A demand by Australian women’s health experts that pregnant and breastfeeding women be included in clinical trials of COVID-19 vaccines was ignored, and doctors say leaving them out is discriminatory.
Representatives of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Breastfeeding Association of Australia, and midwifery expert associate professor Karleen Gribble said pregnant women should have been allowed to volunteer for vaccine trials and the fact they were not means “many more women are at risk”.
Pregnant and breastfeeding women were not included in vaccine trials for COVID-19 but some women’s health experts argue it was discriminatory not to have included them.Credit:Peter Braig
Dr Nisha Khot, a RANZCOG council member and Western Health obstetrician, said pregnant women should be allowed to opt into trials of the non-live mRNA vaccines and must be included in future testing.
They are routinely left out of phase three vaccine and drug trials, including for the Pfizer and Moderna COVID-19 vaccines, but there is growing pressure here and overseas for their inclusion in future trials to enable the health of pregnant and breastfeeding women to be equally protected.
Many pregnant and breastfeeding health workers and others in the US, UK and Israel are choosing to be vaccinated, Dr Khot said, and this amounts to “non-research research” on pregnant women.
“Pregnant women should absolutely be included in clinical trials; because what’s happening now [overseas] is kind of a trial, but outside of a research setting which is not fair because everybody else who took part was part of a research trial. This non-research research is surely wrong and unethical,” said Dr Khot.
“The way to include pregnant women is to give them the option to opt in based on the information given to them. They should be trusted with that judgment.”
Karleen Gribble, an adjunct associate professor in nursing and midwifery at Western Sydney University, said precautionary omission of pregnant women from trials was “blatant sexism”.
“There would have been a few thousand women willing to do it given the circumstances,” she said.
“Because they weren’t included, we have millions of women around the world who are being faced with the decision about whether to be vaccinated while pregnant without the evidence.”
On Tuesday, RANZCOG advised that most pregnant women should not get a COVID-19 vaccine yet due to insufficient data and low case numbers in Australia.
RANZCOG president Dr Vijay Roach said it was “reasonable to wait for more data”.
Naomi Hull, a senior manager of research at the Australian Breastfeeding Association, said barring pregnant and breastfeeding women from trials “leaves them in a position of uncertainty about what should be quite an important health decision”.
“Particularly given the type of vaccination that it is [mRNA] the ABA advocates for future inclusion of pregnant and breastfeeding women in clinical trials,” she said.
In the US, the CDC and American College of Obstetricians and Gynecologists advised pregnant women to make a personal choice about COVID-19 vaccination. The CDC noted those who contract COVID-19 while pregnant are at greater risk of severe illness and of “adverse pregnancy outcomes”.
It stated “based on how mRNA vaccines work, experts believe they are unlikely to pose a specific risk for people who are pregnant”. “MRNA vaccines do not contain the live virus that causes COVID-19 and, therefore, cannot give someone COVID-19.
We knew we needed a vaccine trial to cover the whole population including pregnant and breastfeeding women – and they weren’t.
“Additionally, mRNA vaccines do not interact with a person’s DNA because the mRNA does not enter the nucleus of the cell. Cells break down the mRNA quickly,” the CDC said.
Associate Professor Gribble said 19 maternal and women’s health organisations wrote to the American National Institutes of Health and the Food and Drug Administration arguing pregnant women should be in COVID-19 vaccine trials and a similar letter was sent to the Australian government in May 2020 by organisations including RANZCOG and the Australian Breastfeeding Association.
The US Coalition to Advance Maternal Therapeutics, whose signatories included the American College of Obstetricians and Gynaecologists and American Academy of Pediatrics argued “there needs to be a cultural shift to protect women through research rather than protecting them from research.”
Millions of women around the world … are being faced with the decision about whether to be vaccinated while pregnant without the evidence.
”We knew we needed a vaccine trial to cover the whole population including pregnant and breastfeeding women – and they weren’t,” said Associate Professor Gribble.
The ABA’s Naomi Hull confirmed she had co-signed the Australian letter but that it never received a reply.
Writing in The Conversation on December 20, infectious diseases professor William Petri, of Virginia University, said his advice to pregnant patients was “you can and you should get a COVID-19 vaccine if you are either pregnant or breastfeeding”.
“In a study of 23,000 pregnant women with symptomatic COVID-19, the Centers for Disease Control and Prevention reported pregnant women were 3 and 2.9 times more likely to end up in the ICU or on mechanical ventilation, respectively,” he wrote.
“Neither the Pfizer nor Moderna COVID-19 vaccine contains the live SARS-CoV-2 virus, so there is no risk of the pregnant woman or her fetus developing COVID-19. These vaccines are safe for another reason.
“The mRNA used in both vaccines to stimulate a protective immune response never enters the nucleus of a cell. That means it doesn’t interact with the DNA that encodes the human genome of the mother or fetus.”
He added the caveat that safety data is lacking because pregnant women were intentionally excluded in phase studies for both vaccines.
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