Vaccine Development in Asia Pacific – The risk of fast-paced innovation

Prashansa Daga, Underwriter - Miscelleneous Medical & Life Sciences

The level of innovation within the life sciences’ industry in the fight against COVID-19 – and the development of the first vaccines within a year of the virus’ emergence - has been nothing short of miraculous. However, the pandemic is far from over and work has not stopped, across Asia clinical research and trials into additional vaccine candidates as well as booster shots continue apace.

Insurers have had to pivot quickly over the past twenty months, deploying risk management expertise and developing bespoke wordings that provide protection to organizations involved at each stage of these innovative and fast-moving clinical trials.

There may be longer term implications to consider, particularly now that the public and investors have seen how quickly the industry can adapt to meet a health crisis. Beyond the pandemic, for pharmaceutical companies, being the first to market with a seemingly successful vaccine or therapeutic brings huge financial and reputational gain. When it comes to significant medical innovations in the future there will undoubtably be increased pressure on those involved to get the product to market more quickly.

To put things in perspective, the mumps vaccine, previously considered the fastest to be developed, took four years, while the first COVID-19 vaccines took less than 12 months. However, despite what we have learned about the behaviour of viruses and immunology in the last 200 years, there is no guarantee that any project will produce a safe and effective vaccine. Getting a vaccine to market comes through extensive research, clinical trials and regulatory review; a process that takes 10 to 12 years on average, with a high risk of failure. In the last 20 years only 39.6% of vaccine projects have resulted in a drug being approved to go to market, according to The Massachusetts Institute of Technology, while only 26 diseases are preventable through vaccination according to the WHO.

Reducing the development period from 10 years to a matter of months has been accomplished by conducting Phase I and Phase II studies simultaneously and reviewing data as it becomes available, rather than pausing to review between each phase.  This isn’t to say that the vaccines are any less safe or effective; testing the safety and efficacy of any medical product undergoes robust pre-human trial research before moving to human trials. 

Most jurisdictions across Asia follow the International Convention on Health’s Good Clinical Practice Guidelines (ICH GCP) and the Helsinki Principles. This means that before human trials begin the sponsor or investigator must get approval from the national regulator, which authorises clinical trials and approves new medicines for use, and a research ethics board. 

Not all candidates make it this far. Failure to prove that the proposed trial meets regulatory and ethical standards could mean revising trial protocols or starting the process over with another candidate - costing time and money and potentially losing first-to-market advantage.

Many national regulators have been able to fast track vaccine approval thanks to introducing rolling approval processes, which means rather than waiting for the trial to be completed, and a full data set to be sent for review as would normally be done, new evidence of safety and efficacy is reviewed as it becomes available. This rolling review process has expediated the time it has taken to provide Emergency Use Authorisation (EUA).

While many have concerns about receiving a vaccine which is subject to EUA, they should be reassured that EUA is only given when sufficient evidence has been received which shows the vaccine is safe, effective and good quality. A grant of an EUA is not the end-point and a sponsor must continue to submit data on efficacy and safety after EUA and work towards full approval or risk having EUA rescinded.

This isn’t to say that clinical trials are without risk, human trials inherently carry risk but this can be mitigated through proper trial design and ensuring that rigorous protocols are in place for the duration of the trials. Each phase of the trial informs the next and as a safety measure they will include ‘learn and confirm’ cycles to address any variance from anticipated results. Upholding these standards reduces the potential for human error that can lead to bodily injury and claims against those running the trial.

To complicate matters further, there are many parties involved in a trial beyond the pharmaceutical company sponsoring the trial: contract research organisations (CROs); site management organisations; medical investigators; and medicine manufacturers all play a role in supporting trials. Despite the strength of risk management regimes, human error during clinical trials can cause injury to trial participants or lead to financial losses due to delays or interruption. Robust risk management and having the safety net afforded by specialist insurance is therefore of paramount importance.

Looking forward, the life sciences sector and regulators will have to balance safety and increased expectations against how trials will operate in the post pandemic world. It is possible that national regulators will make some elements of the rolling review introduced by national regulators to expedite approvals will be made permanent while the use of technology - which has helped facilitate virtual trials - will increase. These elements increase complexity and risk with trial design needing to address the risks of remote patient monitoring and technology failure as well as how the trial complies with the changing regulatory landscape.

Sources:

https://www.wusa9.com/article/news/verify/adverse-effects-side-effects-covid-19-can-vaccine-comapnies-be-sued-for-complications-from-symptoms-verify-fact-check/65-ae9305ac-1193-4b7a-a90f-eb8536f06058

https://wexnermedical.osu.edu/blog/covid-19-vaccine-long-term-side-effects

Disclaimer- The opinions expressed in this publication are those of the authors. They do not purport to reflect the opinions or views of Beazley or its affiliates.

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