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Q&A with a vaccine expert on COVID-19 and pandemic response

A male nurse holds a syringe

Photo credit: Dimitri Houtteman on Unsplash

By Ruth Adair, May 4, 2020

The race is on to develop a COVID-19 vaccine. But in an outbreak situation, getting to market fast enough means the process – from discovery research to clinical development to large-scale manufacturing and regulatory approvals – all happens in a condensed timeframe.

What are the implications? When will a COVID-19 vaccine be developed? Who are the key players involved? A recent webinar by vaccine expert Dr. Luis Barreto sheds light on vaccine development in the context of the COVID-19 pandemic response. Watch the webinar.

Dr. Barreto is a member of the international advisory board of the Master of Science in Global Health program, a collaboration between McMaster, Maastricht, and Manipal universities, and a member of the scientific advisory boards of the National Research Council (NRC) Human Health Therapeutics Research Centre and CanSino Biologics Inc. He is also senior scientific advisor with global biotech firm Inventprise/InventVac. His work in vaccinology over the past 30 years has involved helping to eradicate polio, dramatically reduce Haemophilus Influenzae type b (Hib) and whooping cough infections, and shape immunization policy in Canada and around the world.

We asked Dr. Barreto these questions following his webinar, the third of 10 in the series, Expert Perspectives on Pandemics, which is taking place as part of the MSc Global Health program’s capstone project.

When do you think a COVID-19 vaccine will be developed?

There are more then 75 different vaccines in different stages of development with a couple already in Phase 1-2 clinical trials in China, the US and the UK, with a couple more expected to get to Phase 1 over the summer. The WHO and the Coalition for Epidemic Preparedness Innovations (CEPI) are working with academic experts and industry representatives and government research and funding organizations to develop adaptive clinical trials so that vaccines can be introduced. Because this is a pandemic, the usual phases from discovery to licensure happen over a much shorter period of time. Such rapid vaccine developments are expected to take a year and a half to three years as opposed to the 7-10 years or more needed to develop vaccines under normal circumstances.

Who are the key players involved in vaccine development?

There are players from academia, small biotech, and larger pharmaceuticals in developed and developing countries – and they’re all working on different approaches and technologies.

Funding organizations like the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID) in the US, the Canadian Institute of Health Research in Canada, the Chinese Academy of Medical Sciences, the Indian Council of Medical Research, CEPI, Wellcome Trust and the Gates foundation, the WHO and the European Union, amongst others, are all working separately or in partnerships to develop vaccines and the manufacturing capacity to have the quantities necessary over the next couple of years.

The only way vaccines can come into play during outbreaks is through partnerships – WHO, CEPI, funders, scientists and so on – forged and maintained ahead of time. And we have to understand that while there will be many shots at goal, only very few vaccines will make it to the stage beyond discovery. And few will make it to development and be able to manufacture vaccines in the large quantities necessary to meet global needs.

Why does it take so long to develop a vaccine and what are the dangers developing one so quickly?

Vaccines have to be produced to meet strict regulations. Normally, it takes 7-10 years, and often longer, to produce vaccines to have desired outcomes. It’s expensive because manufacturers have to meet a very stringent regulatory process. Plus, funding for development and clinical trials has to become available – not to mention the necessary support, on time, to move the different projects forward.

The strict guidelines for safety and quality have to be adhered to and approved by regulators to avoid any safety issues that may result if appropriate precautions aren’t taken at every stage of development and manufacturing. If that doesn’t happen, there’s a danger of unintended side effects for a variety of reasons. A single incident of a serious adverse event can lead to lack of confidence in immunizations, not only in the vaccine being developed but also in other vaccines that routinely save thousands of life every day.

It’s important to note, though, that every precaution is always taken to ensure the quality of the product can’t ever be compromised. Because most often, it will be given to healthy individuals with the hope of protecting them from potentially getting the infection.

In the case of COVID-19, we assume it could follow a ‘typical’ pattern of outbreak situations, which most often goes like this: The news breaks fast, money flows in from government and non-governmental organizations, academia and small biotech gets involved to move their science and candidates forward. Larger biopharmaceuticals move in to work with government funding organisations and, when necessary, develop vaccines themselves or in partnerships with scientists in universities or smaller biotech and start to scale up the vaccine candidates to produce multimillion doses of vaccines. This process may take at best 2-3 years, by which time the outbreak is has often slowed or might end. So, the interest dies down because the need for a vaccine may not be top of mind of governments and the public unless it keeps coming back and the need for the vaccine persists if a second or third wave appears.

We’ve been hearing about messenger RNA vaccines. Can you explain what’s different about this approach and why it could be promising?

The SARS-CoV-2, like other coronaviruses, has crown-like spikes on its surface. There are three proteins on the surface of the virus: the envelope, membrane and spike, which cover or encapsulate a strand of RNA, the molecule that holds the genetic instructions that make up the virus. The messenger RNA, or mRNA, is a small part of the virus which enables scientists to develop a vaccine rapidly. This platform has been used before to develop Influenza and other vaccines. It allows rapid production of vaccines and an opportunity to respond to outbreaks like the COVID-19. These vaccines are in Phase 1 trials now in the United States.

Similarly, the spike proteins on the surface of the Coronavirus have been included on the Adenovirus platforms used for Ebola vaccine and such adeno-based vaccines are in Phase 1 trials in the UK and in China.

Who do you envision being the primary target for a COVID-19 vaccine? Should we first immunize the elderly/those most vulnerable?

Right now, the elderly and the immunocompromised appear to be most at risk. Health care workers seem to be an important risk group as well. Clinical trials have started in healthy adults in the 18-50 age group, moving up to 65 years, and then over 65. Vaccines for children will also have to be considered. Progression of vaccines studies will depend on the safety and immunogenicity of the vaccine in trials.  The vaccine then can be offered to elderly and immunocompromised populations. 

What are your views on an “immunity passport” that would enable individuals to travel or to return to work assuming they’re protected against re-infection of COVID-19?

Some governments have suggested that the detection of antibodies to the virus that causes COVID-19 could serve as the basis for this “immunity passport.” Based on what we know today about immunity, and based on what the WHO has been indicating, and the experts have suggested, having immunity passports is not the way to go. There may be a false sense of security resulting in transmission to people around you. This may be a question for future discussion as more data about testing and implication of results is known.

How can we best incorporate considerations around global health inequities into vaccine development and distribution?

This is probably very challenging, even in a non-pandemic situation.  However, organizations like GAVI and the Gates foundation and others are working with WHO, UNICEF, Wellcome Trust, and closely with national governments in developed and emerging countries. The large manufacturers, represented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Developing Country Manufacturers Network (DVCMN), all need to work closely together to support the development, rapid scale-up and distribution of vaccines – where and when they’re required. Many of these partners are already working together.

The WHO R&D blueprint offers guidance on adaptive clinical trials to help get the vaccines into trials as the candidate vaccines become available. Various manufacturers in North America, Europe, China and India are all making plans to scale up production to make millions of doses possible. We all need to keep in mind that the development of a safe, affordable and efficacious vaccine is an extremely important first of the many steps that we need to take. The most important step however is to make sure that billions of doses of efficacious vaccines are made available at a reasonable price to those who need it, especially in developing countries so that the pandemic can be controlled for now. This is where our Global Health graduates and students can play a role in developing and shaping policies that can help us all recognize vaccines as global public good.

Watch the webinar