Technical Briefing, the fully vaccinated have a 0.64% chance of death after testing positive for the Delta Variant whereas unvaccinated individuals have a 0.096% chance of death – a seventh of the risk. However, this is likely to be primarily a result of the much younger age profile of the unvaccinated.
  • Dr. Diego Rubinowicz, a Urologist in Palm Beach County Hospital, has observed increased PSA levels in vaccinated men, leading to possible misdiagnosis of prostate cancers.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 15,472 people have died and 1,654,407 have suffered injuries following receipt of the Covid vaccines in the EU.
  • VAERS – the American version of the Yellow Card reporting system – released new data on June 11th bringing the total to 358,379 reports of adverse events following Covid vaccines, including 5,993 deaths and 29,871 serious injuries between December 14th 2020 and June 11th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Vanessa Newton (45); Lucy Taberer (47); Sophia Gomes (43).

Summary of Adverse Events UK

According to an updated report published on June 17th (covering the period up to June 9th), the MHRA Yellow Card reporting system has recorded a total of 949,287 events, based on 276,867 reports. The total number of fatalities reported is 1,332.

  • Pfizer (15.6 million first doses, 10.8 million second doses) now has one Yellow Card in 372 doses, 2.9 adverse reactions (i.e., symptoms) per card. 
  • AstraZeneca (24.6 million first doses, 17.7 million second doses) has one Yellow Card in 211 doses, 3.6 adverse reactions per card.
  • Moderna (0.56 million first doses) has one Yellow Card in 130 doses, 2.8 adverse reactions per card.

Vaccine Safety Update

This is the fifth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the fourth one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • Questions have been raised by Trial Site News on whether Pfizer failed to perform industry standard animal testing prior to the start of human trials, following a worrying response to a Freedom of Information request from a group of Canadian physicians.
  • According to the FDA, in the Pfizer clinical trials on children aged 12-15, of the 1,127 children who received a first dose, no fewer than 86% experienced an adverse reaction. Of the 1,097 children who received a second dose, 78.9% experienced an adverse reaction. Several children also developed deep vein thrombosis (resulting in pulmonary embolism) post-vaccination. 
  • Does the SARS-CoV-2 spike protein trigger certain forms of cancer? An exploration of the data after autopsies found two of eight COVID-19 sufferers with undetected thyroid cancer.
  • Dr Tess Lawrie of the Evidence-based Medicine Consultancy wrote an open letter to Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), calling for the “cessation of the vaccination roll out while a full investigation is conducted” as “the MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans”.
  • A pre-print study from Cleveland, Ohio, reported in the Washington Examiner, finds that vaccination offers no additional protection from COVID-19 infection after a person has been previously infected.
  • The first post-mortem of a patient vaccinated against COVID-19, reported in the Journal of Infectious Diseases, found that the 86 year-old man had viral RNA present in all organs of his body.
  • The BMJ reports on a Norwegian review that finds the Pfizer Vaccine is “likely” responsible for the some of the deaths in the elderly post-vaccination.
  • Switzerland has approved the vaccination of children as young as 12 without their parents permission from July.
  • The BMJ reports further concerns regarding immune thrombocytopenic purpura (ITP) after vaccination with AstraZeneca (also reported in the Daily Mail).  
  • A report from Australia of a probe launched by the medicines regulator after eight people developed Guillain-Barré Syndrome following an AstraZeneca vaccination.
  • Italy has halted use of the AstraZeneca vaccine for the under-60s after the death of a teenager with blood clots following vaccination.
  • There have been further reports of heart inflammation following vaccination with the mRNA vaccines (Pfizer and Moderna). The Daily Mail reports on the CDC calling an urgent meeting over 226 cases of heart inflammation in teenage boys who have had the Pfizer or Moderna shots.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 13,867 people have died and 1,354,336 have suffered injuries following receipt of the Covid vaccines in the EU (as of June 5th).
  • Suspected adverse events in the U.K. as reported in the media: Laura Hamilton (39); Jennifer Rose (65).

Summary of Adverse Events UK

According to an updated report published on June 10th (covering the period up to June 2nd), the MHRA Yellow Card reporting system has recorded a total of 922,596 events, based on 267,671 reports. The total number of fatalities reported is 1,295.

