NEW YORK — New drugs to treat patients already infected with the novel coronavirus, which has sparked outbreaks across multiple continents, will emerge much more quickly than vaccines to prevent infection, a top Food and Drug Administration official said Wednesday.
“The development of a vaccine is not going to prevent a pandemic here,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told STAT at the SVB Leerink Global Healthcare Conference, ahead of a keynote presentation there. And getting a vaccine ready for pivotal testing is going to take more than just a few months, he said.
Marks’ words stand in contrast to recent comments from the White House. Larry Kudlow, President Trump’s director of the National Economic Council, said Tuesday that drug companies are “probably coming up with a vaccine in much shorter time than people realize,” adding that the U.S.’s containment effort is “pretty close to airtight.”
Marks said the FDA is on an “even higher level of alert,” noting that the number of cases has jumped dramatically in South Korea and Italy.
“The fundamental difference over the past several days is the extent of the spread and the speed of the spread,” he said.
To date, there have been more than 80,000 cases of Covid-19, the disease caused by the novel coronavirus, and 2,700 deaths, mostly in China.
“I’m not the one to decide when you declare a pandemic,” Marks said. “I’m just the one who stays awake at night worrying about it now.”
The FDA’s major job in an outbreak is to speed the development of diagnostics for detecting the infectious agent, vaccines to prevent people from catching it, and drugs to treat those who fall ill. Diagnostic tests are handled by the agency’s devices center, which is not under Marks’ purview but which he said is working “very actively.”
On the potential for vaccines and drugs, Marks said Gilead Sciences’ remdesivir has shown promise against other coronaviruses, and may be beneficial in this current outbreak. Gilead’s drug is now being tested in China and the U.S. Marks also said convalescent plasma, a blood product taken from people who have already fallen ill, may have potential.
Multiple companies are advancing vaccines toward human trials, led by Moderna Therapeutics, whose National Institutes of Health-partnered product is expected to enter clinical study in April.
But crafting a vaccine for healthy people presents greater challenges than developing a treatment for those already infected with the virus, Marks said.
“I do have to be honest that for the vaccines, the idea that there’s going to be a vaccine that will really be able to be used in a large patient population and a large clinical trial, in the very near future, as in the next few months, I think that’s just not likely,” Marks said.
Marks said a real late-stage trial to test a vaccine is likely “months away.” One concern is that some previous coronavirus vaccines have caused worsening of the disease, not improvement.
“We have to make sure that as we proceed with development, we’re not creating problems,” Marks said. It might be realistic, he said, for studies of vaccines to begin by the summer, although that timeline is still aggressive.
Another risk related to the coronavirus, Marks said, is a disruption to the global pharmaceutical supply chain, because many of the basic chemicals used to make new medicines come from China. Marks said that with vaccines and other products his center oversees, much of the manufacturing is not in China. But he acknowledged that the FDA is closely monitoring the potential for drug shortages. “We have to be careful, and to try to understand that,” he said.
Marks also spoke in his keynote about the FDA’s position on sometimes risky stem cell therapies, an area in which the agency will stop exercising “enforcement discretion” — meaning that it’s choosing not to enforce rules — in November 2020. That could mean that the FDA’s actions in the area could step up.
And he spoke about the potential for gene therapy, telling the story of a girl who, he said, would not be alive were it not for Novartis’ Zolgensma, a one-time treatment for spinal muscular atrophy.
“She was running around Capitol Hill making senators have tears come to their eyes, which is a really hard thing to make happen,” Marks said.
Marks said the FDA is looking to take new steps to make it easier to develop gene therapy products for rare diseases. The idea would be that for diseases that affect small populations, a drug developer would be able to leverage results from other, similar therapies, in order to get trials done more quickly.
“We’re excited at where cell and gene therapy is headed,” Marks said.