The director of the National Institutes of Health (NIH) said despite the images conjured up by Operation Warp Speed — the Trump administration’s effort to get a COVID-19 vaccine to market as quickly as possible — the federal government is taking all the necessary safety precautions.
In a wide-ranging interview with The Hill on Wednesday, NIH chief Francis Collins said he’s optimistic about the potential for one or more vaccine candidates to make it through phase three trials by the end of the year, and that the Trump administration is making the ancillary plans to deliver that vaccine widely.
He vowed that the government’s top scientists would not be rushed in approving a vaccine before a candidate demonstrates both that it provides a strong immune response and that it does not come with damaging side effects.
“I think in the United States we are on a very solid track, but of course there are many scientific uncertainties that we will need to watch closely,” Collins said.
“I think there is reason to be cautiously optimistic that by the end of 2020 we will have at least one and maybe more than one vaccine that has been judged by rigorous standards to be safe and effective,” he added.
Collins is among the public health experts who does not love the image conveyed by the White House’s Operation Warp Speed.
He said that while the administration was moving swiftly to lay the groundwork for delivering multiple vaccine candidates, scientists would not skip health and safety steps in pursuit of a solution.
“I know there is some concern because of this warp speed label that maybe there are corners being cut that shouldn’t be. I want to reassure you and everybody else that we will not allow that to happen,” he said.
The vaccines entering phase three trials will enroll 30,000 people in areas where the virus is spreading rapidly, half of whom will get a vaccine and half of whom will get a placebo. The studies will be overseen by data safety monitoring boards, the only participants who will know who has received a vaccine and who hasn’t.
Those boards will have the authority to stop a trial if safety issues emerge or serious side effects show up. They can also accelerate the timeline if early data shows substantial evidence that a vaccine is working well.
“All that is a designed strategy that is characterized as the most rigorous way to find out whether something works and whether it’s safe, and that is absolutely going to be applied in this circumstance and there will be no approval of any vaccine that does not pass those high, high standards,” Collins said.
The looming election has cast the U.S. response to the pandemic in sharply partisan terms, but Collins said he feels no pressure to approve a vaccine in a manner that fits a political calendar. Instead, he said, the pressure comes from the number of Americans who have become significantly ill, and the more than 160,000 who have died.
“I feel great pressure to rush the science because people are dying. I feel no pressure at all about any political timetable,” he said. “I am intolerant of anybody who tells me that we have to take longer to do something than I think it should take, and I every day think about ways that we could maybe shorten up steps that potentially are a little more bureaucratic than they need to be.”
“But I have no interest at all in any argument about how this effort needs to meet some political timetable,” he added. “If it’s going to have the confidence of the public and if it’s going to have scientific rigor behind it, we have to go solely on those criteria.”
Collins, 70, has led the NIH since 2009. A geneticist who led the Human Genome Project, he has been awarded both the National Medal of Science and the Presidential Medal of Freedom.
Now, as a member of the White House coronavirus task force, he regularly briefs Vice President Pence and pores over the models and materials produced by Deborah BirxDeborah BirxThe Hill interview: NIH chief addresses concerns about speed of COVID-19 vaccine development Marlee Matlin: ‘Unfathomable’ that White House doesn’t have sign language interpreters at coronavirus briefings It’s our fault ‘the monster’ virus is everywhere MORE, the State Department adviser overseeing the administration’s COVID-19 response.
The numbers he has seen lately are not good, especially per capita death rates that put the United States behind almost every other country in the world, with the exceptions of the United Kingdom, Chile and Peru.
“I really am watching much more closely to what has happened to our mortality rate in the United States as a function of our overall population, and that is still quite troubling,” Collins said. “We are still losing 1,000 or more than that people a day, which is more than it was six weeks ago.”
Collins said he is concerned by Russia’s announcement this week that it had approved a vaccine candidate, without going through the phase two and phase three trials that a more scientifically rigorous country would follow. Skipping those steps, he said, puts Russians at risk — something he is not willing to do to Americans.
“I think what they have decided to do, which is to skip over phase two and phase three testing for safety and efficacy is a very risky step forward,” he said. “They are proposing, therefore, to immunize potentially millions of people with the vaccine without having the data to know whether it’s going to actually be effective in protecting against COVID-19.”
“I think the world community is reacting with concern about whether they’re putting their population at risk,” Collins added. “I guess some clever wag called this Russian roulette.”
Eight vaccine candidates are in phase three trials around the world. The NIH has helped develop a vaccine candidate based on messenger RNA with the pharmaceutical giant Moderna, and this week the government agreed to pay the U.S. company $1.5 billion for 100 million doses if the vaccine proves effective and safe.
The Trump administration has also agreed to take delivery of 100 million doses of a candidate developed by the German company BioNTech and the New York-based Pfizer.
Other phase three candidates are in trials in Argentina, Australia, Brazil, China, Germany, India, Indonesia, Saudi Arabia, South Africa, the United Arab Emirates and the United Kingdom.
Following the necessary steps and demonstrating the safety of a drug will be crucial to building trust in the United States, Collins said, as a troubling movement of anti-vaccination activists has become an increasingly loud voice, though their numbers remain relatively small.
“The best hope we have of having that basically move into the rearview mirror is a vaccine that people are willing to take so that we can reduce the likelihood of transmission, essentially, and cause this disease to burn out by providing enough herd immunity. But if half the nation says, ‘No, I don’t want this vaccine,’ then this coronavirus pandemic could go on and on and on, to the great detriment of our country, and putting vulnerable people at risk,” he said.
“I’m surprised, frankly, that the resistance to this vaccine has reached the level that it has. I thought when people saw the terrible tragedies and suffering that’s around us from this illness that maybe some of the resistance that we’ve seen to other childhood vaccines would not kick in,” Collins added. “But at the moment, it seems to be quite prominent.”
Even without the anti-vaccine movement, fewer Americans seek out vaccines that are commonly available. Less than half of the U.S. population got a flu shot last year.
With the annual flu season looming, public health experts are worried about the stress on health systems that will come if a flood of sick people show up presenting symptoms that could be either influenza or COVID-19. The NIH is working on a program it calls RADx, or the Rapid Acceleration of Diagnostics, to develop a single test that will screen for both diseases.
“It will be a terrible stress on our medical care system if we have both a lot of influenza and a lot of COVID-19 presenting with very similar symptoms all at the same time,” Collins said.
But Collins said there are some signs that the flu season might be milder than normal. Those signs are based on early evidence from the Southern Hemisphere, where the flu season is already underway, and because the social distancing techniques necessary to combat COVID-19 are also effective in stopping flu transmission.
Collins said he regularly speaks with Anthony FauciAnthony FauciFauci defends voting by mail if ‘you don’t want to take the chance’ in person Museum unveils new Fauci bobbleheads after previous edition sells out Marlee Matlin: ‘Unfathomable’ that White House doesn’t have sign language interpreters at coronavirus briefings MORE, a fellow White House coronavirus task force member who runs the National Institute of Allergy and Infectious Diseases within the NIH, about the threat of the flu.
But he was hesitant to critique Fauci’s recent appearance on the mound to throw out the first pitch on Opening Day for the Washington Nationals, a pitch that went well wide of the mark.
“Well, he threw it wide on purpose, because he doesn’t want anybody to catch anything,” Collins joked. “It was a good windup anyway. The form looked pretty good. The aim? Well, OK, I probably would have done worse, so I’m not going to throw any shade in his direction.”