Preliminary Findings of Covid Vaccine Safety During Pregnancy

Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.

The first coronavirus disease 2019 (Covid-19) vaccines available in the United States were messenger RNA (mRNA) vaccines: BNT162b2 (Pfizer–BioNTech) and mRNA-1273 (Moderna). In December 2020, the vaccines were granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as a two-dose series, 3 weeks apart for Pfizer–BioNTech and 1 month apart for Moderna, and were recommended for use by the Advisory Committee on Immunization Practices (ACIP).1-4

Pregnant persons were excluded from preauthorization clinical trials, and only limited human data on safety during pregnancy were available at the time of authorization. However, pregnant persons with Covid-19 are at increased risk for severe illness (e.g., resulting in admission to an intensive care unit, extracorporeal membrane oxygenation, or mechanical ventilation) and death, as compared with nonpregnant persons of reproductive age.5

Furthermore, pregnant persons with Covid-19 might be at increased risk for adverse pregnancy outcomes, such as preterm birth, as compared with pregnant persons without Covid-19.6 The Centers for Disease Control and Prevention (CDC) and ACIP, in collaboration with the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, have issued guidance indicating that Covid-19 vaccines should not be withheld from pregnant persons.7-9

Postauthorization monitoring in pregnant persons is necessary to characterize the safety of these new Covid-19 vaccines, which use mRNA, lipid nanoparticles, and state-of-the-art manufacturing processes. Furthermore, establishing their safety profiles is critical to inform recommendations on maternal vaccination against Covid-19.

We report preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons from three U.S. vaccine safety monitoring systems: the “v-safe after vaccination health checker” surveillance system,10 the v-safe pregnancy registry,11 and the Vaccine Adverse Event Reporting System (VAERS).12

Methods

Monitoring Systems and Covered Populations

V-safe Surveillance System and Pregnancy Registry

V-safe is a new CDC smartphone-based active-surveillance system developed for the Covid-19 vaccination program; enrollment is voluntary. V-safe sends text messages to participants with weblinks to online surveys that assess for adverse reactions and health status during a postvaccination follow-up period. Follow-up continues 12 months after the final dose of a Covid-19 vaccine.

During the first week after vaccination with any dose of a Covid-19 vaccine, participants are prompted to report local and systemic signs and symptoms during daily surveys and rank them as mild, moderate, or severe; surveys at all time points assess for events of adverse health effects. If participants indicate that they required medical care at any time point, they are asked to complete a report to the VAERS through active telephone outreach.

To identify persons who received one or both Covid-19 vaccine doses while pregnant or who became pregnant after Covid-19 vaccination, v-safe surveys include pregnancy questions for persons who do not report their sex as male.

Persons who identify as pregnant are then contacted by telephone and, if they meet inclusion criteria, are offered enrollment in the v-safe pregnancy registry. Eligible persons are those who received vaccination during pregnancy or in the periconception period (30 days before the last menstrual period through 14 days after) and are 18 years of age or older.

For persons who choose to enroll, the pregnancy registry telephone-based survey collects detailed information about the participant, including medical and obstetric history, pregnancy complications, birth outcomes, and contact information for obstetric and pediatric health care providers to obtain medical records; infants are followed through the first 3 months of life. Details about v-safe and v-safe pregnancy registry methods have been published previously.10,11

VAERS

The VAERS is a national spontaneous-reporting (passive-surveillance) system established in 1990 that is administered by the CDC and the FDA.12 Anyone can submit a report to the VAERS. Health care providers are required to report certain adverse events after vaccination, including pregnancy-related complications resulting in hospitalization and congenital anomalies, under the conditions of the EUAs for Covid-19 vaccines1,2; the CDC encourages reporting of any clinically significant maternal and infant adverse events.

Signs and symptoms of adverse events are coded with the use of the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.13 We used a pregnancy-status question in the VAERS form and a MedDRA code and text-string search to identify reports involving vaccination in pregnant persons.14

Outcomes

V-safe outcomes included participant-reported local and systemic reactogenicity to the BNT162b2 (Pfizer–BioNTech) vaccine and the mRNA-1273 (Moderna) vaccine on the day after vaccination among all pregnant persons 16 to 54 years of age and among nonpregnant women 16 to 54 years of age as a comparator. For analysis of pregnancy outcomes in the v-safe pregnancy registry, data were restricted to completed pregnancies (i.e., live-born infant, spontaneous abortion, induced abortion, or stillbirth).

