Trump Narrows Search for Coronavirus Vaccine to Five Firms – Severskiy (News)

WASHINGTON — The Trump administration has selected five companies as the most likely candidates to produce a vaccine for the coronavirus, senior officials said, a critical step in the White House’s effort to deliver on its promise of being able to start widespread inoculation of Americans by the end of the year.

By winnowing the field in a matter of weeks from a pool of around a dozen companies, the federal government is betting that it can identify the most promising vaccine projects at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in huge quantities and distributed across the country.

The announcement of the decision will be made at the White House in the next few weeks, government officials said. Dr. Anthony S. Fauci, the federal government’s top epidemiologist and director of the National Institute of Allergy and Infectious Diseases, hinted at the coming action on Tuesday when he told a medical seminar that “by the beginning of 2021 we hope to have a couple of hundred million doses.”

The five companies are Moderna, a Massachusetts-based biotechnology firm, which Dr. Fauci said he expected would enter into the final phase of clinical trials next month; the combination of Oxford University and AstraZeneca, on a similar schedule; and three large pharmaceutical companies: Johnson & Johnson, Merck and Pfizer. Each is taking a somewhat different approach.

President Trump has been eager to show rapid progress as the nation slowly emerges from lockdown, and as he faces the growing challenge of winning re-election in the midst of national upheaval: more than 106,000 Americans dead from the virus, unemployment at record levels and now discord and violence in the streets.

Despite promising early results and the administration’s strong interest in nurturing a government-industry partnership, substantial hurdles remain, and many scientists consider Mr. Trump’s goal of having a vaccine widely available by early next year to be optimistic, if not unrealistic. Vaccine development is notoriously difficult and time-consuming; the record is four years, and a decade is not unusual.

Moderna, Johnson & Johnson and the Oxford-AstraZeneca group have already received a total of $2.2 billion in federal funding to support their vaccine programs. Their selection as finalists, along with Merck and Pfizer, will give all five companies access to additional government money, help in running clinical trials and financial and logistical support for a manufacturing base that is being built even before it is clear which if any of the vaccines in development will work.

More funding is likely to be announced soon, officials said. Earlier this week, the Department of Health and Human Services added $628 million to a contract with Emergent BioSolutions, a Maryland firm, to expand development of vaccine manufacturing capacity.

Dr. Fauci, who had been sounding cautionary notes, now sounds more optimistic: Among his concerns, he said during the session run by The Journal of the American Medical Association, is how long immunity triggered by a vaccine might last.

“Vaccines are coming along really well,” Mr. Trump wrote on Twitter on Tuesday, hours before he was scheduled to meet with Alex M. Azar II, the health and human services secretary. “Moving faster than anticipated. Good news ahead.”

The project — called Operation Warp Speed — amounts to a sprawling, on-the-fly experiment in industrial policy by a Republican administration that has been otherwise dedicated to giving private industry a free hand.

Democrats in Congress are already seeking details about the contracts with the companies, many of which are still wrapped in secrecy. They are asking how much Americans will have to pay to be vaccinated and whether the firms, or American taxpayers, will retain the profits and intellectual property.

Other countries, including China, are also rushing their own efforts to produce a vaccine, raising concerns that nationalism rather than need could drive decisions about who first gets inoculated.

Two of the vaccine candidates selected by the Trump administration — developed by Moderna and scientists at Oxford — are already in Phase II trials, meaning their effectiveness is being tested on scores of human subjects.

They will likely shift to large-scale human trials, called Phase III, as early as July, two senior administration officials said.

While Johnson & Johnson has said it would begin Phase I trials by September at the latest, that now appears likely to be sped up considerably, officials said. Phase I focuses on testing for safety, a particularly important factor for vaccines since they are administered widely to healthy people.

Several of the companies said that they did not want to speak ahead of any announcement by the White House, and the others did not respond to requests for a comment. Along with Moderna, Merck, Pfizer and Johnson & Johnson are based in the United States. AstraZeneca is based in Britain.

Under the administration plan, according to officials, around 30,000 people will take part in Phase III trials for each vaccine when they reach that stage. If all five companies reach Phase III trials, around 150,000 people, mostly Americans, would ultimately become the test subjects for a vaccine.

All age groups will be covered, including older people and those with underlying health conditions.

