VACCINE BASICS FOR KIDNEY PATIENTS


Amidst all the enthusiastic talk of developing a Vaccine to fight-off COVID19 (the new coronavirus) and the World Immunization Week (24th-30th April) silently passing by, we at Team ATK felt it’s appropriate to help you gain a basic insight on Vaccines and their utility & limitations in kidney patients.

After all, vaccines form a crucial part of medically preparing all patients of Chronic Kidney Disease for a transplant surgery. Add to that, the fact that SOME vaccines are UNSAFE for transplant recipients, and this topic becomes all the more significant.

So, let’s begin then, shall we?

 

Vaccine Basics for Kidney Patients


TABLE OF CONTENTS

WHAT IS A VACCINE?

WHY DO YOU NEED VACCINES WHEN THERE’S VITAMIN C?!

TYPES OF VACCINES

WAYS TO ADMINISTER VACCINES

VACCINE DEVELOPMENT: JOURNEY FROM THE LAB TO THE CLINIC

FACTORS THAT MEDICAL TEAMS CONSIDER BEFORE VACCINATING A KIDNEY PATIENT 

CLINICAL CRITERIA FOR VACCINATING KIDNEY TRANSPLANT RECIPIENTS

TABLE OF VACCINES AND THEIR USAGE ON KIDNEY PATIENTS & TRANSPLANT RECIPIENTS 


 

WHAT IS A VACCINE?

 

A Vaccine is a biological preparation made of “weakened microbes / germs”.

Such microbes /germs undergo artificial tweaking in Vaccine Development Labs in a way that they lose their ability to cause infection but still retain the microscopic features that normally help our immune system identify them before beginning to combat them. This familiarizes our immune system of a “potential enemy” without really causing any true harm.

Hence, vaccines help “train, prepare & strengthen” our immune system to resist an infection from that “specific microbe”, that the vaccine is made of.

Vaccine Illustration Source: NYT
Image Source: NYT

 

So, you must understand that Vaccine is NOT A CURE. Rather, it is a METHOD TO PREVENT INFECTIONS from that specific microbe in future. In a nutshell, Vaccines are the true “immunity-boosters”!

 

 

But why do you need Vaccines to boost your immunity when you have Vitamin C?!

 

We understand your concern. With Multivitamin pills and other “immunity boosting” health products flooding markets, disillusionment is easy. Let us help you understand the importance of vaccines in “boosting our immunity” here.

The “Immune System” of our body is like our personal millitary that fights off any and everything that does not naturally belong within our bodies, whether living or non-living. This ability technically goes by the name, “Immunity”.

But do you really understand what exactly is this Immune System made of?

Here’s the most basic explanation of what comprises your Immune System.

Vaccine Basics: Immune system components

 

As the poster above explains, the ONLY VALID WAY to truly boost your body’s “Immune Power” against infections is to strengthen your body’s ability to generate adequate initial response by T-Lymphocytes in the times of need for an Immune Defence.

Does Vitamin C help with prompt functioning of T-lymphocytes?

 

The short answer is, No.

Vitamin A, C & E are anti-oxidants that oversee timely cell renewal & prevent pre-mature aging. They help lots of blood proteins to carry out repair work in our body. These Vitamins are also critical for a range of body functions such as vision (Vitamin A) & fertility (Vitamin E).

In terms of the immune system, these vitamins help to “repair the borders of our body” in case of any injury. They do so, by collaborating with the necessary surface proteins like Collagen to rapidly heal any micro-scratches, cuts or wounds on our skin, blood vessels and other lining surfaces within the body. This basically prevents foreign bodies, germs, allergens to enter our bloodstream.

However, if germs intrude and make their way into the bloodstream, there is no established evidence or mechanism that lets these Vitamins alone fight it off and protect us. In such a case, the army of White Blood Cells ends up simply doing Damage Control instead of completely preventing the damage.

How do Vaccines help?

 

Vaccines, on the other hand, specifically “train, prepare & strengthen” the T-lymphocytes in our blood regarding a potential germ, beforehand. Each vaccine is specific for the microbe(s) it comprises of. Hence, Vaccines effectively help boost our specific, infection-preventing Immune Power.

Therefore: –

While a generally nutritious diet (and not just mega doses of Vitamin C) is imperative to help keep your “body-borders” secure, Vaccines help your Immune Forces to “specifically identify & effectively combat” any foreign intruder such that you do not suffer any damage at all.

 

So, vaccines are crucial to ramp up your immune system against potential infections. Taking Multivitamin pills alone is unlikely to serve the purpose. 

 

 

CONTINUING WITH VACCINES, WHAT ARE ITS DIFFERENT TYPES?

 

Based on the “status” of the microbe within a vaccine, it could be of two types:

 

Vaccine Types Live Attenuated Inactivated

 

 

DO VACCINES ALWAYS INVOLVE NEEDLES?