Participant-reported pregnancy outcomes included pregnancy loss (spontaneous abortion and stillbirth) and neonatal outcomes (preterm birth, congenital anomalies, small size for gestational age, and neonatal death) (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). In the VAERS, outcomes included non–pregnancy-specific adverse events and pregnancy- and neonatal-specific adverse events.

Statistical Analysis

Demographic information and pregnancy characteristics are described for both v-safe and VAERS participants. Descriptive analyses were performed with the use of v-safe survey data for persons who identified as pregnant through February 28, 2021 (35,691 persons); persons enrolled in the v-safe pregnancy registry who were vaccinated through February 28, 2021 (3958 persons); and VAERS reports involving pregnant women received through February 28, 2021 (221 persons).

Local and systemic reactogenicity was compared between persons who identified as pregnant and nonpregnant women. Descriptive analyses were conducted with the use of SAS software, version 9.4 (SAS Institute). All activities were reviewed by the CDC and were conducted in accordance with applicable federal law and CDC policy.

Results

V-safe Surveillance: Local and Systemic Reactogenicity in Pregnant Persons

From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Age distributions were similar among the participants who received the Pfizer–BioNTech vaccine and those who received the Moderna vaccine, with the majority of the participants being 25 to 34 years of age (61.9 percent and 60.6 percent for each vaccine, respectively) and non-Hispanic White (76.2 percent and 75.4 percent, respectively); most participants (85.8 percent and 87.4 percent, respectively) reported being pregnant at the time of vaccination (Table 1).

Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both vaccines (Table 2) and were reported more frequently after dose 2 for both vaccines. Participant-measured temperature at or above 38°C was reported by less than 1 percent of the participants on day 1 after dose 1 and by 8.0 percent after dose 2 for both vaccines.

These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1). Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar.

Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3).

V-safe Pregnancy Registry: Pregnancy Outcomes and Neonatal Outcomes

As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after Covid-19 vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility).

The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0 percent) identified as health care personnel. Among enrolled participants, most were 25 to 44 years of age (98.8 percent), non-Hispanic White (79.0 percent), and, at the time of interview, did not report a Covid-19 diagnosis during pregnancy (97.6 percent) (Table 3).

Receipt of a first dose of vaccine meeting registry-eligibility criteria was reported by 92 participants (2.3 percent) during the periconception period, by 1132 (28.6 percent) in the first trimester of pregnancy, by 1714 (43.3 percent) in the second trimester, and by 1019 (25.7 percent) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3).

Among 1040 participants (91.9 percent) who received a vaccine in the first trimester and 1700 (99.2 percent) who received a vaccine in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart; limited follow-up calls had been made at the time of this analysis.

Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1 percent), in a spontaneous abortion in 104 (12.6 percent), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2 percent). A total of 96 of 104 spontaneous abortions (92.3 percent) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3 percent) were among persons who received their first eligible vaccine dose in the third trimester.

Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4 percent]), small size for gestational age (23 of 724 [3.2 percent]), and major congenital anomalies (16 of 724 [2.2 percent]); no neonatal deaths were reported at the time of interview.

Among the participants with completed pregnancies who reported congenital anomalies, none had received Covid-19 vaccine in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed. Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4).

Adverse-Event Findings on the VAERS

During the analysis period, the VAERS received and processed 221 reports involving Covid-19 vaccination among pregnant persons; 155 (70.1 p[ercent) involved nonpregnancy-specific adverse events, and 66 (29.9 percent) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases; 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each.

No congenital anomalies were reported to the VAERS, a requirement under the EUAs.

Discussion

This U.S. surveillance review of the safety of mRNA Covid-19 vaccines during pregnancy and the periconception period indicates that some pregnant persons in the United States are choosing to be vaccinated against Covid-19 in all trimesters of pregnancy. Solicited local and systemic reactions that were reported to the v-safe surveillance system were similar among persons who identified as pregnant and nonpregnant women.

