Platform technologies could deliver a vaccine quickly

Developing vaccines is expensive, risky, and time-consuming due to stringent approval processes and logistical challenges. Platform technologies for vaccines, which can be adapted quickly for different pathogens, offer a promising solution. However, current legal regimes are not equipped to evaluate these platforms, and regulators must gain experience with them to accelerate approvals.

This article was first published in The Mint. You can read the original at this link.

Coronaviruses are a family of pathogens that cause respiratory illness. They transmit rapidly and frequently evolve into new variants not previously identified in humans. While at least four strains cause very mild infections every year with symptoms and outcomes no different from those of the common cold, there have been several dangerous variants. The Severe Acute Respiratory Syndrome coronavirus, better known as SARS-CoV, killed 774 people in 2003, and the Middle Eastern Respiratory Syndrome coronavirus, MERS-CoV, has a mortality rate of 35%.

So far, the primary method used to halt the spread of this disease has been active containment. China, situated as it is at the epicentre of the outbreak, reacted aggressively, locking down entire cities to prevent the disease from travelling. In Europe and elsewhere, people were advised to work from home and avoid gathering in public, while conferences around the world were cancelled and employees advised not to travel overseas unless absolutely necessary.

These measures have had some success in slowing the spread in and from China but were never going to halt disease transmission completely. Today, the virus has spread throughout the world and if any country is presently not affected by the disease, health officials are saying that it is probably just a matter of time before it will be. And while there is every chance that the spread of the virus will peak and then die down, if we can develop an effective vaccine that halts the disease in its tracks, everyone will breathe easier.

The trouble with vaccine development is that it is expensive, fraught with financial risk and opportunity cost for the pharmaceutical industry. A single vaccine could cost over a billion dollars to develop, which is why only one that is routinely administered to large segments of a population is ever going to be financially viable. Vaccines for infectious diseases of the kind that are critical for epidemic and pandemic preparedness are the most risky class of vaccines to invest in. They have to be produced in advance, even though there is no immediate market for their use. What’s worse, they have to be produced in large volumes so that when the need arises, they are available in sufficient quantities to prove useful.

Vaccines have longer development lead times than ordinary drugs since they have more stringent approval processes. Unlike ordinary drugs, they have to be administered to healthy people, which means that the margin of safety has to be high. As the later stages of vaccine trials involve field studies, the logistical challenges of refrigeration and transport often complicate the approval process.

In emergencies such as this one, the delay that a heavy regulatory burden imposes on the availability of viable vaccines could have serious consequences. In 2009, though we had developed a vaccine for the H1N1 virus, by the time it was manufactured and delivered, the peak of viral activity had passed. In situations where the rapid deployment of a viable vaccine is our only hope of slowing down a global pandemic, we need to have alternative methods to develop solutions.

Pharmaceutical companies have been working on developing platform technologies for vaccines that could significantly accelerate the developmental cycle. Simply put, a [[platform vaccine]] is a system that uses certain basic components as the backbone but which can be adapted relatively quickly —by inserting new genetic or protein sequences—so that it can be used against different pathogens. Because of this flexible design, these platforms can be set up for rapid use against novel pathogens. Since they can be used for both emerging as well as routine infectious diseases, they have the welcome side effect of also being a means by which pharmaceutical companies can achieve economies of scale, thereby lowering commercial risk.

The problem is that under the current legal regime, regulators are set up to approve products, not platforms. They currently only know how to evaluate vaccines that are intended for human use and simply do not have the tools with which to evaluate the efficacy of products developed using platform technologies. Regulators need to better understand how these platforms work and get comfortable with letting manufacturer reference prior approvals inherent in these platforms as a means to accelerate the approval of a final product. For instance, when the platform is a cell line that allows viral proteins to be expressed, it could be prequalified by the regulator so that the time- consuming steps that are necessary for regulatory approvals do not have to be repeated each time that cell line is used in other vaccines.

It will take time for regulators to gain sufficient experience with vaccines manufactured using platform technologies. But once they do, pharmaceutical companies will be able to move vaccines developed to combat epidemics rapidly through several stages of the mandatory clinical trials.

This might be too late for Covid–19, but at least we will be better prepared for the next pandemic.