The Best and the Worst on Display in Vaccine Effort

Looking back on 2020, I can’t help but think about the words of Charles Dickens in 1859 and how apt they are today.

It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair…

It is hard to believe that one year ago, only those on the bleeding edge were aware of or too concerned about the imminent global COVID-19 pandemic. I admit I was completely unaware at the time and certainly could never have imagined the ensuing devastation that would unfold or how it would change every aspect of our lives. Quarantining, masking, and social distancing were our only weapons initially. Workplaces shut down and unemployment skyrocketed.

Barbara Ryan

The economy was instantly shocked into an unprecedented recession in the first quarter of last year, which was followed by an equally unprecedented V-shaped recovery beginning in May borne from an aggressive economic stimulus package. The best and the worst.

Suddenly, all paths to a recovery in the economy—and life as we knew it—were dependent on the biopharma industry for therapeutics and vaccines. So, biopharma stepped up did what it does best, it focused on innovation and got busy rapidly pivoting pipelines to advance drugs and vaccines to fight this global pandemic. All eyes were on our industry, and while the healthcare system was challenged to the core, innovations continued and were rewarded.

• A record 53 new drugs were approved by FDA last year.
• A sign of the maturing of the biotech industry, half of these represent first-time approvals for the companies who received them, which means over 25 will launch their first drug this year.
• A record $100 billion in new capital went into biopharma in 2020.
• It was a record year for IPOs.
• The biotech sector, particularly the IPOs, massively outperformed the markets.

Over the last 25 years, there have been seven novel vaccines developed, four of these came from Merck. The fastest pace from start to finish was four years, also a feat accomplished by Merck with the approval of a mumps vaccine.

This is hard stuff!! Yet, here is where we are: five vaccines have moved into Phase III clinical trials already and two are authorized, two are completing Phase III, and one may be approved imminently. One other is in Phase IIb and over 100 are in development. This is absolutely incredible.

Again, the best and the worst.

But it should not come as a surprise that there are failures as well, the largest of which is the lack of adequate supply and the disjointed and fractured distribution system, which lacks any uniformity state to state or country to country.

Further, we lack the resources to get vaccines into arms, once, let alone twice to meet the labeled dosing for the current vaccines. There is quite simply not enough idle manufacturing capacity to supply the demand.

COVID is costing the US economy $23 billion a day, when investing $500 million a year in pandemic preparedness efforts would have been paltry in comparison. Sadly, politics appear to make it impossible for our national government make the tough choices and take the long view.

Operation Warp Speed was a visionary plan that brought together science, government, the military, and the private sector— and it accomplished its goal of developing vaccines, getting them manufactured and distributed with near-perfect precision. Of course, this is, unfortunately, being politicized. A runaway success from the perspective of getting started developing vaccines and getting them authorized, Warp Speed has been thrown to the curb and will be renamed. Of course, the goal of developing vaccines is to get people immunized, and at the moment that is failing. UK vaccine ministers are warning of the “dead end of vaccine nationalism” following a shortfall in supply from AstraZeneca. The best and the worst.

The downside of the speed with which the vaccines were developed is we have no idea what the persistency of the immunity of a vaccine is, since we don’t have the time-tested experience. Sadly, even after getting vaccines into arms, the persistency of protection is unknown and there are mutations popping up all around the world. Looks like our first weapons of defense—quarantining, masks, and social distancing—will be around for a while.

Barbara Ryan is Founder, Barbara Ryan Advisors, and a member of Pharm Exec’s Editorial Advisory Board