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.