Trump promises hundreds of millions of coronavirus vaccines by January, but scientists doubt it

The Rose Garden press conference added to the week’s confusing and contradictory remarks about the vaccine’s outlook and schedule. This is seen as the key to returning to normal life. The day before, Formerly Best U.S. Vaccine Authority In front of Congress, he testified that there was suspicion during the 12 to 18-month period that was frequently advertised as a goal. Head of National Institute of Allergy and Infectious Diseases I testified that it was possible for 12-18 months on Tuesday, but there was no guarantee that the vaccine would not work at all.

But Mr. Trump and other officials confirmed Friday that effective vaccines would be widely available by the end of the year, out of 14 promising candidates from more than 100 disciplines. The new initiative’s chief scientist, Moncef Sroy, said he saw early clinical data from an unspecified vaccine trial that gave hope.

“We were even more convinced that this data could provide hundreds of millions of doses of vaccine by the end of 2020,” said Slaui, who was selected during the selection process that was deeply involved by Trump’s son-in-law, Jared Kushner and White. House Coronavirus Corresponding coordinator Deborah Birx, according to two executives.

External scientists have taken the public expectation that the vaccine may be available at any deadline, given the many scientific unknowns and the fact that the first candidate is now being injected into humans. I said that setting it is dangerous. It is unknown which vaccine trial Slaoui refers to, and the first small safety trials in progress are not designed to show whether the vaccine actually works.

“Holding science through news releases is unfair to the American public, or in this case,” I looked behind the curtain, and I saw a good one, and you trust me Must have. “If you have the data, said Paul Ofit, who is in charge of the Infectious Diseases Department at the Children’s Hospital of Philadelphia. “We are confident that we are vulnerable to vaccines in this country, and we need to manage expectations.”

Ofito, who helps advise US vaccination efforts, said the government’s proposed schedule is premature. Scientists do not yet know which of several vaccine technologies work or the level of immune response signals that someone is immunizing.

Peter Jay Hotes, Dean of the National Tropical Medicine, Baylor College of Medicine, said there are some large-scale trials that could start this summer, making it the most relevant way to prove the safety and efficacy of a vaccine. A good schedule is for the second half of next year. It’s still an “absolute record”.

Many government officials said they were skeptical of the president’s schedule on anonymous terms, but Trump wanted to offer “hope.” Birx said he was kind to the president and found it difficult to create a vaccine quickly.

Manufacturing is one of the time-consuming aspects of vaccine production, but a major reason for the long development time is how difficult science is and how high the standards of safety and efficacy are. Unlike rare cancer treatments and treatments for debilitating illnesses, vaccines are given to healthy people and have little resistance to side effects and risks.

Developing a coronavirus vaccine is an additional challenge as the virus has just emerged in the human population this winter and scientists continue to learn how it affects the body.

Leading candidates in US efforts to date have been experiments in every sense, leveraging exciting new technologies never before used in approved vaccines. That is, we have no long-term experience with safety and efficacy. Other illnesses.

Scientists can measure the immune response in people’s blood, but still do not know what level of response immunizes a person or how long it lasts. They also know that vaccines work differently in different people. For example, the immune response of older people tends to be less robust than that of young people, and different populations need to be tested for possible vaccines.

Researchers have put vaccines in human trials before they fully know the answers to most of these questions. Phase 1 trials to test safety have already been done. In the next round, we will test the vaccine in a larger group and begin to show if the vaccine is effective. However, the strongest indicator of whether a vaccine works and has side effects is a large Phase 3 safety trial. These trials traditionally involve tens of thousands of people and can take years, in which case this process is almost certainly omitted.

As the federal government is already working on a vaccine, including a public-private partnership led by the National Institutes of Health, with hundreds of millions of dollars in funding to various pharmaceutical companies, an initiative called Operation Warp Speed It is unclear exactly how it will work from the Department of Biomedical Advanced Research and Development.

Slaoui previously led the vaccine development at GlaxoSmithKline and was praised by Trump as “a world-renowned immunologist who helped create 14 new vaccines”. He will work with Army General Gustave F. Perna, commander of the US Army Task Force, which manages the Army’s supply chain and logistics.

But the practical question about what he does and how he manages potential conflicts of interest is that the companies he is involved in are currently competing for government dollars. It still remains when you think about it.

“There is a need for coordination, and the new emperor can coordinate other institutions within the Department of Health and Human Services, such as the industry, the White House, HHS, NIH, and BARDA,” said a HHS official who spoke of the condition of anonymity. .. He was not authorized to discuss the subject. However, “bringing in a full outsider with no government experience is very difficult during the crisis.”

Peter Lurie, former chairman of the Center for Public Interest Sciences and former chief executive of the Food and Drug Administration, has taken Slawi’s history as a pharmaceutical company executive to ensure that no single product is manufactured. I said that I need to arrange the procedure. Advantageous over another. “The history of the government’s self-dealing is not clean,” he said.

On Friday, Slaui stepped down from the board of Moderna, a biotechnology company that is one of the most advanced companies working on vaccines in partnership with the US government. According to company documents, he was paid $ 490,000 last year.

Warpspeed’s efforts focus on vaccines, treatment and diagnostics. Head of the Vaccine Division is Peter Marks, head of FDA’s Biologics Evaluation and Research Center, who has also been active in the pharmaceutical industry and academic medicine. An oncologist, he is known for overseeing FDA reviews of complex therapies such as CAR T cell therapy for advanced cancer.

The treatment is overseen by Janet Woodcock, director of the Center for Drug Evaluation and Research. As a physician, Woodcock is known for his extensive experience and expertise in clinical trial design.

Bruce Tromberg of NIH leads the diagnostic work.

Acquiring regulators on the ground floor, who have the final say in whether a product is approved by the FDA, has brought both concern and praise.

“I want to see the FDA in the longer term, “said Lurie. “I think it’s appropriate for the FDA to work with manufacturers of vaccine candidates to explain what they need to speed up reviews, but we’re in the same room as the speed-sensitive project. I think is a bad view. “

Others say that respected regulatory authorities, such as Marks, dictate to the government the need for data collection to show that vaccines are safe and effective, and allow them to be evaluated by experts. He said he would make sure that the data was made public.

The White House seems to see this as a scale-up and manufacturing issue. Hotez believes this is the same problem as ventilator problems and diagnostic tests. “I’m really glad they brought in some good people. They are trying to explain to the White House that the biggest problem is to take the time to collect enough data … all To see which vaccine is safe and effective.

Marks said in an online forum on May 4th hosted by Axios: “No one wants to skip part of the development program to develop a safe and effective vaccine. Everything that comes out of this process is ours on vaccine safety and efficacy. You need to make sure you meet the high standards of. ”

“In this particular crisis, we need to respond very quickly and work very carefully to resolve the problem very quickly,” he added.