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NIH begins clinical trial testing COVID-19 vaccine in pregnant women By Reuters

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© Reuters. FILE PHOTO: A woman receives a COVID-19 vaccine at a clinic in Philadelphia, Pennsylvania, USA, May 18, 2021. REUTERS / Hannah Beier / File Photo

By Dania Nadeem

(Reuters) – The US National Institutes of Health (NIH) said on Wednesday they had begun a study to assess the immune responses generated by COVID-19 vaccines in pregnant or postpartum women.

Pregnant women are at increased risk of complications, such as premature delivery, high blood pressure with risk of organ failure, the need for intensive care and possible death, according to the NIH.

A February research study in Israel showed that antibodies were detected in all 20 women given the doses of the Pfizer / BioNTech vaccine during their third trimester of pregnancy and also in their newborns.

Pfizer (NYSE 🙂 and BioNTech in February began a separate trial, with 4,000 international volunteers, evaluating the safety and effectiveness of their COVID-19 vaccine in healthy pregnant women.

The NIH study, MOMI-VAX, will measure the development and durability of coronavirus antibodies in vaccinated women during pregnancy or the first two months postpartum.

The researchers will evaluate the safety of the vaccine and will also evaluate whether vaccinated pregnant women transmit protection to their babies through the placenta or breast milk.

Many pregnant women in the United States have already received the COVID-19 vaccine available under authorization for emergency use.

“The results of this study will fill in the gaps in our knowledge and help inform policy recommendations and personal decision making about COVID-19 vaccination during pregnancy,” said Dr. Anthony Fauci, director of the National Allergy Institute. and Infectious Diseases (NIAID). NIAID is funding the study.

The trial will enroll up to 750 pregnant women and 250 postpartum women within two months of delivery, who have already received or will receive a COVID-19 vaccine cleared by the US Food and Drug Administration (FDA).

The FDA has authorized vaccines of Modern (NASDAQ :), Pfizer-BioNTech and Johnson & Johnson (NYSE 🙂 for emergency use.

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