NIH begins study of COVID-19 vaccines in pregnant recipients
BETHESDA, Md. - The National Institutes of Health announced on Wednesday that it has begun an observational study to evaluate how pregnant or postpartum recipients react to COVID-19 vaccines.
For the study, researchers will measure the development and durability of antibodies to fight COVID-19 in people who get vaccinated during pregnancy as well as vaccinated individuals during the first two postpartum months.
Researchers say they also hope to understand how the antibodies of the COVID-19 vaccine can impact unborn children.
The study is being referred to as MOMI-VAX and is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), a medical wing of the NIH.
"Tens of thousands of pregnant and breastfeeding people in the United States have chosen to receive the COVID-19 vaccines available under emergency use authorization. However, we lack robust, prospective clinical data on vaccination in these populations," said Dr. Anthony Fauci, director of NIAID and the nation’s leading expert on infectious diseases.
"The results of this study will fill gaps in our knowledge and help inform policy recommendations and personal decision-making on COVID-19 vaccination during pregnancy and in the postpartum period," Fauci said.
The NIH said data from its study on pregnant people will hopefully bring peace of mind to those wishing to be certain that getting a shot is safe.
"Pregnant people with COVID-19 are more likely to be hospitalized, be admitted to the intensive care unit, require mechanical ventilation, and die from the illness than their non-pregnant peers. Severe COVID-19 during pregnancy also may put the infant at risk for complications such as preterm birth," the NIH writes.
For the study, 750 pregnant people and 250 postpartum individuals within two months of delivery who have all received COVID-19 vaccines will participate. The infants of the postpartum individuals will also participate.
Data published in April by the U.S. Centers for Disease Control and Prevention found that women make up a majority of those reporting negative side effects from COVID-19 vaccines.
The report consisted of data from the first 13.8 million vaccine doses administered to Americans between Dec. 14, 2020 and Jan. 13, 2021. Of those doses, 61% went to women. Of the 6,994 people who reported experiencing side effects from the vaccines, 79% were women.
Headache, fatigue and dizziness were the most frequently reported symptoms after vaccination, according to the CDC study.
In a separate CDC report published on Jan. 15, researchers said that "most reported anaphylaxis cases after receipt of Pfizer-BioNTech COVID-19 vaccine occurred in women." Anaphylaxis is a life-threatening allergic reaction that can occur after vaccination.
In January, the CDC published a report saying that out of more than 4 million of the first administered doses of the Moderna COVID-19 vaccine, only 10 cases of anaphylaxis — a rare, life-threatening allergic reaction — have occurred.
The CDC says anyone who has experienced anaphylaxis after getting the first dose of a COVID-19 vaccine should not get a second shot of that vaccine.
Some people who have received a COVID-19 vaccine have reported a red, sometimes bumpy rash on their injection arm. Dermatologists are referring to the rash as "COVID arm," but the CDC says it’s no cause for alarm.
"If you experience ‘COVID arm’ after getting the first shot, you should still get the second shot at the recommended interval if the vaccine you got needs a second shot," the CDC said.
RELATED: Coronavirus vaccines: Some side effects are common and expected, experts say
The health agency recommends taking an antihistamine to treat "COVID arm."
While some side effects from taking the vaccine can be concerning, medical experts say most are common and expected.