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New Coronavirus Vaccine Czar Says Finding One by January Is a ‘Credible’ Goal Trump Vows Vaccine by End of Year, and Mobilizes Military to Help
(about 8 hours later)
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. President Trump doubled down on Friday on his promise to have a coronavirus vaccine available by the end of this year, betting that he can rally the pharmaceutical industry and the government to have one available to nearly all Americans at a speed never before accomplished.
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 S. Fauci as necessary for developing the vaccine, which President Trump has rejected, would still outpace what many scientists believe is possible. He made his pledge after the government’s senior medical leadership warned repeatedly this week that there was no assurance a safe vaccine would be available as fast as promised by the president, or even for years.
“Frankly, 12-18 months is already a very aggressive timeline,” Mr. Slaoui said. “I don’t think Dr. Fauci was wrong.” And the president’s credibility on the issue has been clouded by months of overpromising, exaggerating and misleading about other elements of his response to the pandemic, including the availability of testing and the potential of unproven treatments.
But Mr. Slaoui said he was undaunted by the president’s goal. With the nation emerging from two months of lockdown, the economy in near-Depression-level crisis and his re-election prospects at stake, Mr. Trump cast the rapid development of a vaccine as an important, but not essential, component of returning to normalcy.
“I would not have committed unless I thought it was achievable,” Mr. Slaoui said, adding that he told the president that when he met with him for the first time on Wednesday at the White House and Mr. Trump asked if the goal was realistic. “Vaccine or no vaccine, we’re back and we’re starting the process,” he said during an appearance in the Rose Garden.
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. He introduced a longtime pharmaceutical executive and a four-star general to lead a national effort that he compared in size and speed to the Manhattan Project, the race 75 years ago to build the first atomic bomb.
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. The new chief of what Mr. Trump calls Operation Warp Speed, Moncef Slaoui, a former chairman of vaccines at GlaxoSmithKline, called Mr. Trump’s goal “very credible,” even though the fastest a new vaccine has been developed and distributed is four years and most have taken considerably longer.
Mr. 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. Dr. Slaoui, now a venture capitalist, said that he had “recently seen early data from a clinical trial with a coronavirus vaccine, and these data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine” — enough to inoculate much of the United States — “by the end of 2020.”
Their appointments will be formally announced at the White House on Friday. He did not identify which vaccine he was referring to, but until Friday, when he resigned to take on the new job with the White House, Dr. Slaoui served on the board of Moderna, a biotechnology company that has an experimental coronavirus vaccine that just entered Phase 2 of clinical trials to determine if it is effective.
Mr. Slaoui and Gen. Perna met for the first time on 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 M. Azar II, helped devise the program at Mr. Trump’s request. As the chairman of the Moderna board’s product development committee, Dr. Slaoui might have been privy to the early indications of tests of whether the company’s approach appeared promising, now that it is being injected into human subjects.
Mr. Trump said the government was already moving to ensure sufficient manufacturing capacity to produce any vaccine that is developed and to produce the hundreds of millions of glass vials and syringes needed to hold and inject it. And he said the government would call on the military’s logistics skills to distribute any eventual vaccine as quickly as possible.
“That means they better come up with a good vaccine, because we are ready to deliver it,” he said. “This will eliminate any unnecessary delay and enable us to begin providing Americans with a proven vaccine the day our scientists say, ‘We are ready, we’ve got it.’”
Mr. Trump, who during the 2016 campaign repeatedly questioned the use of vaccines, also seemed to acknowledge for the first time that the antivaccine movement could hamper the effort to fully immunize the United States against the coronavirus.
“We are looking for a full vaccine for everyone that wants to get it,” he said when pressed on the timing and whether it would be available by January to all Americans or only to those judged to need it on an emergency basis. “Not everybody’s going to want to get it.”
The president also insisted that even if the United States did not win the race for a vaccine — Chinese and British entries are also in clinical trials — he believed the world would set aside profits and nationalistic instincts to share the most successful approach.
“We have no ego,’’ said Mr. Trump, who only two months ago tried to persuade a German firm to move its vaccine research to the United States. “Whoever gets it, we think it’s great and we’re going to work with them and they are going to work with us.”
Even China would share its findings, he said with confidence — though if China’s vaccine effort advances, its Phase 2 clinical trials will almost certainly take place inside China. Similarly, the United States would most likely prioritize initial distribution to its own citizens, as suggested by Mr. Trump’s reference to the military’s role.
President Emanuel Macron of France said this week that he would call in executives of Sanofi, a major pharmaceutical firm, after its chief executive told Bloomberg News that the United States “has the right to the largest preorder because it’s invested in taking the risk” on new vaccines.
In an interview, Dr. Slaoui called having a safe and effective vaccine in widespread distribution within 12 to 18 months of when work started at the beginning of the year to be “a very aggressive timeline” but said he was undaunted by Mr. Trump’s goal.
“I would not have committed unless I thought it was achievable,” Mr. Slaoui said on Thursday, adding that he told the president that when they met for the first time a day earlier and Mr. Trump asked if the goal was realistic.
Mr. Slaoui will serve as the chief adviser on the effort, and Gen. Gustave F. Perna, a four-star general who is in charge the Army Matériel Command, will be the chief operating officer.
Mr. 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.Mr. 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.
General Perna, who runs the Army’s complex supply chain, said that he was asked by Gen. Mark Milley, the 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. General Perna, who runs the Army’s complex supply chain, said that he was asked by Gen. Mark A. Milley, the 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. Mr. Slaoui and General Perna met for the first time on 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 M. Azar II, helped develop Operation Warp Speed at the president’s request.
Most questions about how the program will work remain unanswered, including its cost, 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 initial doses.
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.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.” “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 University 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 M. Hahn, the commissioner of the Food and Drug Administration, said at a Senate hearing on 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. Dr. Slaoui said that the goal will be to get “three or four” vaccines to large, late-stage trials, called Phase 3.
Dr. Stephen Hahn, the 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. Mr. 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 the one being pursued by Moderna. Dr. Anthony S. Fauci, the government’s top epidemiologist, told lawmakers on Tuesday that his institute, the National Institute of Allergy and Infectious Diseases, was heavily involved in the Moderna project.
Several experimental vaccines are already being tested in humans, including one that Dr. Fauci told lawmakers on Tuesday his institute, the National Institute of Allergy and Infectious Diseases, was heavily involved in, made by the 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, producing one for hundreds of millions of people in the United States alone will be daunting.
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 H. Barouch, the 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.”
“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, the 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 the hope that it will facilitate fast distribution of a vaccine if one is deemed successful.
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,” Dr. Slaoui said.
“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,” Mr. Slaoui said.
General Perna said he had been preparing to retire on July 1 after 37 years of active duty, but agreed to be part of the effort and echoed Mr. Trump in describing what he saw as his mission.General Perna said he had been preparing to retire on July 1 after 37 years of active duty, but agreed to be part of the effort and echoed Mr. 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.“I believe that we’re at war with this virus, and when you’re at war, then you have to win,” he said.
But Dr. Adalja said that for a vaccine to be ready by January, “everything would have to go perfect.”But Dr. 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.”“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.”
Mr. 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 Mr. Slaoui’s past work arose almost immediately after he was announced as the lead of the Warp Speed project. Mr. 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.
Mr. Slaoui said that he had informed Moderna that he planned to retire from its board, and suggested that he was divesting his equity.