After the Emergency Use Authorization was issued for the RN (mRNA) BNT162b2 (PfizerBioNTech) and mRNA-1273 (Moderna) messenger vaccines, persons at highest risk for coronavirus disease 2019 (Covid-19) related to illness and death were granted priority for vaccination.1 Among them were pregnant women, however they were excluded from initial vaccine trials. Pregnant women and their clinicians were left to weigh the documented risks of Covid-19 infection against unknown vaccine safety risks in deciding whether to receive the vaccine.
Prior to the start of the vaccine, numerous group studies documented that pregnant women were at greater risk than non-pregnant women for severe disease after Covid-19 infection, resulting in intensive care unit admission, mechanical ventilation, and death.2.3 Pregnant women with cohabiting diseases such as diabetes, hypertension and overweight were known to be at even greater risk.4 Studies also showed an increased risk of pregnancy complications including premature birth, cesarean delivery and preeclampsia associated with Covid-19 infection during pregnancy.5 Therefore, clinicians relied on data on developing and breeding animals from Moderna that showed no safety concerns and there was no biologically credible reason that mRNA technology would be harmful in pregnancy. Pregnant women were advised to consider the available evidence and make personal decisions regarding vaccination in the absence of human safety data.
In this issue of Diary, Shimabukuro etc.6 provide much-needed preliminary data on the safety of these vaccines in pregnancy based on the v-safe surveillance system and pregnancy register. V-safe, a new smartphone-based surveillance system from the Centers for Disease Control and Prevention that is available to all recipients of Covid-19 vaccines, sends text messages to assess the overall state of health and pregnancy during a period of 12 months after vaccination. Persons identified as pregnant can register in the Safe Pregnancy Register, which contacts participants by telephone to answer in-depth questions.
Report by Shimabukuro et al. includes safety results for 35,691 v-safe participants aged 16-54 who are identified as pregnant and the first 3958 participants who were registered in the v-safe pregnancy register. In both groups, 54% of participants received the PfizerBioNTech vaccine and 46% received the Moderna vaccine. Age distribution, race and ethnicity status, and time of first dose were similar with each vaccine. Among safe v participants, 86.5% had a known pregnancy at the time of vaccination, and 13.5% reported a positive pregnancy test after vaccination. Among participants in the safe pregnancy register, 28.6% received the vaccine in the first trimester, 43.3% in the second trimester, and 25.7% in the third trimester.
Among the 827 registry participants who reported a terminated pregnancy, pregnancy resulted in a miscarriage at 104 (12.6%) and stillbirth at 1 (0.1%); these percentages are within the expected limits as a result for this age group of persons whose other basic medical conditions are unknown. A total of 712 pregnancies (86.1%) resulted in a live birth, mainly among participants who received their first dose of vaccination in the third trimester. Among live births, the incidence of preterm birth (9.4%), small size for gestational age (3.2%), and congenital anomalies (2.2%) were also consistent with those expected based on published literature. There was no neonatal death. These are reassuring data based on reports from pregnant women mostly vaccinated in the third trimester.
Moreover, the levels of local and systemic reactions after vaccination among safe participants v who were identified as pregnant were similar to those in a larger group of non-pregnant women, suggesting that physiological changes in pregnancy do not materially affect such reactions. The most common side effect was injection site pain, with fatigue, headache, and myalgia reported significantly more frequently after the second dose. Fever was reported in a small number of people after the first dose and in approximately one-third of recipients after the second dose.
Given that there were a relatively small number of terminated pregnancies and that live births were usually after vaccination in the third trimester, Shimabukuro et al. acknowledge limitations in their ability to draw conclusions about congenital anomalies and other rare possible newborn outcomes. Despite these limitations, this report provides important information that was not previously available.
With the ongoing pandemic and pregnant women at high risk for serious illness if infected with Covid-19, vaccination is a critical prevention strategy. The lack of safety information about pregnancy, which existed at a time when thousands of pregnant women were struggling with vaccination decisions, underscores the importance of recent efforts to enroll pregnant women in trials, including ongoing vaccine trials; a trial is currently underway to study the effects of the BNT162b2 vaccine on pregnant women and their infants (ClinicalTrials.gov number, NCT04754594)
Overnight as of April 26, 2021, more than 100,000 pregnant women reported receiving a Covid-19 vaccine and yet only a small fraction (4.7%) have been registered in the safe pregnancy register.7 This situation underscores the urgent need not only to involve pregnant women in clinical trials, but also to invest in public health surveillance systems for pregnancy, involving a much larger number of women. To prepare for the next pandemic and improve health outcomes for pregnant women in general, it is time spent investing in maternal health surveillance and research.
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