Trump Narrows Search for Coronavirus Vaccine to Five Firms - The New York Times

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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. 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.

Dr. Anthony S. Fauci has increasingly expressed optimism that a vaccine could be available next year.Credit...Doug Mills/The New York Times

“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 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 Department of Health and Human Services’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 Matériel 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 and senior adviser. 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.

The Coronavirus Outbreak

• Frequently Asked Questions and Advice

  Updated June 2, 2020

  • Will protests set off a second viral wave of coronavirus?

    Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.

  • How do we start exercising again without hurting ourselves after months of lockdown?

    Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.

  • My state is reopening. Is it safe to go out?

    States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.

  • What’s the risk of catching coronavirus from a surface?

    Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

  • What are the symptoms of coronavirus?

    Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

  • How can I protect myself while flying?

    If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

  • How many people have lost their jobs due to coronavirus in the U.S.?

    More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.

  • How do I take my temperature?

    Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.

  • Should I wear a mask?

    The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

  • What should I do if I feel sick?

    If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

  • How do I get tested?

    If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.

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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.”

A hospital worker in Brooklyn last month. New York has had one of the highest infection rates in the world.Credit...Dave Sanders for The New York Times

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 left 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.

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