monotreme1000 | August 1, 2021

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 animal and human data 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 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?

How vaccinated is India, and what vaccine are they using?  Perhaps the CDC was persuaded to bet that we could vaccinate our way out of this mess?  But it's never good to put all your eggs in one basket...

ViQueen24 wrote: How vaccinated is India, and what vaccine are they using?  Perhaps the CDC was persuaded to bet that we could vaccinate our way out of this mess?  But it's never good to put all your eggs in one basket...

You can bet that the 

Upper casts have been vaccinated,

as for the Dalits......very doubtful......

Hence a never-ending covid crisis.........

Take care all 😷😉

Reuters: India reports most new COVID cases in three weeks.

https://www.reuters.com/world/india/india-reports-44230-new-covid-19-cases-overall-tally-3157-mln-2021-07-30/ - https://www.reuters.com/world/india/india-reports-44230-new-covid-19-cases-overall-tally-3157-mln-2021-07-30/