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Pfizer Linked Study Finds COVID-19 Vaccination in Early Pregnancy Safe with No Increased Risk of Birth Defects

In a recent research published in Paediatrics has proven that immunising against COVID-19 within the first 20 weeks of pregnancy does not raise the risk of significant structural birth abnormalities. University of San Francisco researcher Stacey L. Rowe (Ph.D., M.P.H.) and colleagues provide much-needed reassurance to pregnant women thinking about getting a vaccine.

An estimated last menstrual period occurred between August 15, 2021, and December 24, 2021, and the research looked at 78,052 pregnancies that ended in live births. The cohort was based on claims. The group's overarching goal was to evaluate Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273, two different brands of COVID-19 vaccines, in terms of their respective rates of birth abnormalities.

Among all pregnancies, the data showed 1,248 significant structural birth abnormalities; 1,049 of these occurred in vaccinated individuals and 199 in those who did not receive the vaccine. Vaccinated persons had a prevalence rate of 156.4 per 10,000 live births, while unvaccinated individuals had a rate of 160.6 per 10,000 live births. Vaccination status did not seem to have a statistically significant effect on the prevalence of birth defects.

The Moderna and Pfizer vaccines were not significantly different in terms of overall birth defect rates, according to the study that looked at thousands of pregnancies.

The incidence of genitourinary system abnormalities was 24% lower in vaccinated individuals compared to unvaccinated controls, according to the researchers. However, this decrease did not achieve statistical significance. This calls for larger-scale research to confirm or refute the existence of a protective effect.

Following congenital heart abnormalities with 212 occurrences (27.2 per 10,000 live births) came hypospadias, the most common birth defect, with 292 cases (37.4 per 10,000 live births). The vaccinated group had no signs of several serious genitourinary disorders, including posterior urethral valves and bladder exstrophy.

This study adds to the increasing amount of data that mRNA vaccines are safe to use during pregnancy and also points to potential protective regions where vaccination could be beneficial. Particularly encouraging, and suggesting possible advantages beyond only reducing COVID-19 infection, is the absence of certain serious birth abnormalities in vaccinated groups.

Vaccinated people tend to be older (35–44 years old), use assisted reproductive technology more frequently, and get other maternal immunisations, according to the study. On the other hand, a history of pregnancy problems, such as preterm birth or substance or alcohol use, was more common among those who had not received the vaccine.

Within the final analytical cohort of 78,052 pregnancies, 12,725 people (16.3%) received the vaccine between 14 days prior to their last menstrual cycle and 20 weeks of gestation. Within the first thirteen weeks, a vast majority of these immunisations (71.1%) took place. There was a significant difference in vaccination rates between insurance types, mothers' histories of SARS-CoV-2 illness, and those who had received other vaccines for children. It is worth mentioning that privately insured persons had a higher vaccine coverage rate (25.3% vs. 6.0% for those with public insurance).

The importance of these findings in easing worries about COVID-19 vaccination during pregnancy was highlighted by the study's authors. "Our findings align with other comparable studies and provide reassurance to potential vaccinees and vaccine providers considering COVID-19 vaccination early in pregnancy," according to the authors.

The study's findings may influence some individuals, as two of the authors disclosed their affiliations with pharmaceutical companies like Pfizer and Moderna. Nevertheless, prior research on the safety of vaccines during pregnancy is compatible with the study's approach and results.

This extensive study provides additional evidence that immunisation against COVID-19 during the first trimester of pregnancy is safe. There has been no discernible rise in the incidence of serious structural birth abnormalities, so pregnant women can make educated vaccination decisions without putting their unborn children at unnecessary risk. Such evidence-based studies are crucial for directing public health policy and individual healthcare choices as the worldwide battle against COVID-19 persists.


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