Former pharmaceutical exec: What you should know about the race for a vaccine

As the world sets new watermarks daily in the number of coronavirus cases, the search for a vaccine becomes more critical than ever. Desperate times often lead to premature statements, and that has definitely been the case here, with projections about the certainty and immediate availability of a vaccine that frequently sound more like wishes than statements of fact.

As someone who led global manufacturing for one of the world’s largest pharmaceutical firms, I understand the intense feelings around development of a vaccine. I also know the complex factors of vaccine development and what must take place for a successful vaccine candidate to make it through the rigorous challenges of safety and efficacy testing and move into the marketplace.

I write this not to slow our haste to get this done, but to offer a clear-eyed look at what must happen to get there.Everyone should be rooting for the development of a safe, effective vaccine. But we must follow the science and ensure that at the end of the process, we not only have a vaccine that has been thoroughly proven, but one in which the public has confidence.

The road toward a successful vaccine is challenging under any circumstance, which is perhaps why only seven entirely new vaccines have been developed for all diseases in the past 25 years. Vaccines typically take eight to 15 years to develop, trial and approve. It’s a complex, expensive and in many ways sequential process, with one step necessarily following completion of another.

The Ebola vaccine was developed in a somewhat abbreviated time frame – a little less than five years. But it had the advantage of multiple partners in its development, including several universities, a small private company and Merck, where I worked as president of global manufacturing. That helped it become the exception to the rule in terms of length of time from start to finish, and yet, still – five years.

From a purely economic standpoint, development of such a vaccine is daunting. It requires deep investments of money, staffing and time, yet is not often as financially rewarding as therapies for chronic conditions. An individual might take a blood pressure medication daily for many years, for instance, but only one to three doses of a vaccine may be needed to ensure lifelong immunity.

Globally, we have known about COVID-19 for about a year, with some indications that it may have begun emerging as early as September or October of 2019. The virus’ genome was successfully sequenced in January. Research has really only been underway among United States pharmaceutical firms since then. In the normal life of vaccine development, the blink of an eye.

Yet, there are some dynamics that could work in our favor. Some of the best vaccine candidates are being developed using a new RNA platform that allows for a faster process that could dramatically shorten time to get to the marketplace, while maintaining safety and ensuring efficacy. The challenge is that this is the very first time that process has been used. For it to result in a successful vaccine sometime in the next few months would require that it works exactly as it should and that there are no stumbles along the way – the pharmaceutical equivalent of “running the table” in pool.

Still, safety and efficacy must be our top priorities. Rushing a vaccine to market without tending to those fundamental tasks would ensure not only widespread perception that politics, not science, earned it the green light, but that the public greets the drug with deep skepticism. In such a scenario, who would want to take the vaccine?

Once all of the above has been properly tended to, the challenge of manufacturing massive amounts of the vaccine remains. For a single-dose vaccine, at least 7.5 billion doses will be required. For a two-dose vaccine, at least 15 billion doses.

So, when you hear that a COVID-19 vaccine is just around the corner, expected to be available momentarily, listen with hope, but listen critically. Vaccine development is an extraordinarily challenging endeavor – one that ought to get every dollar and hour of support that we can give it, but deeply challenging, nonetheless.

Here’s to the researchers and scientists, pharmaceutical industry leaders, FDA leaders, trial subjects and others working around the clock to produce the result we all need. So much depends on them getting it right, and with their incredible knowledge, skills and resources – and perhaps a little bit of luck – they will.

This story was originally published October 19, 2020 at 12:00 AM.