Register For Our Mailing List

Register to receive our free weekly newsletter including editorials.

Home / 372

How are vaccines actually produced in bulk?

This article is an edited transcipt from ABC Radio with perspectives on vaccines and COVID-19 rarely discussed. How are vaccines actually produced? Can they be contract manufactured in Australia? What new facilities are needed? Are vaccines like drugs, made from mixing chemicals?

The source is ABC RN’s Saturday Extra programme, hosted by Geraldine Doogue (GD). She interviewed two of the world's top virologists on 22 August 2020. Professor Emeritus Ian Gust (IG) is from the Faculty of Medicine at the University of Melbourne and a former Head of Research at CSL. He developed the vaccine for hepatitis A. Dr Jerome Kim (JK) is Director General at the International Vaccine Institute. It has the mission to discover vaccines and deliver them to developing countries.

GD: Ian, let's just for the sake of simplicity, assume that Oxford University has cracked the code and has found a vaccine. And it's on to stage three trials so let's assume that they're successful. What happens next?

IG: Well, what's happening at the moment is unprecedented. What would happen in a normal situation is that as you proceed through phase one-phase two-phase three studies, and you get greater confidence that you've got a product that is likely to be successful, you then try to develop the manufacturing capability to produce the vaccine at scale. Which means designing, building and validating a new production facility. But because of the urgency with COVID and because the financial risks that companies normally take are replaced by governments and philanthropic organisations, these things are happening in parallel. So we've got a very truncated process.

GD: Why do need new facilities?

IG: You’ve got to build a factory to produce the vaccine in very large quantities. And you've got to be able to demonstrate that you can produce it reliably every time.

GD: Jerome, one of the things I have come to understand is that you need specialised vaccine production labs or facilities. They're not just drug company facilities, there's a difference, isn't there?

JK: Vaccines are a little different from drugs. A drug is a chemical, a vaccine as a biological product, which means that the systems that they come from are living organisms, at least in the beginning. Or they come from living organisms. Some of the hepatitis vaccines are now made from cells but they start with a biological product which is inherently more complex. It requires a degree of attention to quality and attention to the final configuration of the product that is a little bit different from manufacturing a drug and showing that it has the right chemical formula.

In this case, you're actually making something from a living product, and then purifying it and subjecting it to all the kinds of quality controls that are necessary before you put a biological product into human being. So it is a much more complicated process, and that's in part why it takes five to 10 years under normal circumstances to get from start to finish.

GD: So all vaccines are effectively living products as opposed to just a collection of drugs.

JK: There is one exception now, and that is the RNA vaccines similar to the one being made by Moderna and one by Pfizer. RNA vaccines can be made chemically but it's complex, it's never really been done before at scale. And we don't have a good idea, at least I don't, of the final cost.

So we could chemically create this long molecule called RNA, then you have to pay for every step, you have to pay for all the chemicals. Some people would argue it's easier for us to characterise a chemical compound than it is a biological compound. Others would say it's easier and cheaper and faster for us to just make it biologically and purify it. Right now, we don't know which process is quicker, faster, cheaper, and safer.

GD: Can I check this with both of you. Basically, there are two types of vaccines. One confers sterilising immunity. This means the immune system is able to stop a pathogen, including viruses, from replicating, like measles is a classic example. And the other reduces its seriousness but not eradicating it. Is that it?

IG: The essential issue that could play a big factor with the COVID vaccine is that we have some extremely effective vaccines against organisms that circulate in the blood. Neutralising antibodies will completely prevent disease occurring. But we have other diseases where the infection occurs at the mucosal surfaces in the respiratory tract and in the gut. And there the vaccines that we've developed are much less effective. Think of typhoid and cholera and even rotavirus and flu. They give between 30% and 70% protective efficacy whereas with measles, mumps, rubella, tetanus, diphtheria and so forth are 95% and upwards effective.

COVID is a pathogen which affects mucosal surfaces. So the thinking is that this vaccine is more likely to have the protective efficacy of say a flu vaccine than for example the polio vaccine. The regulatory agencies, especially the FDA, have said that provided a vaccine will protect 50% of people who receive it from getting the disease, they are prepared to license it for widespread use.

GD: Could you explain about the mechanics, Jerome, of producing this. The idea that you can just scale up suddenly is something that I don't think has been fully discussed.

JK: Different organisations have different capacities. There are some companies that specialise in manufacturing vaccines for other people. We call them contract manufacturers. And so, the United States government has made deals, as part of Operation Warpspeed, with three different contract manufacturers. These are companies that specialise in making things for other people.

For instance, Emergent Biosolutions has the ability to rapidly switch equipment. They use disposable equipment rather than these giant stainless steel vats and stainless steel pipes. They try to do everything disposably which gives them a lot more flexibility to reconfigure rooms to meet the required standards for manufacturing and production. Their turnaround times are a lot faster and they can switch from one vaccine to the next vaccine. Not all companies have that capability. Some companies may make a polio vaccine under a certain level of biosafety. You could potentially with small modifications design the factory to make one of the Chinese vaccines which is a 'whole inactivated vaccine' that’s an old form of vaccine. If you have the right kind of facility, you can quickly manufacturer huge numbers of doses. Hundreds of millions of doses.

