Safety of Booster Doses of COVID-19 Vaccine in Pregnancy

Obstetrics and Gynecology Journal: Published in September, 2022

Vaccination against coronavirus disease 2019 is safe and effective at preventing illness, including hospitalization and death due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, and booster and additional primary dose COVID-19 vaccinations increase protection to known and studied variants.

Pregnant people and recently pregnant people with COVID-19 have an increased risk of severe illness that can result in intensive care unit admission, mechanical ventilation, and death compared with nonpregnant people of reproductive age. 

Pregnant people with COVID-19 are at increased risk of preterm birth and stillbirth and may be at increased risk of other adverse pregnancy complications compared with pregnant people without COVID-19.

Vaccination against COVID-19 is recommended for all people who are pregnant, attempting conception, or who might become pregnant in the future. 

There is growing evidence indicating mRNA COVID-19 vaccines are safe when administered to pregnant people as part of a primary series.

A 2021 study found no safety concerns for mRNA COVID-19 vaccines in pregnant people during the first 2 months of the U.S. vaccination program.

Additional studies of COVID-19 vaccination throughout pregnancy have not found an increased risk of spontaneous abortion, preterm birth, or small-for-gestational-age neonates among people who received mRNA COVID-19 vaccines during pregnancy.

In this study authors reviewed reports of adverse events submitted to VAERS from September 22, 2021, through March 24, 2022, where a booster dose of a mRNA COVID-19 vaccine was administered to a pregnant person to assess vaccine safety.

TAKE-HOME MESSAGE

This retrospective observational study reviewed reports of adverse events in pregnant women who received a booster dose of the COVID-19 vaccine submitted to the Vaccine Adverse Event Reporting System to evaluate vaccine safety.

During September 22, 2021, through March 24, 2022, VAERS received 51,763 reports of adverse events after a booster dose of mRNA COVID-19 vaccine, and 323 of these were reports of pregnant people.

During the first few months after mRNA vaccine roll-out, an initial assessment of VAERS reports after receipt of the primary mRNA series received by those who were pregnant did not identify unexpected or unusual increased reporting of any adverse event.

Findings:

Approximately one-fifth of the reported adverse events in pregnant women who received booster vaccination were spontaneous abortions; this was comparable to the frequency of spontaneous abortions in women who received the primary series doses.

The authors pointed out that spontaneous abortion is a common occurrence during pregnancy, regardless of vaccination status, and their rates increase with increasing maternal age, with rates as high as 80% at 45 years of age.

Other pregnancy-specific conditions such as vaginal bleeding and stillbirths were reported infrequently. Authors noted that reporting rates for stillbirth and preterm delivery were well below background rates for these conditions.

Systemic and local reactions were commonly reported, and the frequency of reporting was similar to that of pregnant people who received the primary vaccination series. 

Conclusions:

This study suggests that the safety profile of the booster vaccine is comparable to that of the primary COVID-19 vaccination in pregnant individuals. Therefore, getting the booster vaccine is safer than risking getting COVID-19 during pregnancy.

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OBJECTIVE: 

To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine.

METHODS: 

We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster dose of an mRNA COVID-19 vaccine from September 22, 2021, to March 24, 2022. Clinicians reviewed reports and available medical records.

RESULTS: 

The Vaccine Adverse Event Reporting System received 323 reports of adverse events in pregnant people who received a booster dose of COVID-19 vaccine; 178 (55.1%) after BNT162b2 from Pfizer–BioNTech and 145 (44.9%) after mRNA-1273 from Moderna. Seventy-two (22.3%) reports were coded as serious. One neonatal death was reported, but no maternal deaths occurred. Pregnancy-specific outcomes included 56 (17.3%) spontaneous abortions (before 20 weeks of gestation), eight (2.5%) episodes of vaginal bleeding, five (1.5%) stillbirths (at or after 20 weeks of gestation), four (1.2%) episodes of preeclampsia, and two (0.6%) preterm deliveries. Reporting rates for stillbirth and preterm delivery were below background rates. Ten instances of adverse events in neonates were reported, which included two reports of birth defects. Non–pregnancy-specific adverse events (n=207; 64.1%) were mostly systemic (eg, headache, fatigue) and local reactions and occurred in proportions comparable with those seen in pregnant people who received the primary COVID-19 vaccination series and reported to VAERS during the same period.

CONCLUSION: 

Review of reports after a booster dose of mRNA COVID-19 vaccine in pregnant people in VAERS found their safety profile was comparable with that of published reports after primary COVID-19 vaccination in pregnant people.

 

Read In Details


https://obgyn.duke.edu/news/acog-promotes-covid-19-vaccine-booster-safety
https://pubmed.ncbi.nlm.nih.gov/35926203/
https://journals.lww.com/greenjournal/Fulltext/2022/09000/Safety_of_Booster_Doses_of_Coronavirus_Disease.11.aspx

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