VAERS

Vaccine Safety Update

This is the 13th of the 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 12th 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 in June 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.

Summary of Adverse Events in the U.K.

According to an updated report published on October 7th, the MHRA Yellow Card reporting system has recorded a total of 1,222,566 events based on 370,574 reports. The total number of fatalities reported is 1,698.

  • Pfizer (22.9 million first doses, 19.6 million second doses) now has one Yellow Card in 189 people vaccinated. Deaths: 1 in 41,486 people vaccinated (552).
  • AstraZeneca (24.9 million first doses, 24 million second doses) has one Yellow Card in 106 people vaccinated. Deaths: 1 in 22,698 people vaccinated (1,097).
  • Moderna (1.4 million first doses, 0.7 million second doses) has one Yellow Card in 84 people vaccinated. Deaths: 1 in 73,684 people vaccinated (19).

Overall, one in every 132 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Vaccine Safety Update

This is the 12th 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 11th 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.

  • Further ‘breakthrough cases‘ in vaccinated people have been reported in Israel, India and Florida. A preprint study in the Lancet has found that: “Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strain”, indicating that fully vaccinated people can transmit the Delta variant. 
  • Further reports of myocarditis and heart conditions post-Covid vaccine have been acknowledged by the CDC. Case studies have appeared in Clinical Research and Cardiology and BMC Cardiovascular Disorders along with a media report in the Daily Mail.
  • The Times reports on rare blood clots caused by COVID-19 vaccines. NICE guidelines have been updated to reflect protocol for the treatment of Vaccine Induced Thrombocytopenia and Thrombosis (VITT) and further guidance is available from the NHS and Thrombosis UK.  Further Clinical Features of VITT appear in the New England Journal of Medicine while the Journal of Korean Medical Science publishes its first case study on intracerebral haemorrhage due to thrombosis with thrombocytopenia syndrome after vaccination against COVID-19. 
  • Results of the Moderna trial on children have been published in the New England Journal of Medicine, reporting local reactions after the first injection in 94.2% of participants and after the second injection in 93.4%.  Systemic adverse reactions were reported in 68.5% of the participants after the first injection and in 86.1% after the second injection; grade 3 events were reported in 4.4% and 13.7%, respectively, and one participant reported a grade 4 event. No cases of myocarditis were reported although the authors acknowledge that the sample size (2,489) was likely too small.
  • Eleanor Riley, Professor of Immunology and Infectious Disease at Edinburgh University, is reported in the Herald as saying vaccinating young people will not protect adults.
  • Public Health England have published their SARS-CoV-2 variants of concern and variants under investigation in England Technical Briefing 21. This continues to demonstrate a similar risk of death for the under-50s between the double vaccinated and unvaccinated (0.07% and 0.04% of Delta cases respectively), questioning the need to continue the vaccination drive in younger people.
  • A new analysis by TrialSite News finds that Covid vaccines have 98 times the rate of deaths reported to VAERS than flu vaccines. A comparison of the event rates reported for different vaccines and different adverse reactions provides “material evidence that the increase is not due mainly to an increase in the number of vaccinations given, nor to stimulated reporting”.
  • CNBC reports that two senior FDA officials responsible for reviewing COVID-19 vaccine applications – Marion Gruber and Phil Krause, respectively the director and deputy director of the Office of Vaccines Research & Review – have quit the agency, because they are unhappy about the CDC overruling them and moving forward with booster shots.
  • VAERS – the American version of the Yellow Card reporting system – released new data on August 13th bringing the total to 595,622 reports of adverse events following Covid vaccines, including 13,068 deaths and 81,050 serious injuries.
  • Suspected adverse events in the U.K. as reported in the media: Michael Mitchell (65); Pawel Panasiuk (45); Alex Evans (31); Lisa Shaw (44).

Summary of Adverse Events in the U.K.

According to an updated report published on August 26th, the MHRA Yellow Card reporting system has recorded a total of 1,165,636 events based on 351,404 reports. The total number of fatalities reported is 1,609.

  • Pfizer (21.3 million first doses, 16.6 million second doses) now has one Yellow Card in 199 people vaccinated. Deaths: 1 in 41,929 people vaccinated (508).
  • AstraZeneca (24.8 million first doses, 23.9 million second doses) has one Yellow Card in 108 people vaccinated. Deaths: 1 in 23,485 people vaccinated (1,056).
  • Moderna (1.4 million first doses, 0.7 million second doses) has one Yellow Card in 100 people vaccinated. Deaths: 1 in 50,000 people vaccinated (28).