Although not directly comparable, the proportions of adverse pregnancy and neonatal outcomes (e.g., fetal loss, preterm birth, small size for gestational age, congenital anomalies, and neonatal death) among participants with completed pregnancies from the v-safe pregnancy registry appear to be similar to the published incidences in pregnant populations studied before the Covid-19 pandemic.15-26

Many participants in the v-safe pregnancy registry were included in the phase 1a (highest) priority group for Covid-19 vaccination owing to their work as health care personnel.27 V-safe participation is voluntary, and registration information is not uniformly available at all vaccination locations, although information about the surveillance system is included on the EUA fact sheets for health care providers and patients.

Thus, comparisons of the proportions of vaccinated women with these outcomes to previously published estimates are limited by likely differences between these populations in age, ethnic group, and other social, demographic, and clinical characteristics that are known to be associated with pregnancy and neonatal outcomes. However, such comparisons are helpful to provide a crude sense of whether there are any unexpected safety signals in these early data.

At the time of this analysis, just 14.7 percent of persons who identified as pregnant in the v-safe surveillance system had been contacted to offer enrollment in the pregnancy registry.

Other limitations should also be noted. As with all participant-reported surveillance systems, mistakes in completion of v-safe health surveys can result in misclassification of participants as pregnant; as a result, data for local and systemic reactions that participants reported to the v-safe platform may include some reports from nonpregnant persons. Participants are not required to complete surveys at the same time every day, and our ability to assess onset or duration of adverse events, such as fever, is limited.

The registry data are preliminary, are from a small sample, and describe mostly neonatal outcomes from third-trimester vaccination; the findings may change as additional pregnancy outcomes are reported and the sample size increases, which may facilitate detection of rare outcomes.

We were unable to evaluate adverse outcomes that might occur in association with exposures earlier in pregnancy, such as congenital anomalies, because no pregnant persons who were vaccinated early in pregnancy have had live births captured in the v-safe pregnancy registry to date; follow-up is ongoing.

In addition, the proportion of pregnant persons who reported spontaneous abortion may not reflect true postvaccination proportions because participants might have been vaccinated after the period of greatest risk in the first trimester, and very early pregnancy losses might not be recognized. Whereas some pregnancies with vaccination in the first and early second trimester have been completed, the majority are ongoing, and a direct comparison of outcomes on the basis of timing of vaccination is needed to define the proportion of spontaneous abortions in this cohort.

Because of sample-size constraints, both pregnancy and neonatal outcomes were calculated as a proportion instead of a rate.

This is taken from a long article. Read the rest here: nejm.org

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Comments (21)

  • Avatar

    sir_isO

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    So I been harping on about the magnetic stuff, graphene and iron oxide, EMF, BBB…

    So neutrophils get attached to graphene oxide. Magnetic properties associated, particularly with iron oxide. Additionally, the graphene oxide “helps” compromise the BBB.

    Here are some clues:
    https://techxplore.com/news/2021-08-tiny-maniac-robots-drugs-central.htm

    Targeted drug delivery to the brain using magnetic nanoparticles
    https://www.future-science.com/doi/10.4155/tde.15.56

    Remote control of the permeability of the blood–brain barrier by magnetic heating of nanoparticles: A proof of concept for brain drug delivery
    https://www.sciencedirect.com/science/article/abs/pii/S0168365915001376

    Microscopic Robots Deliver Drugs to the Brain
    Researchers turned white blood cells called neutrophils into drug-smuggling “neutrobots,” which penetrated the blood-brain barrier to treat brain cancer in mice.
    https://www.the-scientist.com/news-opinion/microscopic-robots-deliver-drugs-to-the-brain-68616

    Reply

  • Avatar

    Howdy

    |

    “pregnant persons”
    Excuse me?? I see the New England Journal of Medicine are a little confused on the basics of Biology. They just made themselves, and their article, irrelevant to me. FACT, not fantasy.

    Reply

    • Avatar

      Alan

      |

      I thought I didn’t have to worry about this aspect but now it seems all men should be concerned.

      Reply

    • Avatar

      Ron

      |

      Yeah, “pregnant persons”. Glad somebody else saw that load of bull. I guess the pc virus of wokeness has infected even this website.
      Hey Principia-Scientific: How hard is it to say something like: “pregnant women” or “pregnant females”? You know, the way we used to say it, in a time long ago and in a place far away before insanity struck humanity.

      Reply

      • Avatar

        Howdy

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        Don’t critisize Ron. I just found out It is frowned upon.

