Mucosal vaccines go directly into the mucosal tissue where infection begins – for example, intranasally or via tablets. If they could induce…
Meet the Women Leading Vanguard Covid-19 Vaccine Trials: A Sign of Progress & Reminder of What’s At Risk
Good news and inspirational women are coming in this post, I promise! But first, there’s a bunch of grim reading. Back in 2017, I wrote about pockets of de-feminization in science’s past. Women’s involvement in science hasn’t been a trajectory of straight-up progress. Progress was generally uneven, tending to be mostly for more socially advantaged, white women. Then, from time to time, women’s participation in sciences has plummeted, as they’re left behind or driven out.
I wrote about a few examples. Botany at the end of the 19th century. Science generally when women were shoved out to make more room at the top for men swept into universities on scale with the US’ GI Bill at the end of World War II. The de-feminization of computer science in the US in the 1980s. I said we needed to learn from the study of this phenomenon, because it could happen again.
And then 2020 happened.
Economic research is booming in the pandemic, but who’s doing all that coronavirus-related work? Noriko Amano-Patiño and colleagues are seeing worrying signs: “Our preliminary analysis suggests that the productivity of female and, more generally, midcareer research economists has been disproportionately affected by the lockdown measures. It is mostly senior male economists who are currently exploiting the myriad research questions arising from the COVID-19 shock”.
There have been signs of an uneven drag on productivity elsewhere, too. Over at the major preprint servers, bioRxiv and medRxiv, a rough and ready gender analysis by Megan Frederickson from the University of Toronto found “the number of male authors is growing faster than the number of female authors”, possible signals that a new gender gap could be prising its way into science. In an analysis of journals, Jens Peter Andersen and colleagues concluded that the pandemic may have “amplified [the] gender gap in the medical literature”, too.
Meanwhile, in a report for the Bill and Melinda Gates Foundation, Luba Kassova reports on data from 6 countries: the voices of male experts are swamping female ones in the media about the coronavirus, and despite the heavy burden women and girls are carrying as care workers and in families, the male perspective on the pandemic is swamping that out, too. The consequences could be dire:
The absence of women’s perspectives in COVID-19-related news coverage means that women have limited influence over the framing of the crisis in the news and consequently, limited influence over policymaking directions. As a result, women are at ever greater risk of being further marginalized within different societies amid the most significant global health crisis of our lifetimes.
National Covid-19 task forces have the same problem: Dheepa Rajan and co report that “female representation is particularly paltry”, with women typically being less than a quarter of the group, and none at all in some countries. The US White House task force? 2 women; 21 men. Out of the countries they could assess, just one task force had more women (42) than men (26): Portugal.
Nancy Spector and Barbara Overholser wrote in JAMA about the risk of women in academic medicine “sliding backwards”, noting: “For Black women, the picture may be even more threatening”. In Undark, Teresa Carr discussed the “silencing of female expertise” in coronavirus coverage: “Once you notice the dominance of the (typically White) male expert, it’s hard to un-see it”.
I’ve been spending a lot of time following the development of Covid-19 vaccines, and when I first decided to write a post on gender and clinical trial leadership, I expected the story there to be just as grim. Women often coordinate clinical trials, doing the really hard day-to-day slog and generating much of the knowledge and many of the insights, it’s the principal investigators who get the , and as Jill Fisher writes, it’s very gendered. She points to studies in the mid-2000s, 82% of clinical trial principal investigators in the US were men, while coordinators are predominantly women.
I was looking for people listed as principal investigators or specific leadership roles on clinical trial register entries, first or last authors of preprints/papers of trials in humans, and women prominently associated with the trials who are profiled or speaking in the media.
I didn’t try to work out the proportion of women in leadership positions. And we don’t know yet who will be the leading and senior authors of the big phase III papers. But although I’d started off assuming the worst – I even had the question Are they unicorns? in one of my notes at the start – there was at least one woman in a leading role for all of the frontrunner vaccines. In fact, I’ll now look at the Covid-19 vaccine race as driven, to a large extent, by a powerhouse of 50- and 60-something women.
Before we get to the women, some notes: I was only chasing down people with first names that are typically female. After that, I could often find only the most negligible information searching in English. My deep apologies if I have overlooked anyone who’s not a man (and please do let me know of others who should be in this list).
Secondly, I’m not addressing the science side here, just the person’s leadership role. Nor am I addressing the politics behind the vaccines and the trials, or the countries and companies for/in which these women are working. That’s not because I think science and clinical trials are completely separate from political, human rights, or corporate issues. This was just a very narrow exercise.
