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Making Moral Vaccine Decisions - Part D: Vaccine Safety and Efficacy

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JMJ
 
For the lack of a better phrase, there has been a lot of noise concerning the safety and efficacy of the vaccines under development.

The initial safety and efficacy of the vaccines are established during three phases of clinical trials.  Monitoring does not stop with these trials, but remains in force for as a long as the drug is issued.

Adverse events and various reactions happen both with, without and due to the vaccines. 
 
Some of these adverse events happen on their own and in order for a vaccine to be deemed unsafe due to them, the incidence needs to be statistically significant.  In other words, they need to establish that the vaccine caused the event and is not just a result of someone having a latent or undeclared illness. In some cases causality is easily established.

In order to assure ourselves of the safety and efficacy, the best way is to read the latest monograph that accompanies the vaccine.  
 
Examples:

These monographs provide vital for making a safey and efficacy decision, but not a moral decision.

Key elements that I look for are:
  1. Contra-indications:Identifying who should not normally receive the vaccine.
  2. Indications: Identifying who can normally receive the vaccine.
  3. Warnings and precautions: Just what the words say.
  4. Special populations: I pay attention to the advice on pregnant and breast-feeding women, children, and elderly.
  5. Adverse reaction data: Provides information on how people reacted to the medication during trials.
  6. Post-market adverse reactions: Provides information about reactions that have been verified after the introduction of the vaccine.
  7. Study Results: This tells you how effective the vaccine proved in establishing what amounts to a preemptive immune response to the virus. Basically, training the recipients immune system to successfully,after sufficient time, combat post vaccination infection.

 

These factors need to be weighed against the risk of the disease to one-self, the close associates and the common-good.

P^3
 

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