Vaccine Testing and Trials | AstraZeneca | UPSC

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Vaccine Testing and Trials _ AstraZeneca _ UPSC

Vaccine Testing and Trials | AstraZeneca

      HEADLINES:

Why is Phase-3 of vaccine trial complicated?

      WHY IN NEWS:

With University of Oxford and AstraZeneca announcing resumption of COVID-19 vaccine trials, how will the process be monitored for safety?

SYLLABUS COVERED: GS 3:Health:Diseases : Vaccine

      LEARNING: 

For PRELIMS go through all the different phases of testing . Note one key point from each phase in your Prelims Book.

For MAINS it is important to understand the whole process . Let us dive in !

      ISSUE: 

On Saturday, the University of Oxford and AstraZeneca said they were resuming clinical trials for a new coronavirus vaccine across all U.K. sites.

SUSPENSION OF AZD1222

  • On Tuesday, the U.K.-based biopharma company AstraZeneca had said it was suspending the Phase-3 global trial of AZD1222.
  • The COVID-19 vaccine it has been developing with Oxford University researchers.
  • The vaccine, by all accounts, was among the handful that had reached the final stage.

The most daunting stage of trials and is slated to be available commercially by mid-2021.

  • The pause was announced after a volunteer in Britain fell ill.
  • Following a nod from the regulator, trials would resume in the U.K.
  • There was no word in the releases about resumption of global trials or details of the volunteer’s illness.

HOW ARE VACCINE TESTED IN TRIALS?

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

After a drug has proven safe in a variety of animals usually mice, rabbits, hamsters and primates. 
 

  • These animals form mirror human physiology and the way it reacts to diseases — it enters Phase-1 studies.

PHASE 1

  • A small group of volunteers is given the drug in small doses.
  • Then monitored to see if it is safe and whether it was well tolerated.

This is also when any occurrences of side effects are closely monitored.

  • On an average, 10-50 candidates are chosen.
  • In the normal course, those undergoing the trial must report results to the drug regulator .
  • He is the authority who gives the go-ahead for the next stage of trials.

PHASE 2

  • Phase-2 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 necessary for desired response.

  • This is the stage when it’s determined if the inoculation had triggered a desired level of antibodies.
  • Thus a 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 .

This includes the time taken to recruit patients as well as the time involved in observing the effects of vaccines.

  • 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.

In the case of a vaccine for a new disease, there is usually nothing to compare it to, so Phase-3 becomes a larger version of the Phase-2 trial.

  • 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,

There is concept of an ideal trial, neither the doctor nor the recipient knows who is getting the drug and who the placebo

  • 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, phases 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 licensed 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.

Once the product goes out into the field, there is post-marketing surveillance is done. 

  • 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.

WHAT HAPPENED WITH ASTRAZENECA?

  • The vaccine candidate, called AZD1222 for now, the company had begun recruiting 30,000 volunteers for Phase-3 trials in the United States.
  • The Pune-based Serum Institute of India, which had been contracted to manufacture a hundred million doses for 92 countries including India.
  • Serum institute had also started to test the vaccine on a proposed group of 1,600 volunteers in India.
  • This led AstraZeneca to pause its trials.

      IASbhai WINDUP: 

  • Serum Institute initially said it would not halt the India trial because no adverse reactions had been reported here.
  • However, after a show-cause notice from the regulator, the Drugs Controller- General of India, the company said it would halt recruitment of volunteers until AstraZeneca finishes evaluation of the safety data.
     SOURCES:THE HINDU & PIB | Vaccine Testing and Trials | AstraZeneca

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