 

 

Mostly, but not always. Vaccines can chiefly be of the following types:

Vaccine Facts Tick GIVEN BY MOUTH (ORAL VACCINE)

Oral Vaccine

Vaccine Facts Tick INJECTED VIA EITHER OF THE WAYS AS SHOWN BELOW

 

Injectable Vaccine Types

Further vaccines can come as a powder that needs to be “re-constituted” with a solution provided with the vaccine kit before administering it. Your nurse has the necessary training to carry out this procedure.

Alternatively, vaccines can come prepared as the more familiar liquid, ready-to-use variant.

 

 

 

THE VACCINE DEVELOPMENT JOURNEY

 

Before we go into vaccines in the context of kidney patients, here’s a rundown of the rigorous journey any new vaccine undertakes, before it reaches you in the clinic.
Let us first talk about the pre-requisites for developing a vaccine.

 

INFRASTRUCTURE NECESSARY FOR VACCINE DEVELOPMENT

i. Approved Biotech Research & Development

An appropriate laboratory space with necessary laboratory equipment for uninterrupted daily workflow (microscopes, sterilizers – steam and autoclaves, other research inventory) is of the essence before attempting Vaccine Research.

Vaccine Development Lab Space
Under license CC 4.0

 

 

ii. “Biosafety Cabinets/ Hoods”

You must have seen media-visuals of some scientists working with pipettes, test-tubes, petri-dishes & tiny cylindrical bottles of chemicals kept within a glass chamber. There is only enough space for a person to insert their hands into the chamber. The technical name for such a chamber is a Biological Safety Cabinet or a BSC.

Biosafety Cabinet BSC Scientist working
Under license CC 4.0

 

 

BSCs are sort of like the work-desks of wet-lab researchers and serve two purposes:

 

Vaccine Biosafety Cabinet UsesThey help keep the scientific material within, clean & infection-free

Vaccine Biosafety Cabinet UsesThese also prevent spread of any potential infection to the user.

 

Bio-safety Cabinets can be of different types depending on the level of infectious material that can be safely used for experiments within it.

Biosafety Cabinet Types
Under license CC 4.0

 

 

iii. “Isolated”, expanded & “purified” germ/microbe sample

Next up is the microbe/germ itself that needs to be turned into a vaccine.

To use microbes for research purposes, we cannot simply draw infected blood, urine or nasal discharge and begin our work.

It is imperative, that the germs are “completely separated out” from rest of the material in these infected patient samples (blood, urine, nasal discharge) and grown in clean lab environments before utilizing them for any other biotech applications.

 

Vaccine Streptococcus Pneumoniae colonies in Blood Agar
Lab grown version of Streptococcus pneumoniae — one of the major bacteria that causes Pneumonia, bacteria isolated from patients throat swab. The Pneumovax vaccine is made by inactivated forms of these bacteria. Image Source: Centre for Disease Control, https://www.cdc.gov/meningitis/lab-manual/chpt08-id-characterization-streppneumo.html

 

 

Doing so, “isolates the germs” & helps avoid any cross-reaction or cross-contamination during vaccine development. Usually there are separate biological research companies that provide this service.

It makes the Vaccine much more “specific” than otherwise. The more specific, the better. Else your immune system would stand a chance of ending up “confused” as to what exactly it must be “prepared to fight against”.

 

 

iv. Appropriate Genetic engineering tools

 

Image Sourced under license from CC 4.0

These tools are essential for tweaking the microbe on a microscopic level, as medically necessary, before using them for preparing the “draft” vaccine product.

 

 

v. Personal Protective Equipment (PPE) Kits

 

Scientist wearing PPE working with a Biosafety Cabinet

Personal  Protective Equipment (PPE) is a must for avoiding any cross-infection or contamination during the laboratory workflow.

A PPE Kit usually consists of overalls, face shields, masks, gloves & eye-protection gear for frontline human resource dealing with the infectious material directly.

 

 

INFORMATION REQUIRED BEFORE DEVELOPING VACCINES

 

i. Complete knowledge of the microscopic structure of the organism

 

For knowing where to use genetic engineering tools to appropriately tweak the microbe, a clear distinction of the “antigenic” (identity) and “virulent”(infection-causing) segments of the microbe is necessary. It is only then that the infection causing parts of the microbe can be correctly weakened or removed for developing a vaccine.

 

This part can take anywhere between 2 months to a year depending on how urgent, well-funded & infrastructure-supported, the whole research effort towards developing that vaccine is.

 

For instance

In case of COVID19 (the new coronavirus) that fast turned into a public health nightmare worldwide, protecting the still unaffected community holds utmost importance. Hence, research efforts worldwide have understandably, been pretty focussed. Academic journals reported the microscopic structure of this coronavirus as early as 2 months from when the first of the cases were reported.

 

 

ADEQUATE FUNDING FOR EVERY STEP OF VACCINE DEVELOPMENT

 

Usually, Academic Research Grants come in from Charities working on a related area, Philanthropic grants and International Research Consortia. The whole pace of vaccine development efforts is entirely dependent on such funding in-flow for the purpose. Right from procuring specific tools and the microbe sample from central agencies to starting clinical trials, seeking regulatory approvals and starting commercial production on a large scale for community use, uninterrupted funding is of the essence.

