Amid the chaos and rancor of the first presidential debate, President Trump gave a dramatic and troubling look into his ideas about the vaccine approval process.
He also left the clear impression that he trusts pharma companies more than government scientists. In fact, he called out three biopharma companies by name — Pfizer, Johnson & Johnson, and Moderna.
That seemed to be a striking turnaround in presidential esteem for an industry that, in 2017, Trump said was “getting away with murder,” referring to the industry’s pricing practices. It’s an even bigger turnaround from his rhetoric before he ran for office, when Trump was a prominent voice questioning the safety of vaccines.
Moderator Chris Wallace said Trump had “repeatedly either contradicted or been at odds with some of your government’s own top scientists.” He mentioned comments from Robert Redfield, the head of the Centers for Disease Control and Prevention, saying that a vaccine would not be widely available until summer. Trump had said he was confused and mistaken. But Moncef Slaoui, the chief advisor to the government’s Operation Warp Speed vaccine effort, had said exactly the same thing, Wallace said. Trump reiterated that his top scientists were wrong.
“Well, I’ve spoken to the companies and we can have it a lot sooner,” Trump said. “It’s a very political thing because people like this would rather make it political than save lives.”
“God,” Biden interjected. Trump insisted: “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. They can go faster than that by a lot.” The president went on to say that he disagreed with both administration officials, and that Slaoui didn’t say that. Later on, Biden returned to the topic. “In terms of the whole notion of a vaccine, we’re for a vaccine, but I don’t trust him at all,” Biden said about Trump. “Nor do you. I know you don’t. What we trust is a scientist.”
Trump replied: “You don’t trust Johnson & Johnson, Pfizer?”
One person who previously didn’t trust drug companies: Donald Trump.
On CNBC in 2012, Trump blamed vaccinations for an increase in autism, a risk that has never been recognized by the Food and Drug Administration and has been disproven by repeated large studies. “Autism is so prevalent today. I’ve been saying this for a long time,” he said. “I’m not against vaccination but I’m against massive vaccinations at one time in order to save doctor visits with the doctors. And frankly, a lot of people love that and some people didn’t like it.”
In 2015, during the presidential debates, Trump repeated the assertion, saying: “Just the other day, 2 years old, 2 1/2 years old, a child, a beautiful child went to have the vaccine, and came back, and a week later got a tremendous fever, got very, very sick, now is autistic.”
No matter what Trump thinks about the trustworthiness of vaccines or drug companies, he should certainly be in a position to understand why a rushed process might make people uncomfortable taking a vaccine. And a vaccine that a large number of people decide not to take will not do much to speed the end of the coronavirus pandemic.
Let’s clarify a bit of what Wallace, Trump, and Biden were discussing, because, amid all the interruptions, interjections, and insults, information was not presented clearly. There are at least two different events here, which will occur at different times. If any of the vaccines in large clinical trials are effective at preventing Covid-19 infection, we may find that out by the end of the year. But while distribution of the vaccine may start soon after those results emerge, most of the country won’t get the vaccine until later — and that is what Redfield and Slaoui were referring to.
Biden explained this clearly. “Every serious company is talking about maybe having a vaccine done by the end of the year, but the distribution of that vaccine will not occur until sometime beginning of the middle of next year to get it out, if we get the vaccine,” Biden said. “And pray God, we will.”
Here is what we know about the timelines here. Pfizer and its partner BioNTech have said that it is likely, not certain, that there will be efficacy data from their vaccine study in October. Moderna could have results in November. AstraZeneca, which was once expected to have results in the fall, has seen its main trial paused for weeks as a result of a potential side effect, which will slow it down. Johnson & Johnson just started a study of its vaccine, but will not reveal any positive results until at least 30,000 of the 60,000 patients in its study have been followed for two months — probably taking a readout to the end of the year.
Any of the trials could take longer than expected, because they run not based on time, but by how many people in the study get Covid-19. If there are successful results, there will be a question of how quickly an emergency use authorization can be granted. A normal FDA approval takes three months at a minimum. Is it really likely a sufficient review could be done in a matter of days?
If the Pfizer-BioNTech vaccine were approved in November, the CDC estimates that only enough doses to vaccinate between 5 million and 10 million people would be available. For the Moderna vaccine, doses for fewer than 5 million people would be available at that time. The number of doses available will increase dramatically as we move into next year, in part because of investments made by the U.S. government.
It’s also worth remembering that we already know these vaccines cause frequent side effects, like fever, and that they must be kept at cold temperatures. Getting multiple vaccines cleared will probably be necessary to have enough supply to vaccinate the whole country.
But the biggest concern about Trump’s answers is not that his statements don’t give a clear picture of vaccine timelines, but that they seem to neglect the normal role of the CDC and the FDA. There are many great researchers at Pfizer and Johnson & Johnson, but both companies have also, over the years, been accused of putting marketing over science. The point of the FDA is that even if a drug or vaccine is developed by criminals, an independent regulator has examined the data thoroughly and determined that the medicine’s benefits outweigh its risks.
This is not an abstract formulation. Sam Waksal, the former CEO of ImClone Systems, went to jail for insider trading, but the drug his company developed, Erbitux, helped many cancer patients. Scott Harkonen, the former CEO of biotech firm InterMune, was convicted of wire fraud in 2009 but the drug his company developed, Esbriet, was helpful to patients with a type of obstructive lung disease.
Yet the FDA has been under attack, and has granted emergency use authorizations to several treatments — including hydroxychloroquine and convalescent plasma — based on data that would not pass muster for a normal approval. On Tuesday, seven former FDA commissioners wrote an editorial in the Washington Post saying the Trump administration is undermining the agency. The signatories were bipartisan, and included Trump’s own former FDA commissioner, Scott Gottlieb, who is a Pfizer board member.
Susan Desmond-Hellmann, another Pfizer board member and the former CEO of the Bill & Melinda Gates Foundation, said vaccines are “like a miracle” at a STAT event last month. To be able to prevent diseases like measles, whooping cough, and pneumonia is one of the most amazing examples of science helping people there is, she said.
But she said she’d learned at the Gates Foundation that one of the main dangers to the use of vaccines is if people don’t have confidence in their doctors, the government, and science and medicine. And in the U.S., maintaining such confidence is very much the role of FDA review.
“It is absolutely clear that a very strong and powerful FDA is necessary to make all the scientific breakthroughs real for people,” she said.
There are appropriate ways for a president to push regulators to move faster. But there are also lines that should not be crossed if vaccines are going to have their full benefit during a pandemic.