The Trump administration is willing to use wartime powers to ramp up coronavirus vaccine production to meet the president’s target of 100 million doses by the fall, according to his health secretary, despite scientific skepticism that such an ambitious goal is possible.
“Operation Warp Speed” has identified 14 possible vaccines for development.
Secretary of Health and Human Services Alex Azar said the federal government was ready to mobilize resources and trigger massive production, including using the Defense Production Act, even before human trials have been completed.
“We’ll use all tools that are needed,” he said. “We have substantial manufacturing capacity for biologic production here in the United States, but if we need to, we are going to add [to that], and if we need to, we will use the Defense Production Act.”
The aim is to compress a timeline that typically takes more than a decade into less than a year.
In a briefing on Tuesday, members of the White House coronavirus task force said the effort involved an international collaboration between governments and pharmaceutical companies, plus a streamlined approach to clinical trials and accelerated regulatory approval.
Their goal, set by Trump, is for 100 million doses in the fall, rising to 300 million by January.
Seasoned vaccine researchers welcome the approach but are doubtful such an ambitious target can be met.
With a high attrition rate (more than 90% of tested vaccines fail to reach the market), it makes sense to develop multiple candidates and to begin mass manufacture before human trials are complete, said Dr. Peter Hotez, an expert on infectious disease at Baylor College of Medicine where he is working on a COVID-19 vaccine.
“The problem is, while doing all those good things to accelerate things, you still have to accumulate enough data in humans that the vaccines actually work and that they are safe,” he said. “And I don’t see how you accumulate that data by the end of the year.”
Emergency authorizations for coronavirus tests or therapies, he added, raised different questions than vaccines raise. The former are noninvasive or given to patients who are already sick, whereas immunizations are deployed among healthy populations.
“With a vaccine, where you inject something into a healthy person to prevent them from getting sick, you don’t want an emergency use authorization out there for something you don’t know is safe and effective,” he said.
Clinical trials are already underway in the U.S., Europe, and China amid a global race to end the pandemic. Public health experts believe an effective vaccine is the best way to protect against future waves of infection without a return to the social distancing that has ravaged the economy.
Hundreds of millions of doses would be needed to provide the necessary levels of immunity.
Speeding up the development process will include using a common trial platform for multiple candidates, comparing the results of different vaccines with a single control group, said Azar after a meeting of the White House coronavirus task force.
He added that the most complex part of the process would be scaling up manufacture. That will be accelerated by the government funding production even before conclusive proof of efficacy.
“We will go at risk and fund the production of hundreds of millions of doses of vaccines, so if we get hits or multiple hits, we are ready to use the vaccine right away instead of the traditional delays,” he said.
Vice President Mike Pence said an “efficacy waiver” could be applied if a clear data signal indicated success before the conclusion of phase three clinical testing, speeding up regulatory approval.
But he admitted that early manufacture could produce millions of unusable doses.
“We’re going to go ahead and start manufacturing now, and we’re going to pay for that even if we get to the end and there’s 50 million doses that actually don’t work,” he said.
