Clinical supply


approved. But thanks to some calculated risk taking, this process took a matter of months for Covid-19 vaccines.


Pharmaceutical companies would generally ‘play it safe’ and build a supply chain once a product was, or was close to, being approved, says Cordon. This minimises the risk of loss because if you’ve already started manufacturing but the drug isn’t approved, you lose not only the doses you’ve made but the time and money it took to make them. During the pandemic, the need for vaccines was so acute that companies decided to risk these losses in order to speed things up. Of course, it helped that government programmes like Operation Warp Speed in the US and the UK’s Vaccine Taskforce were willing to shoulder some of that risk, allocating billions in funding to companies with vaccine candidates.


The next generation of vaccines could move faster than pre-pandemic, thanks to the changes to the supply chain.


What do these extraordinary changes to the supply chain mean for the next generation of vaccines? Things will probably move faster than they did pre-pandemic, but it really depends, say supply chain experts Kevin Sample, senior consultant at GHX, and Carlos Cordon, professor of strategy and supply chain management at IMD business school. Various forces had to align to get the supply chain in shape for the Covid-19 vaccines, and so too will they in future if the world wants to maintain that same speed and volume.


“We have been so conservative in the past...I think in future, vaccines are going to be made faster, and we might go back to ‘gambling’ in the sense of saying: let’s build the facilities, let’s build the capacity, even if we are not sure [that a drug will be approved].”


Carlos Cordon 413 Airfinity 14 million


Doses of Covid-19 vaccines produced at the beginning of March 2021.


“I think the work that’s been done over the last two years has really boosted forward how you go from zero to vaccine in a very short time,” says Sample. “[But] because of the exceptional circumstances [during Covid-19], I think a lot of exceptional things happened to make it work at that level.”


Clinical trial phases


Phases of a clinical trial are usually run in a sequence, one after the other. This can take up to seven years, with production typically starting after trials have ended and the drug has been


The result was that clinical trials were run in parallel, with later phases beginning before the previous ones had finished and production starting before the vaccines were approved. This was a sort of ‘educated bet’ that the drug would be successful, so that everything was in place for it to be rolled out as soon as possible after approval. Could this speed be replicable for future vaccines? Maybe, says Cordon. “We have been so conservative in the past... I think in future, vaccines are going to be made faster and we might go back to ‘gambling’ in the sense of saying: let’s build the facilities, let’s build the capacity, even if we are not sure [that a drug will be approved].”


The degree to which a pharma company is willing to ‘gamble’ to get a vaccine out quickly, then, will be a question of commercial risk weighed against the urgency of patient need — which is tricky to predict for drugs that don’t exist yet. An important piece of the puzzle in the development of Covid-19 vaccines was also the previous knowledge of existing technology for the other coronaviruses SARS-CoV and MERS-CoV. Because of this, the discovery phase – an exploratory preclinical phase – was skipped, shaving years off the development time.


This may not be possible for future vaccines using novel technologies and, therefore, they’ll likely take longer to develop, says Cordon. This might affect the decision to pursue a certain drug if under time pressure, he adds.


Faster time to approval


It typically takes one to two years for a regulator to review and approve a vaccine, but during the pandemic this process was shortened to one to two months. This was made possible by regulators revising their processes to authorise the emergency


Clinical Trials Insight / www.worldpharmaceuticals.net


Nordroden/Shutterstock.com


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