It is possible, officials and corporate executives in several of the firms said, that some of the Phase III trials will be conducted outside of the United States, and may be focused on coronavirus hot spots, where a greater possibility of infection could speed the process of determining the effectiveness of a potential vaccine. The other alternative — deliberately exposing inoculated volunteers to the disease —  is fraught with ethical issues and officials seem reluctant to take that route, even if it might speed results.

The plans are being assembled in an office suite on the seventh floor of the Health and Human Services Department’s headquarters, where two newly appointed leaders of the project, Dr. Moncef Slaoui and Gen. Gustave F. Perna, have set up temporary offices.

Dr. Slaoui comes from the pharmaceutical and venture capital worlds. General Perna heads the Army Materiel Command and is an expert in complex logistics but not medicine.

Their work is monitored by Mr. Azar, Defense Secretary Mark T. Esper and Jared Kushner, the president’s son-in-law. They are coordinating with the senior infectious disease experts on the White House’s coronavirus task force, Dr. Fauci and Dr. Deborah L. Birx, who is overseeing the task force’s day-to-day operations.

Weeks ago, Mr. Trump compared the Warp Speed effort to the Manhattan Project, the government-led program during World War II to develop the atomic bomb. There are superficial similarities: Lives at stake, crushing deadlines, and a combination of civilian and military leadership. (The Manhattan Project was headed by J. Robert Oppenheimer, a theoretical physicist, and Gen. Leslie R. Groves, who oversaw the project to deliver the bomb to its targets in Japan.)

But even some of the president’s top aides say the analogy goes only so far: This effort is an amalgamation of private-industry vaccine projects, with an overlay of military coordination.

One senior administration official said the more appropriate comparison would be Lockheed Martin’s “Skunk Works” program in California, where the company’s most sensitive aircraft projects have been developed and built. Many never left the design stage.

Much of the work at the Warp Speed project involves making sure no surprises slow development.

But Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins University Center for Health Security, said that the administration should “be prepared for things to slow down once we get further along.”

“All of the timelines are optimistic,” he said. “Vaccine development doesn’t always go as predicted. There are a lot of hiccups in the production process.”

Democratic lawmakers on Tuesday wrote to Mr. Azar with concerns about how his department was awarding contracts to the pharmaceutical companies.

Representative James E. Clyburn, Democrat of South Carolina and the chairman of the House’s select committee on the coronavirus, and Representative Carolyn B. Maloney, Democrat of New York and the chairwoman of the Committee on Oversight and Reform, said that they were “seeking to determine whether these contracts include provisions to ensure affordability and prevent profiteering.”

Agreements have included promises from pharmaceutical companies related to intellectual property, the number of doses that will be produced if a candidate is successful and the price of a vaccine, one senior administration official said. But few details have been made public.

Contracts are being awarded through the department’s Biomedical Advanced Research and Development Authority. Congress allocated billions of dollars for vaccine development in various components of the $2 trillion coronavirus relief package.

Senior administration officials said that between new congressional funds and money that can be drawn from appropriations for the federal health agencies, the project will have plenty of funding.

Behind the scenes, the project has undergone upheaval in its leadership.

Dr. Peter Marks, the federal scientist who devised and initially oversaw the project at the Food and Drug Administration, stepped aside from his role as its lead vaccine specialist, in part because he believed Dr. Slaoui had potential conflicts of interest, according to senior administration officials.

Dr. Slaoui, a venture capitalist and a former executive at the pharmaceutical firm GlaxoSmithKline, sat on the board of Moderna before accepting his current role last month. The value of his stock holdings in Moderna jumped significantly when the company released preliminary data from an early phase of its candidate vaccine trial. He sold his $12 million in shares afterward, and the administration said he would donate the increased value to cancer research.

Dr. Slaoui also joined the project on a contract rather than as a government employee, leaving him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. The arrangement is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow.

In a May 20 meeting, according to one official, Dr. Marks, the director of the F.D.A.’s Center for Biologics Evaluation and Research, informed Dr. Stephen M. Hahn, the agency’s commissioner, that he wanted to exit the vaccine program.

He also departed the White House’s coronavirus task force, a group he had been named to five days earlier.

Two senior officials said that Col. Matthew Hepburn, who is also a physician, has stepped in for Dr. Marks on the vaccine program.

The post Trump Narrows Search for Coronavirus Vaccine to Five Firms appeared first on New York Times.

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