The vaccine waiting game

Recently, the once-staid world of vaccine research has come to resemble a late-night TV huckster’s dream. From trusted medical organizations to biotech startups, various research teams are all but promising a vaccine against the novel coronavirus in the near future.

Israel’s MIGAL Galilee Research Institute said its researchers “have developed an effective vaccine against avian coronavirus Infectious Bronchitis Virus (IBV), to be adapted soon [to] create a human vaccine against COVID-19.” Adapting a vaccine from one virus to a closely related one is a reasonable goal, but note the leap from “avian” to “human”: MIGAL apparently hopes a vaccine intended for chickens will have the desired effect on people. It could—but that’s a big assumption to make.

Closer to home, British American Tobacco (BAT), maker of Lucky Strike cigarettes, hopes to strike it lucky with a coronavirus vaccine made from genetically modified tobacco plants. Credit BAT for thinking outside the box, but its web announcement offers hype, claiming the vaccine the company is developing “has the potential to deliver an effective immune response in a single dose.” That sounds like great news! Coronavirus immunity, without even needing a second shot? Where do I sign up?

Let’s pause for a moment. Any new vaccine theoretically “has the potential” to do that. The boring stuff—vaccinating test subjects, drawing lab tests to see how many gained immunity, analyzing data—is how the U.S. Food and Drug Administration (FDA) knows whether a proposed vaccine fulfills that potential. Both MIGAL’s and BAT’s new vaccines are now in “pre-clinical testing”—that is, mouse studies.

Let’s look down the road at the steps each vaccine has yet to face in the development process: A vaccine that appears useful in animal studies will then move on to small “phase 1” trials. If all goes well, it may move on to “phase 2” trials involving up to 1,000 people, and then to “phase 3” trials with thousands more. (Analysis of a drug that’s already come to market serves as “phase 4.”) These studies address several questions: Is the vaccine safe? Does it work? What dosage should patients receive, and how should we give it to them?

Even though the public is anxiously awaiting a vaccine for the new coronavirus, the FDA doesn’t insist on these safety steps for no reason. The agency’s conservative approach dates back to the days of thalidomide, the morning-sickness treatment that led to nightmarish birth defects. The majority of those injuries took place in Europe, because the FDA repeatedly turned down the application to market thalidomide in the United States.

Even an excellent vaccine may have quirks: Readers who’ve had a smallpox vaccination, for example, will never forget the strange way nurses had to administer it, using multiple pricks with a bifurcated needle.

As an aside, I am one of a few hundred people in my age bracket (I’m 41) to have received a smallpox vaccine, during a post-9/11 research project at my medical school. This seemingly hopeless study used a live-virus vaccine decades past its intended useful life, diluted it with as much as 90 percent water, then gave the resulting mix to willing medical students. End result? Every single person in the study became immune to smallpox, for a success rate of 100 percent.

The standard pipeline for FDA vaccine approval takes more than a year. Given the lengthy testing necessary to ensure a safe and effective vaccine, I think we’d be largely guessing to predict when a vaccine for SARS-CoV-2 might be on the market—even assuming the FDA drops everything else to prioritize it.