There are serious concerns about publication bias or selective omission of data, whereby adverse events are less likely to be published than positive results. A systematic review in PLOS journal analysed 28 studies and found that adverse events were less likely to appear in published journal articles than unpublished studies (e.g. industry-held data).
How? Let us understand by following examples:
Remote reporting to limited problems
In the Pfizer and AstraZeneca vaccine trials, participants were given digital apps to record adverse events remotely – a more convenient, time efficient and cost-effective way of gathering patient data. A major problem however, is that the pre-determined options on the digital apps have a narrow focus on particular adverse events. For example, the app only allows a participant to record what the company deems as ‘expected’ events such as fever, pain at injection site, temperature, redness, swelling, fatigue, headache, diarrhoea, chills, muscle and joint pain. But if they experience a serious adverse event like myocarditis or early signs of transverse myelitis, Guillain-Barre Syndrome, a myopathic disorder, myocarditis or thrombosis, there is no option for them to record it on the app. (Case in point: Brianne Dressen, a participant in the AstraZeneca (AZD1222) trial.)
Blaming an underlying condition
One of the participants in the trial was 13-year-old Maddie De Garay. She was randomly assigned to the vaccine group and following her first injection, Ms De Garay suffered a severe adverse reaction, leaving her in a wheelchair and fed by a nasogastric tube. The doctor decided that a pre-disposition to “hysteria,” was to blame for her physical disability but Dr David Healy, a psychiatrist based in Ontario, Canada, subsequently conducted a thorough review of Ms De Garay’s medical records, including an interview with her family and found no such history of pre-existing conditions or mental illness.
Failure to count deaths
When publishing deaths in the AstraZeneca trial for example, investigators excluded any deaths that occurred immediately after the first dose of the vaccine, up to 14 days after the second dose of the vaccine. In other words: 1) first injection, 2) wait for three weeks before having second injection, 3) wait a further two weeks. That is a total of five weeks where deaths were not published.
The investigators say it is because participants are not “fully immune” until two weeks after their second dose. That is true. However, ignoring deaths in that five-week period fails to capture any deaths that might be caused by the vaccine.
It is important to know what happens in that five week gap because real world data obtained from the CDC (as at 25 June 2021) shows that the majority of reported deaths after a Covid-19 vaccine, occur within 30 days.