        Reply

    • Avatar

      Ron

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      I no longer have any respect whatsoever for any of the establishment medical periodicals or institutions. At least Principia-Scientific could have called attention to the stupid in the NEJM and poked fun at it. They should not miss a chance to mock this stuff every time they see it. Otherwise, it appears they endorse everything such articles promote.

      Reply

      • Avatar

        sir_isO

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        Hey I’ve been trying to mock some of this shit. And I think PSI intentionally posts those articles to point out BULLSHIT, along with trending…you know the sort of crap being pushed that people tend to believe, thus giving us an opportunity to mock it.

        Reply

        • Avatar

          Howdy

          |

          “thus giving us an opportunity to mock it.”
          I doubt such an ethos would allow the site to last very long, and my own experience suggests otherwise.

          Why mock, when truth is so much more powerfull.

          Reply

          • Avatar

            sir_isO

            |

            Satire is one of the most effective tools for truth.

            And if it is not allowed, then you have bigger problems. And you are politically corrected through your meekness.

          • Avatar

            sir_isO

            |

            “Politeness, delicacy [and] decency … are but three different names for hypocrisy, chicanery, and cowardice.”
            – John Adams

            When something is not respectable, why should it be respected with fake niceties and such?

        • Avatar

          Howdy

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          Can’t respond to your two comments osiris, so:
          “Politeness, delicacy [and] decency … are but three different names for hypocrisy, chicanery, and cowardice.”
          – John Adams”
          I would agree, when taken in a certain context, or set of circumstances.

          When something is not respectable, why should it be respected with fake niceties and such?
          Too few want attention directing at themselves. Afraid of the consequences if they mess up, which I’ll admit, can be harsh.

          Too many people are lost. Being with the “in-crowd” brings protection, some fame, and maybe power. It’s certainly the in-thing. What’s a bit of fakery between friends? It has such benefits. This is where mankind is flying, but the aircraft is coming in to land, with no undercarriage.

          Reply

          • Avatar

            sir_isO

            |

            That totally triggered me…

            Do you tend to the ceiling of hell or the floor of heaven?
            https://www.youtube.com/watch?v=D9cERLLasUc

            Let’s say someone tries to abuse your child and you’re not around, and some guy sees that…how polite do you want him to be?

          • Avatar

            Howdy

            |

            “let’s say someone tries to abuse your child and you’re not around, and some guy sees that…how polite do you want him to be?”
            In that circumstance, politeness would be the last thing on the agenda. What did expect me to say, The guy should counsel the offender perhaps?

            Why would you be triggered?

  • Avatar

    Howdy

    |

    Yeah, I get you.

    Reply

  • Avatar

    sir_isO

    |

    Dr Robert Young
    https://www.drrobertyoung.com/post/is-nanobot-technology-artificial-intelligence-viable-inside-the-human-body

    “Dr. Young may be on the threshold of a new biology, whose principle—if proven—could revolutionize the biology and medicine worlds.” Neil Solomon, M.D., Ph.D. Former Head of Research for John Hopkins University.

    In 1994, Dr. Young discovered the biological transformation of red blood cells into bacteria and bacteria to red blood cells. He has since documented several such transformations.”

    Pity that was already known, to some extent. I’ve observed the biological transformation of plants to aphids.

    Reply

    • Avatar

      sir_isO

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      But I mean, like what’s his name with the somatids, bechamp, etc.

      This is also why I’ve (and certainly not only me) been saying what could be considered viruses are simply results from your body.

      Reply

    • Avatar

      sir_isO

      |

      About that Gain of Function stuff. There seems to be a misconception.

      The function they gain, if you consent to their shit, is of course, that of your body. Your body then, is used as an R&D lab, drug factory for pharma (aside from you paying for it). So essentially, they delegate “work” to you AND you pay them for it.

      How do you feel about those vaccines now?

      Reply

  • Avatar

    Howdy

    |

    “So essentially, they delegate “work” to you AND you pay them for it.”
    And since the “lab” contains their copyright materials, even claim ownership of the lab or parts thereof, in the process?

    Reply

    • Avatar

      sir_isO

      |

      Derived toxins, could perhaps be something they try claim ownership of, yes.

      I’d imagine that is their reasoning of using your body as a drug lab. So imagine them using some of those derived toxins, and then trying to sell that to you as medicine.

      Reply

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