What are the challenges to making a COVID-19 vaccine? – World Economic Forum

The coming months are going to be crucial for vaccine development and decisions around how we distribute COVID-19 vaccines equitably, who gets them first and how to gain the publics trust.

These were some of the challenges discussed in two sessions at the World Economic Forum's Sustainable Development Impact Summit.

With 42 vaccine candidates in clinical trials on humans, scientists are working hard to fast-track the development of a safe and effective vaccine that would typically take decades work.

We are at the beginning of the beginning, said Sai Prasad, President of the Developing Countries Vaccine Manufacturers Network.

We are just at the end of the first year, and we have a few candidates that are moving forward. None of them are successful yet. Time will tell the next three to four months as to which one of these candidates will be successful.

Thats the end of the beginning, because once you know whats successful, you have to manufacture that at scale. The devil is in the detail. After you manufacture, you have to get these products approved and then distribute them.

How close is the world to finding a coronavirus vaccine?

Image: Statista

In the first six months of the pandemic, more than 700 products for treatment or prevention of COVID-19 went into the pipeline, which is unprecedented, said Julie Gerberding, Executive Vice-President of pharmaceuticals company Merck.

She compared the response speed with that of the AIDS epidemic: It was several years before there was even a test and it was 15 years before a highly active antiviral remedy. Were living in an era where the science has brought possibilities.

Antivirals, which Merck is also working on, will help. If we can take mortality down, it buys us time... I dont think we should put all our eggs in the vaccine basket, but clearly its a huge component of securing global protection and we have to prioritize it.

Once a vaccine is successful, how can world leaders ensure against vaccine nationalism and make sure its distributed fairly across the globe?

Gavi, The Vaccine Alliance, along with the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI), have created the COVAX Facility, a global initiative that brings together governments and manufacturers to ensure eventual COVID-19 vaccines reach those in greatest need.

So far, a total of 156 economies, representing nearly two-thirds of the global population, are now committed to or eligible to receive vaccines through the Facility.

Responding to the COVID-19 pandemic requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forums mission as the International Organization for Public-Private Cooperation.

Since its launch on 11 March, the Forums COVID Action Platform has brought together 1,667 stakeholders from 1,106 businesses and organizations to mitigate the risk and impact of the unprecedented global health emergency that is COVID-19.

The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.

As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.

"A vaccine is the way we're going to get out of this pandemic that is the best way we have to go back towards normal, said Seth Berkley, Chief Executive Officer of Gavi.

Our belief in a fast-moving pandemic is youre not safe unless everyone is safe. What the COVAX Facility is trying to do is to get a vaccine out to all countries, rich and poor, at the same time.

Initially, he said, this would be frontline health workers and those most at risk and then the broader population.

Gavi is working with the pharmaceutical industry to scale up production and it is looking to have 2 billion doses available by the end of 2021.

Before COVAX, countries didnt have the option of working together, said Richard Hatchett, Chief Executive Officer of CEPI.

They were behaving in their own rational self-interest, which would have been inequitable and resulted in a perpetuation of the pandemic.

We have had to devise institutional arrangements in real time to develop and create a space for international collaboration in development, procurement and delivery. Designing a system to solve all those at one time is a huge challenge.

He said its encouraging to see emerging momentum around global solidarity and collaboration and willingness to work with us.

Global coverage, local plans

Companies need to look at the issues of the developing world during product development, said Prasad of the Developing Countries Vaccine Manufacturers Network, particularly around vaccine storage temperature, transportation and biomedical waste disposal.

Many companies are doing that. But if they only have a US focus, they might not see the needs of the middle-income and low-income countries.

Gavi's Berkley said each country would need a bespoke plan for who to vaccinate first.

In the US, it might be [people in] prisons or meat-packing plants, the elderly, but in developing countries, you might not have a high elderly population, but you might have urban slums and displaced people, so you really have to understand the local situation even though we can have global guidelines.

Johnson & Johnson's candidate is the latest to go into Phase 3 clinical trials and will now be studied as a single-dose vaccine on 60,000 people.

The pharmaceutical company says its on track to meet its goal of providing 1 billion doses of an affordable vaccine each year. It anticipates the first batches to be available in early 2021, if proven to be safe and effective.

Paul Stoffels, Johnson & Johnson's Chief Scientific Officer, said the first vaccines would be ready early next year and explained the trial size was determined by transmission rate.

"To reach a statistically significant end point, we need to have significant numbers, so there's a lot of data science to see where we have to target people most at risk."

He said the company has learned from developing vaccines for the Ebola virus that single-shot vaccines are efficacious, but they will be testing booster shots at a later date.

All eyes are on the pharmaceutical companies during the development process, and once a vaccine is ready to be distributed, will the global public want to take it?

In a recent World Economic Forum-Ipsos survey of nearly 20,000 adults from 27 countries, 74% said they would get a vaccine for COVID-19.

This majority might still fall short of the number required to beat COVID-19, with just 37% strongly agreeing they would be willing.

Pascal Soriot, the CEO of AstraZeneca, said companies working on COVID-19 vaccines are looking at how to provide greater transparency without impacting on vaccine trials.

AstraZeneca, which is developing a vaccine with the University of Oxford, paused its Phase 3 trial earlier this month, after a patient became sick. The trial has now restarted in the UK, but in the US, it's waiting on the go-ahead from the FDA.

"Stopping a trial in a vaccine programme is not uncommon and if you place safety at the centre of what you do, you're going to have to stop and look at events.

"Typically, the clinical guidelines recommend you don't disclose patient-level information or much information at all because you could compromise the study.

"We're looking at how much transparency we can provide... as an industry without compromising patient privacy or the trial itself."

"At the end of the day, people have to accept that they have to trust someone... So many regulators will look at this data and these results with different eyes... Medicine shouldn't be practiced by the media, it should be practiced by experts."

Trust is everything, said Gerberding. We need to involve opinion leaders and trusted doctors at the local level to communicate the actual facts and stand strong.

Its an understandable concern that in our race to get additional population protection, safety shortcuts will occur. That is not the case. The major vaccine manufacturers recently signed a pledge promising that they would adhere to safety requirements of the regulatory agents and not jump ahead of the curve in an effort to win the race.

We are self-policing and making sure we dont overstep that confidence barrier.

Preparing for the next one

We cant afford to be short-termist while were focusing on COVID-19, Gerberding and Berkley also warned.

It is evolutionarily certain we will have more outbreaks, said Berkley. The way to build back better is to have routine systems and continued investment. The cost [of COVID-19] has been between $9 and $12 trillion. A little bit of investment in peacetime is exactly the right thing to do.

Gerberding added: "We have to make sure that while we're fighting this pandemic, we're preparing for the next, because I do believe it's only a matter of time before we face another of these situations or potentially something worse."

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What are the challenges to making a COVID-19 vaccine? - World Economic Forum