How the Three Major Challenges To Creating A Vaccine Are Being Overcome

Identifying effective vaccines, manufacturing them at scale and distributing them globally are the three meta-challenges. All are being researched. JL

Charlotte Edmond reports in World Economic Forum:

The speed at which researchers have been able to get authorization and tests to market has been increased significantly – one had a turnaround time of three hours. In order to meet the production demand, industry needs to start preparing for manufacturing in parallel with research – long before clinical results become available. To make this happen, scientists, regulatory bodies and industry need to work together.several versions of the vaccine may be manufactured simultaneously in order to meet demand. A vaccine needs to reach all corners of the world. Distribution companies such as UPS are coming up with solutions and looking into drone technology.

• There are multiple teams working on a coronavirus vaccine, with the hope that several could be approved in record speed.
• Billions of doses will need to be manufactured, meaning collaboration between industry, regulators and the scientific community will be crucial.
• The vaccine needs to be available in all parts of the world to ensure that a reservoir of the virus does not remain.

Researchers around the world are working against the clock to create a vaccine to halt the spread of coronavirus.

From the moment it was clear we were facing a global pandemic, it was apparent that a vaccine would be a crucial tool in limiting spread and infection. And while we are seeing unprecedented cooperation between researchers, industry and regulators, there are still some huge challenges to be overcome in a very short space of time. Here are the main three:

1. Finding a vaccine that works

Across the world there are multiple teams working on various forms of vaccines, and the hope is that several will ultimately be approved. Given the need for rapid development, many of the regulatory hurdles have been relaxed to speed up processes - which can typically take up to a decade.

Vaccine development can take many years - and lots of money.

Image: Wellcome Trust

In the US, the speed at which researchers have been able to get authorization and tests to market has been increased significantly – one had a turnaround time of just three hours.

One of the vaccines furthest down the line is being developed by biotech company Moderna. Chief Executive Stéphane Bancel, talking on the World Economic Forum’s COVID Action Platform, argues that in some ways we got lucky with this virus. Although thousands have tragically died, unlike previous outbreaks such as the 1918 flu outbreak, children seem to be largely unaffected; equally, the virus itself is not very complex. HIV, by contrast, was discovered in the early 1980s and there is still no vaccine. Work on other coronaviruses such as SARS and MERS has also given us a head-start, he points out.

“We are days away from starting phase two trials,” Bancel says. The goal is “to be in a position to potentially go to the regulators and ask for product approval as early as the end of this year.”

Some countries already have emergency use provisions written into law which would allow early use of the vaccine. Bancel adds there may be circumstances where phase three trials could be conducted in parallel with emergency use among populations such as healthcare workers, or those at particular risk of developing severe symptoms.

2. Production at massive scale

Once an effective vaccine has been identified, it will need to be produced rapidly and on a massive scale.

“What is unique is we have to go so fast and so huge,” says Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “When Ebola was a problem in Central Africa, with a few hundred thousand vaccines you could get it under control. Here you need billions of vaccines.”

He highlights that in order to meet the production demand, industry needs to start preparing for manufacturing in parallel with research – long before clinical results become available. To make this happen, scientists, regulatory bodies and industry need to work together.

“The collaboration is unprecedented,” Stoffels adds. “If I look at how we work today with the regulators in the world, where normally we have paper processes which take weeks and months to get feedback, today we talk about getting feedback from regulators within the day.”

There are more than 100 vaccines in development right now, of which eight are already in clinical trials. The challenge is identifying which of these will be taken forward, says Seth Berkley, CEO of vaccine alliance GAVI. Industry can invest in manufacturing, but companies need to know that someone will buy the product. “What we are trying to create now is an advanced market commitment,” he says.

This goes more so for manufacturers in developing countries. Many have been hit hard by the pandemic, and it is important that they also continue to make existing vaccines for other diseases. “We may need to provide them some finance upfront so that they’re available to help scale into the billions and billions of doses that we are going to need,” says Berkley.

What seems likely is that several versions of the vaccine may be manufactured simultaneously in order to meet demand.

“No pharma company could make five billion doses in the next year or so, but if several of us get to the finish line in the type of timelines I talked about, then we should be able to put a big dent in the spread of the virus,” Bancel believes.

3. Widespread distribution

Distribution is going to be another challenge, particularly when it comes to the last mile. A vaccine would need to reach all corners of the world in order to effectively tackle the virus.

“We have a global problem that requires a global solution,” says Berkley. “We need the best science in the world. We need the best manufacturing in the world. And obviously we are going to need industry from around the world to engage. If we have anybody left over anywhere as a reservoir of virus, it not only threatens them, but threatens the world.”

GAVI is working with distribution companies such as UPS to come up with solutions, and is also looking into drone technology to deliver equipment. Alongside this, they are building a system of tracking and contact tracing.

Stoffels adds: “We have tried to do this at the lowest possible cost, not for profit. We have tried to make sure there is a very large capacity available so that the quantity can support a large part of the world. And we are fighting for equitable access in the world, so that people can get access wherever they need it in the world. If we don’t solve this infection in every part of the world, it will not be solved for the world.”