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As a doctor of nursing practice, Tara Cavazos is very comfortable being the one giving the shots. But last month, she found herself in the role of “patient” as a participant in Pfizer’s COVID-19 vaccine trial in Dallas.
In the trial, participants don’t know whether they’ve received the vaccine or a placebo—a hypertonic saline solution. Cavazos reported feeling “some discomfort” during her first injection, along with residual pain in her bicep.
“It felt different than a typical flu shot or a tetanus vaccine,” she said.
After her second injection, she developed a minor headache and felt fatigued, symptoms that went away within a day. Now she’ll undergo regular nasopharyngeal swabs and blood draws to detect the presence of the virus or antibodies. Researchers will also monitor her for any unexpected side effects.
She and other trial participants are playing a key role in ongoing testing of coronavirus vaccines. Health officials say widespread immunization against COVID-19 is essential for society to return to normal. But as pharmaceutical companies race to create effective vaccines, some people wonder whether those shots will be safe.
Despite a pledge in September by nine drug companies to prove vaccine safety and efficacy in large clinical trials, the public is hesitating. Last month, Pew Research Center found that 49 percent of Americans said they “definitely or probably would not” get a COVID-19 vaccine if it were available today. Seventy-eight percent are concerned the process “will move too fast, without fully establishing safety and effectiveness.”
As of mid-October, Pfizer, Moderna, AstraZeneca, and Johnson & Johnson’s subsidiary Janssen have entered phase 3 testing in the United States—the final phase before FDA approval for marketing. Other vaccine manufacturers, like Novavax, are close behind.
Dr. Anthony Fauci told Congress on Sept. 23 he predicts that “by the end of the year—let’s say November or December,” federal regulators will know if the vaccines in development are “safe and effective.”
The three trial phases in vaccine testing are designed to catch any potential problems. In phase 1, companies monitor 10-50 individuals for side effects, making necessary adjustments to dosage and formulation. Phase 2 requires hundreds of participants, and by phase 3, trial administrators track immune response and assess side effects in tens of thousands. For many approved vaccines, common side effects include soreness at the injection site, a mild headache, or a low-grade fever.
On Oct. 12, Johnson & Johnson announced it had “temporarily paused” its trial due to an “unexplained illness in a study participant.” The company noted that even serious side effects are “an expected part of any clinical study.”
Dave Thompson is a toxicologist whose company Inotiv works with pharmaceutical companies before their products are ready to be tested on humans. While acknowledging some people have suffered serious reactions to vaccines, he compared vaccine safety to that of the common medication ibuprofen, which is widely regarded as safe even though, for certain people, “life-threatening complications can come” from taking it. He said everyone should weigh their own vaccine risk, but he calls vaccines “very safe. ... There’s a risk involved, but it’s a reasonable risk.”
Thompson is confident that COVID-19 vaccine manufacturers are not compromising on safety, even though they are speeding up testing. Removing red tape accounts for the faster pace: The government has authorized some steps that have traditionally run consecutively to run concurrently.
Even Americans who feel assured of the new vaccines’ safety may not be able to get one: Dr. Jeff Barrows, senior vice president of bioethics and public policy for the Christian Medical & Dental Associations (CMDA), says manufacturers almost certainly won’t have enough doses for everyone—at least not at first.
However, the National Academies of Science, Engineering, and Medicine has recommended a way to prioritize distribution in a manner Barrows calls a “equitable and ethical”: High-risk healthcare workers likely will get the first crack at a vaccine, followed by first responders, people with significant health risks, the elderly, and so on.
In Dallas, Cavazos continues to log any symptoms in a secure app weekly to help Pfizer trial coordinators monitor safety. She hopes she received the vaccine rather than a placebo. Her medical practice in Dallas has been swabbing patients for COVID-19 infection since the beginning of the pandemic, and immunization would allow her to continue serving her patients while keeping them and her family safe.
She relishes being part of a greater good: “If I can contribute in a small way by being in a clinical trial, it’s a way to give back to medicine.”
Christians have another issue to wrestle with regarding COVID-19 vaccines. All of the vaccines currently in phase 3 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 Janssen are using them in production. If the only vaccine to make it to market comes from that group, Jeff Barrows says the CMDA will still encourage its members to get the vaccine: “The good that will be accomplished is much, much greater than any complicity with evil ... [that] occurred at a minimum of 35 to 40 years ago.”
The pro-life Charlotte Lozier Institute has published up-to-date information on COVID-19 vaccine candidates and abortion-derived cell lines. It appears a handful of pharmaceutical companies, including giants such as Sanofi Pasteur (in partnership with GlaxoSmithKline) are not using such cell lines for their COVID-19 vaccines. At the time of this writing, those manufacturers have not entered phase 3 testing.
Barrows said Sanofi’s vaccine will likely enter phase 3 trials before the end of 2020, and if safety and efficacy data hold up, it could be available to the public by summer 2021. One caveat: Sanofi hasn’t published data regarding the development of its vaccine candidate. If the Sanofi vaccine is found to have used a fetal cell line during research, Barrows said the wait for another alternative vaccine could be long—and those waiting for it would have a greater likelihood of contracting COVID-19.