MARY REICHARD, HOST: It’s Tuesday, the 6th of October, 2020. Glad to have you along for today’s edition of The World and Everything in It. Good morning, I’m Mary Reichard.
NICK EICHER, HOST: And I’m Nick Eicher. First up: vaccine trials.
Pharmaceutical companies are racing to create a safe, effective way to build immunity against the novel coronavirus. Health officials say viable vaccines are key to getting back to normal. But some people have questions: how are scientists developing them and are they safe?
WORLD senior correspondent Katie Gaultney reports.
KATIE GAULTNEY, SENIOR CORRESPONDENT: As a doctor of nursing practice, Tara Cavazos is very comfortable being the one giving the shots.
DOCTORS OFFICE: [knock, door opens] Good morning. How are you doing today? You’re going to get your flu shot. Is that right? Yes. Okay, perfect. So remember with the flu vaccine…
But last month, she found herself in the role of “patient,” as a participant in Pfizer’s COVID vaccine trial in Dallas. Being a member of the medical community means she’s probably savvier than the average participant about how to interpret her experience. She’s doing close analysis to try to figure out if she got the “real deal” or the placebo.
CAVAZOS: They use hypertonic saline in the placebo, and the injection when I got it, it hurt, which most of them do. But it felt different than a typical flu shot or a tetanus vaccine. I had some discomfort. So part of me thinks maybe that was the hypertonic saline that was making my muscle feel sore.
In other words, she felt like it was a placebo. But she hopes she’s wrong. Her office has been swabbing patients for COVID since the pandemic arrived in Dallas.
CAVAZOS: And so for me, it’s a way to keep my patients safe. Because if I have some sort of immunity, I can keep serving them, keep my family safe, and also to be something greater than just myself. And if I can contribute in a small way by being in a clinical trial, I feel like it’s a way to give back to medicine.
Over the course of several appointments, Cavazos will get two injections, along with regular nasopharyngeal swabs and blood draws to detect the presence of the virus or antibodies. She says she isn’t too worried about complications, since this is phase three of the trial. The vaccine manufacturers already have a lot of research and testing under their belts at this point.
Dave Thompson is a toxicologist who works with pharmaceutical manufacturers on testing before they’re ready to try out a product on humans. He explains the vaccine trial process.
THOMPSON: For phase one, a vaccine would be given to a small number of people and this would be between, say 20 and 100 individuals.
Then comes phase two…
THOMPSON: …which would involve several hundred, maybe a thousand patients here. They would evaluate the proper dose that they want to use in the ultimate trial, the phase three trial.
That’s the last and biggest trial, with many tens of thousands of participants per vaccine candidate. Pfizer’s is just one. Moderna, AstraZeneca, and Johnson & Johnson’s subsidiary Janssen, are among the other companies running trials around the world. It’s a horse race to see who can develop a safe and effective COVID-19 vaccine.
Dr. Anthony Fauci told Congress last month, that’s a good thing for the rest of us.
FAUCI: And so as these trials go on, we predict that some time by the end of the year, let’s say November or December, we will know whether or not these are safe and effective.
He says the trials are showing an immune response from the vaccine that may be better than natural immunity, and without the potential for long-term complications. Some people who have had COVID-19 struggle with ongoing negative neurological, cognitive, or vascular effects.
The ticking clock means companies are conducting research and testing at an unprecedented pace. That’s one reason it’s called “Operation Warp Speed.” Manufacturers are already producing vaccines so they’ll be ready for distribution if and when FDA approval comes through. It’s a gamble because there’s a chance those vaccines will never go to market.
Dr. Jeff Barrows is senior vice president of bioethics and public policy for the Christian Medical and Dental Associations. He says even with that huge production effort, we almost certainly won’t have enough doses for everyone who wants one, at least at first. So the National Academies of Science, Engineering, and Medicine has come up with a way to prioritize.
BARROWS: Their model basically goes from trying to get the best good out of the vaccine itself. And so what they’re going to do is try and label those individuals or those workers that are in certain sectors of our society that are number one most exposed to the virus. And so they’re laying out the groups of individuals who should get access to the vaccine first, I think in a very equitable and ethical way.
High-risk healthcare workers likely will get first dibs, followed by first responders, people with significant health risks, the elderly, and so on.
But not everyone who can get a vaccine wants one. Some are worried about vaccine safety.
Toxicologist Dave Thompson says everyone should weigh their own risk.
THOMPSON: I respect people’s right to either take a vaccine or not. I don’t think people should be made to, to do that. But myself, I think that vaccines are very safe. There’s a risk involved, but it’s a reasonable risk.
Christians have another issue to wrestle with. All of the vaccines currently in phase-three testing have used one of two aborted fetal cell lines at some point along the way. Those cells were gathered from abortions done in 1972 and 1985.
Moderna and Pfizer used them in the research phase, while AstraZeneca and J&J’s Janssen are using them in production. If the only vaccine to make it to market comes from that group, Barrows says his organization will still encourage its members to get the vaccine.
BARROWS: The good, that will be accomplished is much, much greater than any complicity with evil. And again, again, recognizing that the evil occurred at a minimum of a 35 to 40 years ago.
But those who object to any use of fetal cell lines—no matter how long ago the abortions took place—have another option: wait. Developers can use cell lines derived from sources other than human fetal tissue.
Barrows says it can be hard to get accurate data on the exact developmental steps taken for many of these vaccine trials. But it appears a handful of pharmaceutical companies, including giants like Novavax, Sanofi Pasteur, and GlaxoSmithKline are using ethically sourced cell lines for their vaccines.
Reporting for WORLD, I’m Katie Gaultney in Dallas, Texas.