Emergency Use Authorization and More

One thing I’m learning from doing this particular blog is that just as viruses change, so does the science about them. My original draft for this blog was biased from a source I had trusted for over a year.  However, after re-reading through the full article, “Mapping the Technological Landscapes of SARS, MERS, and SARS-Cov-2 Vaccines”;  (https://www.tandfonline.com/doi/full/10.1080/03639045.2021.10908343, my viewpoint changed. To explain, I had believed scientists had not followed Koch’s postulates in the development of vaccines, when actually with SARS-Cov-1, they had done so.

Heinrich Hermann Robert Koch is considered to be one of the founders of modern microbiology. His postulates were:

  • The microorganism must be found in abundance in all organisms suffering from the disease, but not found in healthy organisms.
  • The microorganism must be isolated from a diseased organism and grown in a pure culture.
  • The cultured microorganism should cause disease when introduced into a healthy organism.
  • The microorganism must be re-isolated from the now diseased experimental host which received the inoculation of the microorganisms and identified as identical to the original specific causative agent.

In the mapping article I referred to at the beginning of this blog, the concept of identifying a virus by the protein sequencing in its DNA began with SARS-Cov-1. Since then scientists have been struggling to find a thoroughly safe and effective vaccine, in the manner, we have been led to believe with other vaccines Continuing with this article, on February 19, 2021, there were 181 vaccines under development. Without going into the details of each, there were 10 different methods being pursued: protein subunits, non-replicating viral vector (VVnr), DNA, activated virus, RNA, replicating viral vector (VVr), virus-like particle (VLP), VVr, and antigen-presenting cell (APC), live attenuated virus, and VVnr and APC. Pfizer/BioNTech’s vaccine is based upon an mRNA encapsulated in lipid nanoparticles (LNP) and in phase III, had 4 different formats of mRNA and target antigens. Bottlenecks for those groups doing nucleic acid vaccine development are finding suitable delivery systems and the low magnitude of immune responses. Some research groups had to change course when a heightened immune response caused a cytokine storm, according to another research article.

.In the case of SARS-Cov-2, diagnosis is based solely upon a positive rtPCR (real-time polymerase chain reaction) test. An rtPCR test involves amplification cycling under a microscope seeking those SARS DNA particles. Cycling thresholds (CT) correlate with the validity of the test. A true positive test result ought to be run at 17 cycles.  A  CT of 34 or more cycles means the test is 100% useless as a measure of a true positive case. Mayo utilizes CTs from greater than 24 through to greater than 34, as a means for diagnosing and assessing for recovery. Another point is that those particles may or may not be alive. (Stand for Health Freedom has more information on PCR testing, with actions for changing the number of cases as the basis for our social restrictions.)

Now for Emergency Use Authorizations (EUAs), which began in 2004 with the Project Bioshield Act. Quoting from the FDA website:” The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating availability and use of medical countermeasures (MCMs) needed during public health emergencies. …..when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by the CBRN threat agents when certain criteria are met, including there are no adequate or approved and available alternatives.”

The Public Readiness and Emergency Preparedness Act (PREP Act) gives the HHS Secretary ability to issue declarations. An HHS declaration under the PREP Act may support certain uses when it is based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defence.”.For example, In March 2020 a declaration provided liability immunity for activities related to MCMs, such as tests, drugs, and vaccines utilized against Covid-19. 

As with any medication or vaccine, there is always the potential for adverse side effects. If any U.S. resident experiences adverse side effects from a vaccine, they are encouraged to report it to the VAERS (Vaccine Adverse Event Reporting System).  A person can file an injury report on VaxxTracker.com, which is a nongovernmental adverse event tracker, or report the injury on the Children’s Health Defense website

Finally, an observational study was published on August 25, 2021 (medRxiv ), stating it found that natural immunity confers longer-lasting and stronger protection against infection, symptomatic disease, and hospitalizations caused by the Delta variant of SARS-Cov-2 compared to the BNT162b2 two-dose vaccine-induced immunity.” 

Thank you, reader.  My next blog will be on the cytokine storm.

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