The pharmaceutical company Pfizer and its German partner BioNTek have started a study of their covid-19 vaccine on pregnant women, and it is being carried out in nine countries.
The companies announced today that the first volunteers received the vaccine in a study involving about 4,000 healthy pregnant women over the age of 18. Some will receive two doses of the vaccine and others a placebo, three weeks apart and between 24 and 34 weeks pregnant.
Volunteers will be monitored for seven to ten months, depending on whether they received the vaccine as a placebo, to see how effective and safe the vaccines are in pregnant women. The study included women from the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Spain and the United Kingdom.
“Pregnant women have an increased risk of complications and the development of severe covid-19. It is critical that we develop a vaccine that is safe and effective for them,” said Dr. William Gruber, Head of Pfizer’s Clinical Research and Development Division.
Pregnant women were excluded from previous studies of the vaccine, which received approval for emergency use in the United States, the European Union and other countries.
When babies are born, mothers who have received a placebo will be vaccinated against covid.
The study will monitor the effect on babies for about six months, check the safety of the vaccine and whether they received protective antibodies from their mothers.
The companies plan to start vaccinating children aged five to 11 and younger than five later this year, to test the vaccine on people with a weaker immune system. Their study on children aged 12 to 15 is currently being evaluated.
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