13 April 2020

Vaccine production: the necessary steps to creating a vaccine for coronavirus

By Deborah Nicholson

Among the organisations that Ideagen supports, many are involved in the response to the COVID-19 pandemic. This has given us an insight into vaccine production and the work currently going on against the coronavirus. In this blog, we share a look at the steps taken in developing a vaccine and the challenges facing experts in the field.

Producing and manufacturing a vaccine is a complex process for life science organisations, with many regulatory requirements. Quality control of vaccines is essential to ensure that they work correctly and are safe to use. The outbreak of coronavirus has significantly impacted all walks and areas of life. While current government advice centres around social distancing and staying at home, researchers are working on developing a vaccine to protect against COVID-19, a novel strain of coronavirus.

How does a vaccine prevent disease?

A vaccine introduces a type of virus or bacteria to the immune system so that it can recognise and fight it before the virus can spread through the body and cause illness. Once the vaccine has been distributed into the general population, this prevents the virus from being able to find enough hosts to survive and spread to. This is known as herd immunity and helps to protect vulnerable people who can’t be vaccinated, for example, pregnant women, infants and immune compromised individuals.

The regulatory bodies and requirements

In the U.S, a vaccine is classed as a biological product. The U.S Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines. The European Medicines Agency (EMA) is responsible for regulating vaccines in all EU countries. Before the development process can start, an investigational new drug application must be submitted to the FDA. For the vaccine to be approved, all data collected from clinical, non-clinical and manufacturing processes is submitted to the FDA and EMA for review and to gain a Biologics Licence Application.

What goes into producing a vaccine?

There are a lot of factors that need to be addressed and tested. A laboratory’s quality management system (QMS) is often used to keep track of the various tasks that need to be completed, helping researchers, developers and other departments work together. The main factors that are involved include:

Safety

It’s critical to ensure that a vaccine is safe to use. In order to do this, researchers need to determine if it causes side effects and if so, what they are and if they are considered mild or severe. They also need to test if there are any other risks associated with it, such as reversion or allergic reactions.

Cost

Before beginning, there is the cost of developing and producing the vaccine to consider. How many trained professionals are needed to work on it? What materials are required? How much time and effort will it take to produce?

Efficacy

Once a potential vaccine has been created, they need to determine how well it works. This is done by conducting clinical trials to test the effectiveness of the vaccine to find out how many vaccinated people have become resistant to the virus.

Administration of the vaccine

After the vaccine has been developed and approved, there is then the question of administering it. This means having enough sterile needles available for health professionals to be able to vaccinate patients.

Number of doses

Each vaccine is unique to the type of virus, bacteria or pathogen it is designed to fight. While one dose might be enough for some types of vaccines, others might require a higher amount of the drug to adequately assure immunity.

Duration of the immunity

Another important consideration is how long the vaccine lasts. Researchers need to be certain that their vaccine is robust enough to continue providing immunity after the initial administration.

Development and clinical phases

During the development of a vaccine, there are three main phases involved: research, pre-clinical development and clinical development. After this there are also three phases of clinical trials that a vaccine must successfully go through in order to be approved: phase 1 tests how the immune system responds with a small number of people; phase 2 expands on this by testing hundreds of people and finding out the correct dose; phase 3 increases the test numbers to thousands of volunteers, closely examining both the safety of the vaccine and how effective it is.

How close are we to finding a coronavirus vaccine?

Understandably, this is a concern for many people right now. A coronavirus vaccine is currently in the research phase, with a variety of approaches being taken. Scientists predict that it could take a year longer for a vaccine to be made available and nothing is yet certain. This is due to everything that goes into developing and manufacturing a vaccine, coupled with gaining an adequate understanding of COVID-19 as a new virus which had never been seen in humans until December 2019.

What can we do to help?

Once a vaccine is ready to be tested, researchers will be looking for healthy volunteers to take part in clinical trials. There is a lot to consider when applying to take part, and organisations will usually do screening tests to ensure volunteers are eligible for it.

Ideagen support pharmaceutical organisations with our laboratory quality management system. It provides a solution for regulatory control with the audit, CA/PA and analysis functions, with access to robust reporting and asset management which can be used for equipment calibration and other necessary tasks. Our lab QMS solution helps to maintain quality and adherence to regulatory standards from the research phase right up to undergoing clinical trials during vaccine production.

 

Additional sources:

Public Health> How Vaccines Work: https://www.publichealth.org/public-awareness/understanding-vaccines/vaccines-work/

Phillip L. Gomez & James M. Robinson, Chapter 5 – Vaccine Manufacturing, Plotkins Vaccines (Seventh Edition) 2018, pp. 51- 60

Susan Payne, Chapter 7 – Viral Vaccines, Virus: From Understanding to Investigation, 2017, pp. 73- 79

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