Yet even though more than 40 experimental COVID-19 vaccines are being tested in humans, insurance companies with decades of experience evaluating clinical trial risks see nothing to unduly worry about.
Executives at insurer Allianz and brokers Gallagher and Marsh, among the major players in clinical trial insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.
They argued that there was little structural difference from trials conducted in the past, despite drug manufacturers around the world competing to break the fastest time in history to develop a vaccine, which stands at around four years. .
“Rates have been relatively stable. Even this year, so far, we have only seen moderate price increases on average, with higher price increases for COVID-19 trials particularly exposed,” said Mark Piazzi, senior underwriter at responsibility of Allianz Global Corporate & Specialty (AGCS).
David Briggs, managing director of the life sciences practice at Gallagher, echoed this, saying that each trial was scored based on its methods and the types of patients involved.
Gallagher said premiums in Britain, for example, started at around 5,000 pounds ($ 6,500) per test.
Total claims limits on the policies were generally set at roughly $ 6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.
In Britain, for example, claims limits were generally set at no less than 5 million pounds, while in Germany the figure was around 10 million euros ($ 11.8 million).
‘LOSS OF EXPERIENCE IS NOT DRAMATIC’
However, part of the reason premiums haven’t risen as dramatically as some people might have hoped is that claims at trial are generally rare, according to executives. This is because patients have often signed so-called informed consent agreements, they said.
Jim Walters, managing director of Life Sciences & Chemical Group in the Aon corridor, said those agreements describe the risks patients were taking by participating in the trial.
“So, you know, everything from where you could have a sore spot on your arm. Until you could potentially die. And you know, they would literally go that far on some of these protocols,” he added.
“Generally, these tend to hold up in courts and legal systems around the world. That means that the experience of loss that comes from clinical trials is not very dramatic.”
Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than the side effects of the treatment, executives said.
Such has been concern about the vaccine race among some members of the public, who fear safety standards will slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process.”
ASTRAZENECA TEST SUSPENSION
AstraZeneca and Oxford University’s suspension of global phase III trials of its experimental COVID-19 vaccine early last month due to a participant’s illness made the risk of side effects in clinical trials public.
But insurers said such delays were not unexpected and could even reflect the added caution of vaccine developers given the lack of data on COVID-19.
“Side effects always occur with clinical trials, but they are usually mild and expected. It is not very common to delay or suspend trials, although it does happen,” said Piazzi at AGCS, whose top peers in underwriting trials include Chubb , HDI and Newline from Fairfax.
“Both drug companies and insurers are even more careful than usual with COVID-19 trials because the stakes are high, especially for patient safety.”
All trials of the candidate vaccine have been resumed, with the exception of the US study.
However, there have been examples in recent memory of drug trials that have gone catastrophically wrong.
In 2016, for example, one participant died and five were hospitalized in a phase I trial conducted by the French company Biotrial in the city of Rennes, testing an experimental mood lightener manufactured by the Portuguese pharmaceutical company Bial.
In 2006, six patients required intensive care after receiving possible treatment for leukemia and autoimmune disease in London. One was described as “the elephant man” after his head swelled. Another lost fingertips and toes. TeGenero of Germany, the initial developer of the drug, withdrew.
But insurance executives emphasize that such disasters are rare, given the thousands of clinical drug trials that take place each year.
Walters de Aon, speaking about the 2016 trial, said it was “obviously a horrible situation.”
“But that’s one of the few really bad loss experience incidents the industry has faced. So clinical trial insurance is not very expensive. Let’s put it that way.”
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