(Bloomberg Notice) – Think of 2020 as a lucky year. This may seem odd considering the world is grappling with a pandemic that has killed nearly 1.8 million people and crippled the economies of many countries. The “luck” is linked to the effectiveness of over 90% of the two vaccines – the Pfizer Inc.-BioNTech SE vaccine and the Moderna Inc. candidate – which gained emergency approval after extensive clinical analysis. Huge scientific and technological advancements have helped achieve this and may well accelerate the end of the pandemic. And more vaccines are on the way. Unfortunately, there is a risk that this early success will lead to complacency.
The virus responsible for the Covid-19 disease – SARS-CoV-2 – is mutating, as viruses do all the time. It just happens at random. Sometimes the changes give a variant a slight edge over its peers, but often they make no difference from an immunological standpoint. Over time, however, it is likely that mutations will develop that are less sensitive to the protection provided by vaccines. It is for this reason that a global and coordinated surveillance effort is needed to ensure that we are aware of the evolution of the virus. Unfortunately, that doesn’t seem to be happening.
The UK is well ahead in this surveillance effort, led by the Covid-19 Genomics UK Consortium, a group of scientists that has analyzed the complete genome of more than 150,000 SARS-CoV-2 viruses isolated from infected individuals . This gargantuan endeavor helped them identify 1,777 changes in the proteins of the virus, including the so-called B.1.1.7 variant, whose apparent ability to transmit more efficiently has worried experts and forced stay-at-home measures and UK travel restrictions. The variant is impressive in that it harbors more mutations, 23 in total, than ever before in a single virus, including eight in the spike protein – the protruding rod-like structure that decorates the exterior of the virus and is targeted by the majority of vaccines, including Pfizer and Moderna. Although there is no hard evidence yet that this variant is more resistant to existing vaccines, it does raise concerns.
I was worried about the possibility that “escape” mutations would occur after vaccinations are widely deployed, but it appears that these changes occur even in the absence of widespread inoculations. The problem is, while we have an idea of the types of changes that are happening in the UK, we don’t know how many other variants are circulating in the EU, US and Asia because the data are not properly followed. This must change if we are to effectively manage the virus.
What needs to be done? Three things. First, governments around the world must cooperate and increase their surveillance of the virus to match that of the UK so that we can better assess any changes in the response to vaccination. We will soon know if the B.1.1.7 variant is as sensitive to vaccines as the most common strain, the probability being that it is. But we need any new variant found around the world to be evaluated for its responsiveness to vaccine-induced immunity so as not to be surprised. The manual for this already exists: this is done for the influenza virus, and we develop a new vaccine every year. The same should apply here if necessary. In addition, a set of rules must be developed and accepted globally to determine what constitutes a variant of concern. For example, are we developing candidate vaccines for every new variant found with mutations – which would have meant around 4,000 candidates by now – or just those whose sensitivity to our vaccines has been demonstrated in laboratory tests?
The next step is to make sure that vaccine companies work closely with governments and develop versions of their vaccines that incorporate any new variants of concern. While there is a cost and effort to do this, it will be relatively low for those using new technologies, such as Pfizer-BioNTech and Moderna with their mRNA injections, and AstraZeneca Plc and Johnson & Johnson with their “viral vector” vaccines. These technologies lend themselves to the rapid development of new candidates in less than two months. Companies should perform preclinical and non-human tests on primates to compare these new vaccine candidates with those that have already been approved. That way, they’ll be ready to deploy them in trials if the need arises.
The final piece of the puzzle is the regulatory framework for bringing new vaccines to market. Again, we have a handbook on the flu shot. Businesses, regulators, and governments need to come up with a simple set of rules so that we don’t have to wait for massive end-stage trials before we roll out a new vaccine formula. It should be possible to get a modified vaccine to the masses within a few months if the preclinical work is already done.
I am convinced that all of these things can be done. The UK is already doing generalized genomic analysis. A rejuvenated American Center for Disease Control and Prevention would be an important addition. With the accession of a few more regions, such as China and the EU, a global consortium could systematically track the virus. And our pharmaceutical and biotechnology industry has shown its ability and willingness to move quickly.
After such good news about vaccines, it would be a shame to lose ground in the fight against the virus, especially if it can be avoided. We just need to act on these things as soon as possible.
This column does not necessarily reflect the opinion of the Editorial Board or of Bloomberg LP and its owners.
Sam Fazeli is Senior Pharmaceutical Analyst for Bloomberg Intelligence and Research Director for EMEA.