Refusal to give pregnant women vaccines branded unacceptable

Failure to vaccinate pregnant women during deadly infectious disease outbreaks is putting them and their unborn children at risk, a new report has warned. 

Pregnant women are usually excluded from vaccination campaigns because vaccines against infectious diseases like Ebola are rarely tested or approved for use in pregnant women.

This approach has led to anger among some that women are being put unnecessarily at risk during the current Ebola outbreak in the Democratic Republic of Congo (DRC). Studies of previous outbreaks showing that between 80 and 90 per cent of all pregnant women who contracted the disease died.

But now a new report from an international group of experts in the United States calls for pregnant women to be included in vaccine development and campaigns.

It says the exclusion of pregnant women from vaccine research and development is unacceptable and “business as usual simply cannot continue”.

The report says that during an epidemic the default should be to offer vaccines to pregnant women, not the reverse, and it urges pharmaceutical companies and biotechs to develop vaccines for this group.

It also says that during an epidemic, decisions about whether pregnant women will be offered vaccines should consider not only any potential risks of the vaccine but also the risks pregnant women and their babies face if vaccines are denied.

The World Health Organization’s Scientific Advisory Group of Experts recently ruled that the vaccination campaign during the current Ebola outbreak in DRC should not include pregnant women.

A poor security situation is hampering efforts to contain what WHO has said is the second worst outbreak of the disease in history, with 453 cases and 268 deaths since August.

Ring vaccination - where the contacts and contacts of contacts of those who have contracted the disease - is now a vital part of Ebola control measures and was seen as a key reason why an outbreak earlier in the year in DRC was quickly contained.

The group said that officials are following a a small number of women who didn't know they were pregnant when they received the rVSV-ZEBOV vaccine.

Carleigh Krubiner, one of the authors of the report from the Johns Hopkins Berman Institute of Bioethics, said that there was a strong case for vaccinating pregnant women against the disease.

She said: “We recognise that decision makers are in a tough situation, since this particular vaccine is not the ideal platform we’d want for use in pregnancy, and that there is very little data on its use in pregnant women since they were categorically excluded from the previous clinical trials.”

Dr Krubiner added that pregnant women were vulnerable during any infectious disease outbreak - this was recognised as far back as 1918 during the deadly Spanish flu pandemic, thought to have killed 50 million people around the world.

“For Ebola, we know that infection in pregnancy nearly always leads to miscarriage, stillbirth or neonatal death, not to mention the high rates of maternal mortality. Lassa fever has been shown to be over five times more deadly among pregnant women in their third trimester, with 87 per cent of women losing their babies,” she said.

Richard Hatchett, chief executive of the Coalition of Epidemic Preparedness Innovations (Cepi), a Wellcome Trust funded body co-ordinating the development of new vaccines, said researchers were still unclear over the effects of vaccines on pregnant women.

“We think pregnant women’s immune systems are altered so that they don’t reject the foetus and that may put them at heightened risk of contracting an infectious disease,” he said.

He said that studies were not routinely carried out on pregnant women - usually data was accumulated when women were vaccinated without knowing they were pregnant.

“At Cepi we’re grappling with how we can take some of these recommendations forward. One of the easy things we could do is carry out reproductive toxicology tests on pregnant animals much earlier in the process,” he said.

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