Pfizer-BioNTech on Thursday Start of clinical trial The first such trial involving pregnant women in the United States of its COVID-19 vaccine in pregnant women
Pharmaceutical companies aim to enroll approximately 4,000 pregnant women in the study. This includes 24-34 week old women over the age of 18 in the United States, Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the United Kingdom. Eligible for their pregnancy.
According to Pfizer, the first dose will be in the United States.
Dr. Brenna Hughes, an expert in maternal-fetal medicine at Duke Health in Durham, North Carolina, said Pfizer “absolutely praises” the study of vaccines in pregnant women.
“There is an urgent need for any data that will help pregnant patients reassure that vaccines are safe for them,” said Hughes, a member of the American College of Obstetrics and Gynecology.
Dr. William Gruber, senior vice president of vaccine clinical research at Pfizer, said, “We started this study in pregnant women with the safety to potentially support the use of vaccines by important subpopulations. We are proud to continue collecting evidence of effectiveness. ” In the statement.
Some women get real shots, while others get placebo. They do not know what kind they received until they gave birth. At that point, the vaccine will be given to women who have obtained the placebo.
Researchers monitor the negative side effects of women, including miscarriage. Some women in early studies of the COVID-19 vaccine became pregnant while participating in clinical trials, so there are some preliminary data on safety during pregnancy.
“There is no danger signal from everything we’ve seen from vaccinated pregnant women,” said Stacey Stewart, president of the March of Dimes.
However, there is evidence that COVID-19 itself can be harmful to pregnant women.
according to Centers for Disease Control and PreventionPregnant women infected with SARS-CoV-2, the virus that causes COVID-19, are at increased risk of complications such as preterm birth and preterm birth. You need to wear a ventilator..
“We’re in a pandemic,” Hughes said. “We are not in a situation where we can actually take risks, and in my view we do not provide vaccines to all potential individuals who may benefit.”
Currently, there is no clear guidance from the CDC on whether pregnant women should be vaccinated against COVID-19. Authorities say women “may choose to be vaccinated.”
Pfizer’s study will follow newborns for 6 months after birth to see if antibodies from the mother are transferred to the baby.
There is precedent for such protection. Babies born to women who have been vaccinated against the flu have a level of protection from the flu for at least 6 months before they can be vaccinated.
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