Rad Doc Consultant

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28 May 2021

 

To all,

 

1. Explosion at Bushehr--again:

     Two weeks ago I mentioned the massive fire that broke out in Bushehr, Iran, where Iran's sole functioning nuclear power plant (NPP) is located. Earlier this week another explosion occurred at the NPP, reportedly from an oxygen pipeline, killing one worker. This was the latest in three explosion incidents in Iranian "petrochemical" plants in 4 days, including an explosion at a drone facility on 24 May. Causes of these incidents haven't been published, to my knowledge.

 

2. Plague in Democratic Republic of Congo (DRC):

     At least 11 people, out of at least 15 cases, have died in an outbreak of plague in the DRC. Symptoms have been headache, fever, cough, and hematemesis (bloody vomit). The outbreak has spread to at least two villages in one province. Since the beginning of 2020 Ituri Province has seen 64 plague cases with 14 deaths in five health zones. In 2019 there were 286 cases including 27 deaths. Incubation period is from 1-7 days. The outbreaks appear to be endemic; there is no evidence at all of bioterrorism. Health officials have recommended persons wear masks, practice social distancing, and avoid handling corpses.

     The worst pandemic in world history was the "Black Death", which occurred in Eurasia and North Africa during the 14th century, killing somewhere between 100 to 200 million people. During the period from 1348 to 1665, London had about 40 outbreaks roughly every decade, each one claiming about 20% of the population. During the "Great Plague" of 1665, 100,000 Londoners died in seven months. The plague was stopped in part by forcibly shutting victims into their homes to prevent spreading of the disease.

     There is an interesting article in history.com that describes the medical and public health initiatives employed to end five of the world's worst pandemics. (Trivia question: three of these were plague. What were the other two?) Even as far back as the "Black Death" pandemic people realized that disease spread had something to do with proximity. Ships arriving at the harbor in Venice, Italy were required to sit at anchor for 40 days; the term "quarantine" is derived from the Italian word "quarantino", meaning "forty".

 

3. DIfference between Emergency Use Authorization (EUA) and full FDA approval:

     These terms, and their legal implications, are sometimes confusing to those who want to know whether a particular medical product, such as a vaccine, is safe, effective, legal, or some combination thereof! Basically an EUA is a shortcut in a crisis, which the COVID-19 pandemic certainly is. An EUA presumes no adequate or approved alternatives exist, and that the vaccine meets pre-specified success and safety criteria. This means successful phase 1 and phase 2 studies, and then a phase 3 clinical trial with at least 2 months of follow-up. Even if EUA is authorized (NOT the same word as "approved"), the FDA expects manufacturers to continue follow-up of their trials. "Approval" means the FDA has officially decided a product is safe and effective for its designated use (or, more accurately, that its benefits outweigh its known and potential risks). "Standard Review" is applied to drugs that offer only minor improvement over existing therapies; goal for review time is 10 months. "Priority Review", which is used for a treatment where none currently exists, has a 6 month goal. The Pfizer-BioNTech mRNA vaccine received EUA on 11 December 2020 and the Moderna mRNA vaccine 18 December 2020. Both are seeking full approval this month. The Johnson & Johnson vaccine received EUA 27 February 2021, so its full approval is at least a month off.

 

4. "Good news: Mild COVID-19 induces lasting antibody protection":

     So suggested researchers at the Washington University School of Medicine (where I did my internship and residency!) in an article published in Nature. Antibody levels normally decrease after an acute infection, but instead of hitting zero they plateau at a low level. The researchers found antibody-producing long-lived plasma cells in people 11 months after their first symptoms; these antibodies will presumably last a lifetime. Research was conducted using bone marrow biopsies from 19 participants 7-8 months after infection, and from 11 controls. Only 6 of the 18 had required hospitalization. Since inflammation, which plays a major role in severe COVID-19 cases, can lead to defective immune responses, the study needs to be replicated in those with severe infections. They are also studying whether vaccination induces long-lived antibody-producing cells.

 

5. Breakthrough COVID-19 in over 10,000 vaccinated Americans:

     The CDC has reported more than 10,000 fully vaccinated Americans have experienced a second infection as of 30 April. The CDC realizes these figures are underestimates. About a quarter (27%) of these were asymptomatic. A majority (63%) occurred in women. The median age was 58 years. Nearly two-thirds (64%) of the 5% upon whom genetic sequencing of the infective virus was performed had a variant of concern, i.e. increased transmissibility, more serious disease, or decreased effectiveness of treatments or vaccines compared with the initial SARS-CoV-2 virus. For reasons unclear to me, after 1 May the CDC limited its investigation of breakthrough cases to only those cases who are hospitalized or die from the disease.

 

6. Medical WMD Trivia:

     As Dr. Bruce Cohen and Minoo Rouhanian noted (congrats to them!), the United States developed Brucella suis as a biological weapon in 1942 and tested it in field trials using animal targets. The bacterium was altered to maintain long-term viability. Brucella is fairly stable in the environment and can persist for several weeks in soil or water. The good news is that organisms are easily killed by disinfectants such as bleach or by thorough heating of contaminated food and water. Once patients began treatment they are no longer infectious after 3 days, according to "Responding to Terrorism: A Medical Handbook". There is no commercially available vaccine however.

 

7. Correction (10% correction, anyway):

     Last week I stated that the Moderna mRNA vaccine contains SM-102, which "...is suspected of damaging fertility or the unborn child as well as severe skin and serious eye irritation." Data were taken from the "Safety Data Sheet Acc. to OSHA HCS", which covers "Trade Name: SM-102", one of the inactive ingredients listed in the CDC description of "Moderna COVID-19 Vaccine: Vaccine Preparation and Administration Summary". (Both links available upon request.) However, the Safety Data Sheet on "Trade name: SM-102" lists, under Section 3 ("Composition/information on ingredients"), that it is a mixture of chloroform (90%) and "Other ingredients--SM-102" (10%). The former is listed as the "dangerous component", but not the latter. (Yes, they really did use the same term to describe both the material and one of its components.) So my apologies for conflating the mixture, SM-102, with its non-toxic ingredient, SM-102. The Moderna mRNA vaccine does not contain chloroform, which is the dangerous component of SM-102, only the inactive ingredient, SM-102. Hope this clarifies things...

 

To your health,

Glen

Rad Doc Consultant, Inc
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