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

5 new trends driving the future of biotech companies

Amid vaccine hope and skepticism, testing is key

Most Australians live better than the Rockefellers

banner

Most viewed in recent weeks

Is it better to rent or own a home under the age pension?

With 62% of Australians aged 65 and over relying at least partially on the age pension, are they better off owning their home or renting? There is an extra pension asset allowance for those not owning a home.

Too many retirees miss out on this valuable super fund benefit

With 700 Australians retiring every day, retirement income solutions are more important than ever. Why do millions of retirees eligible for a more tax-efficient pension account hold money in accumulation?

Is the fossil fuel narrative simply too convenient?

A fund manager argues it is immoral to deny poor countries access to relatively cheap energy from fossil fuels. Wealthy countries must recognise the transition is a multi-decade challenge and continue to invest.

Reece Birtles on selecting stocks for income in retirement

Equity investing comes with volatility that makes many retirees uncomfortable. A focus on income which is less volatile than share prices, and quality companies delivering robust earnings, offers more reassurance.

Comparing generations and the nine dimensions of our well-being

Using the nine dimensions of well-being used by the OECD, and dividing Australians into Baby Boomers, Generation Xers or Millennials, it is surprisingly easy to identify the winners and losers for most dimensions.

Anton in 2006 v 2022, it's deja vu (all over again)

What was bothering markets in 2006? Try the end of cheap money, bond yields rising, high energy prices and record high commodity prices feeding inflation. Who says these are 'unprecedented' times? It's 2006 v 2022.

Latest Updates

Superannuation

Superannuation: a 30+ year journey but now stop fiddling

Few people have been closer to superannuation policy over the years than Noel Whittaker, especially when he established his eponymous financial planning business. He takes us on a quick guided tour.

Survey: share your retirement experiences

All Baby Boomers are now over 55 and many are either in retirement or thinking about a transition from work. But what is retirement like? Is it the golden years or a drag? Do you have tips for making the most of it?

Interviews

Time for value as ‘promise generators’ fail to deliver

A $28 billion global manager still sees far more potential in value than growth stocks, believes energy stocks are undervalued including an Australian company, and describes the need for resilience in investing.

Superannuation

Paul Keating's long-term plans for super and imputation

Paul Keating not only designed compulsory superannuation but in the 30 years since its introduction, he has maintained the rage. Here are highlights of three articles on SG's origins and two more recent interviews.

Fixed interest

On interest rates and credit, do you feel the need for speed?

Central bank support for credit and equity markets is reversing, which has led to wider spreads and higher rates. But what does that mean and is it time to jump at higher rates or do they have some way to go?

Investment strategies

Death notices for the 60/40 portfolio are premature

Pundits have once again declared the death of the 60% stock/40% bond portfolio amid sharp declines in both stock and bond prices. Based on history, balanced portfolios are apt to prove the naysayers wrong, again.

Exchange traded products

ETFs and the eight biggest worries in index investing

Both passive investing and ETFs have withstood criticism as their popularity has grown. They have been blamed for causing bubbles, distorting the market, and concentrating share ownership. Are any of these criticisms valid?

Sponsors

Alliances

© 2022 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. Any general advice or ‘regulated financial advice’ under New Zealand law has been prepared by Morningstar Australasia Pty Ltd (ABN: 95 090 665 544, AFSL: 240892) and/or Morningstar Research Ltd, subsidiaries of Morningstar, Inc, without reference to your objectives, financial situation or needs. For more information refer to our Financial Services Guide (AU) and Financial Advice Provider Disclosure Statement (NZ). 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.

Website Development by Master Publisher.