“We will have a vaccine, we believe, before the end of this year, and it will have the capacity to save countless American lives,” Vice President Mike Pence declared at Wednesday night’s debate. This was just the latest suggestion from the Trump administration that we could have a COVID-19 vaccine very, very soon. Earlier this week, President Donald Trump blamed the Food and Drug Administration for making it difficult to have a vaccine by Election Day—the agency “tapped ever so softly on the brakes” of Operation Warp Speed, as Stat News put it, pushing the timeline for vaccine approval to mid-November. The Warp Speed plan still promises to have doses of a vaccine available by Jan. 1. This is still an incredibly rushed timeline.
Health care workers like me would be among the first to be offered the COVID-19 shot. I desperately want a vaccine: I’m trained as an epidemiologist, and I’m accordingly cautious when it comes to SARS-CoV-2. I have spent the pandemic foisting my caution on the extended family I’ve been in quarantine with: I made my mother-in-law wash her shrink-wrapped mushrooms (that may have been overkill) and refused to let my brother come over three days after getting his hair cut (I stand by that one). I’m also in medical school, which I recently returned to, after being on maternity leave. This means I’ll have regular contact with classmates, as well as professors coming from the hospital. I want to do my part to keep everyone, including my elderly family members, and myself, safe.
But I’m worried about this vaccine. If it arrives as quickly as Trump and Pence are promising, I won’t be taking it right away. A rushed vaccine makes me nervous. I am hardly the only scientist who is very pro-vaccine—and is now in the tough position of being potentially against one.
“We certainly need a mass vaccination program,” Irwin Redlener, founding director of Columbia University’s National Center for Disaster Preparedness, told me. “But we need to be sure that a new vaccine is effective and safe. With the proposed short follow-up time, we won’t be seeing possible intermediate and long-term complications. Is that OK? It’s a trade-off: controlling a raging, lethal outbreak ‘now’ vs. waiting for years of safety monitoring.” A vaccine that isn’t effective and safe could erode public trust in both a fully vetted COVID-19 vaccine and other vitally important immunization programs. “We need to be really careful, because any missteps or untoward complications from the new vaccine may well give fuel to the already strong and growing anti-vax movement,” Redlener said.
That was a common theme among the other experts I spoke to: We’re now grappling with communicating the fact that vaccines are vitally important and so is the proper clinical testing process. “To be clear, vaccines save lives,” Etta Pisano, professor at Harvard Medical School and chief research officer of the American College of Radiology told me. “I just don’t want this one to be rushed out to widespread use before its safety and efficacy are proven.” She recalls receiving the swine flu vaccine that “was rushed to production in 1976.” This is the most recent example of the U.S. government hastily pushing through a vaccine intended for mass immunization. The circumstances were a little different than with COVID-19—it was a novel flu strain, with a much smaller outbreak—but the vaccine was also created in a hurry before an election. It ended up causing 450 cases of Guillain-Barré syndrome, which is when the immune system goes haywire after encountering a disease and attacks the nerves. Pisano and her husband, also a physician, might trust a rushed vaccine—we are in a pandemic, after all—but only if it’s rolled out alongside transparent data from the clinical trials so they can judge the results for themselves.
That doesn’t seem likely, when a president who routinely contradicts the scientific evidence is the loudest voice saying we might have a vaccine soon. Zoya Grigoryan, an internal medicine resident at Lenox Hill Hospital, has kept her own two children up to date with the vaccine schedule laid out by the American Academy of Pediatrics—because of the high safety standards and slow, careful testing of those vaccines. Which is exactly why she’s hesitant about a COVID-19 vaccine. “Warp speed really isn’t something I want from my medications, especially not ones for my children,” she says. Gmerice Hammond, a cardiologist and health policy research fellow at Washington University, does not plan on getting the Operation Warp Speed vaccine or giving it to her children. (Both kids are fully vaccinated.) Her feeling is that we have strong evidence from other countries and places like New York that public health policies can work well to keep spread low. We should use the time they buy us to properly work on a vaccine and not be “reckless,” she explains. “We’ve seen this movie before, in 1976. We should know better.”
For me, there is also the added wrinkle of the Centers for Disease Control and Prevention’s recent erratic behavior. The CDC is the branch of government responsible for managing pandemics and vaccine guidelines, but the boundaries between science and politics in its policies seem to be eroding. Take the testing guidelines debacle, in which the CDC pushed through new guidance while Anthony Fauci was under anesthesia that said asymptomatic people who had been exposed to the virus did not need to get tested. Or that time it finally posted a warning that the coronavirus spreads via aerosols only to take it down after 72 hours, saying that it had been posted in error. (Weeks later, similar guidance is now back up.) Similar oddities are also happening at the FDA, where Commissioner Stephen Hahn was pressured by the White House to “get on Trump time” and approve convalescent plasma therapy, against the advice of Fauci and other scientists (because there is no evidence that it works). The FDA and CDC exist because letting the companies monitor the safety of their own products in the face of such financial gains represents a massive conflict of interest—but now we’re largely being left to trust the companies not to cut corners.
People will undoubtedly continue to die of the coronavirus absent an effective vaccine. But even more could die if we don’t take our time to get it right. When we do take our time to get it right—and I’m confident it will—I will happily roll up my sleeve. But I would prefer to wait for a vaccine that goes through full FDA licensure—the typical vaccine—not an emergency use authorization. The latter, by design, acknowledges that not all the data are there yet.
Realistically, as a medical student, I will probably end up getting a dose earlier than I would like. In that case, like quite a few of my colleagues in the medical world, I want to see all of the data for myself before getting a rushed COVID-19 vaccine, along with the full statistical plan from the company who made it, outlining all the reasoning behind their methodological choices.
For people who don’t have the time or training to wade through the data, the transparency itself will be an important cue that the vaccine is trustworthy, as science journalist Maggie Koerth notes in a primer for FiveThirtyEight on how to know when to trust a vaccine. Other factors she notes: look at when the vaccine is released and look for opinions from scientists who have been skeptical of a quick COVID-19 vaccine. We’re certainly out there.