The former pharmaceutical executive picked this week to lead a crash program to develop a coronavirus vaccine said Thursday that developing and mass-producing a successful vaccine by January 2021 is a “credible objective” but acknowledged it would be difficult.
Moncef Slaoui, a former chairman of vaccines at GlaxoSmithKline, who is heading the program, conceded in an interview that even the time frame repeatedly cited by Dr. Anthony Fauci as necessary for developing the vaccine, which President Donald Trump has rejected, would still outpace what many scientists believe is possible.
“Frankly, 12-18 months is already a very aggressive timeline,” Slaoui said. “I don’t think Dr. Fauci was wrong.”
But Slaoui said he was undaunted by the president’s goal.
“I would not have committed unless I thought it was achievable,” Slaoui said, adding that he told the president that when he met with him for the first time Wednesday at the White House and Trump asked if the goal was realistic.
The president announced the effort, which he called Operation Warp Speed, with the goal of having 300 million doses of a vaccine available by January, a number that would likely be needed to halt the spread of the pathogen, an unheard-of timeline to develop, test and produce a vaccine on such a scale.
The Warp Speed project has been described by administration officials as an organizing mechanism for an already fierce race to find a vaccine, one that involves big pharmaceutical and biotechnology companies and a handful of government agencies.
Slaoui will serve as the chief adviser on the effort, and Gen. Gustave F. Perna, a four-star general who is in charge of the Army’s readiness as head of the Army Matériel Command, will be the chief operating officer.
Their appointments will be formally announced at the White House on Friday.
Slaoui and Perna met for the first time Wednesday, and they have been in frequent contact since then, the general said in a separate interview. They will have offices in the Department of Health and Human Services, where the secretary, Alex Azar, helped devise the program at Trump’s request.
Slaoui said he discussed the job with Jared Kushner, the president’s son-in-law and senior adviser, who had been searching for a so-called czar for therapeutics and vaccine development, and Dr. Deborah L. Birx, the White House’s coronavirus response coordinator.
Perna, who runs the Army’s complex supply chain, said that he was asked by Gen. Mark Milley, chairman of the Joint Chiefs of Staff, to help run the manufacturing logistics related to the vaccine development. Beyond the vaccine itself, there are also substantial challenges in ensuring adequate capacity of the supplies needed to distribute and administer it, starting with the special glass in which vaccine doses are transported.
Most questions about how the program will work remain unanswered, including the cost of it, whether the Defense Production Act will be used to impel companies to produce a vaccine developed by a different firm or whether particular groups may get access to the initial doses of a vaccine.
But public health experts said that the program was perhaps the only way to keep the United States on a brisk timeline in a health crisis as complex as the coronavirus pandemic.
“There may be no other way to do this other than through the government,” said Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “Vaccine development has been plagued with economic difficulties that have gotten vaccine manufacturers out of the business.”
The Warp Speed project is only the latest effort by the government to develop a vaccine.
Dr. Stephen Hahn, commissioner of the Food and Drug Administration, said at a Senate hearing Tuesday that his agency would evaluate about 10 vaccine candidates in early studies and then select four or five to progress into larger studies in humans. Slaoui said that the goal will be to get “three or four” vaccines to large, late-stage trials, called Phase 3.
Several experimental vaccines are already being tested in humans, including one that Fauci told lawmakers Tuesday his institute, the National Institute of Allergy and Infectious Diseases, was heavily involved in, made by biotechnology company Moderna.
Scientists hope that several of the vaccines will be successful and for different parts of the population. But even if a vaccine candidate shows promise this year, it may not be easily produced for many Americans.
“If there’s only a small amount of vaccine, a million or 100,000 doses, there will be very difficult decisions about who gets the vaccine first,” said Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a professor at Harvard Medical School who is also working with Johnson & Johnson on its coronavirus vaccine. “Is it high-risk people, different racial groups, different socioeconomic groups? Those discussions will be difficult.”
The Pentagon will be heavily involved in the Warp Speed effort, in hopes that it will facilitate fast distribution of a vaccine if one is deemed successful.
“The Department of Defense is going to be putting resources that are unheard-of in any industry setting, in any private company setting, behind the process, development, and manufacturing and distribution of the vaccine,” Slaoui said.
Perna said he had been preparing to retire July 1 after 37 years of active duty but agreed to be part of the effort and echoed Trump in describing what he saw as his mission.
“I believe that we’re at war with this virus, and when you’re at war, then you have to win,” he said.
But Adalja said that for a vaccine to be ready by January, “everything would have to go perfect.”
“Vaccine development doesn’t always go as predicted,” he said. “There are a lot of hiccups in the production process. We’re going faster than we ever have with a vaccine, but we have to be prepared for things to slow down once we get further along.”
Slaoui, who has been a venture capitalist since leaving GlaxoSmithKline in 2017, worked for 30 years at the company, helping lead the development of dozens of vaccines. He has a doctorate in molecular biology and immunology and studied at Harvard Medical School and Tufts University School of Medicine in Boston.
Questions about potential conflicts of interest involving Slaoui’s past work arose almost immediately after he was announced as the lead of the Warp Speed project. Slaoui sat on the board of Moderna, a public company working on developing a coronavirus vaccine. And GlaxoSmithKline is working with Sanofi, another company developing a vaccine.
Slaoui said that he had informed Moderna that he planned to retire from its board and suggested that he was divesting his equity.