Tag: mRNA vaccine

State Surgeon General Dr. Joseph A. Ladapo Issues New mRNA COVID-19 Vaccine Guidance

Mary Pat Campbell

Link: https://content.govdelivery.com/accounts/FLDOH/bulletins/3312697

Guidance: https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-doc.pdf?utm_medium=email&utm_source=govdelivery

Analysis: https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf?utm_medium=email&utm_source=govdelivery

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Today, State Surgeon General Dr. Joseph A. Ladapo has announced new guidance regarding mRNA vaccines. The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety.

This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. Non-mRNA vaccines were not found to have these increased risks.

As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines. Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.

Author(s): Joseph A. Ladapo

Publication Date: 7 Oct 2022

Publication Site: Florida Dept of Health

Cerebral venous thrombosis: a retrospective cohort study of 513,284 confirmed COVID-19 cases and a comparison with 489,871 people receiving a COVID-19 mRNA vaccine

Mary Pat Campbell

Link: https://osf.io/a9jdq/

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Abstract:

Using an electronic health records network we estimated the absolute incidence of cerebral venous thrombosis (CVT) in the two weeks following COVID-19 diagnosis(N=513,284), or influenza (N=172,742), or receipt of the BNT162b2 or mRNA-1273 COVID-19 vaccines(N=489,871). The incidence of portal vein thrombosis (PVT) was also assessed in these groups, as well as the baselineCVTincidence over a two-week period. The incidence of CVT after COVID-19 diagnosis was 39.0 per million people (95% CI, 25.2–60.2). This was higher than the CVT incidence after influenza (0.0 per million people, 95% CI 0.0–22.2, adjusted RR=6.73, P=.003) or after receiving BNT162b2 or mRNA-1273 vaccine (4.1 per million people, 95% CI 1.1–14.9, adjusted RR=6.36, P<.001). The relative risks were similar if a broader definition of CVT was used. For PVT, the incidence was 436.4 per million people (382.9-497.4) after COVID-19, 98.4 (61.4-157.6) after influenza, and 44.9 (29.7-68.0) after BNT162b2 or mRNA-1273. The incidence of CVT following COVID-19 was higher than the incidence observed across the entire health records network (0.41 per million people over any 2-week period). Laboratory test results, available in a subset of the COVID-19 patients, provide preliminary evidence suggestive of raised D-dimer, lowered fibrinogen, and an increased rate of thrombocytopenia in the CVT and PVT groups. Mortality was 20% and 18.8% respectively. These data show that the incidence of CVT is significantly increased after COVID-19, and greater than that observed with BNT162b2 and mRNA-1273 COVID-19 vaccines. The risk of CVT following COVID-19 is also higher than the latest estimate from the European Medicines Agency for the incidence associated withChAdOx1 nCoV-19 vaccine (5.0 per million people, 95% CI 4.3–5.8). Although requiring replication and corroboration, the present data highlight the risk of serious thrombotic events in COVID-19, and can help contextualize the risks and benefits of vaccination in this regard.

Author(s): Maxime Taquet, Masud Husain, John R Geddes, Sierra Luciano, Paul J Harrison

Date Accessed: 19 April 2021

Publication Site: OSFHOME