Coronavirus jabs have been developed in record time by speeding up cumbersome scientific and regulatory processes – not cutting corners
Nine months ago, when Covid-19 has first declared a pandemic, the question everyone was asking was why it takes so long to produce vaccines. With the UK rolling out the first Covid-19 shots, researchers and vaccine manufacturers have pulled out all the stops to develop and deliver them in record time.
But as the beginning of the end of this crisis draws tantalizingly close – and we should be worrying about whether there will be enough vaccine doses to go around – we are now faced with an alarming number of people unwilling to be vaccinated precisely because they have been developed so quickly.
According to a survey by Ipsos Mori, more than half of Britons don’t believe that enough time has passed to see if the vaccines really work, and even more say it’s too soon to know what the side effects are.
Unless public concerns over the efficacy and safety of Covid-19 vaccines are addressed, we could see significant numbers of people refusing vaccination, or delaying it.
That would be disastrous because it would allow the virus to continue to circulate and prolong the pandemic.
The only way to minimize human suffering and resume our normal lives, commerce, trade, and travel, is to stop the virus from spreading. Vaccines alone can’t do that; for that we need as many people protected all across the world, and as quickly as is humanly possible.
Dismissing people’s concerns about the safety of the vaccine would be the wrong way to go about this. All across the world countless millions of people who are normally supportive of vaccination, have genuine concerns about the speed at which these vaccines have been developed.
After all, for months they have repeatedly been told that it normally takes over a decade to develop a vaccine, so it seems quite reasonable to ask, how we have now got here so quickly without cutting corners.
To understand how this is possible, it’s important to remember that clinical trials make up just one stage of the normally lengthy vaccine development process. At the preclinical stage – before the vaccine is tested on humans – it can take years to develop a suitable antigen – the part of the vaccine used to trigger an immune response.
But with some of the novel RNA vaccines, the first Covid-19 antigens were mapped out within hours of the genome for the coronavirus being made public. Similarly, the development time of the other more traditional vaccines was sped up by building on previous work to develop antigens against Sars and Mers, also coronaviruses. All this has potentially saved us years.
Another important reason why it normally takes so long is that manufacturers usually do clinical trials sequentially, pausing between each phase and sometimes repeating trials with changes in the antigen as already described.
Then manufacturers usually wait until their candidate vaccine has completed clinical trials and passed all the regulatory hurdles before scaling-up their production facilities so they can produce large numbers of doses.
Given that a single manufacturing plant can cost in excess of half a billion dollars and that vaccine candidates at the clinical stage still only have a less than 20 percent chance of succeeding, it is understandable why manufacturers are normally reluctant to make such significant investments until they can be sure they have a licensed and marketable product.
This can add years to how long it takes before vaccines become available. With Covid-19 the situation is different, largely due to the global nature of the threat. Scientists have stepped up to the challenge, developing more than 300 candidate vaccines and high-income countries have invested heavily.
But another difference this time is that there is also a global collaboration involving 189 governments and economies – representing nearly 90 per cent of the global population – aimed at making access to these vaccines rapid, fair, and equitable to people all across the world.
This initiative is called Covax and through it governments help manufacturers share some of the risk, encouraging them to scale-up and start manufacturing large volumes for the world before the vaccines are licensed. This means that as soon as they are approved for use, we are able to hit the ground running and roll them out immediately, avoiding years of delay.
With clinical trials, the main savings have come from carrying out the various phases almost in parallel, rather than one after the other, and adapting them as we go. This has not only allowed us to accelerate the process but has actually helped refine it by enabling us to learn as we go, adding different risk groups along the way to build a more complete profile of how effective the vaccines will be across different demographics. But at no point has any of this come at the expense of safety.
That has remained paramount, with the same strong regulatory systems that are stringent, science-driven, and free from political interference, being applied as would normally be the case.
This crisis has shown that there was plenty of fat that could be trimmed off the vaccine development processes, including the regulatory stages. And to have ended up with such encouraging efficacy results from more than one vaccine candidate puts us in an extraordinarily promising position.
Some people have pointed to the seemingly low sample sizes involved, that is the number of vaccinated people in these trials that have actually ended up being exposed to the virus. But as we will see when these results are eventually published, as they must be, these sample sizes are quite normal and in fact higher than for some existing vaccines.
That should give us confidence. And so as more vaccines become available, we need people lining up for them, because that’s the fastest and safest way to get out of this crisis. We must not lose sight of that, and the fact that some people most at risk won't think twice and they should not.
The good news is that the views people often give in polls are not always reflected in how they act. And given that demand, at least initially, will almost certainly outweigh supply, we may find vaccine hesitancy starts to wane and confidence grow as more people start to get access.