Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil

Article activity feed

1. 

   ScreenIT

   Dec 21, 2021

   SciScore for 10.1101/2021.12.14.21267777: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	not detected.
   Sex as a biological variable	Pregnant women were identified in the datasets as those who reported to be pregnant at the time they received the vaccine and postpartum were considered those women who reported to be breastfeeding in the SI-EAPV and who declared to be at postpartum at the moment of the vaccination.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Surveillance Systems and Covered Population: In Brazil, records of adverse events following immunization (AEFI) in vaccinated individuals in the public services are made available by the General Coordination of the National Immunization …

   SciScore for 10.1101/2021.12.14.21267777: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	not detected.
   Sex as a biological variable	Pregnant women were identified in the datasets as those who reported to be pregnant at the time they received the vaccine and postpartum were considered those women who reported to be breastfeeding in the SI-EAPV and who declared to be at postpartum at the moment of the vaccination.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Surveillance Systems and Covered Population: In Brazil, records of adverse events following immunization (AEFI) in vaccinated individuals in the public services are made available by the General Coordination of the National Immunization Program (NIP).	National Immunization Program suggested: (Centers for Disease Control and Prevention, RRID:SCR_012976)
   Data analyses were conducted using Python version 3.6.5 (Python Software Foundation).	Python suggested: (IPython, RRID:SCR_001658)

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   Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Our study has some limitations. The AEFI notifications used in this study are subject to limitations of passive surveillance system. This means that each health level routinely and periodically sends information about the events subject to surveillance at the immediately superior. In the same way, the classifications in the database might be susceptible to the interpretation of the person filling out the system, implying in the possibility of lack of uniformity in reporting the characteristics of the event and in the place where the information is filled in the form of the surveillance system. Although these systems generate valuable information regarding the description of the occurrence of adverse events, they usually do not allow establishing causality between the occurrence of AEFI and the vaccine.11,33–35 In that sense, our study is unable to evaluate AE outcomes that might occur in association with exposures earlier in pregnancy or postpartum period. Furthermore, the definition of postpartum women varied in the data sources used - which may underestimate the incidence in this population. In the same direction, the Brazilian obstetric observatory for COVID-19 has been showing that there are inconsistencies in the vaccination information fulfilling, since they found pregnant and postpartum women of male sex, and AEFI notified for COVID-19 vaccines administered previous to the vaccination campaign start and over 55 years old.4 Another potential limitation of our analyses i...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   Results from rtransparent:

   • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
   • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
   • No protocol registration statement was detected.

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   Results from scite Reference Check: We found no unreliable references.

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   Read the original source
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   Version published to 10.1101/2021.12.14.21267777v1 on medRxiv

   Dec 17, 2021