 

Once all pre-requisite infrastructure and information is in place, the research lab can begin developing the vaccine. Additionally, the research sponsors start preparing for necessary regulatory approvals when due.

 

 

TESTING BEFORE VACCINE LAUNCH – PRECLINICAL & CLINICAL TRIALS

 

Normally, when there is a public health crisis related to an infection, more than one lab across the world would be vying for developing a Vaccine for the same. These versions produced in the lab are called “Candidate” Vaccines. These serve as a “Rough Draft”.

 

Such “Candidate” Vaccines go through rigorous testing & trials before some of these can be approved for widespread community use. These are time consuming and expensive. (Think in billions for one vaccine!)

 

These trials include:

 

Vaccine Trials Bullet  Pre-clinical trials –

 

i. In the laboratory on human cells


ii. In lab animals like mice to get an idea of how the vaccine reacts in a whole mammal

 

Vaccine Trials Bullet  Clinical trials –

 

Based on conclusive evidence of the extent of immune protection & it’s safety profile, a segment of these candidate vaccines gets through to Clinical Trials on Humans.

 

These trials are completely supervised by competent Drug Regulatory Authorities set up by respective Governments. These include:

 

Vaccine Facts TickCentre for Biologics, evaluation & research (CBER) under the FDA in the US

Vaccine Facts TickMedicine & Healthcare Products Regulatory Authority (MHRA) in the UK

Vaccine Facts TickDrug Controller General of India (DGCI)

 

and the like.

 

 

The sponsors of the Vaccine Candidate follow a multi-step application process that includes:

Vaccine Regulatory Approval Bullet Application for IND (Investigational New Drug)

Vaccine Regulatory Approval Bullet Application for Pre-Licensure Vaccine Trials

 

 

These applications for Clinical Trials go to a review team which is a mix of a number of stakeholders from various domains. They include but may not be limited to the Project manager, Medical Officer, Statistician, Pharmacologist, Pharma-kineticist, Chemist & a Microbiologist.

 

Once approved, the Vaccine Candidate undergoes a rigorous testing under multi-phase Clinical Trials as below:

Clinical Trial Phases for a Vaccine

 

 

REGULATORY APPROVALS FOR MARKET LAUNCH

 

Upon completion of Clinical Trials, the Vaccine research sponsors need to file a separate set of applications with competent local regulatory body. This is for Scrutiny & Approval of the new Vaccine for large scale production for community use.

 

These require the following:

 

Vaccine Regulatory Approval Bullet Biologics License Application

Vaccine Regulatory Approval Bullet Inspection of manufacturing facility

Vaccine Regulatory Approval Bullet Presentation of findings of the Clinical Trials to the Advisory committee of the competent local Drug-Regulatory Body.
In case of USFDA, findings are presented before the Vaccines & Related Biological Products Advisory Committee (VRBPAC).

 

Regulatory Approvals for commercial manufacture of Vaccine Products are subject to:

Vaccine Facts TickIf the vaccines are proven to be safe & effective

Vaccine Facts TickIts Benefits outweigh risks

Vaccine Facts TickIf a valid manufacturing facility with appropriate health & safety standards

 

 

 

MARKET LAUNCH FOR COMMUNITY USE & FEEDBACK

 

Once the Vaccine Product matures through all the above stages of Regulatory approval and goes into the market, the respective regulatory bodies keep track of the vaccine’s “clinical performance”. This is to monitor, collect & analyse information related to Side-effects of the Vaccine Product in the larger community. If warranted, a vaccine product could also be “recalled”.

 

The US FDA allows all concerned segments ranging from Patients, Parents, Healthcare providers, pharmacists and Vaccine manufacturers to report side-effects under due procedure.

 

So, that is about the journey of your Vaccine from the lab to the clinic.

Vaccine Facts TickOnly 1 out of 10 Vaccine Candidates are able to complete all the above phases of trials to be approved for use in the clinic!

Vaccine Facts TickUnless there is an unprecedented emergency like the COVID-19 crisis right now, the average time to bring in each Vaccine Product to the market ranges from minimum 5-7 years.

 

You see, just how rigorous, resource-heavy, capital-intensive, time-consuming and strictly monitored, the entire process of Research and Market Launch of just ONE vaccine is. And that’s because public health is serious business and rightly so.

 

 

Armed with all this knowledge, let us delve into the topic of Vaccination in Kidney Patients and transplant recipients. Click on the image below to go to the article.

Vaccine guidelines for kidney patients image link

 

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REFERENCES

  1. https://www.cdc.gov/vaccines-basics/test-approve.html
  2. https://www.cdc.gov/vaccines/parents/infographics/journey-of-child-vaccine.html
  3. https://fda.gov/patients/drug-development-process/step-3-clinical-research

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