COVID-19 Vaccine: trials and tribulations

JOHANNESBURG, South Africa – Even as countries hobble out of lockdown, coronavirus retains its firm grip on the planet. Dozens of vaccines against Covid-19 are being explored and tested. Can new methods accelerate the development of a solution for the pandemic?

The year was 1796. A man scraped pus from the cowpox blisters on the hands of a milkmaid and injected it into an eight-year-old boy. It was just a pinprick. Or was it? In time, that would turn out to be the beginning of one of the greatest medical experiments ever.

The man was British physician Edward Jenner, who was testing a method to immunize the boy against smallpox. Jenner succeeded, going down in history as one of the biggest contributors to the development of vaccination.

In the two centuries plus that have followed, vaccines have eradicated smallpox, treated around 30 diseases and are well on their way to eliminating about 10 more diseases.

Amid a raging coronavirus pandemic, there’s nothing that humans are longing for right now more than a vaccine against the pathogen. It’s a situation unprecedented in modern times. The virus seems unstoppable and quick. Until May 21, it had killed more than 330,000 people and infected over 5 million. 

Understanding the urgent need, countries and global associations have come together to support the research and development of vaccines and medicines against Covid-19.

However, the challenges are many, the risks are real and the chances of failure are high. Will the crisis lead to the evolution of new ways for developing vaccines? What are the risks and the rewards? And finally, what role does insurance play?

Scientific Adviser Johannes Klose and Senior Underwriter Mark Piazzi from Allianz Global Corporate & Specialty (AGCS), the corporate insurer of the Allianz Group, are evaluating many requests for clinical trial insurance these days and share some insights on vaccine development…

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Old vs New

A small vial of vaccine packs a powerful punch. Its diminutiveness hides the extensive work that goes behind it. “On an average, it takes 10 long years to develop a vaccine,” says Johannes, who holds a degree in Pharmacy and a PhD in neuro-biochemistry. “If it goes very quick, it takes about four-five years.”

In the case of coronavirus, waiting that long is not an option. Experts contend that a vaccine could come by in 12-18 months but that’s a rather optimistic estimate. Can modern technologies accelerate the process? “Possibly, depending on which concept is the first to find an effective solution,” says Johannes.

The traditional way to develop a vaccine is to isolate the virus, inactivate it and inject it into the human body to trigger an immune response. If such a vaccine has to be produced for billions of people, the virus will have to be grown in large quantities in controlled settings. “You can only imagine the kind of lab facilities, time and resources it would take,” he points out.

Newer ways work with the genetic information of the virus. Before diving into the concepts, we must first understand the basic structure of a virus – each virus particle has genetic material (DNA or RNA), a protective protein cover (capsid), and in cases like the flu virus or the coronavirus, an additional envelope with surface proteins.

The surface proteins protect enveloped viruses from the immune system. When the surface protein recognizes the right kind of host cell, it attaches to it and releases the virus’s genetic material into the cell. As a virus cannot multiply on its own and needs a host cell’s machinery to grow, the surface protein plays the most important role in the survival and propagation of enveloped viruses such as the coronavirus.

Three genome-based key concepts being explored make use of the pathogen’s genetic information, for example the parts that direct the production of these surface proteins, elaborates Johannes.

In the first kind of genome-based vaccine, part of the virus’s genetic material is inserted into a vector, which is transferred to bacteria or cells that produce the viral surface protein that is used as vaccine.

In the second kind, part of the virus’s genetic material is inserted into harmless carrier viruses, which are then injected into humans to ‘teach’ the body to respond appropriately to the real threat. 

In the third type, the viral RNA itself is delivered to the body as a vaccine. The RNA directs the production of parts of the viral surface proteins. The vaccinated person’s cells produce the viral protein from this RNA, which then triggers an immune response. 

“Such genome-based vaccines can be developed and produced much quicker than traditional vaccines,” Johannes says. However, they need to be tested thoroughly before being rolled out to the public. “A vaccine is not a 100 percent bullet against any virus. Plus, the safety aspect cannot be underestimated. Just because a vaccine was found safe in 100-200 people during the trials doesn’t mean it is safe for 5 billion plus people,” he warns.

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A mysterious virus

Coronavirus first emerged in November 2019. While we know that it has changed the world in many ways, not much is known about the pathogen itself.

Coronavirus is believed to have jumped from animals to humans but that too has not been proved conclusively. New reports reveal new facets of the virus daily and virologists are focusing all their energies on understanding its behavior, its effect on the human body and its mode of transmission. 

“The first test for the new coronavirus was done in January this year. That in itself is quite an achievement in terms of speed,” Johannes says.

To develop a vaccine, the most important step is identifying the weakest part of the virus which, when attacked with an antibody, kills the virus’s ability to infect. “The coronavirus is clever. Its key protein changes shape shortly before the virus invades the cells. That’s when the most vulnerable surface is exposed. We need antibodies that can successfully target this surface.”

A good understanding is needed of what the surface proteins look like, how they change shape and what are the most promising surfaces to attack.

This research is time-consuming. But with so many projects under way, it might happen quicker than usual. According to the World Health Organization (WHO), more than 100 vaccine candidates are being reviewed, eight of which have been approved for clinical trials. Four of these are in China, two in the United States, and one each in the UK and Germany. 

Before a vaccine is mass produced and successfully launched, it has to go through adequate testing to ensure it doesn’t harm humans in other ways. In addition, several issues such as intellectual property, patents, regulatory permissions and insurance for trials have to be resolved.

“Before any pharmaceutical product can get market approval and can be prescribed to the public, it has to undergo clinical trials,” says Mark Piazzi, who specializes in the underwriting of pharma and clinical trials. “Clinical trials themselves also need to be approved by regulators and ethics committees and as part of the approval process insurance has to be organized. In many countries, trials insurance is mandatory.”

These trials generally comprise three phases before market approval. In the first, the tolerability and safety of the drug or vaccine is tested on a small group of people. The second phase determines the right dosage on a larger set of participants, usually patients. The third phase is testing on a large group of patients over a longer period to prove efficacy and medium-term safety. There is a fourth phase, which is the post-market approval phase. This studies the safety and superiority of the product over similar drugs on a long-term basis. This phase is not always mandatory.

Clinical trial insurance protects the participants of the trials, in case they are injured in the process. Usually, the second phase is the most delicate, where intolerances and severe side-effects are revealed. However, the first phase could also result in some major injuries, especially in trials involving new active ingredients that have not been tested on humans before.

In the case of Covid-19, an added risk is that of infection when people go to hospitals to participate in these trials. “In case of a pandemic, their exposure to the virus is greater because a large number of infected people – often also healthcare workers – are there,” Mark says.

When a vaccine is finally launched, coverage shifts to product liability insurance of the manufacturer. “That is the normal way of doing things but in this case, it is possible that some governments will give certain waivers to protect manufacturers if someone is injured due to the vaccine.” As the vaccine has to come into the markets relatively quickly, it will not be tested as thoroughly as a normal vaccine. “So the risks are higher,” adds Mark. 

Given the widespread impact of the coronavirus, we are in a race against time. Now and then, encouraging signs emerge in terms of promising treatments and vaccines. It’s obvious that the pandemic has changed the face of healthcare forever. And possibly, its brain too.