Overall, one in every 135 people vaccinated (0.7%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures. On average there have been 47 deaths and 10,500 adverse event injuries reported per week.

Vaccine Safety Update

This is the tenth 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 ninth 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.

  • There have been international reports of adverse events following COVID-19 vaccines in Indonesia (reporting the deaths of 131 health care workers post Sinovac vaccine), India and Canada (reporting 22 cases of heart inflammation).
  • Further reports of Bell’s Palsy developing following vaccination, including a featured case report in the BMJ. Immunologist Dr. J. Bart Classen has written in the Journal of Medical – Clinical Research & Reviews on the risk of Parkinson’s disease following Covid vaccination, especially AstraZeneca (summarised here).
  • A study in the Lancet suggests that antibody responses wane rapidly and are low within two months of vaccination (though the authors note that protection via cellular immunity may remain).
  • A report on ‘breakthrough’ cases from NBC Boston, reporting 5,100 cases in Massachusetts and 80 subsequent deaths. 
  • The Royal College of Paediatrics and Child Health has said that it supports the recommendations of the JCVI on not vaccinating children below the age of 18 unless they have underlying health conditions.
  • The inventor of mRNA technology, Dr. Robert Malone, has spoken of his fear that current data shows a worrying trend of possible ADE (Antibody-Dependent Enhancement) as the vaccine may cause the virus to be more dangerous in the vaccinated than the unvaccinated.
  • Lawyers have warned that ‘ethical veganism’ is a protected belief that would be among those that would have to respected in any effort to introduce mandatory vaccination in workplaces, the Telegraph reports
  • Chief Midwife for England, Jacqueline Dunkley-Bent, has penned a letter to midwives, obstetricians and GP practices, asking them to recommend COVID-19 vaccines to pregnant women.  This follows some surveillance data that suggests some increased risk to pregnant women from the Delta variant. A study interim report published in the New England Journal of Medicine concludes that while 13% of the 827 vaccinated women in the study suffered a spontaneous abortion (miscarriage), this is not an elevated number. Dr. Peter McCullough has written in TrialSiteNews detailing some serious concerns with the study, stating: “The effect of the vaccines on early pregnancy losses (<20 weeks) is concerning and remains to be determined.” To date the Yellow Card system has reported 600 adverse events relating to pregnancy conditions including 10 deaths and 381 spontaneous abortions.
  • A Spanish preprint study in the Lancet suggests that the safety profiles of Pfizer and AstraZeneca vaccines are similar in terms of blood clotting. It also suggests that the risk of blood clotting is greater for those infected with SARS-CoV-2.
  • A preprint study in Medrxiv reports no difference in viral loads when comparing unvaccinated people to those who have ‘breakthrough’ infections post-vaccine, suggesting “that if vaccinated individuals become infected with the Delta variant, they may be sources of SARS-CoV-2 transmission to others”. 
  • Report in the Telegraph that AstraZeneca may end its future development of vaccines after offering its COVID-19 vaccine at cost to contribute to the pandemic effort. Pfizer, on the other hand, has reported record profits and is discussing increasing the costs of booster shots, according to the Guardian.
  • Statistician Mathew Crawford has argued that the CDC’s definition of a safety signal prevents it from picking up safety problems with the Covid vaccines, essentially because it compares the Covid vaccines to one another rather than to an established baseline.
  • VAERS – the American version of the Yellow Card reporting system – released new data on July 23rd bringing the total to 518,581 reports of 2,426,531 adverse events following Covid vaccines, including 11,940 deaths.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged (up to July 31st) 779,048 reports of 1,940,012 adverse events, including 20,595 deaths.
  • Suspected adverse events in the U.K. as reported in the media: Gemma O’Shea (35); Natalie Simpson (38).

Summary of Adverse Events in the U.K.

According to an updated report published on July 21st, the MHRA Yellow Card reporting system has recorded a total of 1,102,228 events based on 331,240 reports. The total number of fatalities reported is 1,517.

  • Pfizer (20.4 million first doses, 12.9 million second doses) now has one Yellow Card in 215 people vaccinated. Deaths: 1 in 43,777 people vaccinated (466).
  • AstraZeneca (24.7 million first doses, 23.2 million second doses) has one Yellow Card in 110 people vaccinated. Deaths: 1 in 24,263 people vaccinated (1,018).
  • Moderna (1.3 million first doses, 0.3 million second doses) has one Yellow Card in 118 people vaccinated. Deaths: 1 in 162,500 people vaccinated (8).

