The FDA Approval Process and Military Readiness
Current SARS-CoV-2 vaccines are only approved under an Emergency Use Authorization (EUA). For this reason, it is more difficult to mandate that US military personnel get vaccinated against SARS-CoV-2. This is ridiculous. This virus, and others to come, can seriously degrade our ability to respond to military threats by causing widespread illness and possibly death of our warfighters. I do not know what is going on at the FDA, but they need an intervention. They have had ample access to animal and human data sufficient to give full approval for the two mRNA vaccines. I’ve heard that they are “working hard”. My question is: what is the nature of this work? What are the barriers to approval of vaccines that have already been administered to hundreds of millions of people with few side effects? There is a cost to approving a medical intervention too soon. But there is also a cost to approving a medical intervention too late. FDA procedures need to be examined to speed up the approval of medical interventions where the risk-benefit ratio is obviously favorable.
CDC Guidance Change and Booster shots
The CDC has recently reversed their dangerous previous guidance that vaccinated people could take their masks off in crowded rooms. I don’t believe that CDC scientists only just learned that the Delta variant of SARS-CoV-2 is more infectious, more lethal and better able to evade the immune system than previous versions. I think they knew this before. If not, what were they doing when Delta was burning up India? Didn’t they send a team of epidemiological service officers to India? Didn’t Indian scientists tell them that Delta was different? In any case, I’m glad to see that they have seen the light. But it would have been better if the CDC had kept a consistent policy. Politicians who are cognitively challenged will use the confusion around these sharp changes in guidance to cast doubt on the value of masks.
There is evidence that although the immune response generated by vaccines to SARS-CoV-2 wanes more slowly than the immune response generated by an infection, it does wane. Fully vaccinated individuals are now shown to be capable of carrying high viral loads of SARS-2. This is apparently because the Delta strain can breach one level of host defense. People who are fully vaccinated still have substantial protection against severe illness and death because another level of defense is still working. Studies have shown that booster shots can provide better protection against the Delta strain. The CDC and FDA need to work quickly to get booster shots approved and administered before too many fully vaccinated people start to get sick and die. There is plenty of vaccine available in the US for this purpose. Although I think the US should make any extra vaccine we can produce or buy available to our allies, US citizens should come first. I hope that OneWorldism at the CDC is not responsible for the slowness of our country in providing booster shots. Israel recently approved booster shots for everyone over 60. What are we waiting for?
I’ve changed the subtitle to this blog to: “A blog about catastrophes”. Although my domain knowledge is most suitable for pandemics, it has started to seem ridiculous to only pay attention to preparing for and responding to pandemics given that the risk of WW III has increased dramatically within the last year. Indeed, if the spread of SARS-CoV-2 was deliberate, WW III has already begun. WW III will likely be fought with biological, cyber and nuclear weapons. I’ve posted many blogs about biological warfare, which I think has been grossly underestimated as a threat. However, the risk of a cyber attack on critical infrastructure (the grid, water treatment plants, etc.) has increased. Indeed, some would say that probing attacks on US infrastructure have already begun. Xi Jinping has ordered a massive build up in nuclear weapons production in China. These are being constructed in ways that only make sense if he plans a first strike against the US or others. Many of the preparations that we make for pandemics will apply to other catastrophes. However, some will not be sufficient. Having N95s and plenty of food and toilet paper won’t do you any good if a thermonuclear weapon lands nearby. I will discuss deeper preps in future blogs.