In this case, a whole inactivated vaccine presents the entire virus to your body's defense or immune system that allows you to make responses against not only the little spikes that people see on the models with the coronavirus spike, but also the other proteins in the other parts of the virus particle that may actually give you a better type of protection. The one complication for COVID-19 is that the vaccine has to be made under what we call ‘BSL3 conditions’, it's a very high level of biosafety in case the virus were to escape.

Not all countries have a BSL3 factory that's available, and it would take special construction and special permits and the process of proving that the factory can in fact do this safely is more extensive. If you don't have the preexisting capacity, it's much more difficult.

GD: Okay, the final word to Ian Gust. So where is CSL, what sort of vaccine would it be happy to produce, do you know the answer?

IG: No, there's a kind of a misconception that just because you've got a plant in the country which makes vaccines, you can make any vaccine. That’s not true because for most vaccines, the manufacturing process is unique for that particular project, and that particular product. CSL is a very large producer of influenza vaccines. It produces those mainly in eggs and in cell culture, but many of the vaccines that are candidate vaccines for the coronavirus infection are produced by other technologies, so it would mean CSL basically starting the whole thing from scratch again.

What seems to me more likely, at least in the short term, is that if an overseas manufacturer entered into a relationship with CSL, the overseas company would produce it in bulk in their production plant, ship the bulk to CSL who would then finish it and distribute it locally.

 

The full 14-minute version from ABC's Radio National can be found here. This article is general information only.

 

RELATED ARTICLES

Is ResMed a trap or an opportunity?

5 new trends driving the future of biotech companies

Amid vaccine hope and skepticism, testing is key

banner

Most viewed in recent weeks

Meg on SMSFs: Clearing up confusion on the $3 million super tax

There seems to be more confusion than clarity about the mechanics of how the new $3 million super tax is supposed to work. Here is an attempt to answer some of the questions from my previous work on the issue. 

Welcome to Firstlinks Edition 566 with weekend update

Here are 10 rules for staying happy and sharp as we age, including socialise a lot, never retire, learn a demanding skill, practice gratitude, play video games (specific ones), and be sure to reminisce.

  • 27 June 2024

Australian housing is twice as expensive as the US

A new report suggests Australian housing is twice as expensive as that of the US and UK on a price-to-income basis. It also reveals that it’s cheaper to live in New York than most of our capital cities.

The catalyst for a LICs rebound

The discounts on listed investment vehicles are at historically wide levels. There are lots of reasons given, including size and liquidity, yet there's a better explanation for the discounts, and why a rebound may be near.

How not to run out of money in retirement

The life expectancy tables used throughout the financial advice and retirement industry have issues and you need to prepare for the possibility of living a lot longer than you might have thought. Plan accordingly.

The iron law of building wealth

The best way to lose money in markets is to chase the latest stock fad. Conversely, the best way to build wealth is by pursuing a timeless investment strategy that won’t be swayed by short-term market gyrations.

Latest Updates

Investment strategies

Have value investors been hindered by this quirk of accounting?

Investments in intangible assets are as crucial to many companies as investments in capital equipment. The different accounting treatment of these investments, however, weighs on reported earnings and could render ratios like P/E less useful for investors.

Investment strategies

Investors are threading the eye of the needle

As investors cram into ever narrower areas of the market with increasingly high valuations, Martin Conlon from Schroders says that sensible investing has rarely been such an uncrowded trade.

Economy

Persistent, but not permanent

There is universal consensus that the Earth is experiencing climate change. Yet there is far more debate about how this will impact different economies across the globe. New research sheds more light on the winners and losers.

SMSF strategies

How super members can avoid missing out on tax deductions

Claiming a tax deduction for personal super contributions can end in disappointment if it isn't done correctly. Julie Steed looks at common pitfalls and what is required for a successful claim.

Investment strategies

AI is not an over-hyped fad – but a killer app might be years away

The AI investment trend looks set to continue for years but there is only room for a handful of long-term winners. Dr Kevin Hebner also warns regulators against strangling innovation in the sector before society reaps the benefits.

Retirement

Why certainty is so important in retirement

Retirement is a time of great excitement but it is also one of uncertainty. This is hardly surprising given the daunting move from receiving a steady outcome to relying on savings and investments.

Economy

This vital yet "forgotten" indicator of inflation holds good news

Financial commentators seem to have forgotten the leading cause of inflation: growth in the supply of money. Warren Bird explains the link and explores where it suggests inflation is headed.

Sponsors

Alliances

© 2024 Morningstar, Inc. All rights reserved.

Disclaimer
The data, research and opinions provided here are for information purposes; are not an offer to buy or sell a security; and are not warranted to be correct, complete or accurate. Morningstar, its affiliates, and third-party content providers are not responsible for any investment decisions, damages or losses resulting from, or related to, the data and analyses or their use. To the extent any content is general advice, it has been prepared for clients of Morningstar Australasia Pty Ltd (ABN: 95 090 665 544, AFSL: 240892), without reference to your financial objectives, situation or needs. For more information refer to our Financial Services Guide. You should consider the advice in light of these matters and if applicable, the relevant Product Disclosure Statement before making any decision to invest. Past performance does not necessarily indicate a financial product’s future performance. To obtain advice tailored to your situation, contact a professional financial adviser. Articles are current as at date of publication.
This website contains information and opinions provided by third parties. Inclusion of this information does not necessarily represent Morningstar’s positions, strategies or opinions and should not be considered an endorsement by Morningstar.