mRNA Covid-19 vaccines in pregnancy: A systematic review

Nando Reza Pratama; Ifan Ali Wafa; David Setyo Budi; Manesha Putra; Manggala Pasca Wardhana; Citrawati Dyah Kencono Wungu

doi:10.1371/journal.pone.0261350

Peer Review History

Original SubmissionJuly 18, 2021
30 Sep 2021 Decision Letter - Linglin Xie, Editor PONE-D-21-23400mRNA Covid-19 Vaccines in Pregnancy: A Systematic ReviewPLOS ONE Dear Dr. Wungu, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by 11/28/21. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Linglin Xie Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. We note that this manuscript is a systematic review or meta-analysis; our author guidelines therefore require that you use PRISMA guidance to help improve reporting quality of this type of study. Please upload copies of the completed PRISMA checklist as Supporting Information with a file name “PRISMA checklist [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: No ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: GENERAL : There are several grammatical errors and wrong use of tenses that make significant portions of the text difficult to understand. ABSTRACT: Page 2, under methods, line 38 EU should be written in full 1st before abbreviating. Throughout the text abbreviations should 1st be written in full. In lines 39-40 what do the authors mean by he databases were queried? Lines 61-62 should be recasted. Grammatical errors and wrong use of tenses. INTRODUCTION: Page 3,line 69, which pandemic is being referred to? The statement in lines 74-75 about the risk of severe COVID 19 in pregnancy seems to be at variance with the 1st sentence in the objective section of the abstract. The term "pregnant women should be substituted for pregnant people throughout the text. The aim of the study in page 3 lines 87-90 should be recasted. METHODS: Several grammatical errors. Under inclusion criteria, lines 100-101 page 4, number 4 is no clear. Where studies that were not conducted in English included? Page 5,under statistical analysis, pages 139-140 is not clear. RESULTS: Page 5,lines 144 is not clear, Are 4.018 and 200 both all the records that were yielded? Several grammatical errors. Under outcomes, page 6 lines 168-171 is not clear, DISCUSSION: TOO many grammatical errors and wrong use of tenses. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0261350.r001
Revision 1
22 Oct 2021 Author Response Responses to the reviewer #1 comments: We would like to start by thanking the reviewers for careful and constructive comments and questions. It prompted us to change some of the aspects of our original manuscript, mainly the introduction and discussion along with the conclusion. We strongly believe that our manuscript is much better now than it was before the rewriting. After careful reading of the comments, we decided that many parts of the article definitely need improvements, especially those with grammatical errors and wrong use of tenses. Also, the description of abbreviations within the table has been attached below each table. We tried to incorporate all suggestions made by the reviewer in this new version of our manuscript. We decided to err on the side of caution and fix the language issue of our manuscript this time. Reviewer #1: GENERAL : There are several grammatical errors and wrong use of tenses that make significant portions of the text difficult to understand. • We have modified the previous manuscript into the revised manuscript with the more appropriate writing English this time. We also got a proofread certificate from a language editing center (Enago). We hope that this at least partially addresses the reviewer's concerns about some issues in our manuscript. ABSTRACT: Page 2, under methods, line 38 EU should be written in full 1st before abbreviating. Throughout the text abbreviations should 1st be written in full. In lines 39-40 what do the authors mean by he databases were queried? Lines 61-62 should be recasted. Grammatical errors and wrong use of tenses. • We have replaced European Union instead of the EU in the abstract. • The word queried here means that we conducted the search in the databases mentioned in the abstract. To make it clearer, we have changed the word ‘queried’ into ‘systematically search’. • We have recasted this sentence. If you think it is still not suitable, please any feedbacks are welcomed. INTRODUCTION: Page 3,line 69, which pandemic is being referred to? The statement in lines 74-75 about the risk of severe COVID 19 in pregnancy seems to be at variance with the 1st sentence in the objective section of the abstract. The term "pregnant women should be substituted for pregnant people throughout the text. The aim of the study in page 3 lines 87-90 should be recasted. • The term pandemic refers to the Covid-19 pandemic and we have changed ‘Covid-19 pandemic’ in this revision. • We agree with the reviewer which this sentence seems to be at variance with the first sentence in the objective. Since pregnancy has been known to be a factor that leads to poorer outcomes in Covid-19 infection, we decided to revise this sentence so that it would be linear to our objective in the abstract. • Recently, some opinions suggest the use of pregnant people instead of pregnant women. For this reason, we used this term in our previous manuscript. However, we consider changing the term pregnant people throughout the texts as per the reviewer's suggestion in this revised manuscript. • We have recast the aim and integrated it into the end of the second paragraph. METHODS: Several grammatical errors. Under inclusion criteria, lines 100-101 page 4, number 4 is no clear. Where studies that were not conducted in English included? Page 5,under statistical analysis, pages 139-140 