What is emergency use of COVID vaccine?

 What is emergency use of COVID vaccine?

Dear all you may be confused about the sentence “Emergency use of COVID vaccine”. You may feel if a vaccine is ready and safe for use in the general population, then what is the purpose of this sentence.

Let me help you to know-

In medical sciences if any of drug molecule/ vaccine prepared. It will take a minimum of 10-20 years for introducing into the market. Or sometimes it may take>20 years. Because this is a very long and time taking process, let me explain you in a brief and easy way.

Whenever we start working on any Drug/ Vaccine, Initially, we try to find the efficacy in pre-clinical study. Steps are as follow-

1.      Screening tests

2.      Tests on isolated organs, bacterial cultures, etc.(  In-vitro study)

3.      Tests on animal models of human disease

4.      Confirmatory tests and analogous activities

5.      Systemic pharmacology

6.      Quantitative tests

7.      Pharmacokinetics

8.      Toxicity Test- Acute toxicity, Subacute toxicity, Chronic toxicity, Reproduction and teratogenicity, Mutagenicity, Carcinogenicity.

If we fail to know anyone above point, we cannot go for clinical trials (use in human). Now if we did these all, we will start clinical trials and this is the most complicated stage. On average 9/10 molecules fail in clinical trials.

What is the phase of clinical trials?

Phase I: Human pharmacology and safety

Mostly healthy volunteers are exposed to the drug one by one (total 20- 100)

Phase II: Therapeutic exploration and dose-ranging

 

This is conducted by physicians who are trained as clinical investigators, and involve 100–500 patients selected according to specific inclusion and exclusion criteria.

 

Phase III: Therapeutic confirmation/ comparison

 

Generally these are randomized double-blind comparative trials conducted on a larger patient population (500–3000)

 

Phase IV: Postmarketing surveillance/ studies

 

The drug will send into the market but need surveillance for many years.

 

Now you can understand this is not an easy job it always takes time. But we cannot wait for 10-20 years as current situations. So we have an option we can introduce COVID vaccine into the market by using the sentence “Emergency use of COVID vaccine”.

However this is not 100% Investigated but all collected data analysis is safe and effective. So we have to go for it but Investigation will be continuing for the coming 10-20 years.

 

Hope you all understand the topic if you feel to know any point in detail. Or want to know about any other medical science topic please Comment here. Good Luck and God bless you all.

 

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