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Home Science & Tech

Vaccine phase 2

February 26, 2021
in Science & Tech
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Vaccine phase 2
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In News: India to vaccinate citizens above 60 years, comorbid patients above 45 from 1 March

Testing Methods for vaccine and drugs

    • There are similarities and differences in the way new drugs and vaccines are tested. 
    • Broadly both follow a four-stage process when they are tested in people. 

Phase-1 

  • After a drug has proven itself safe in a variety of animals usually mice, rabbits, hamsters and primates that mirror human physiology and by noticing its reactions it enters Phase-1 studies.
  •  A small group of volunteers is given the drug in small doses and monitored to see if it is safe and well-tolerated. 
  • In the normal course, those undergoing the trial must report results to the drug regulator which gives the go-ahead for the next stage of trials.

Phase-2-

  • It is when a group of volunteers, usually in the hundreds, are selected. 
  • This is the stage when researchers try to determine what dosage would be required to get the desired response.
  •  In the case of the COVID-19 vaccine, this is the stage when it’s determined if the inoculation had triggered the desired level of antibodies and sufficient cell response in terms of stimulating T-cells that are known to block and neutralise the virus particles respectively. Again, side effects and adverse reactions are monitored and reported.

Phase-3

  • Each of these stages can take several months .
  • Such data is again sent to regulators, who, if satisfied, give the green signal for Phase-3.
  • In this stage, the drug or vaccine is tested at multiple locations in thousands of volunteers or patients.
  • This is the stage when a new drug is compared to the existing standard of care and when it must prove its efficacy.
  • A Phase-3 trial is held at multiple locations to capture the demographic variability in the population.
  • It is also double-blinded and randomised and may have multiple treatment arms, meaning some participants may get a placebo.
  •  Some may get lower doses, some higher doses,
  • A diverse population group is exposed to a new vaccine, the odds of encountering adverse and the dreaded ‘severe adverse reaction’ are magnified.
  • If severe then, medical researchers have to determine a pattern is apparent, a drug or vaccine can be pulled out.
  • Because of the multiple locations and the number of patients that are required, this is also the most expensive stage of a trial.
  • Sometimes, phrases are combined, given the kind of drug or vaccine and the urgency of the situation.
  • Several COVID-19 vaccines are being developed on accelerated time lines.

Phase-4

  • A drug or vaccine candidate that clears Phase-3 is usually approved .
  • The license and the entire infrastructure of the company is devoted to ramping up production.
  • The logistics of storing the drug or vaccine safely is sorted out without degrading or losing potency.
  • Phase-4, where all instances of the product’s failure and adverse events are recorded.
  • Companies are expected to furnish periodic data to the drug regulator.

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Source: PIB and The Hindu
Tags: PIBPrelims

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