is not clear. • Some studies do not report the minimum age of the participants, but we decided to include these articles. As a result, we think that it would be more appropriate to just write pregnant women in the inclusion criteria, without restricting the age. • Criterion no 4 in the previous manuscript has been modified into a clearer sentence. All studies were reported in English. Therefore, we changed ‘no language restriction’ (at line 110 of the previous manuscript) in order to be in line with the inclusion criteria. • We initially borrow the term Synthesis Without Meta-analysis (SWiM) from PRISMA guideline, for use in systematic reviews examining the quantitative effects of interventions for which meta-analysis of effect estimates is not possible, or not appropriate, for a least some outcomes. Because this review had already adhered to PRISMA guidelines 2020, we decided to omit the SWiM term and simplify this sentence to make it clearer in the revised manuscript. RESULTS: Page 5,lines 144 is not clear, Are 4.018 and 200 both all the records that were yielded? Several grammatical errors. Under outcomes, page 6 lines 168-171 is not clear, • In this revised manuscript, the number of studies obtained from our search has been combined into 4218, instead. • The vaccine efficacy was represented by the infection rate in which the lower infection rate indicates a higher efficacy. We are trying to emphasize that some studies evaluate the efficacy in a different way, i.e. different grouping. In this revised manuscript, we have attempted to improve the grammatical errors. DISCUSSION: TOO many grammatical errors and wrong use of tenses. • We have reworked the discussion to justify the writing style with more appropriate use of grammar and tenses as per the reviewer's suggestion. Any feedbacks are welcome if necessary. Attachments Attachment Submitted filename: 4. List of Responses.docx https://doi.org/10.1371/journal.pone.0261350.r002
23 Nov 2021 Decision Letter - Linglin Xie, Editor PONE-D-21-23400R1mRNA Covid-19 Vaccines in Pregnancy: A Systematic ReviewPLOS ONE Dear Dr. Wungu, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by 12/22/21. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Linglin Xie Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: METHODS: Line 83should be --maternal antibody titre instead of maternal titre antibodies. Likewise, line 85 should be cord blood antigen titre. Under search strategy87, it is not clear if all the studies used for this research were conducted between June 20th and 22nd 2020--line 90-91. Lines 142-143 is not clear, was the median age of the women actually estimated in weeks? Lines 178-179 is not clear. DISCUSSION: The following should be written in full 1st--CDC, ICD, Tdap, DENV, RCTS. Lines 324-326 is not clear, did the authors actually assess pregnancy, delivery and neonatal outcomes in non pregnant women? ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0261350.r003
Revision 2
25 Nov 2021 Author Response Responses to the reviewer #1 comments: We would like to start by thanking the reviewers for careful and constructive comments and questions. We strongly believe that our manuscript is much better now than it was before the rewriting. Reviewer #1: METHODS: Line 83should be --maternal antibody titre instead of maternal titre antibodies. Likewise, line 85 should be cord blood antigen titre. • Thanks for the suggestion. We have incorporated your suggestion into our manuscript. Under search strategy87, it is not clear if all the studies used for this research were conducted between June 20th and 22nd 2020--line 90-91. • We really appreciate this very useful feedback. We actually performed the search between 20th and 22nd of June, 2021 and include all articles before these date. We have fixed the sentence and we hope the meaning will be clearer after this. Lines 142-143 is not clear, was the median age of the women actually estimated in weeks? • Thank you for addressing this issue. We actually mean it as gestational age, not age of the mother. Therefore, we use ‘gestational age’ this time. Lines 178-179 is not clear. • Thank you for the insightful feedback. We have paraphrased this sentence, thus it should have a clearer meaning. DISCUSSION: The following should be written in full 1st--CDC, ICD, Tdap, DENV, RCTS. • Thank you for the meticulous observation. We have corrected this issue and all of these abbreviations have been written in full at 1st. Lines 324-326 is not clear, did the authors actually assess pregnancy, delivery and neonatal outcomes in non pregnant women? • Thank you for spotting this mistake. We realized that we have mistaken to write the comparison as pregnant vs non-pregnant. Indeed, the reference evaluated the outcomes between vaccinated and unvaccinated pregnant women. Additionally, since we have defined pregnancy and delivery outcomes as maternal outcomes, we simplify the outcomes to be maternal outcomes and neonatal outcomes, instead of pregnancy, delivery and neonatal outcomes. Attachments Attachment Submitted filename: 4. Responses to Reviewers new.docx https://doi.org/10.1371/journal.pone.0261350.r004
1 Dec 2021 Decision Letter - Linglin Xie, Editor mRNA Covid-19 Vaccines in Pregnancy: A Systematic Review PONE-D-21-23400R2 Dear Dr. Wungu, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Linglin Xie Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0261350.r005
Formally Accepted
6 Dec 2021 Acceptance Letter - Linglin Xie, Editor PONE-D-21-23400R2 mRNA Covid-19 Vaccines in Pregnancy: A Systematic Review Dear Dr. Wungu: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Linglin Xie Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0261350.r006

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