Vaccine tests and delays

Federal regulators last week issued new safety guidance for pharmaceutical companies developing coronavirus vaccines. The Food and Drug Administration stated that researchers would need to observe volunteers participating in final-stage vaccine testing for at least two months after giving them their last shot. The two-month period is meant to ensure that volunteers do not develop serious reactions to the vaccines.

The White House had reportedly resisted the revised rules, which mean U.S. approval of a COVID-19 vaccine before Election Day is technically infeasible. But by reassuring a nervous public about the safety of new vaccines, the new rules and delay might actually encourage more people to get their coronavirus shot.

Mass vaccination would be a crucial turning point in the battle against the coronavirus, so it stands to reason that it should start as soon as we’re sure a given vaccine is safe and effective. But where do we set the goal posts for “safe and effective,” and who should get the vaccine first?

“Effective” has a relatively simple definition here: If a given vaccine decreases the chance of getting the coronavirus (or getting very sick from it) by 50 percent compared with a placebo shot, the FDA considers it effective. “Safe” is harder to define: What if vaccine-caused health problems only appear in patients later? By definition, the longer researchers follow their test patients, the lower the chance that they’ll miss something with a delayed effect—but the higher the chance that patients will miss out on a vaccine they could have benefited from.

Current trial results are beginning to show the wisdom of taking our time. Oxford and AstraZeneca have paused their ChAdOx1 vaccine trial while researchers evaluate whether a volunteer’s illness resulted from the vaccine. Johnson & Johnson’s vaccine trial is likewise paused, as is Eli Lilly’s monoclonal antibody treatment. These pauses aren’t unprecedented in large trials, since, in a group of thousands of participants, it’s unsurprising one or two might become sick for some reason in any given few months. But the trials serve a valuable function: letting researchers determine whether they’re about to release a dangerous or safe product.

The balancing act between speed and safety, along with disagreement about which is more important, has stoked fears among the public. In a Kaiser Family Foundation poll published Sept. 10, over half of Americans said they would not want to receive a vaccine approved before the election. (Interestingly, despite the Trump White House’s pressure for early approval, Democrats in the poll were more likely to say yes to such a vaccine. Fifty percent of Democrats said they would get it, but only 36 percent of Republicans.)

That’s who’s willing to get it, not who will get access first. Inevitably, all Americans can’t receive the vaccine at the same time. The National Academies of Sciences, Engineering, and Medicine (NAS) has released a draft document discussing who should go first.

The highest priority—what the NAS calls phase 1A—involves high-risk health workers and first responders. Without them, there’s nobody to take care of everyone else. Going second (phase 1B) are people most likely to suffer severe harm from an infection: those already in poor health and older adults in crowded settings. Phase 2 involves teachers, child care workers, the homeless, those in prison, and people with less severe health issues, along with “all older adults.” Phase 3 covers children, young adults, and “workers in industries important to the functioning of society.” Phase 4 covers whoever remains—the equivalent of an airport gate agent’s “All passengers, all rows!”

The NAS doesn’t make laws, but its framework for discussion sets a path for the deliberations that will need to take place in coming months. And amid those phases, there’s good news. As soon as any number of people start receiving the vaccine, the virus will have a harder time finding new people to infect. Deaths should also decline more sharply at the beginning, as those at highest risk go to the head of the line. I will recommend the vaccine for almost everyone, but especially for sick, elderly people, who are at far higher risk than others.

When it comes out, I encourage you to get it. Until then, please stay safe.