As of the end of September, there are vaccines from 8 groups in phase III trials around the world. Let’s start with the woman who is the most prominent and celebrated in her country: Major General Chen Wei (PhD), from the Chinese Academy of Military Medical Sciences, who is one of the 4 people (and only woman) awarded the title People’s Hero for their contributions during the Covid-19 outbreak. Wei has leadership roles in the phase 3 trial for the 2 Sinopharm vaccines that were the first to be fully recruited, and in CanSino’s as well. Her Wikipedia page lists her as an epidemiologist, whose bachelor’s degree was in chemical engineering.
Here’s the best life story about her that I could find in English (with several great photos, too). Although she was born in 1966, this story only goes back to the SARS outbreak in 2013. She was away from her family for almost six months, working with a team on isolating the virus and developing a nasal spray that aimed to protect medical works. It was arduous: “Every time before I went into the lab, I tried not to drink or eat, and sometimes I would wear adult diapers just for staying inside longer”. In 2018, when she went to Sierra Leone to help in the ebola outbreak, developing an ebola vaccine that was used in Africa. With Covid-19, it was 50 days from her arrival in Wuhan till they had a vaccine ready for clinical trials. You can read more about the Chinese “military-civil infusion” for Covid-19, including Wei’s role, here.
Many people have been irritated by their lockdown hair situation. For Wei, though, it’s tells the story of her Covid-19 experience in Wuhan, where she was deployed the day after Chinese Lunar New Year in January. It’s worth watching this 3-minute video, to see what it was like, and for the tribute to the thousands of female frontline workers in Wuhan. (The hair part? She had it chopped short because of the amount of time in the protection gear and negative pressure laboratory. And she started out with totally black hair in January, with lots of white by April.) Here’s another 3-minute promotional video, highlighting Wei in the CanSino vaccine development process.
Let’s get round other women leading in clinical trials for the group of Chinese vaccines in phase 3 trials – that’s the 3 already mentioned, plus CoronaVac by Sinovac. And we get to the extraordinary achievement of Nawal Al Kaabi, where she’s leading the first phase 3 trial to fully recruit its first targeted sample size, in the United Arab Emirates (UAE). It’s called the #4Humanity trial, and as far as I can see, has managed to recruit at a speed none of the others has yet gotten close to: 7,000 people a day at a high point, with a converted convention center running incredibly long hours to pull it off. You can see film, including Al Kaabi being interviewed, here.
Al Kaabi is the Chief Medical Officer for a health service in Abu Dhabi, and chair of the country’s Clinical National Committee for Coronavirus. She’s a pediatrician and vaccine researcher who trained in both UAE and Canada. You can see a presentation she gave about the trial in a streamed seminar here. When the UAE authority was deciding on emergency use authorization for the vaccines, Al Kaabi discussed trial results there, too, but data hasn’t been published yet.
And in Sinopharm’s Argentinian trial, Florencia Cahn is listed as principal investigator for the Buenos Aires center. Cahn is an infectious disease specialist, and President of the Argentine Society of Vaccination and Epidemiology. She’s interviewed here, and profiled here and here.
Listed as a contact, but not principal investigator, for the CoronaVac trial in Indonesia, check out Novilia Sjafri Bachtiar, the impressive Head of Surveillance and Clinical Trial Division of the country’s state-owned vaccine manufacturer, which is a major player for Covid-19 vaccines there. (CoronaVic was developed by Sinovac, which is part of the same structure as Sinopharm.)
Back to the CanSino vaccine now, where one of the principal investigators in its large international phase 3 trial comes from Canada. (The name, CanSino, reflects the starters’ ties to both Canada and China.) She’s co-chair Canada’s Covid-19 Vaccine Task Force, Joanne Langley, and the woman in the middle of this montage:
Langley is a pediatrician and epidemiology, specializing in infectious diseases. As well as her leading role in academic life, her university bio reflects long involvement in public service roles nationally for vaccines. And she was interviewed by CBC radio, on safety in Covid-19 vaccine trials.
To England next. Sarah Gilbert, probably the most prominent face for the Oxford/AstraZeneca vaccine, was profiled in BBC radio’s, The Life Scientific.
Gilbert is a biologist and vaccinologist from Oxford University, who is also co-founder of the company that’s developing the vaccine, working with AstraZeneca. Her career has been in academic and pharmaceutical company labs. Like many (most?) of the women in this post, she’s a mother but I think it’s safe to say she’s probably the only one who has triplets, and she says, that was good training for what 2020 has been like for her: “If you get four hours a night with triplets, you’re doing very well. I’ve been through this”. Her principal work prior to Covid-19 was directed to trying to develop a universal flu vaccine.
