The world of clinical research has historically excluded pregnant people. Most drugs currently available have not been trialled in this group to see if they are safe, either for parent or unborn child.
The situation with Covid-19 is no different. Only in recent months have some of the vaccines currently approved for Covid-19 begun to be studied in pregnant people.
This is despite the evidence that the disease is far deadlier for those who contract it while carrying a child.
According to a survey of 9,000 pregnant women conducted by UK campaigning group Pregnant Then Screwed, three-quarters of respondents said they feel anxious about the easing of Covid-19 restrictions.
The survey also found that 40% have not had a single dose of an approved vaccine and only 21% have had two doses.
The group’s founder Joeli Brearley has said, according to The Guardian, that pregnant women were the only vulnerable group not to have been prioritised for the vaccine, and misinformation had “spread like wildfire” causing many to not want to get jabs.
“Welcome to freedom day. The day thousands of pregnant women, who have been repeatedly forgotten by the Government, have no choice but to go into lockdown to keep themselves safe,” tweeted Pregnant Then Screwed on 19 July. “It could have been so different if they had been considered from the outset.”
The pregnancy paradox
Research is increasingly showing that pregnant people are more at risk of getting seriously ill if they contract Covid-19, particularly in their third trimester.
New data from the UK Obstetric Surveillance System (UKOSS) shows that one in ten pregnant women admitted to hospital with symptoms of Covid-19 need intensive care.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women who contracted a symptomatic Covid-19 infection were two to three times more likely to give birth prematurely.
A study published in the American Journal of Obstetrics and Gynecology found women who tested positive for Covid-19 around the time of birth were twice as likely to have a stillbirth.
Despite these concerning findings, virtually all Covid-19 vaccine trials have excluded pregnant or lactating people from participating in them.
It’s only very recently that trials in this vulnerable group have begun.
In June, the US National Institutes of Health (NIH) started MOMI-VAX, a new clinical study to assess immune responses induced by Covid-19 vaccines in pregnant or postpartum individuals.
Researchers will measure the development and durability of antibodies against Covid-19 in people vaccinated during pregnancy or in the first two months after delivery. They will also assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
This month, Moderna also announced that it was soon to start trials in pregnant people.
However, many experts and expectant parents believe it is too little too late, as vaccine hesitancy in this group has become rife because of all the mixed messaging they have received.
“It is high time pregnant women’s needs are considered and prioritised by the government before more tragedies occur,” said Brearley, who has implored the government to prioritise pregnant women for the vaccine and promote clear information.
Advice from doctors, governments and industry bodies alike around getting inoculated against Covid-19 while pregnant has been mixed and inconsistent.
As the Journal of the American Medical Association (JAMA) reports, January 2021 was a hotbed for contradictory advice for those expecting.
On 7 January, the US Centers for Disease Control and Prevention (CDC) updated its Covid-19 vaccination guidelines for pregnant people: “Based on how [messenger] RNA [Pfizer-BioNTech and Moderna] vaccines work, experts believe they are unlikely to pose a specific risk for people who are pregnant.” The CDC said that, ultimately, vaccination “is a personal choice for people who are pregnant.”
The very next day on 8 January, in a recommendation about the Pfizer-BioNTech vaccine, the World Health Organization (WHO) recommended withholding the vaccine from pregnant women unless the benefit of vaccination outweighs the potential risk.
A few weeks later on 25 January the WHO issued an interim recommendation for use of Moderna’s vaccine, giving the same advice it gave for pregnant women in its recommendation about the Pfizer-BioNTech vaccine.
In reply to the WHO’s recommendations to withhold vaccines from pregnant people unless they are at high risk of exposure or severe Covid-19, on 27 January the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) issued a joint statement reaffirming that all pregnant individuals should be able to decide whether they want to be vaccinated against a potentially life-threatening virus.
“The conflicting information being provided to pregnant individuals stems from long-standing obstacles to the inclusion of pregnant and lactating people in clinical research,” declared Eunice Kennedy Shriver National Institute of Child Health and Human Development director Diana Bianchi and co-authors in a JAMA Viewpoint editorial about the need to involve pregnant people in Covid-19 vaccine research.
In April, pregnant people in the UK were advised by the JCVI to have the Pfizer/BioNTech or Moderna jabs, after data from the US CDC showed that about 90,000 pregnant women had been vaccinated without any safety issues.
Then in May, the government announced it would amend the system to let pregnant women select their vaccine, after organisations representing obstetricians, GPs and midwives said they were being passed “from pillar to post.”
Hesitancy from healthcare practitioners
Pregnant people have been left to do their own research about whether to be vaccinated or not, with little concrete clinical evidence about the jabs’ safety profile for them and their foetuses.
To make matters worse, there have been several anecdotal reports that pregnant people are receiving unhelpful advice from the doctors and midwives that they turn to.
“One reason #pregnant people are having trouble deciding if they should get the #COVID19 #vaccine is because not all midwives and GPs feel confident about the evidence on this,” tweeted immunologist working on pregnancy at Imperial College, Viki Male.
Social media consultant Jen Thorne said she was “shocked” when a midwife said to her, “probably don’t want to risk another thalidomide situation by having the vaccine.”
Yep – I was told by midwife ‘probably don’t want to risk another thalidomide situation by having the vaccine’. Shocked that a midwife would say this for many reasons! https://t.co/LatzyRytzd
— Jen Thorne (@beautyjunkieldn) July 11, 2021
Ceri Williams, who was 30 weeks pregnant at the time, said she had to “fight” for her second jab and that “support from midwife and healthcare professionals has been awful. I was asked repeatedly yesterday at the vaccination centre if I was sure about going ahead – I felt judged and it was very upsetting.”
Male-dominated JCVI partly to blame in the UK?
UK Minister for Mental Health, Suicide Prevention and Patient Safety Nadine Dorries said she was “shocked” to discover the number of men and women on the JCVI suggesting that scientific committees taking decisions about women’s health should have a gender balance.
The Government’s JCVI webpage lists 16 members – 12 men and four women.
“I am unsurprised at the JCVI not emphasising or prioritising pregnant women for vaccination,” said the MP.
“That is a point I am raising within the department and in particular with the women’s health strategy – because maybe all scientific committees that make decisions about women’s health should have a gender balance.”
Better info and inclusion on the horizon?
While there is now evidence available to show that Covid-19 vaccines are safe for people who are pregnant or breastfeeding and their infants, with more than 130,000 people who received one while pregnant or breastfeeding joining the V-safe registry in the US, the pandemic has shone a light on the historic failing and exclusion of pregnant people in clinical trials.
Spurred on by these shortcomings that Covid-19 has bought to the fore, regulators around the world are calling for the inadequacies in research to be addressed through a paradigm shift in the approach to studying drugs, vaccines and other medical products in these populations.