A specific clinical trial is to investigate the best COVID-19 vaccine schedule for pregnant women, it has been announced.
Researchers hope to find the best way to reassure women at a time when it has emerged that unvaccinated pregnant women are highly vulnerable to the virus.
The British government has deployed £7.5 million for the project, to be led by St George’s, University of London.
Researchers say that nearly 52,000 pregnant women in England have been vaccinated with no safety concerns raised – as have 130,000 pregnant women in the USA.
They also say that pregnant women are more likely than others to fall seriously ill from the virus – and that 98% of those who end up in hospital needing treatment have not been vaccinated.
Participants in the study will have their vaccines either at intervals of four to six weeks or of eight to 12 weeks. Women will be studied intensively to analyse their reactions to the vaccine.
Researcher Professor Paul Heath said: “Tens of thousands of pregnant women have now been vaccinated in both the US and the UK with no safety concerns reported, but we still lack robust, prospective clinical trial data on COVID-19 vaccines in pregnant women. This includes the best schedule to use to maximally protect them against COVID-19.
“We are extremely pleased to commence the Preg-CoV trial, which aims to fill these gaps in our knowledge and will ultimately inform policy recommendations on the optimal use of COVID-19 vaccines in pregnancy.”
Dr Pat O’Brien, vice-president of the Royal College of Obstetricians and Gynaecologists, said: “We welcome this trial as the next step in further monitoring the protection provided by the vaccine, to understand the risk of any potential adverse side effects, and observe the immune response within those who are pregnant and their babies.
“We encourage all pregnant women to get vaccinated, as the protection that it provides against COVID-19 to both mother and baby outweigh the risks. We are seeing more pregnant women being admitted to hospital with COVID-19, and we know that the Delta variant is causing more pregnant women to have severe illness than previous strains of the virus.
“We hope that this research will help to gain the confidence of pregnant women that the recommendation of vaccination in pregnancy is based on robust evidence.”
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