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Pfizer-BioNTech has announced the beginning of their Covid-19 vaccines clinical trials among healthy pregnant women. These trials will be conducted internationally across 4000 volunteers and are intended to evaluate the vaccines’ safety and effectiveness in said group.
Senior Vice President of Vaccine Clinical Research at Pfizer, Dr. William Gruber released the following statement,
“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.”
According to the CDC, expectant mothers are at a higher risk of having severe Covid-19 and are left vulnerable to complications, premature births, and the need for ventilators. These increasing risks prompted public health officials to push for coronavirus vaccine tests on pregnant women in high-risk professions. These tests will be carried out despite any proof of their being safe for women during pregnancy.
Only last week, the US National Institute of Health demanded wider inclusion of lactating as well as expectant mothers in this research. Maternal health and vaccine experts, and bioethicists alike uphold that pregnant women be part of clinical trials for pandemic vaccines to avoid wait.
However, despite their calls, pregnant women were excluded from nationwide trials intended to gain emergency authorization of the Covid-19 vaccines.
The pharmaceutical companies have explained their initials tests were carried out to make sure the vaccines were generally safe. According to US regulations, drugmakers have to first establish a vaccine’s safety in animals and ensure the fetus is unharmed. The companies reported their animal studies turned out clear and they are now ready to test on pregnant women.
The study will evaluate the vaccine’s efficacy on pregnant women aged 18 and above, from the UK, South Africa, Spain, Mozambique, Chile, Canada, Argentina Brazil, and the US. Women in the have already been given their first shots.
Following birth, women who were part of the placebo trials will be allowed to get the actual vaccine, while being part of the study. Pfizer will also be following the newborns up to six months to evaluate if the mother’s antibodies are transferred to the baby.
Though evidence of the Covid-19 vaccine being suitable for pregnant women has yet to come, many doctors insist the benefits are already obvious. Professor of medicine from New York Medical College, Dr. Bob Lahita, said,
“I recommend highly that all pregnant women be immunized, from the initial discovery of the pregnancy right up to term."He then pointed to the lack of evidence that the vaccine“has any effect on the placenta, on the fetus, on the mother. Except if one gets the infection, the COVID, and you are pregnant, you run the risk of becoming very, very sick."