Early exploration of COVID-19 vaccination safety and effectiveness during pregnancy: interim descriptive data from a prospective observational study.
Vaccine
; 39(44): 6535-6538, 2021 10 22.
Article
in English
| MEDLINE | ID: covidwho-1447214
ABSTRACT
OBJECTIVE:
During December 2020, a massive vaccination program was introduced in our country. The Pfizer-BioNTech, BNT162b2 vaccine was first offered exclusively to high-risk population, such as medical personnel (including pregnant women). In this study we compare short term outcomes in vaccinated vs. non-vaccinated pregnant women.METHODS:
In this prospective observational cohort study, vaccinated and non-vaccinated pregnant women were recruited using an online Google forms questionnaire targeting medical groups on Facebook and WhatsApp. A second questionnaire was sent one month after the first one for interim analysis. Our primary outcome was composite complications in vaccinated and non-vaccinated groups, considered any of the following vaginal bleeding, pregnancy loss, hypertension, gestational diabetes, and preterm birth. Secondary outcomes included vaccine side effects, diagnosis of COVID-19 since the last questionnaire, prevalence of vaccinated participants, and reasons for refusal to be vaccinated.RESULTS:
Overall, 432 women answered the first questionnaire, of which 326 responses were received to the second questionnaire. Vaccination rate increased from 25.5% to 62% within a month. Maternal age, gestational age at enrollment, nulliparity and number of children were similar in both groups. The rate of composite pregnancy complications was similar between vaccinated and non-vaccinated group (15.8% vs 20.1%, p = 0.37), respectively. The risk for COVID-19 infection was significantly lower in the vaccinated group (1.5% vs 6.5%, p = 0.024, Odds Ratio 4.5, 95% confidence interval 1.19-17.6).CONCLUSIONS:
mRNA vaccine during pregnancy does not seem to increase the rate of pregnancy complications and is effective in prevention of COVID-19 infection.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Premature Birth
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Child
/
Female
/
Humans
/
Infant, Newborn
/
Pregnancy
Language:
English
Journal:
Vaccine
Year:
2021
Document Type:
Article
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