Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
Dr. Ron Brown – Opinion Editorial
July 10, 2021
“A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine.” COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021 | MMWR.
As of May 1, 2021, Centers for Disease Control and Prevention (CDC) counted only breakthrough COVID-19 infections that occur in fully vaccinated people who are hospitalized or who die. This surveillance policy appears to be based on the assumption that only a small percentage of breakthrough infections will occur in people who received vaccines with extraordinarily high efficacy rates of approximately 95%, as in the mRNA vaccines.
CDC readily admits that their surveillance policy will result in undercounting breakthrough infections that are asymptomatic or mild. But with so few breakthrough infections expected, due to the high efficacy of the vaccines, the number of underreported non-severe infections is expected to be insignificant; except that there are a few serious flaws with this assumption which bias the breakthrough infection count.
First, the mRNA vaccines’ absolute risk reduction of COVID-19 is approximately 1%, not 95%. Medicina | Free Full-Text | Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials (mdpi.com). In clinical terms, this means that as many as 99% of fully vaccinated people could potentially develop breakthrough infections.
Second, the randomized controlled trials of the mRNA vaccines were not designed to test severe infections, hospitalizations, and deaths as the clinical endpoints of vaccine efficacy. The clinical endpoints of the mRNA vaccines in healthy trial participants were a laboratory-confirmed infection with a mild or moderate clinical symptom. There is no causative proof of vaccine efficacy in preventing severe infections, hospitalizations, and deaths in unhealthy people participating in clinical trials. Furthermore, you can’t even call these severe infections “breakthrough infections” because the vaccines were never proven to prevent severe infections in the first place.
Nonetheless, sticking to their surveillance policy, CDC will never know how many breakthrough infections within the vaccinated population are asymptomatic or non-severe because, well, ignorance is bliss! And Pfzier-BioNTech and Moderna will avoid potential exposure of major vaccine failure. And research will continue to pump out more useless vaccines with virtually nil clinical benefits and unknown risks. And the public will continue to invest their tax dollars and place their trust in sponsoring snake-oil salespeople who promise to cure their ills.
In the meanwhile, all infections in unvaccinated people continue to be counted!
And finally, CDC predicts “the number of COVID-19 cases, hospitalizations, and deaths that will be prevented among vaccinated persons will far exceed the number of vaccine breakthrough cases.”
Really? First show me the unbiased breakthrough infection count that includes ALL infections, CDC, and prove it!