MedPage Today, 11.09.2020

As drug companies and the U.S. government scramble to develop a COVID-19 vaccine, experts on vaccine production and distribution questioned whether a vaccine could be in public hands by the end of the year and dismissed the idea that it could be ready before the Nov. 3 general election, which President Trump has openly championed.

Federal health officials, at the FDA and elsewhere, have all promised not to let politics dictate authorization or approval of a vaccine, but they’ve also been careful not to rule out a decision before the election.

As drug companies and the U.S. government scramble to develop a COVID-19 vaccine, experts on vaccine production and distribution questioned whether a vaccine could be in public hands by the end of the year and dismissed the idea that it could be ready before the Nov. 3 general election, which President Trump has openly championed.

Federal health officials, at the FDA and elsewhere, have all promised not to let politics dictate authorization or approval of a vaccine, but they’ve also been careful not to rule out a decision before the election.

“There’s lots of agendas at play here, not just public good,” said Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.

“It’s extremely optimistic to think you will be able to deploy a vaccine by the election or even by the end of the year,” he added. “Deployment fully will be at least another year.”

Bar-Zeev and other experts detailed production and distribution cycles. Research challenges aside, they cited many obstacles to meeting the time frame offered by the Trump administration’s Operation Warp Speed.

“You need to do things sequentially,” said Paul Offit, MD, who directs the Vaccine Education Center at Children’s Hospital of Philadelphia.

Manufacturing and Distribution Challenges

Once the trials theoretically yield results demonstrating a vaccine’s efficacy and safety, experts said manufacturing doses should be the easiest part of the whole process. Investments in production capacity have substantially increased, Bar-Zeev said, and RNA vaccines especially are easier to replicate reliably. He estimates doses will be available for 20% of the global population by the end of next year and the U.S. will have a large amount of doses by then. Several manufacturers have promised to have hundreds of millions of doses ready in 2020 alone.