As the nation makes the final push this summer to vaccinate as much of the population as possible, the tremendous achievement of pharmaceutical companies Moderna, Pfizer-BioNTech, and Johnson & Johnson in developing three effective COVID-19 vaccines cannot be overstated. Emergency use authorization of the vaccines by the U.S. Food and Drug Administration—accomplished in less than a year as part of the federal Operation Warp Speed initiative—hinged on the results of clinical trials, which represent stages of testing on humans. Each phase of a trial requires more and more volunteers for evaluating the safety and effectiveness of the vaccine. For Phase III, involving thousands of participants undergoing tests at sites worldwide, Moderna and Johnson & Johnson enlisted Rutgers to conduct the critical trials.

Jeffrey Carson—a Distinguished Professor of Medicine at Robert Wood Johnson Medical School and a provost at Rutgers Biomedical and Health Sciences (RBHS)—was the principal investigator at Rutgers for the Johnson & Johnson trial, the company’s second largest, with 840 participants out of close to 44,000 nationally. Shobha Swaminathan—an associate professor in the Department of Medicine at New Jersey Medical School and medical director of the infectious diseases practice at University Hospital in Newark—was the leader of the clinical research site for Moderna, which was one of two in New Jersey and which had 57 participants of the 30,000 nationally. Rutgers was chosen because of its vast experience in administering clinical trials and because Rutgers could recruit volunteer subjects from New Jersey communities particularly hard hit by COVID-19.

As the race for a vaccine began at the start of the pandemic, Johnson & Johnson was aware that Rutgers had begun a large study to evaluate hundreds of health care workers who had direct patient exposure and non-health care workers who had no direct patient contact. “We made the case that because we had permission to contact these participants for future research,” Carson says, “it would serve as a starting point for recruiting people into a vaccine trial.”

New Jersey Medical School made sense, too. Its Research With a Heart site, which already had been funded by the National Institutes of Health for about 15 years, had conducted multiple HIV and hepatitis clinical trials. “The experience and trust in our clinical site made it easier to pivot to the COVID-19 clinical trial,” says Swaminathan. “Given the rapid timeline required to develop the COVID-19 vaccine studies, clinical sites that were connected to the community, were trusted, and had a record of effectively conducting clinical trials were needed rather than building one from scratch. We didn’t have that kind of time.”

There was a lot of initial spadework before the trials commenced, such as securing contracts, hiring and training additional staff, and getting the word out in the community. For the Johnson & Johnson trial, the university got permission to send emails to the Rutgers community and alumni who live nearby, notifying them that Rutgers was part of a vaccine trial. After giving their consent online, potential participants were asked by the trial team to complete a confidential survey containing their medical and personal information.

“Using all these avenues, including the study of health care worker participants,” says Carson, “we were able to identify about 6,000 people who were eligible for the vaccine trial. Success in clinical research doesn’t happen by chance. Because we were trying to recruit so many people, most of our staff in the clinical research units became dedicated to this study. That made the difference.”

After initially concentrating efforts in Essex County, which was heavily hit by the virus, Swaminathan and her team expanded elsewhere in New Jersey. Participation was voluntary and required those involved to provide their informed consent—after they had received a detailed overview of the study, including possible benefits and side effects. “Participants also had the option to leave the study at any point,” says Swaminathan. “Participation in clinical trials is the only way we can find answers that will ultimately help us all to overcome the COVID-19 pandemic.”

Early in their medical careers, Carson and Swaminathan learned the value of clinical trials for treating and caring for patients. As a fellow at the University of Pennsylvania, Carson performed observational research, which made it clear to him that clinical trials were the gold standard. Carson also did a sabbatical at Oxford University, where he worked with leaders in clinical trial methods and wrote his first National Institutes of Health grant for a clinical trial that evaluated transfusion thresholds in patients undergoing hip-fracture repair. “No doubt, clinical trials have the greatest impact on how patients are cared for,” Carson says.

Swaminathan was introduced to the value of clinical trials through her research interest in hepatitis and HIV. When she came to Rutgers in 2004, treatment options for people infected with hepatitis were very limited. “This piqued my interest because I had many hepatitis B patients and didn’t know how to treat them,” she says. “This pushed me to want to have treatment options for them—which is how I got introduced to clinical trials. Over the years, most of these patients have been successfully treated, with some completely cured of the disease. These successes have been leveraged into other clinical trial opportunities to help save more lives in other disease areas.”

Once the COVID-19 clinical trials were successfully concluded, with the efficacy and safety of each vaccine ascertained, the U.S. Food and Drug Administration issued emergency use authorization for the Moderna and Pfizer-BioNTech vaccines in December 2020 and, two months later, for the Johnson & Johnson vaccine, which had the added benefits of requiring only one shot and not having demanding shipping and storage criteria. Help was finally on the way.

For Carson and Swaminathan and their teams, the work is not over. They will follow up with the participants over the next two years, checking for new infections and doing blood tests to check for immunity. In the meantime, the public is being encouraged to get any one of the authorized vaccines when one is available.

“As I have been saying over and over, take the first vaccine that you can get; don’t sweat which one it is,” says Carson. “The sooner we can vaccinate the country—and the world, of course—the better off we are and at less risk for a COVID-19 variant.”

Story originally appeared in Rutgers Magazine.

Read about Rutgers’ Center for COVID-19 Response and Pandemic Preparedness. 

