Last Friday, at the end of a week in which the coronavirus infected more people than it ever had before, President Trump held a press conference to congratulate himself on his stewardship of the crisis. “My Administration has initiated the single greatest mobilization in U.S. history,” he said. It was one of many false assertions he made in his brief remarks.
Trump also attempted to claim credit for the coronavirus vaccine developed by Pfizer, in collaboration with the German biotech firm BioNTech. The vaccine has not yet been approved, but in preliminary studies it protected more than ninety per cent of its recipients from infection. Trump attacked New York’s governor, Andrew Cuomo, who has said that federal approval of any such vaccine would not be enough for him to grant access to residents of his state. “As soon as April, the vaccine will be available to the entire general population, with the exception of places like New York,” Trump announced. (On Monday, a second company, Moderna Therapeutics, released preliminary data demonstrating that its vaccine had protected more than ninety-four per cent of the people who received it.)
“Frankly, I’m not going to trust the federal government’s opinion,” Cuomo has stated. “New York State will have its own review.” The governor has done a remarkable job of dealing with the pandemic, and it is impossible not to contrast his active, vigorous, and largely successful intervention with the President’s repeated lies and almost complete indifference. But to ignore any eventual approval made by the Food and Drug Administration, a decision that Cuomo stressed again in an interview with Katy Tur, on MSNBC, immediately after Trump spoke, is worse than dangerous. This can only have been a political decision, because Cuomo understands as well as anyone else that there will be a different President in charge of distributing this vaccine. “Polls say fifty per cent of American people say they will not take the vaccine if it were available today, because they don’t trust the way this federal government has politicized the process,” Cuomo said on Sunday, during remarks at Riverside Church in New York City.
That’s true. There is a crisis of confidence in vaccines in this country, which has existed for years, long before the emergence of the coronavirus, and it has only grown worse in the past year. But can Cuomo genuinely think that this kind of response will increase public confidence? He was the first to undertake this misbegotten mission, but he is no longer alone. Officials in California, Connecticut, West Virginia, and the District of Columbia have also appointed committees to review coronavirus vaccines offered for F.D.A. approval, while the governors of Nevada, Oregon, and Washington have joined California’s effort, with each state adding a representative to that review panel. If approval relied solely on Trump, or on the “federal government’s opinion,” such an action would make sense. But it does not. The Food and Drug Administration is responsible for approving vaccines, and, although its leadership has been bullied and weakened by Trump, the Office of Vaccines Research and Review, the group within the agency that has evaluated vaccines for decades, has no such taint.
Vaccine approvals in the United States follow a detailed, lengthy, and public process. And the F.D.A.’s success is unrivalled. “We uphold globally respected standards for product quality, safety, and efficacy,” Peter Marks wrote last month, in an opinion piece for USA Today. Marks is the director of the agency’s Center for Biologics Evaluation and Research. As the headline of his piece noted, “I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.”
“I understand the frustration and anger that Trump and his team have generated by their mismanagement of highly regarded federal health agencies, but the answer is not to create fifty state agencies to do their work,” Harold E. Varmus told me. Varmus, a Nobel Prize winner, is a former director of the National Institutes of Health and the National Cancer Institute. He asked if we would want a system in which a Vermont Cancer Institute and forty-nine other such centers replaced the National Cancer Institute.
Let’s suppose that the states’ plans for individual reviews go forward. The F.D.A. will eventually approve several vaccines for the prevention of the coronavirus. There are at least a dozen such vaccines in advanced stages of testing (including the two that have announced such promising early results), and dozens more in earlier stages. Will each vaccine have to gain the approval of every state? I live in New York, but I also spend considerable time in California. What if New York accepts the Pfizer vaccine, but California prefers another—perhaps the similar vaccine now in Phase III trials from Moderna, or one of the others that will almost certainly also be approved. What if I am in California when I am vaccinated? Would I be allowed back in New York if it has not also approved the Moderna vaccine? Or would I be required to get an additional vaccine that meets with the Cuomo Administration’s standards?
Will people need the national equivalent of the World Health Organization’s international vaccination certificate—the yellow card that travellers carry to countries where they need to prove that they have been vaccinated against diseases like yellow fever? Will the standards for safety and efficacy be the same in Nevada and Oregon as they will be in New York or Washington? It’s not hard to imagine that one state will prefer one vaccine, perhaps from a company based there, over another. This is one reason that we have a federal system.
It is perhaps worth remembering how intensely vaccines are studied before they reach the level of F.D.A. approval. Making billions of doses—all to the same standard—is not a simple feat. Before a drug or vaccine enters human trials, it is first tested on animals (and cells in laboratories). That leads to an initial phase of testing in humans, in which a vaccine is administered to a small number of healthy people, to make sure that it is safe. In the second phase, scientists look to see if the vaccine produces an immune response, and, if it does, it moves to Phase III. At that point, tens of thousands of people enter the trial: half of them receive the vaccine; the other half get a placebo. The assignments are random, and neither the patients nor the people who administer the shots know which is which. That’s why they are referred to as double-blind tests.
The researchers look periodically at how many people become infected with the virus. If they find that a statistically greater number of people who took the placebo fall ill, then the vaccine would almost certainly be the reason for the difference.( There are more than thirty thousand participants in the Moderna study. The company reported that ninety-five of them contracted the coronavirus: five who were vaccinated, and ninety who received placebos. Statistically, the difference between the two groups was highly significant. And, of the ninety-five cases, eleven were severe—all in the placebo group. The results have not yet been peer-reviewed or published, but, as is the case with other vaccines under study, they are monitored closely by independent analysts.
More than forty-three thousand people have participated in the study of the Pfizer vaccine. That study, as well as those of other potential coronavirus vaccines, has been continuously analyzed by a data-safety monitoring board, which consists of independent experts (who do not work for the agency or the company). If the data establishes that a vaccine is sufficiently effective, it will be scrutinized by an internal F.D.A. committee. The F.D.A. had initially stated that coronavirus vaccines would need to be at least fifty per cent effective for approval, but, if the results from Pfizer and Moderna are accurate, that figure will no longer make sense. The agency will then place any approval request before a public advisory committee for open discussion. “The materials discussed during open sessions of these meetings, which will be live-streamed, will be posted on FDA’s website,” Marks wrote in his USA Today piece.
“This is a system that works,” Margaret A. Hamburg, who was the F.D.A. commissioner for six years during the Obama Administration, told me. She pointed out that Marion F. Gruber, who directs the Office of Vaccines Research and Review, has decades of experience. “Marion is a world-class expert,” Hamburg said, “and she has an excellent team working with her.”