  • Pfizer (14.7 million first doses, 10.7 million second doses) now has one Yellow Card in 374 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 62,562 doses. 
  • AstraZeneca (24.5 million first doses, 15.7 million second doses) has one Yellow Card in 205 doses, 3.7 adverse reactions per card, one fatal reaction in 46,581 doses.
  • Moderna (0.46 million first doses) has one Yellow Card in 140 doses, 2.8 adverse reactions per card, one fatal reaction in 115,000 doses.

A curiosity is that the rate of Yellow Cards went up for Moderna from an already very high level (higher than at any point for AstraZeneca) despite there being only 60,000 shots administered this week.

Key events analysis:

Vaccine Safety Update

This is the fourth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the third one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • A new study from the Journal of Pharmaceutical Policy and Practice on adverse events among Japanese women receiving the Pfizer vaccine (known in the study as tozinameran), in particular cerebral venous sinus thrombosis and intracranial haemorrhage (ICH), finds a “disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine”.
  • Dr Andreas Greinacher, Head of the Institute of Immunology and Transfusion Medicine at University Hospital Greifswald in Germany, has proposed a mechanism to explain the blood clotting adverse events connected with the AstraZeneca vaccine. Scottish physician Dr Malcolm Kendrick has published an article exploring the connection between the spike protein in SARS-CoV-2 and blood clotting. The UK Medical Freedom Alliance has produced a document looking into the relationship between the spike protein, cellular fusion and tissue damage.     
  • The Sun highlights the emerging link between the Pfizer vaccine and heart condition symptoms, advising people on five key symptoms to look out for post-vaccination.
  • The journal Paediatrics has an article entitled “Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer-BioNTech COVID-19 Vaccination“. 
  • The MHRA has cleared the use of the Pfizer vaccine for 12-15 year-olds in the UK. The regulator says the benefits outweigh the risks, though its analysis supporting this is awaited. In the U.S., the FDA has released its guidance on using the Pfizer vaccine in this age group. There is a petition on the Parliament website asking the U.K. Government to stop Covid vaccination in children for reasons discussed by HART’s Dr Ros Jones on the TalkRadio Mark Dolan Show (1hr 10 mins). Further petitions started this week: “Reform the VDPA 1979 to improve support for those harmed by COVID-19 vaccines“; “Do not mandate COVID-19 vaccinations for British soldiers under 25“.
  • Dr Byram Bridle, a Viral Immunologist and Associate Professor at the University of Guelph, Ontario has drawn attention to the findings of a Japanese study on the biodistribution of the Pfizer vaccine in the body, highlighting the presence of the spike protein in several organs, including the brain, liver and ovaries. (More information on this here.)  
  • International Vaccine Injury Awareness Day was marked on June 3rd with a peaceful vigil in London (close to BBC Broadcasting House) remembering the victims of all vaccine injury, including those damaged by COVID-19 vaccinations.
  • VAERS – the American version of the Yellow Card reporting system – released new data on June 4th bringing the total to 294,801 reports of adverse events following Covid vaccines, including 5,165 deaths and 25,359 serious injuries between December 14th 2020 and May 28th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Tanya Smith (43).

Summary of Adverse Events UK

According to an updated report published on June 3rd (covering the period up to May 26th), the MHRA Yellow Card reporting system has recorded a total of 888,196 events, based on 256,224 reports. The total number of fatalities reported is 1,253.

  • Pfizer (14 million first doses, 10.6 million second doses) now has one Yellow Card in 382 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 62,121 doses. 
  • AstraZeneca (24.3 million first doses, 13.4 million second doses) has one Yellow Card in 200 doses, 3.7 adverse reactions per card, one fatal reaction in 45,637 doses.
  • Moderna (0.4 million first doses) has one Yellow Card in 162 doses, 2.8 adverse reactions per card, one fatal reaction in 100,000 doses.

Key events analysis:

Why Boris Must Halt the Child Vaccine Programme

There follows a guest post by Dr Ros Jones, a retired consultant paediatrician and member of HART.

If, a year ago, someone had asked if we should give children a brand-new vaccine with no long-term safety data for a disease that barely affects them, they would have been laughed out of court. But here we are today, considering doing exactly that and not even with the pretence that it is for their own safety. It is because adults think it is okay to ask children to take a medicine which may cause them harm to protect us. Yet the adults clamouring for this have all been vaccinated already. 

