Primary Series and Boosters — No Impact on Maternal COVID-19 Test Positivity
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My attention was recently drawn by a commentary from Emily Harris in JAMA implying that COVID-19 vaccination during pregnancy had benefits from a study previously published in the British Medical Journal. There has never been any randomized, prospective, double-blind placebo controlled trial of COVID-19 vaccines in any group demonstrating clinical benefit defined as reductions in hospitalization and death. Among pregnant women, COVID-19 vaccination is category X, meaning it should not be given. So naturally I was suspicious on how a report indicating benefit made into the British Medical Journal. The literature is accumulating numerous invalid analyses making false claims of benefit without adequate design or consideration of drug safety.
Jorgensen et al published from the Canadian Immunization Research Network (CIRN) Provincial Collaborative Network Investigators a study from automated sources of data on pregnant women and infants tested using nasal PCR-testing. As a former editor I found this paper misleading because: 1) diagnostic codes for safety events (heart damage, blood clots, stroke, maternal death) were not disclosed and analyzed, 2) no adjudication for COVID-19 illness, so healthy test positive “cases” were reported, 3) focus was on infants was irrelevant since they not develop clinically significant COVID-19.
The interesting finding in the Jorgensen paper, not mentioned by the authors is in the Table. As you can see, primary series and boosters had no statistically significant impact in test positivity among the mothers. This means the intervention was completely useless and had no laboratory or clinical benefit reported.
Jorgensen SCJ, Hernandez A, Fell DB, Austin PC, D’Souza R, Guttmann A, Brown KA, Buchan SA, Gubbay JB, Nasreen S, Schwartz KL, Tadrous M, Wilson K, Kwong JC; Canadian Immunization Research Network (CIRN) Provincial Collaborative Network (PCN) Investigators. Maternal mRNA covid-19 vaccination during pregnancy and delta or omicron infection or hospital admission in infants: test negative design study. BMJ. 2023 Feb 8;380:e074035. doi: 10.1136/bmj-2022-074035. PMID: 36754426; PMCID: PMC9903336.
The medical literature is burgeoning with fraudulent papers extolling false claims of COVID-19 vaccination from nonrandomized, non-adjudicated data while at the same time ignoring horrific safety outcomes well known to occur as a result of vaccination. Jorgensen and the Canadian Immunization Research Network (CIRN) Provincial Collaborative Network Investigators can be added to this long list of culpable authors. The conclusions of this paper serve as a stark warning to view the primary data and realize the authors are biased and not fairly evaluating these emerging potentially dangerous genetic biotechnologies.
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