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Wednesday, November 25, 2020

ANALYSIS/OPINION:

The race for a vaccine will continue at “warp speed” — but it’s not an individual sprint, it’s a relay race. 

The baton will shortly be passed to distribution logistics and patient compliance by citizen-patients. If the Pfizer/BioNTech and/or Moderna vaccines get an Emergency Use Authorization (EUA) before the end of November, that means we can begin inoculating health care and other essential workers even before we’re done with the Thanksgiving leftovers. 


This is crucial as the COVID-19 infection rate and the exposure for health care professionals, public safety officials, public transportation employees, teachers and other high-priority sectors increases.

We’ll likely see data (hopefully positive!) from AstraZeneca before the end of the year, too. It will be interesting to see if any of these programs produce robust data for specific subpopulations (children, senior citizens, “at risk” groups such as people with respiratory and heart conditions, etc.). Choices for specific cohorts are crucial.

It will also be interesting to see how far away we are from “next generation” single-dose vaccines. This would greatly assist in patient compliance. Innovation will be incremental — but that doesn’t make it any less important.

Ninety-percent-plus effectiveness for any vaccine is amazing — for COVID-19 it is a game-changer. Not only does this mean we can charge hard toward real herd immunity, it also means we have a good chance of achieving it sooner rather than later. 

But we need to convince the 40% of Americans who say they will not be vaccinated to become part of the solution. A vaccine with a 90% effectiveness rate together with a new man in the White House will certainly help convince Americans to do the right thing. Job one for President-elect Joe Biden is to convince a divided nation that getting vaccinated is their personal responsibility and patriotic duty. A relay race is won by the team with the strongest anchor leg. And the final lap is getting Americans inoculated. All Americans.

The election of Joe Biden should help those who doubt the safety and effectiveness of a “Trump Vaccine.” The president-elect and vice president-elect should roll up their sleeves and insist on being the first two people vaccinated. Optics are important. Now that the election is over, we all need to be cheerleaders rather than critics.

The president-elect’s COVID-19 task force should include a public education campaign on the importance, urgency and safety of getting vaccinated for not just COVID-19 but also the annual flu. Mr. Biden should specifically identify a task force member to lead this educational effort. How about Vice President-Elect Kamala Harris? Having a vaccine that no one uses would be a disaster. This is a teaching moment for Team Biden — literally.    

An initial Emergency Use Authorization is important and exciting. It marks a turn from the end of the beginning to the beginning of the end. But we’re not there yet. If the Pfizer/BioNTech and Moderna data trends hold true, full approval for their vaccine could yet be granted this year — a wonderful holiday gift.

But there are still significant hurdles to achieve full access for all Americans, specifically the logistics of getting the right amount of doses to hospitals and doctors’ offices all across the nation. This isn’t as simple as loading up planes, trains and trucks.

It will also require sophisticated refrigeration technology both en route and at the various points of dispensation. Many small-town physicians, pharmacies and regional hospitals do not have these essential capabilities. These are soluble problems. Just as we reinvented ventilator technology, so too can we solve the vaccine cold-storage question.

As we prepare for the annual viewing of “It’s a Wonderful Life,” we mustn’t forget the tens of millions of citizens who live in the thousands of Seneca Falls-size towns across America. Easy access to a safe and effective COVID-19 vaccine is on the horizon but there remain hidden shoals and rough seas ahead.

• Peter J. Pitts, a former FDA Associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris Descartes School of Medicine.


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