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Eva Marie Uzcategui/Bloomberg via Getty Images

A health worker injects a woman during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Fla. (Eva Marie Uzcategui/Bloomberg via Getty Images)

Health

Lending an arm to end COVID-19

Trials and volunteers assist pharmaceutical companies as they race to make a safe coronavirus vaccine for the public

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.”


Question of ethics

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.  

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Jerome Delay/AP

A mobile unit for COVID-19, HIV, and tuberculosis testing in Johannesburg, South Africa. (Jerome Delay/AP)

Health

A battle against two viruses

As the coronavirus plagues South Africa, aid groups scramble to provide routine treatments to HIV patients

Portia Makamba-Otto, a South African mother of four, first found out she had contracted COVID-19 in June when her flulike symptoms intensified after a week. Her husband took her to a hospital in the capital city of Johannesburg when she became weak and struggled to breathe. 

The experience was extra harrowing for her because Makamba-Otto is also HIV positive. 

Spending two weeks at an isolation center in the city, she remained on oxygen support as her breathing problems persisted. Her experience with HIV regularly brought her in and out of hospitals, but this was the worst yet: “At one point, I thought this was the end for me.” 

Makamba-Otto made a full recovery and afterward returned to work in July as the treasurer at Sister Mura Foundation, which assists migrants living with AIDS. South Africa has the biggest HIV epidemic in the world, with 7.7 million people living with HIV. At the same time, it is the African country hardest hit by the coronavirus, with more than 680,000 cases and more than 16,000 deaths. The combined health crisis has made the situation especially difficult for HIV patients there, and AIDS organizations have had to find creative ways to reach this vulnerable population.

South Africa went into strict lockdown in late March, closing schools, shutting borders, and urging residents to stay home. The restrictions made it more difficult for people living with HIV to pick up their medicine. In South Africa’s eastern Gauteng province, the Department of Health reported a 20 percent reduction in medicine collections, totaling around 11,000 people.  

“We found that with the lockdown, [HIV patients] were scared to leave their homes,” said Dino Rech of the Aurum Institute, a nonprofit working to eradicate HIV and tuberculosis. “We’ve seen some patients drop off treatment as a result of COVID.” While South Africa began a gradual reopening in June, some restrictions on public gatherings remain.

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Yaraslau Saulevich/iStock

(Yaraslau Saulevich/iStock)

Health

Blowing the coronavirus away

As cold weather approaches, consider these ways to minimize indoor coronavirus exposure

Mugs of hot cocoa, falling leaves, and—for those in northern climates—an approaching end to warm evenings outside with friends, 6 feet apart but still together. 

It’s autumn, and the coronavirus has even changed how we think about the changing seasons. We know the virus travels through the air, and as Harvard School of Public Health professor Roger Shapiro told The Hill in May, “It definitely spreads more indoors than outdoors. … The virus droplets disperse so rapidly in the wind that they become a nonfactor if you’re not really very close to someone outdoors.”

So staying outside makes sense while the weather permits. But what about when it doesn’t? Indoors, things get more complicated with that 6-foot rule: Research suggests the virus spreads most efficiently in poorly ventilated spaces. At the website The Conversation, several engineering professors described this by pointing to how the smoke from one cigarette travels to every corner of an indoor room—and sticks around once there. Masks help prevent many virus particles from getting into the air, but how can we further reduce the risk of indoor transmission?

The simplest solution is the way we’ve all cleared the air after burning dinner: Just open a window, or better yet, several windows. A box fan in a window would speed up air exchange further. To consider airflow more precisely in settings like schools and churches, a carbon dioxide meter lets us quantify how we’re doing: People breathe out carbon dioxide, and it builds up when air stagnates. Conversely, when ventilation improves, carbon dioxide levels go back toward the near-zero level in outdoor air. (Note that carbon dioxide is the stuff we exhale, while carbon monoxide is the odorless, poisonous stuff in car exhaust.)

When falling temperatures make open windows impractical, air purifiers can still help remove the virus from the air. Their effectiveness does vary, and the simple, charcoal-based filters that take odors out of a room won’t remove meaningful amounts of virus from the air. HEPA filters, those old friends of hay fever sufferers, will. They won’t remove every last bit of virus, but they can reduce its load substantially. Other filter technologies exist but aren’t normally used in residential homes. For commercial settings, a powerful UV-C light system—installed inside an air duct or otherwise aimed away from eyes—can also help disinfect air.

Where a budget allows it, the best solution combines warmth with fresh air: A “heat recovery ventilator” exchanges stale air for fresh air from outside, and it also recycles the heat, using the stale air to warm the colder air coming in. Heat recovery ventilators aren’t cheap, but they work. My own church installed one several years ago, and testing with a carbon dioxide meter revealed that the system refreshed the air inside the church much better than opening the doors would have. They’re also more economical than leaving windows open in the winter.

Apart from the amount of virus in the air, one other factor affects potential viral exposure indoors: the amount of time you spend breathing that air. When all else fails, Mom’s time-honored advice for visiting friends still applies—don’t stick around until they wish you’d leave.

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