Pfizer and BioNtech have announced that the companies are going to commence clinical trials of its COVID19 vaccine in pregnant women. These are the first such trials in the US, which will include expecting mothers as well. The officials have said that these trials will target to enroll nearly 4000 pregnant women. The trials will enroll participants from the US, Argentina, Brazil, Canada, Chile, Mozambique, South Africa, and the UK as well. As per the report, women who are into 24 to 30 weeks of their pregnancy will be eligible to take part in the trials. The first dose of the trails will be given to participants from the US, said the experts. Dr. Brenna Hughes, who is a maternal-fetal medicine specialist at Duke Health in Durham, has lauded the decision of the drugmakers to test their vaccine in pregnant women. Hughes has said that any data, which reassures pregnant women that the COVID19 vaccine is safe for them, is required at this time. Dr. Brenna Hughes is also a member of the American College of Obstetricians and Gynecologists. Dr. William Gruber, the senior vice president of Vaccine Clinical Research at Pfizer has said that the company is delighted to start the trials to test the efficacy and safety of the vaccine to support the use of the vaccine by important subpopulations.
In clinical trials, some of the pregnant women will be given real shots and some of them will be given a placebo. Participants will not be informed about which kind of shots they have been given until they give birth to their infants. At that time, women who have been given a placebo will receive the actual vaccine, said the experts. Health experts will be monitoring if there are any negative side effects of the vaccine among women who have received real shots. Experts have said that there are some safety data available for pregnant women as some women who have been included in earlier trials of the COVID19 vaccine have become pregnant during the time they have participated in clinical trials.
The President of the March of Dimes, Stacey Stewart has said that health experts have not seen any red flag among pregnant women who have received the vaccine during the early clinical trials. However, some shreds of evidence show that COVID19 infection might be damaging for expecting mothers. The US Centers for Disease Control and Prevention (CDC) has said that pregnant women who have contracted the SARS-CoV-2 virus, which leads to COVID19 infection, are at a higher risk of many complications such as preterm delivery, stillbirth, miscarriage, or being on the ventilator. Dr. Brenna Hughes has said that amid the pandemic, health officials are not in a position to take any risk and prevent any potential individual from taking the vaccine, who might benefit from it. The CDC has not issued any guidance on whether pregnant women should receive the COVID19 shots yet. The agency has said that such women can choose to be inoculated. The officials from Pfizer have said that they will keep a track of newborns for six months after their births to identify whether the antibodies have been transferred from the mothers to the infants. Experts have said that infants who are born to mothers who have been given a flu shot acquire some level of immunity against influenza for at least six months after their births until they are eligible to get the vaccine.