Clinical supply
use of vaccines. One such revision, as seen with the European Medicines Agency (EMA), was allowing pharma companies to submit data on a rolling basis and officially apply for approval using their previous submission. Lead times for other parts of the usual procedures, such as publication of assessment reports, were also shortened.
“Obviously all of the checks and balances have to remain in place,” says Sample. “But I think some of the unnecessary bureaucracy was put to one side to help expedite the process.” If this fast-track procedure doesn’t compromise on safety, why did the process take so long in the first place? “In the future, people are going to ask questions,” says Cordon. “Why are we going to go back to the other process, if the new process has proven much faster and much better for people?”
Cordon predicts that vaccine supply chains, which are global in nature, will become more regional in future – and one of the reasons why is the potential for faster approval. “If something is made in the EU, it’s much faster to get [approvals] then it is for something that’s made outside,” he says. However, regulators are traditionally very conservative and whether they will maintain their sped-up processes without the urgency of the pandemic is another question, he adds. Ultimately though, he expects that we will see some change. “I think in the future, the vaccines are going to be made faster... because the approvals process is going to be faster.”
Scaling up
An industrial ramp-up of the magnitude seen during Covid-19 called for extra resources and expansion of facilities to support both the production and fulfilment parts of the chain. But it might not be possible to maintain this capacity once this pandemic is over, says Sample.
Extra facilities and expansion cost money, which, in part due to government support, wasn’t an object in this time of crisis, he adds. In non-emergency times, though, it may be more of a sticking point. “Money will become a factor eventually,” Sample says. “Organisations such as AstraZeneca and Pfizer won’t want to be producing and selling stuff at cost. Once we are at that stage where Covid-19 is being managed globally... maybe they’ll want to bring some profit in on the back of that.” The sheer scale of production has also created supply challenges that could affect the production of other drugs. The supply chain is already seeing bottlenecks, such as shortages of borosilicate glass, which is used to make the vials the vaccines come in, says Sample.
Clinical Trials Insight /
www.worldpharmaceuticals.net
An ‘F’ in ethics
Since Covid-19 vaccine roll-outs began, it’s become abundantly clear that self-interest has controlled the buying behaviour of states and it’s been to the detriment of those without deep pockets. “We passed the science test. But we are getting an F in ethics”, was how UN’s secretary-general Antonio Guterres framed the situation in September 2021. Back in February 2021, it was reported that many of the world’s richest countries, including the US and UK, had purchased several times what was needed to vaccinate their populations. Fast forward to now and according to Oxford University’s tracker Our
World in Data, 56% of the world’s population has received at least one dose of the vaccine. While only 7.1% of people in low-income countries have received a jab. The bulk purchasing agency Covax, which was formed to equalise this distribution, was promised 870 million doses in June from the G7 nations’ surplus, but only 100 million have been sent.
“We have to consider that this isn’t just about vaccines, because these facilities are able to produce other types of drugs and treatments. While you may be producing vaccines to save lives as Covid-19 vaccines have, the flip side of that is that you have a lot of people who become increasingly ill or die from other things, and that model needs to be continually reviewed to make sure that you’re not doing more harm than good.”
“Obviously all of the checks and balances have to remain in place. But I think some of the unnecessary bureaucracy was put to one side to help expedite the process.”
Kevin Sample
Cordon adds that, because the increased manufacturing capacity was only designed to be temporary, these new ways of working aren’t likely to carry on for the next generation of vaccines. “We were going to use that capacity for a short time, at full,” he says. “That is why many companies weren’t concerned about building something that was going to last.”
While both Cordon and Sample believe that future vaccines will be available faster than they were before Covid-19, there are plenty of variables at play as to how fast this could feasibly happen. How quickly a given vaccine can be developed is not only a question of approvals and logistics, but also of commercial strategy: how much risk are pharmaceutical companies willing to take on to get a drug out faster?
Probably a bit more than before, says Cordon. “I always said that pharma companies are a big casino, because they bet on several active ingredients. That part was always in product development, it was almost never in the supply chain. And now, for the first time, we are taking those bets in the supply chain too.” ●
8.47 billion
Doses administered worldwide.
Our World in Data 5 billion
Combined doses of vaccines worldwide before the pandemic.
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