Two weeks ago, 40 UK doctors wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) calling for a halt to any proposals to widen the temporary emergency authorisation for COVID-19 vaccines to include children on the grounds of major safety concerns. We now learn that this is such a complex ethical question that the JCVI will pass the responsibility to the Prime Minister. The entire management of the pandemic has been politicised to the detriment of open scientific and ethical debate and it is totally inappropriate for child health to become a potential political football.  The urgency for such debate has increased by the approval, first in North America and now Europe, for vaccination of 12-to-17-year-olds, and Pfizer’s application is currently lodged with the MHRA. So what is the medical, ethical and legal basis for such a move?

The medical case for children

Children are mercifully at incredibly low risk for COVID-19, with the vast majority having mild to no symptoms, few hospital admissions and even fewer requiring intensive care. There were nine Covid-associated deaths in under-15s in the whole of 2020, all with prior life-limiting conditions and accounting for 0.3% of all cause deaths in this age group. Any adolescent at extremely high risk may already receive a vaccine and this should not inform policy for an entire age group. Long Covid has also been raised as a concern, but in children it is milder and shorter-lived than in adults, with studies reporting complete recovery.

Safety

So if the disease is extremely mild for children, what of potential adverse effects of vaccination? Tragically, in recent weeks we have seen reports of thrombotic thrombocytopenia (VITT), an extremely rare condition, occurring in a significant number of young adults following vaccination, with cerebral venous strokes, some fatal. VITT was not detected in any of the trials but the MHRA now quotes the incidence following AstraZeneca vaccination as 1 in 77,000, stating ‘the data shows there is a higher reported incidence rate in younger adult age groups compared with older groups’. Doctors advising an individual on benefits and risks are left to guess how much higher but AstraZeneca vaccine was withdrawn for under 30s and latterly under 40s, and the Oxford children’s trial was suspended. Pfizer appears to have similar thrombotic problems though possibly at a lower rate and this is likely to be a class effect involving the spike protein. With Pfizer, the Israel Health Ministry have confirmed that myocarditis is occurring  at a rate of 1 in 41,730 for the 2nd dose in young men aged 16-30s, but highest in 16-19s. These are not trivial side-effects: they are potentially fatal or life-changing and appear to be occurring at a rate which is higher than that of severe outcomes for childhood Covid infections. This is without considering any as yet unknown longer-term adverse effects and bearing in mind that only 1,134 children were vaccinated in the Pfizer trials. Following the tenet “First do no harm”, routine vaccination of children against COVID-19 is contra-indicated.

Vaccine Safety Update

This is the third of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the second one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • The U.S. CDC is investigating reports of heart problems following vaccination with the mRNA vaccines (Pfizer and Moderna), particularly in young adults aged between 18 and 30, according to the Mail. It is estimated that around 1 in 100,000 vaccine recipients suffer myocarditis – an inflammation of the heart muscle – as an adverse event. The Israeli Health Ministry has announced further investigation into the issue while the Pentagon is reportedly monitoring it in the U.S. after 14 cases were reported following military vaccination. A study in the Lancet suggests a possible mechanism by which the virus itself could trigger such a condition.
  • The European Medicines Agency has approved the Pfizer vaccine for children of 12 years and above, the Metro reports. In Israel, 93 Doctors have signed an open letter calling for vaccines not to be offered to children on account of the low risks to them of the disease and the unknown risks of the vaccines. America’s Frontline Doctors have filed for a temporary restraining order against the use of COVID-19 vaccines in children in the Northern District of Alabama. In the U.K., the JCVI has not made a recommendation on the vaccination of children, and it will reportedly be left to Prime Minister Boris Johnson to make a decision in the coming weeks. If true, this seems a very unsatisfactory state of affairs – in the absence of a clear medical and scientific recommendation to authorise the use of a medicine on children, the default position should surely be not to authorise it?
  • A comment piece in the Lancet has raised the issue of the missing consideration of Absolute Risk Reduction (ARR) in the vaccine trials and studies. The authors, including Professor Piero Olliaro of the Centre for Tropical Medicine and Global Health at the University of Oxford, calculate an ARR of 1.3% for AstraZeneca, 1.2% for Moderna, 1.2% for Janssen and 0.84% for Pfizer.
  • A letter in the Journal of Neurology, Neurosurgery and Psychiatry (BMJ) (also reported by the Mail and ITV) highlights the risk of stroke following receipt of the AstraZeneca vaccination, linking it to the newly identified condition of Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) (blood clots).
  • The U.K. Government has released two reports on the hospitalisation rates of vaccinated people with COVID-19 over the winter and spring. One, from PHE, suggests 57% of patients admitted with Covid over the period had received at least one vaccine dose. The other, from the ISARIC4C consortium, suggested just 7.3% of Covid hospital admissions over the period had received at least one vaccine dose. This large discrepancy has not been acknowledged or explained.
  • The Johnson & Johnson vaccine has received conditional marketing authorisation in the UK. 
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 12,184 people have died and 1,196,190 have suffered injuries following receipt of the Covid vaccines in the EU.
  • Suspected adverse events in the U.K. as reported in the media: Stephanie Dubois (39); Lisa Shaw (44); Kirsty Hext (25).

