In the U.S. government’s race to create an effective COVID-19 vaccine, there are more than American lives at stake — so are billions of taxpayers’ dollars.
The program, called Operation Warp Speed, is a partnership between the Department of Health and Human Services and the Department of Defense. It aims to inoculate 300 million Americans against the coronavirus by next spring, an effort that dramatically condenses the usual vaccine production timeline, which can ordinarily take five to ten years.
The U.S. government has already poured billions of dollars into Operation Warp Speed. Gen. Gus Perna, an Army supply officer now leading the project, estimates he has spent $12 billion so far and projects that sum may climb to as much as $26 billion by the time vaccines are distributed.
But with no vaccine contenders having yet received FDA approval, that total in taxpayer funds is ultimately a gamble.
“If the vaccines that we’re producing ultimately aren’t approved for use in the population by the FDA, they will be discarded,” said Sean Kirk, the executive vice president of manufacturing and technical operations for Emergent BioSolutions. “That has been the financial risk associated with this endeavor from the beginning.”
Kirk’s company has already begun manufacturing large quantities of vaccines, a step they would ordinarily not take because of the financial implications of failure. But in this instance, it is more than his company’s money on the line.
“It’s taxpayer money,” Kirk said. “It’s money that’s being leveraged to de-risk the availability of doses, should these product candidates navigate the safety and efficacy clinical trials successfully.”
Kirk said his company is dedicated to safety in manufacturing of the vaccine. He is confident risk does not come from the speed in which his company is progressing—only the financial implications if the vaccine does not meet FDA approval.
“It would be an unfortunate situation,” Kirk said. “But if you’re going to shave months off of vaccine availability, then it’s a financial risk worth taking.”
THE NEED FOR FOREIGN EXPERTISE
Operation Warp Speed and foreign talent
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In addition to the financial assistance the U.S. government is providing companies to manufacture an effective vaccine, it is also helping open borders to overseas help — including securing visas for foreign expertise.
Operation Warp Speed backs biotech and pharmaceutical companies, which are rushing to manufacture and successfully complete trials for vaccines that meet approval by the Food and Drug Administration. According to Kirk, that includes expediting foreign assistance.
“Operation Warp Speed has certainly been invaluable in ensuring that we get access to the materials and that they open up the borders as appropriate to get labor — experts, for example, in engineering or equipment installation and qualification — or materials through to us,” he said.
Foreign labor requires a visa, and Kirk said the government coordinates the visas when biotech and pharmaceutical companies request particular expertise.
The vaccine effort comes at a time when the Trump administration has restricted an employment-based visa program that allows highly skilled foreign workers to come to the United States. Last month, the administration announced new regulations on H-1B visas, which are intended for foreign workers with highly specialized knowledge or skills.
It was the second time this year the administration had restricted the visas. Citing high unemployment resulting from the coronavirus pandemic, the president in June signed a proclamation limiting H-1B visas, among several others, through the end of the year. The proclamation made an exception for anyone “whose entry would be in the national interest.”
According to a State Department official, enabling travel by skilled foreign workers has been a focus in the effort to combat the coronavirus.
“Throughout the pandemic, the Department of State has prioritized visas and travel facilitation for medical professionals, researchers, and anyone positively contributing to the eradication of COVID-19,” the official told 60 Minutes.
The videos above were produced by Will Croxton and Brit McCandless Farmer. They were edited by Will Croxton.