But there are more pernicious reasons: they drive up the cost of running clinical trials, as their children need to be followed up, and they might push up the cost of insurance. Pharma companies worry about facing litigation.
Meanwhile, the position of experts is approaching unanimity. The Australian and American colleges of obstetricians and gynaecologists, the Australasian Society for Infectious Diseases Vaccination Special Interest Group, the US National Institutes of Health and Medicine, and the overarching Council for International Organisations of Medical Sciences are all on board with including pregnant women in vaccine trials, and often have been for years.
Dr Claudia Richartz inoculates a healthcare worker against COVID-19 in Brandenburg, Germany. Credit:Getty
And yet here we are – with 75 per cent of COVID-19 clinical trials banning pregnant women and with essentially no data on the safety of vaccines.
We stuffed this up with the Ebola vaccine, and here we are again.
This is causing something close to apoplexy among experts – and among some of my friends.
“Carrying a fetus does not suddenly remove a woman’s ability to think,” science journalist and mother Rachel Williamson tells me.
“Pregnant women already live in a grey area, unsure if they can drink coffee or even sleep on their back. So giving them that ability to choose to do a clinical trial, or even just relevant data about the vaccine, would give them something to work with.”
Another friend who has just had a baby points out that pregnant women are already taught to be scared about even minuscule risks.
“With this in mind, it is difficult to see how any woman would opt in to a clinical trial,” she says.
“Saying that, if I knew the risks and was pregnant, I would at least consider taking part. I think it’s important for global health and broader society.”
In an article for the New York Times, Yale’s Alice Lu-Culligan sets out a range of reasons why not getting vaccinated when pregnant poses a higher risk than the vaccine itself.
But that relies on basic science and animal data, not human data.
“The ethics of this blanket exclusion are bad,” she tells me.
“The barriers against the inclusion of pregnant women need to be reduced – they should have been given the option to provide their informed consent to participate in the vaccine trials, as many doctors and patients were advocating very early on.”
To make matters worse, many pregnant women are going to be vaccinated anyway – probably those with other risk factors such as diabetes – despite there being no safety data.
This leaves us in the ridiculous position of giving a drug to pregnant women that we refused to test on pregnant women. It passes the risk from scientists to individual women. “Non-research research,” Dr Nisha Khot, a Royal Australian and New Zealand College of Obstetricians and Gynaecologists council member and Western Health obstetrician, terms it.
Meanwhile, government surveys indicate it is women aged 30 to 39 who are most likely to hold concerns about vaccine safety.
Is there a relationship? It’s complex – pregnancy has long been known to make women more vaccine-hesitant – and we don’t have any firm evidence to prove it, but leading vaccine hesitancy researcher Professor Julie Leask certainly thinks so.
“I don’t know if the exclusion from clinical trials encourages vaccine hesitancy. But I would much rather be in a position where I have complete safety and efficacy data to inform pregnant women,” says Monash’s Professor Giles.
And let’s not forget women in more disadvantaged countries, who face real challenges accessing healthcare. For them, getting a vaccine is a matter of life or death, says Murdoch Children’s Research Institute vaccine expert Professor Fiona Russell. “We need a major rethink about this.”
It should not be this way.
Science and health explained and analysed with a rigorous focus on the evidence. Examine is a weekly newsletter by science reporter Liam Mannix. Sign up to receive it every Tuesday.
Liam is The Age and The Sydney Morning Herald’s science reporter
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