Summary of Adverse Events UK

According to an updated report published on May 27th (covering the period up to May 19th), the MHRA Yellow Card reporting system has recorded a total of 859,481 events, based on 246,970 reports. The total number of fatalities reported is 1,213.

  • Pfizer (12.7 million first doses, 10.5 million second doses) now has one Yellow Card in 380 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 61,000 doses. 
  • AstraZeneca (24.2 million first doses, 10.7 million second doses) has one Yellow Card in 190 doses, 3.7 adverse reactions per card, one fatal reaction in 43,000 doses.
  • Moderna (0.3 million first doses) has one Yellow Card in 152 doses, 2.8 adverse reactions per card, one fatal reaction in 75,000 doses.

Note that these rates have dropped slightly from last week.

Vaccine Safety Update

This is the second of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the first one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not be taken. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers come to their own conclusions about what is best for them, based on the available data.

News Round-up

  • The U.S. CDC is investigating several dozen reports of heart inflammation in teenagers and young adults after receipt of the Covid mRNA vaccines, reports the New York Times
  • According to the India Times, heart attacks and strokes are the leading causes of death among vaccine recipients
  • A study in the journal Cureus claims there’s a link between receipt of a COVID-19 vaccine and the onset of Type 2 Diabetes
  • America’s Frontline Doctors has done a cost/benefit analysis of the Pfizer vaccine 
  • The Royal College of Emergency Medicine, The Society of Acute Medicine and Royal College of Physicians have released guidance on treating blood clots caused by the AstraZeneca vaccine
  • According to articles in the BMJ and the Telegraph, there are still concerns about giving the Covid vaccines to Children. The AstraZeneca trial involving children and teens has been suspended following fears of blood clots. HART has petitioned Parliament not to give Covid vaccines to children until Phase 3 Trials are complete
  • In the U.S., the FDA has given approval for children to receive the Pfizer vaccination following recommendations from the CDC ACIP Committee
  • An article in the Journal of Experimental and Clinical Transplantation addresses key concerns about COVID-19 vaccines (pre-print)
  • Three people have died in Scotland from what are believed to be side effects of the vaccines, as reported by the BBC and Telegraph
  • The BMJ and the UN have both published advice about how to counteract “vaccine hesitancy”, acknowledging that “when you look at hesitancy and parental vaccine hesitancy in the U.S., the group who is most likely to purposefully choose to not vaccinate are highly educated. In speaking with them, these are people who have read the primary literature themselves, and they’re correctly interpreting it, so it’s not a misunderstanding.” (p.26 of the UN Guide to Covid Vaccine Communications)  
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 10,570 people have died and 405,259 have suffered injuries following receipt of the vaccine in the EU up to May 8th
  • VAERS – the American version of the Yellow Card reporting system – has logged reports claiming 5,888 have died from vaccine side effects in the U.S. since 1990, of which 4,196 (71%) are linked to Covid vaccines administered in the last five months

Summary of Adverse Events UK

According to an updated report published on May 20th (covering the period up to May 12th), the MHRA Yellow Card reporting system has recorded a total of 822,078 events, based on 235,223 reports. The total number of fatalities reported is 1,178.