COVID vaccines will deliver long-term health boost for drugmakers

Vaccine development was once the ultimate long-distance race for drugmakers. In the pandemic, the industry showed it can run a sprint when needed.

It is hard to overstate the role drugmakers, working in tandem with the federal government, played in bringing the pandemic to heel in the U.S. Regulators authorized several vaccines for emergency use just over a year from when the virus was first discovered. To date, more than 320 million doses have been administered in the U.S., and serious side effects have been rare. Regulators have been able to perform their normal duties like policing safety issues and manufacturing hiccups without slowing down the rollout.

Before the pandemic, such a development timeline was unthinkable. In the eyes of regulators, safety issues with a vaccine are far more worrisome than for most drug classes since vaccines are typically meant for a broad population. As such, long development timelines are the norm. It isn’t unusual for a new vaccine to take a full decade to reach the market.

But the industry’s recent success challenges that reality. Taxpayers certainly got a return on their investment: In addition to saving untold lives, the speedy development helped revive left-for-dead industries like travel and hospitality. And the vaccine developers have rightly become Wall Street darlings for their trouble. For example, Moderna said last month it expects to book at least $19.2 billion in vaccine sales this year; its market value has reached $88 billion. Such results are hard to ignore. What is more, there is reason to hope that messenger-RNA vaccine technology like that used in Moderna’s and Pfizer’s Covid-19 vaccines can be effective against other serious diseases.

To be sure, the Covid-19 success required unprecedented financial might and collaboration. The U.S. government provided billions of dollars in funding that allowed clinical trials to be organized and conducted more quickly than ever by smaller biotechs with relatively limited resources. Large academic centers like Oxford University worked hand in hand with the drug industry.

Because the pandemic made patients skittish about visiting healthcare facilities, regulators relaxed policies on issues like remote data collection in clinical trials. Even rival drugmakers collaborated with each other to speed up manufacturing.

“It was like repairing the airplane while you’re flying,” said Ron Cohen, former head of the industry trade group Biotechnology Innovation Organization and chief executive of Acorda Therapeutics.

Given that extraordinary effort, it seems unlikely that future vaccines will be developed this quickly in a non-emergency setting. Still, necessity is the mother of invention; companies, investors, regulators and the general public have discovered what can be accomplished.

The experience is bound to have concrete effects on future drug-approval policy. For instance, the law governing how the FDA handles drug approvals is due to expire in September of 2022. While the reauthorization will be a product of always-messy negotiations on Capitol Hill, it wouldn’t be surprising if it provided more resources to regulators, coupled with a mandate to review applications for new drugs more quickly in the future.

The drug industry has long pushed for more flexible regulation. The pandemic response showed that isn’t merely an empty talking point. Live Mint