The 2020 election provided its share of drama. What was less of a surprise, as recent history is proving, was the number of women who ran for public office, leading to another historic year for American women participating in politics. A record-breaking 583 women, representing both major political parties, ran for the U.S. House of Representatives—up from the high of 476 in 2018. The election also marked more firsts for women candidates, most notably the first Black woman and first South Asian-American to run on a major ticket [as well as the first woman elected vice president of the United States]; a surge among women GOP candidates; and the largest number of woman versus woman races, 51, in the nation’s history.

Debbie Walsh and Kelly Dittmar, two oft-quoted scholars with the Center for American Women and Politics (CAWP) at Rutgers University–New Brunswick who were interviewed for this story in September, are encouraged by the statistics, which represent more glass ceilings being shattered. The pair considers Kamala Harris’s vice presidential run nothing short of a watershed moment that further will soften the ground for women presidential candidates in the future.

“Nominating a woman for vice president shouldn’t be seen as revolutionary, but it is. However, I don’t think we will see an all-white-male ticket on the Democratic side again, which makes me feel hopeful,” says Walsh, the director of CAWP. “We can’t overstate the importance of this moment particularly for Black women—especially young Black women—and the recognition of the importance of Black women, who have been the backbone of the party.”

Despite ground gained by women in the last decade, they occupy only a quarter of congressional seats, according to CAWP data. The results of the 2020 election aside, Dittmar and Walsh say there is still much work to do to ensure women are represented equally at all levels of government systems. “There is disappointment that six women were running in the presidential primary and ultimately an older white man was at the top of the Democratic ticket,” says Dittmar, director of research at CAWP and an associate professor of political science at Rutgers University–Camden. “You’re seeing a lot of us grappling with that.”

“Women are still seen as a bit of a novelty,” says Walsh. “The fact that we are celebrating firsts and keeping track of woman versus woman races speaks to that. When is the last time you heard, ‘Oh, it’s going to be an all-male contest!’ ” So, when will the political playing field be level? When women running becomes unremarkable, Walsh and Dittmar say, and when gender-specific questions, especially those related to electability, go unasked. Achieving this equity requires stronger support for recruiting and financially backing women candidates, says Dittmar. And the barriers that uniquely burden many women on the campaign trail and in political life, such as the need for childcare, should be identified and removed.

“At the same time, a strong case needs to be made that it’s worth it,” says Dittmar. “You can create all the access women need to run, but if they think politics is ridiculous and that you can’t get anything done, they won’t run.”

In 2020, not only were more women taking the political plunge, but those who did were more diverse in ethnicity, sexual identity, education, and profession than ever. And they ran more authentic and unapologetic campaigns, building on a trend that gained traction in 2018. “The question was, ‘Is 2018 going to be a one-off?’ ” Walsh says. “But in 2020, things once seen as vulnerabilities were seen as strengths.”

In 2018, instead of shying away from the subject of motherhood, women talked about the strength and skills they gained as mothers, with a few even nursing their infants in campaign ads. They spoke about coming from homes disrupted by violence or shared their experiences with homelessness, addiction, and financial insecurities. Their straight talk resonated with voters, says Walsh.

Dittmar believes this shift in women’s campaigning styles has occurred over time, but she credits Hillary Clinton’s 2016 bid for the presidency and arrival of the #MeToo movement in 2017 with upending the way women run today.

“When Hillary Clinton ran for president in 2008, it was very much about proving she was man enough. In 2016, she ran in a way that was much more embracing of who she was as a woman and a mother,” says Dittmar. “In 2018, there was this national reckoning with #MeToo and gender equality, and women had more space to embrace it. In 2020, we saw a continuation of that.”

But that’s a narrative largely told within the Democratic Party alone, the pair points out. Unlike 2018, this year’s election included a robust slate of women running on Republican tickets, most of whom eschew identity politics. “Women Republican candidates don’t advocate for a given number of women on governing boards because to them it’s about getting the best person for the job. They are less likely to focus on being a woman and how that changes their approach,” Dittmar says. “The Republican women who ran for the House this year had a formula: they were pro-life, pro-Trump, pro-guns, and anti-socialism.”

“Thirty-six new women were elected to the House in 2018 and only one of them was a Republican. Some of what we are seeing is a response to that,” says Walsh. “They want to have a voice—a very conservative, anti-‘Squad’ voice—in the mix. They want to have more like Marsha Blackburn in Congress,” referring to the Republican U.S. senator from Tennessee who was elected in 2018.

By the same token, pollsters should stop viewing “suburban white women” as a homogeneous demographic of voters, says Dittmar. They are a varied group whose politics swing left or right depending on age, education, economics, and sexual identity. However, one bloc of women who have been reliably Democratic are Black women voters, whom Democrats have taken for granted, according to Walsh and Dittmar.

“Black women are the most dependable bloc of voters, with well over 90 percent voting Democratic in the last three presidential elections. And when U.S. Senator Doug Jones (D-AL) got elected in 2017, everyone was thanking Black women. But Black women are saying ‘stop thanking us and do something for us. Pay attention to what’s affecting our lives and our communities,’ ” says Walsh. “They want some return on their vote. Kamala Harris’s nomination was an acknowledgement of the value of Black women to the party and gave a woman of color a seat at the most powerful table.”

Now that the 2020 election is over, with both women candidates and voters having had a considerable impact on it, what’s on the horizon for women in politics in 2022 and beyond? If participation continues to rise at current rates, Dittmar and Walsh say more firsts will invariably take place—including a woman as president.

In 2020, not only were more women taking the political plunge, but those who did were more diverse in ethnicity, sexual identity, education, and profession than ever.

 

Story originally appeared in Rutgers Magazine.