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).

Key events analysis: