PGPH-D-22-01340

Increased adverse events following third dose of BNT162b2/Pfizer vaccine in those with previous COVID-19, but not with concurrent influenza vaccine.

PLOS Global Public Health

Dear Dr. Raw,

Thank you for submitting your manuscript to PLOS Global Public Health. After careful consideration, we feel that it has merit but does not fully meet PLOS Global Public Health’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 Jan 05 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at globalpubhealth@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pgph/ 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 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'.

Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

We look forward to receiving your revised manuscript.

Kind regards,

Muhammad Imran Nisar, MBBS, MSc

Academic Editor

PLOS Global Public Health

Journal Requirements:

1. 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 If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references.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 If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

2. Please send a completed 'Competing Interests' statement, including any COIs declared by your co-authors. If you have no competing interests to declare, please state "The authors have declared that no competing interests exist". Otherwise please declare all competing interests beginning with the statement "I have read the journal's policy and the authors of this manuscript have the following competing interests:"

3. Please amend your detailed Financial Disclosure statement. This is published with the article. It must therefore be completed in full sentences and contain the exact wording you wish to be published.

a. State the initials, alongside each funding source, of each author to receive each grant.

b. State what role the funders took in the study. If the funders had no role in your study, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

c. If any authors received a salary from any of your funders, please state which authors and which funders.

If you did not receive any funding for this study, please simply state: “The authors received no specific funding for this work.”

4. Please provide separate figure files in .tif or .eps format only and remove any figures embedded in your manuscript file. Please also ensure that all files are under our size limit of 10MB.

For more information about figure files please see our guidelines:

https://journals.plos.org/globalpublichealth/s/figures 

https://journals.plos.org/globalpublichealth/s/figures#loc-file-requirements

5. We have noticed that you have uploaded Supporting Information files, but you have not included a list of legends. Please add a full list of legends for your Supporting Information files after the references list. 

6. In the online submission form, you indicated that "All raw data will be made available upon request to the corresponding author". All PLOS journals now require all data underlying the findings described in their manuscript to be freely available to other researchers, either 1. In a public repository, 2. Within the manuscript itself, or 3. Uploaded as supplementary information.

This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If your data cannot be made publicly available for ethical or legal reasons (e.g., public availability would compromise patient privacy), please explain your reasons by return email and your exemption request will be escalated to the editor for approval. Your exemption request will be handled independently and will not hold up the peer review process, but will need to be resolved should your manuscript be accepted for publication. One of the Editorial team will then be in touch if there are any issues.

Additional Editor Comments (if provided):

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does this manuscript meet PLOS Global Public Health’s publication criteria? Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe methodologically and ethically rigorous research with conclusions that are appropriately drawn based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available (please refer to the Data Availability Statement at the start of the manuscript PDF file)?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception. 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

Reviewer #2: Yes

Reviewer #3: No

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS Global Public Health 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

Reviewer #2: Yes

Reviewer #3: Yes

**********

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: Reviewer Comments:

The authors have a grandiose study, very important to health, as it tries to shade light on the implication for covid-19 vaccine uptake and immunization protocols. The study is very promising, but some minor points must be reviewed before possible publication.

Abstract:

The authors in the present study had a sample size of 534 HCW who were enrolled in the study:

The authors should be specific how many individuals were analysed separately for AEs following all three doses of BNT162b2/Pfizer vaccine and those were involved in the concurrent seasonal influenza immunisation.

Methods:

The authors needs to provide ethical approval number for this study

The authors should clearly demonstrate how they arrived at sample size of 534 (show sample size calculation)

Results

In line 156-157 the authors states that “A similar pattern of results was found for prolonged AEs, which were scored as total number of vaccine-associated AEs rated as moderate/severe, lasting >24 hours”. In the subsequent studies they could have performed correlation analysis between the adverse events within less than 24hrs and after prolonged period in order to paint a clear picture as to whether the development and increase in AEs is observed after long period of vaccination.

Conclusion

Since the large sample size that was analyzed constituted 85% female, can we conclusively state that AEs witnessed during covid-19 vaccination programs may be gender specific?

Reviewer #2: Reviewer’s comment

Introduction

(1)Line 41: Authors should indicate the exact AEs that were frequently reported

(2)Lines 43/46: It would be appropriate if authors differentiate or state the specific AEs reported following a single dose of BNT162b2/Pfizer vaccine and the events reported during ongoing COVID-19 symptoms vaccination with BNT162b2/Pfizer 47 vaccine after second dose.

Methods

(1)Lines 78-80: Provide the ethics approval reference number

(2)The methodology employed in this students has some gaps that need to be addressed or filled.

a.Authors employed the use of email to invite responses. However, it was not clear how the respondents were selected, no clear inclusion and exclusion criteria were stated.

b.Sample size was not predetermined.

c.The use of emails did not allow authors to verify the AEs being described. How were you able to verify these events?

d.Was the questions structured or unstructured?

e.Were there avenue for follow up, if you required further information

f.The use of emails did not allow anonymity. In this case, how did you ensured anonymity?

Results

(1)Lines 99/101: Avoid beginning a sentence with a number. Please revise

(2)Line 101: 144 HCWs (29.3%) did not indicate time interval. This seems a flaw in the design of the questionnaire. Authors should have envisaged this, even at the design stage.

Discussion

(1)Line 204: stud---study

(2)Our findings have implications for vaccine hesitancy and immunisation protocols. This was the concluding part of the abstract. The discussion section only has this on vaccine hesitancy ‘Given that vaccine safety plays a central role in people’s decision to accept a vaccination, our present work has implications for vaccine hesitancy’ It makes it very difficult to understand how this study could have implications on vaccine hesitancy and immunization protocols, in general. Please discuss the study to take care of this.

Reviewer #3: The authors are advised to include a statement about the type of study design that was employed.

Page4 line 88: The authors should provide citation for the software JASPv0.16.3.0.

Authors should avoid starting a sentence with abbreviations.

There are also a couple of spelling errors in the discussion aspect of the manuscript, the authors are advised to revise for punctuation and spelling.

**********

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.

Do you want your identity to be public for this peer review? If you choose “no”, your identity will remain anonymous but your review may still be made public.

For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: JAMES NYABUGA NYARIKI (PhD)

Reviewer #2: No

Reviewer #3: 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.

Increased adverse events following third dose of BNT162b2/Pfizer vaccine in those with previous COVID-19, but not with concurrent influenza vaccine.

PGPH-D-22-01340R1

Dear Dr Raw,

We are pleased to inform you that your manuscript 'Increased adverse events following third dose of BNT162b2/Pfizer vaccine in those with previous COVID-19, but not with concurrent influenza vaccine.' has been provisionally accepted for publication in PLOS Global Public Health.

Before your manuscript can be formally accepted you will need to complete some formatting changes, which you will receive in a follow up email. A member of our team will be in touch with a set of requests.

Please note that your manuscript will not be scheduled for publication until you have made the required changes, so a swift response is appreciated.

IMPORTANT: The editorial review process is now complete. PLOS will only permit corrections to spelling, formatting or significant scientific errors from this point onwards. Requests for major changes, or any which affect the scientific understanding of your work, will cause delays to the publication date of your manuscript.

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 globalpubhealth@plos.org.

Thank you again for supporting Open Access publishing; we are looking forward to publishing your work in PLOS Global Public Health.

Best regards,

Abram L. Wagner, PhD, MPH

Academic Editor

PLOS Global Public Health

***********************************************************

Reviewer Comments (if any, and for reference):

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: All comments have been addressed

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Does this manuscript meet PLOS Global Public Health’s publication criteria? Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe methodologically and ethically rigorous research with conclusions that are appropriately drawn based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available (please refer to the Data Availability Statement at the start of the manuscript PDF file)?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception. 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

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS Global Public Health 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

Reviewer #2: Yes

Reviewer #3: 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: All the issues I raised in the manuscript has been addressed to my satisfaction

Reviewer #2: All comments have been adequately addressed

Reviewer #3: The authors have satisfied all my concerns, the manuscript can now be accepted for publication.

**********

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.

Do you want your identity to be public for this peer review? If you choose “no”, your identity will remain anonymous but your review may still be made public.

For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Dr. JAMES NYABUGA NYARIKI

Reviewer #2: Yes: Enoch Aninagyei

Reviewer #3: No

**********