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Large-scale study confirms mRNA vaccine safe for use in pregnant women

According to a large-scale Canadian study published in The Lancet Infectious Disease journal, COVID-19 mRNA vaccines are safe to use during pregnancy, with the rate of health-related events following vaccination in pregnant women of similar age to those of non-pregnant vaccinated women.

The COVID-19 pandemic has disproportionately affected pregnant women, who are at higher risk of serious infection than non-pregnant individuals of the same age.

Reportedly, this study is one of the first to look at vaccine side effects in a group of vaccinated pregnant women, as well as enabling comparisons between all three between a non-vaccinated pregnant group and a vaccinated non-pregnant group. have to has to.

β€œIn the early stages of the Covid-19 vaccine rollout, there was a shortage of vaccines in pregnant people due to concerns about data availability and safety. Still below average in non-pregnant women of reproductive age, says Dr. Manish Sadarangani of the British Columbia Children’s Hospital Research Institute and the first author of this study in the report.

This new study from The Canadian National Vaccine Safety (CANVAS) Network looked at data from participants from seven Canadian provinces and territories between December 2020 and November 2021. All vaccination participants were asked to self-report any health event during the following seven days. Each dose of the COVID-19 vaccine. Overall, 191,360 women aged 15–49 years with known pregnancy status-completed the first dose survey, while 94,937 completed the second dose survey.

A β€œsignificant health event” was defined as a new or worsening health event that was sufficient to cause the participant to miss school/work, require medical consultation and/or prevent daily activities in the past seven days. A “serious health event” was defined as any event that resulted in emergency department visits and/or hospitalizations in the past seven days.

The researchers found that of the mRNA-vaccinated pregnant women, 4.0 percent (226 out of 5,597) reported a significant health event within seven days of a single dose and 7.3 percent (227/3,108) after two doses. The most common significant health events after dose two in pregnant women were a general feeling of being unwell, headache/migraine and respiratory tract infection.

In comparison, 3.2 percent of pregnant non-vaccinated participants reported similar events in the seven days before the survey was completed. In the vaccinated non-pregnant control group, 6.3 percent reported a significant health event at week one after dose one and 11.3 percent after dose two. Serious health events were rare in all groups (less than 1 percent) and occurred at similar rates in vaccinated pregnant individuals, vaccinated non-pregnant people, and non-vaccinated controls after dose one and dose two.

Miscarriage/stillbirth was the most frequently reported adverse pregnancy outcome with no significant difference between rates in vaccinated and unvaccinated women; 2.1 percent of non-vaccinated pregnant women and 1.5 percent of vaccinated pregnant women experienced a miscarriage or stillbirth within seven days after a dose of any mRNA vaccine.

“The low rate of significant health events among vaccinated pregnant people, compared with non-pregnant people, is unexpected and more research is needed,” said Dr. Julie Bettinger from the British Columbia Children’s Hospital Research Institute and senior author of the paper.

The authors caution that the majority of participants who reported ethnicity in this study were White and, therefore, these data cannot be fully generalized to other populations. Additionally, this study focused on health events occurring within the first seven days after vaccination and, therefore, nothing can be concluded about responses over a longer period.

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