Pfizer-BioNTech has launched its first Covid-19 vaccine trials for pregnant women, and the company said that the first doses would be administered in the US.
In the study, the company aims to include 4000 expectant mothers who are over 18 years old and are 24-34 weeks into their pregnancy. The participants are from countries including the US, Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the UK.
"We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations," said Dr William Gruber, senior vice president of Vaccine Clinical Research at Pfizer.
Some of the women in the study will get the real vaccine shot and others, a placebo. They will not know which kind they received until after giving birth. At that point, women who consumed the placebo will be given the real vaccine. Researchers will continuously monitor for any negative side effects in women, including miscarriage. The trial will also assess whether vaccinated pregnant women transfer protective antibodies to their babies.
"Now that we are seeing the successful initial implementation of vaccine campaigns with the Pfizer-BioNTech vaccine across the globe, it is time to take the next step and extend our clinical program to other vulnerable populations, such as pregnant women, to potentially protect both them and future generations," said BioNTech Chief Medical Officer Dr Ozlem Tureci in a statement.
Pfizer and BioNTech have clarified that their research had found no evidence of any toxicity posed to the foetus or the mothers. Pregnant women who are typically highly vulnerable to the virus were excluded from the Covid-19 vaccine trials due to the potential risk the vaccine could have on the foetus and also on the mother's health and well-being. However, without the vaccine, pregnant women are again at risk of being infected and hospitalized, necessitating data to prove the vaccine's safety for pregnant women.