Several injured people made this claim, and with more detail, the speaker at 2:39:00 in the AZN trial. This is the paper results and protocol documents for that trial
https://www.nejm.org/doi/10.1056/NEJMoa2105290?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2105290/suppl_file/nejmoa2105290_protocol.pdf
The adverse events procedure are in section 8 and appendix B from the latter. From that document ,
All participants will be assessed for efficacy and safety. The first 3 000 participants randomized will also participate in a substudy assessing the reactogenicity and immunogenicity of AZD1222.
Thatâs 10% of the total 30k trial, 20k of which got the vaccine vs 10k with the placebo.
Participants in the substudy will have additional assessments for predefined solicited AEs for 7 days post each dose of study intervention and for humoral and cellular immune responses. Solicited AEs are defined in Section 8.3.7.
Each participant who has received at least one dose of study intervention will be followed for the full study period unless consent is withdrawn specifically from further study participation, or the participant is lost to follow-up.
A participant may withdraw from the study at any time at his/her own request, or may be withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or administrative reasons.
Room for bias perhaps but not evidence of that.
I think itâs clear from paper that the vaccine efficacy data excluded anyone who withdrew or otherwise didnât complete the 2 dose plan or was lost to the study, didnât get relevant tests, etc. from the supplemental notes,
All efficacy analyses were based on the fully vaccinated analysis set (FVAS) unless otherwise specified, which included all participants who were SARS-CoV-2 seronegative at baseline, received two doses of trial intervention, and who remained in the trial 15 days or more after their second dose without having had a prior confirmed SARS-CoV-2 RT-PCRâ positive infection.
furthermore, if you looked at the % of initial trial participants who made it thru to the fully vaccinated group, it was higher in the vaccine arm and relative sizes of groups removed for various reasons were similar. So I wouldnât think the efficacy data would be biased by the final trial inclusion conditions, but thatâs not the safety part tho.
For example, one of the speakers in the video had transverse myelitis and was paralyzed from the waist down due to a spinal cord injury. The AZN trial was halted for this condition (3 cases, 2 vaccine / 1 placebo), and judged one vaccine arm case for be possible related to the vaccine. For reference, given the time and size of the trial, about 1 case was expected in the vaccine arm, so 2 was slightly elevated but not obviously a strong signal.
However, one of the important questions in the assessment of an adverse event is whether the medical professional judges it to be causally related to the vaccine or not. They gave this specific guideline
Consistency with known IMP profile. Was the AE consistent with the previous knowledge of the suspect IMP (pharmacology and toxicology) or drugs of the same pharmacological class? Or could the AE be anticipated from its pharmacological properties?
so to the extent some of these vaccine side effects were not âtypical vaccine side effectsâ there may have been a bias towards not reporting them as related. Of the half a dozen guidances given for causality (Appendix B3, page 76/78), the only one that really could have mattered for an unexpected outcome was timeliness of the health problem vs vaccine administration. None of the others could reasonably apply. They were looking out for immediate allergic reactions, low platelet issues, worsening respiratory issues, and certain neurological issues so those should have been reported regardless.
The main paper only discussed the âsolicitedâ adverse events, ie fever, fatigue, site soreness, etc, that were expected and handled via their reporting app for all patients. unsolicited adverse events, such as all these weird ones, were not discussed in the paper except for the trial halting one mentioned above, but there was more info in the paper appendix starting on page 31 in tables S4-S5.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2105290/suppl_file/nejmoa2105290_appendix.pdf
The reported MAAEs (seeing a doc for some issue) did show elevated incidences of heart issues, tinnitus, and a few other things people mentioned in the hearing. Broadly, the reported adverse events at a high level, across the full study, seemed to be similar in most ways between the control and the placebo groups on a relative basis. However, note also from the supplement,
SAEs, MAAEs and AESIs are reported through trial completion or withdrawal.
So all the âunexpectedâ stuff not logged via the app appear to indeed have been truncated as of trial withdrawal, so if they somehow were systematically withdrawing patients with bad reactions early on (which the above quotes show the doctors can do, not just the patients), their ongoing issues would not be recorded past that withdrawal designation.