The race to getting a COVID-19 vaccine is global and its causing public concerns about safety which had led to nine leading developers being compelled to issue a pledge to uphold scientific standards and testing rigour.
There have been more than 40 experimental COVID-19 vaccines which have been tested on humans but the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.
Insurers at Allianz and brokers Gallagher and Marsh who are part of the top players in clinical trials insurance told Reuters that premiums had only marginally increased so far in the current pandemic.
They laid their claims to being the inadequacy in structural difference to trials being carried out in the past despite drugmakers all over the globe competing about who will make the vaccine which stands at about four years.
“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty (AGCS).
This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.
Gallagher further made it known that premiums in Britain started at about GB£5,000 pounds (US$6,500) per trial. And total claims limits in policies were typically set at about US$6 – 12 million but that depends on the country’s rules an the several insurance companies interviewed by Reuters.
In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).
One of the reasons why premiums haven’t yet risen sharply is because some people might have expected that claims from trial are generally uncommon which is due to patients that have often signed informed consent agreement.
Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.
“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.
“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”
Claims are therefore limited to circumstances linked to the improper conduct of trials or other wrongdoing instead of side-effects of the treatment, said the executives.
This had been the primary worries about the vaccine race among members of the public because of the fear of safety measures being put in place could slip meanwhile some nine developers have issued a joint pledge that they’ll “uphold the integrity of the scientific process”.
AstraZeneca and Oxford University had to pause the global phase II trials of their experimental OCIVD-19 vaccine earlier on last month due to adverse side effects in clinical trials.
The insurer said that this type of delay were not unexpected and could reflect extra caution of vaccine developers due to the lack of data about the COVID-19.
“Side effects always happen with clinical trials, but these are typically mild and expected. It is not very common to delay or suspend trials, it does happen though,” said Piazzi at AGCS, whose main peers in underwriting trials include Chubb, HDI and Fairfax’s Newline.
“Pharma companies and insurers alike are even more careful than usual with COVID-19 trials because there is so much at stake, particularly for the patients’ safety.”
However, vaccine candidate have resumed with the exception of the U.S. There have in fact been cases whereby drug trials went really wrong as with a case in 2016 whereby one participant died while five others were hospitalized in a Phase I trial that was run by French company Biotrial in Rennes while testing an experimental mood brightener made by Portuguese drugmaker Bial.
Another serious case was back in 2006 when potential treatment against leukemia and auto-immune disease in London was being carried out. One of the patient’s head swelled so big that he was described as looking like “the elephant man” while the other lost fingertips and toes. Germany’s TeGenero, the initial developer of the medicine, folded.
But insurance executives stress such disasters are rare, given the thousands of clinical drug trials being carried out every year.
Walters of Aon, speaking about the 2016 trial, said it was “obviously a horrible situation”.
“But that’s one of very few incidents of really bad loss experience that the industry has faced. So, clinical trial insurance is not hugely expensive. Let’s put it that way.”