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.

Raising the Alarm on Myocarditis After Covid Vaccination

We’re publishing an original article today on the risks of heart problems following receipt of a Covid vaccine by Dr Clare Craig, a Diagnostic Pathologist in London and member of HART, and Dr Andrew G. Bostom, MD, a MS Research Physician at Brown University’s Center For Primary Care and Prevention at the Memorial Hospital of Rhode Island. They originally submitted it to the BMJ as a ‘Rapid Response’, but it was rejected. Here is an extract:

The FDA has expressed concerns around the rate of reported myocarditis within the VAERS reporting system, especially in the young. A presentation by the FDA on June 10th 2021 compared the reported rates of myocarditis with background expected rates, with data up to May 31st 2021. However, the expected rates to which observed rates were compared were those expected over a 31-day period. For under-18s, 90% of cases had an onset by day five after vaccination, making comparison with expected rates over 31 days unreasonable. A further meeting on June 23rd 2021 examined the reports in a seven day window with data up to 11 June 2021. A four fold increase above baseline was evident in the seven days after the first dose for under-24 year-olds, rising to over 27-fold for the seven days after the second dose. The rate per million doses given in males 12-17 years old was 17 times higher than in men aged over 50 years seven days after the first dose, rising to 74 times seven days after the second dose. (For females the risk was 50% higher and 13 times higher respectively.)

Worth reading in full.

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:

Deaths Linked to Covid Vaccines are 30 Times More Common than with Other Vaccines – Is the Safety Reporting System Fit for Purpose?

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

We have heard a lot in the last few weeks about Yellow Card reports for any adverse effects of vaccination, so I shall seek here to give a little background to the system and where it can work well but where it can seriously fall short. 

The Yellow Card system was introduced in 1964 following the thalidomide disaster as a way of formalising the reporting of adverse effects, especially for new drugs. Tear-out cards, printed on yellow paper, were inserted at the back of the British National Formulary (BNF), which acts as the bible for UK prescribing. This book, updated twice yearly, was given to every practising doctor. Any doctor or pharmacist seeing a patient with unexpected symptoms relating to a prescribed medicine could quickly complete one of the cards and send it to the regulatory authority. But already you can spot the problem here – the system depends on the health care professional recognising that the symptom might be related to a particular drug, so if the connection is not made then neither is the report. Take for example a busy orthopaedic SHO treating an elderly lady with a fractured hip. Will they think to report this as an adverse reaction to her blood pressure tablets? This matters. Studies show up to one third of hospital admissions are due to iatrogenic causes i.e., drug side-effects. Nowadays, the BNF is an online book and the Yellow Card system is also online, so perhaps even more ‘out of sight, out of mind’, especially if the ward is really busy at the time. If you ask colleagues whether vaccine adverse outcomes have been reported to MHRA, they often reply: “I’m not convinced it was the cause, it could have been due to anything.” But physicians are not responsible for deciding whether a clinical event was caused by a drug or was coincidental – that is the role of the MHRA

All new drugs and vaccines are subject to trials, starting with animal trials usually involving a number of different species, then building gradually through small pilot studies on humans to establish dosage regimes (for example) and short term safety, before rolling out to large scale trials looking for both efficacy and longer term safety. In such trials, all adverse outcomes will be reported, with the control group acting as the base-line for any symptoms against which the new drug is compared. The system works well for reasonably common side-effects and here the size of the trials is important. You will see in drug information leaflets side effects listed as “very common: affecting greater than 1 in 10 people”, through to “very rare: affecting less than 1 in 10,000”. Generally speaking, “very rare” side effects are only listed if severe. Many drug and vaccine trials are only large enough to detect “uncommon” side effects and for any new drug it is only through post-marketing surveillance that rarer side-effects can be discovered. New drugs are marked in the BNF with a black triangle for two years, to remind doctors to complete yellow card reports. In addition, most drug trials will exclude certain groups – for example children, pregnant women and people with risk factors such as kidney and liver disease, so safety for these groups is very much dependent on animal studies or assumptions from other similar drugs. Species difference in adverse effects may occur too, so damage to the developing foetus may only be seen after a drug starts being used by humans. Certain age groups that are under-represented in trials, such as the very elderly, may also be at greater risk. If post-marketing surveillance reveals an unexpected problem then the drug licence may be withdrawn or modified (e.g. limited to certain age groups, as with the AstraZeneca vaccine).