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Here’s the big question: Should I stay in the trial for months more, not knowing if I got the real vaccine, or should I quit and get an authorized shot or two as soon as I can?
For the first time in my life, I’ve been really hoping to experience some unpleasant side effects. Come and get me, body aches! Bring it on, flu-like symptoms. Malaise and fatigue? Yes, please. So far, though, I’ve gone 0-for-2: a pair of injections and not even a sore arm to write home about. Maybe the next round – if I don’t quit first – will be more conclusive.
This is what my life is like as a COVID-19 vaccine guinea pig. There’s hope and uncertainty plus a few not-so-precious moments spent sprawled semi-conscious on the floor of a research facility in a Kearny Mesa business park.
The saga began in January, when I signed up to be part of the San Diego arm of a study into the experimental Novavax COVID-19 vaccine. While the federal government has authorized two vaccines, by Pfizer and Moderna, they’re far from perfect. Drug-makers like Novavax are testing other vaccines to see if they can come up with alternatives that won’t have as many limitations, such as requirements for multiple doses and extreme refrigeration.
Here’s where the big questions come in: Now that authorized vaccines are more widely available, should study participants like me ditch the trials in order to make sure we get the real thing instead of a placebo? And how can drug companies manage to test COVID-19 vaccines from now on without putting participants in unnecessary danger?
Getting all this right isn’t a minor matter. The fate of ongoing vaccine research could play a major role in determining whether the world can get the pandemic under control.
My choice to join the Novavax trial was a pretty easy one. While it’s risky to take an unproven, experimental vaccine, it’s also risky to live in San Diego County during the pandemic. We’ve hardly been a bright spot: In terms of per-capita deaths, we’ve been pretty average compared to the rest of the state. People who live here have been about half as likely to die of COVID-19 as those in Los Angeles County, but about twice as likely as in San Francisco.
I also want to protect my family from more loss. Just before Christmas, the worst happened. My 85-year-old father, a retired Chula Vista elementary school teacher, died of COVID-19 after spending more than a month in isolation at Palomar Medical Center in Escondido. My mother got very sick too but she’s still with us.
I could wait to be eligible for an authorized vaccine. But no one knows when that will be. Like most people, I don’t fit into any of the eligible groups now (mainly health care workers, those over 65 and certain essential workers) or in the group that will become eligible on March 15 (mainly those with serious health conditions or certain kinds of disabilities). Considering the endless hiccups in the rollout, I may not be able to have a shot at a vaccine until the summer or fall – or even later.
So I joined the Novavax trial and got a pair of shots three weeks apart. The injections were utterly uneventful, but there was still drama.
At the first visit for a shot, I shared rooms with nurses, screeners, participants and a doctor – by far the most human contact I’ve had in almost a year. Yikes! Somebody hold me! Wait, nevermind. Back off and don’t hold me.
Then came a blood test and a self-administered nasal swab to test me for COVID-19. The nurse told me to take off my mask and swirl the swab around each nostril five times. Ever an overachiever, I swished it around about 20 times, and it tickled. Suddenly I felt the need to sneeze. The nurse watched me sharply inhale about half the air in the room, and she jumped away to escape the blast radius. But I managed to stifle the sneeze and only let out a loud huff.
At the second visit, I got another blood test. The nurse took forever to find a vein, and things suddenly started to go black. At 6-foot-7, I’m too big to fail – but I ended up on the floor, woozy and nearly passed out. Two nurses joined me on the floor to take blood from the back of my hand. Maybe we should have ordered burritos and enjoyed some lunch down there.
No side effects appeared after my shots, suggesting that I may be in the 33 percent of the trial’s 30,000 participants in the United States and Mexico who got the placebo. (The Novavax trial is designed to see how many people develop symptomatic COVID-19 after 66 percent of participants get the vaccine and 33 percent get a placebo. If fewer people in the vaccine group get sick, that’s a sign that the vaccine works. For now, we’re “blinded” as to which group we’re in.)
Novavax has finished enrolling participants. Now those of us in the trial are figuring out what to do next.
Here’s the big question: Should I stay in the trial for months more, not knowing if I got the real vaccine, or should I quit and get an authorized shot or two as soon as I can? “If you’re eligible for the vaccine, you may be actually rolling the dice because you don’t know if you’re in the active or placebo wing,” said bioethicist Mary Devereaux, assistant director of the Research Ethics Program at UC San Diego, in an interview. “And you don’t know if the Novavax vaccine works as well as those that have gotten emergency authorization already.”
To make things even more complicated, Novavax has announced that it’s adopting a “crossover” design. That means those who got the placebo will get the real Novavax vaccine and vice versa. But we don’t know when.
So I could decide to pull out of the trial, learn for sure whether I got the real Novavax vaccine (the study leaders will tell me) and go from there – without any more payments of $150 or $125 per office visit. But if a lot of people in the Novavax trial make the decision to leave – as some already have – it will throw off the results of the study.
Michael McDuffie, a bioethicist at Cal State San Marcos, told me I have the right to pull out of the study. “That right is sacrosanct,” he said. “You don’t need to give anybody any reason. You can walk with no questions asked.”
And in light of the fact of my father’s death from COVID-19, he said, it’s especially acceptable to leave the study in order to make sure I get a real vaccine and protect my mom from more heartache. “You need to be there for her and support her in these times. I think you’d be blameless,” he said.
Maybe it’s no longer feasible in the U.S. to compare experimental vaccines to placebos when authorized vaccines are available. That’s where alternative research strategies come in – and they raise their own moral questions.
One option: “We might end up doing all these trials in low- to middle-income countries that don’t have access to the effective, safe vaccines,” National Institutes of Health bioethicist David Wendler told me.
But “that will set off another set of concerns about whether we’re exploiting poor countries,” he said. Indeed, The Washington Post reported in late January that 28 of 29 poor countries haven’t started vaccinating their people. The sole exception is Guinea in West Africa.
Another strategy: Researchers could test experimental vaccines against those that are currently available to the public. “If we have an established vaccine that works and is safe, then it should be the control treatment. Not a placebo,” University of Oxford epidemiologist and research fellow Jeremy Howick told me. But that approach would still require participants to risk getting a vaccine – the one being tested – that potentially doesn’t work or is even dangerous.
Yet another approach, even more controversial, is known as “human challenge” research: Scientists could expose young, healthy and unvaccinated people to COVID-19 to see if an experimental vaccine protects them. (This kind of study is getting underway in the United Kingdom to help researchers better understand the virus.) “These studies need to have a lot of safeguards in place. But they shouldn’t be completely ruled out,” Reuven Brandt, the UC San Diego bioethicist, told me.
My dilemma, of course, is small compared with these big conundrums. I don’t know what’s next. For now, my fingers are permanently crossed. Now that I think about it, maybe I’ve finally developed a side effect after all.