Over to the US now, and the other vaccine that was first injected into people at the same time as the first Chinese vaccine was. Lisa Jackson is leading the NIH/Moderna phase 3 trial. It really says something, doesn’t it?, that I couldn’t find a picture of her in a tweet to embed here – or much about her at all, really. (I have resorted to embedding tweets for photos in this post, because of the lack all round of clearly copyright-free photos of all these women scientists.)
Jackson is an internist and infectious disease epidemiologist, and she talks about the vaccine and trials here at CNN, and she appears in this video, and this NPR interview.
Now we get to the BNT/Pfizer vaccine, which has seen it leapfrog over the other Euro-American vaccines seems to be in pole position for first phase 3 results, there’s Kathrin Jansen, who was profiled in STAT News. Which includes discussing leading a 650-person team via Zoom meetings!
Jansen is the Head of Vaccine Research and Development for Pfizer, and she’s another towering figure in vaccines. She grew up in the former East Germany, and her interest in drug development was spurred by frequent bouts of illness as a child. The family fled to West Germany just before the Berlin Wall went up, drugged with sleeping tablets so she wouldn’t spill any beans to border guards.
Jansen studied biology at the University of Marburg in Germany, and then did a postdoctoral fellowship at Cornell in the US, and her career has been in the pharmaceutical industry. She moved to the US in 1992 and pursued her concept of a yeast-based HPV vaccine: so Gardasil is a notch on her belt, as is a pneumococcal vaccine. The strong connection with the German company, BioNTech (BNT), that developed the BNT/Pfizer also makes sense as you read about her.
Next, we’re back to Europe. The Johnson & Johnson (J&J) vaccine, now in the largest single international phase 3 trial, doesn’t seem to have named principal investigators yet. Hanneke Schuitemaker is the Global Head of Viral Vaccine Discovery and Translational Medicine at J&J’s Janssen Vaccines and Prevention – and a professor of virology at the University of Amsterdam. Schuitemaker led the vaccine’s development and was senior author of the first clinical trial.
Her career path began – and continued – with HIV research, including an HIV vaccine: Results from a phase 3 trial for that are expected in 2021. It was talking with a young HIV+ artist – “I felt so useless” – and his death changed and drove her to pursue that disease.
From another company profile of Schuitemaker: “I really hope we will learn lessons from this period, not only from a virological point of view, but also in terms of how we choose to live our lives”.
The Novavax vaccine is the newest entrant to the Covid-19 vaccine phase 3 trial club. That brings us to Cheryl Keech – another woman I could find little information about. This picture comes from one of her roles, with PPD, a contract research organization. She’s an internal medicine physician, with a PhD in biochemistry and molecular biology: a short company bio is the best I could find. And here’s a little video snippet.
Finally, there’s the Russian vaccine, Sputnik V. That may turn out to be the one with the most women trial authors, although the lead author of the first paper isn’t. The study chair, though, and one of the spokespeople for the vaccine, is Elena Smolyarchuk, Director of the Center for Clinical Research of Medicines at Sechenov University in Moscow. She is apparently a pharmacologist, but I couldn’t find out much about her.
There are lots of gaps, not just in how much is out there about many of these women, but in leadership roles – so far – in trials several parts of the world, particularly Brazil and South Africa. And as I said, I don’t know what proportion of principal investigators of vaccine trials are women. Muge Cevik and colleagues did a study of clinical trial register entries for Covid-19 in general, not just trials. Their rough method didn’t enable analysis of all the trials, but of those they could, the authors concluded that “less than one-third of COVID-19-related clinical trials are led by principal investigators who were predicted to be women” – and that was half what their method showed for trials in breast cancer and type 2 diabetes for the same time period.
Gender gaps aren’t only about responsibilities for children, though. As I’ve written before on the subject of physician-scientists, it’s a gap that could have dire consequences, and factors like the gender pay gap could be contributing, too.
In Spector and Overholser’s commentary on the risk of a Covid-19-driven backslide for women in academic medicine, gender and racial diversity both matter a lot, and “we need to ensure that equity is operationalized”. They point to a letter in Science by Fernanda Staniscuaski and colleagues on the impact of the pandemic on academic mothers, and the urgent need to postpone deadlines and create granting programs that take family needs into account.
Kassova & co’s report on what amounts to “suppression of women’s voices” in coronavirus coverage is a critical area for journalist action, of course. But everyone should try to chip away at it by amplifying women’s voices whenever we can, so keep an eye out for them. If you’re involved with a journal, push for diversity in commissioned editorials and more. Those pockets and waves of de-feminization aren’t just in science’s past any more.
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The cartoons are my own (CC BY-NC-ND license). (More cartoons at Statistically Funny and on Tumblr.)