Experts on lessons from COVID: Improve manufacturing, distribution and regulation

Asked what this pandemic taught us that will help us prepare for the next one, a panel of experts mentioned the need to improve manufacturing, distribution and global harmonization of vaccine regulation—and the need to appreciate how much we did right.

Today’s panel on “Stopping the Next Pandemic Before it Starts: What We’ve Learned” at the BIO International Convention, moderated by Anjalee Khemlani, Senior Reporter, Yahoo Finance, looked at challenges from the perspective of business, government and global initiatives. It opened with a presentation from Rasmus Bech Hansen, CEO of AirFinity, a global health intelligence company, who gave data on the current state of the pandemic.

“How do we prevent the next pandemic? I think there’s a pretty easy answer to that. Let’s deal with the current one,” Hansen said, before sharing statistics about weaknesses in distribution efforts, responses to variants and testing. He noted that we wasted two months at the beginning of COVID-19 in deciding whether, and how, to react and also said the current drop-off in testing worldwide is concerning. Nonetheless he maintained that we responded well, given the circumstances, a theme repeated by other panelists.

““Let’s make one thing clear: What was accomplished in this pandemic was one of the most unbelievable things that people have witnessed,” said John Trizzino, Chief Commercial Officer and Chief Business Officer of Novavax, the session sponsor.

Regulators need to work together

Regarding areas for improvement, Trizzino mentioned the challenge of poor harmonization of regulatory authorities. This was a key challenge discussed by Emma Wheatley, Director, Access and Private Partnerships, Coalition for Epidemic Preparedness Innovations (CEPI).

Wheatley said the European Medicines Agency (EMA) coordination with the WHO was helpful and something the FDA could have joined. She also noted that the FDA and EMA were forced to carry a lot of the regulatory burden because they had the capacity. The solution, she said is to develop more robust regulatory capacity worldwide, and then harmonize all the authorities, to allow faster approval.

Regarding distribution of vaccines Colonel (Ret.) Matthew Hepburn, Department of Defense Countermeasures Accelerate Group spoke of the challenges of getting public acceptance of the vaccines as posing the greatest barrier.

All the panelists said the challenges of manufacturing were to overcome an amazing task of scaling up, and that we must acknowledge the remarkable feats accomplished.

Hepburn noted that Operation Warp Speed helped facilitate manufacturing, but not by rushing clinical trials or taking a safety risk. “The risk was financial,” he said, explaining that the U.S. government paid for companies to begin manufacturing before FDA authorization and took the risk that the manufactured vaccines would have to be thrown out if authorization did not come.

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