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PONE-D-23-02102Safety Profile of An Inactivated SARS-CoV-2 Vaccine (Sinovac/CoronaVac) in Healthy Adults aged ≥ 18 Years: a Passive Surveillance in IndonesiaPLOS ONE

Dear Dr. Leonard,

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. Particularly, the study's primary strength is its use of appropriate statistical analysis of national surveillance data. Nevertheless, its weak aspect is the insufficient depth in analyzing and discussing the study's findings. In addition, stating the exact percentage of the Sinovac COVID-19 vaccine administered is crucial, rather than merely indicating that it constituted the majority of the vaccine utilized. Finally, the discussion section should be more comprehensive and in-depth.

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Mohammad-Reza Malekpour

Academic Editor

PLOS ONE

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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

Reviewer #2: Yes

Reviewer #3: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

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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: No

Reviewer #2: Yes

Reviewer #3: No

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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

Reviewer #2: No

Reviewer #3: Yes

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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: The study is aimed to investigate the rate of adverse reactions of COVID-19 vaccination in Indonesia to decrease the vaccination hesitancy and be a reliable source for Indonesian people's bodies' probable pathological response to the vaccine. I do agree that these kind of studies are required for each nation but there are some points that need to be considered first:

The manuscript needs intensive language editing. I suggest using language editing services.

Introduction, lines 21-24: the statistics needs to be updated.

Materials and methods: the first three subheadings can be merged.

In the study results it is reported that female gender was accounted for more adverse events after 1st, second, or booster dose. But is there any proof that females weren’t more vaccinated than males? For concluding that adverse events are more common among females, we are going to need such fractions: females having symptoms/total vaccinated females Vs. males having symptoms/total vaccinated males.

Generally, it is highly recommended to report the study population’s characteristics as a part of your results.

Reviewer #2: The manuscript by Nastiti et al looked into the Safety Profile of Inactivated Vaccine COVID-19 in Healthy Adults Aged above 18 years in Indonesia. The study is good but need following major revision

1. Too many grammatical errors throughout the manuscript. It required a through combing grammatical and spelling error preferably from an expert.

2. The abstract first line ‘…………is one of the methods to prevent…..’ may be reframed.

3. Sentence in line 52-55 not clear.

4. Line 55 ‘world’ not ‘word’.

5. Authors may consider adding the ‘Study design’ section briefly.

6. The sum of ‘Total Serious AEFI reported (n cases)’ in table 1 is not correct.

7. Fix line 143 and 144: 5.104 instead of 5,104 and 1.391 instead of 1,391.

8. Line 167 to 180: Figure numbering seems inconsistent

9. Line 176: remove , with . in data

Reviewer #3: 1. The manuscript reports on the incidence and severity of Adverse Events Following Immunization (AEFI) after the nationwide roll out of the Sinovac COVID-19 vaccine in Indonesia. The data consists of passive national surveillance developed by the government of Indonesia, and reported to a vaccine safety website and through manual data collection. Data for the study were collected between January 13th 2021 and 31st June 30 2022. The strength of the study lies in the analysis of national surveillance data and the use of appropriate statistics. However, the weakness of the study is in the lack of depth in the analysis and discussion of findings. I have recommended minor revisions .

2. Given that a major strength of the study is the use of the national surveillance data, the analysis should go beyond provides descriptive outputs about AEFI but include an assessment of the quality or completeness of the data. Authors mention that all health facilities are required by policy to report into the system, but there is no analysis to show if indeed all facilities providing the COVID-19 vaccine are reporting. This is important to inform the interpretation of the AEFI incidence rate presented in the analysis for the whole country.

3. It is important to report the proportion of COVID-19 vaccines in use that was Sinovac. It is not enough to say it was the majority of the vaccine used, since the paper positions this analysis as a study of AEFI associated with the use of Sinovac. If other vaccines were in use at the same time, please report them and their percentages.

4. The methods section does not describe their approach to analysis. Authors should revise this section and include what analysis was done and what statistically tests were done - if any. There should also be a statement around ethical review - if one was sought or done, if not why not.

5. The discussion section should do a bit more than report what was found, it should interpret the results and tell the reader the implications of the findings. For example, authors could discuss the AEFI rates in relation to expected rates or discuss any potential challenge with the data that could affect the inference drawn from their findings.

6. The manuscript could do with copy editing to clean out grammatical errors and fix punctuations.

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Reviewer #1: Yes: Mohammadreza Azangou-Khyavy

Reviewer #2: No

Reviewer #3: Yes: Dr. Chizoba Barbara Wonodi

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Safety Profile of An Inactivated SARS-CoV-2 Vaccine (Sinovac/CoronaVac) in Healthy Adults aged ≥ 18 Years: a Passive Surveillance in Indonesia

PONE-D-23-02102R1

Dear Dr. Leonard,

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,

Mohammad-Reza Malekpour

Academic Editor

PLOS ONE

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)

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

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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

Reviewer #2: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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

Reviewer #2: Yes

Reviewer #3: Yes

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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

Reviewer #2: Yes

Reviewer #3: Yes

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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: Regarding the previous comment about females experiencing higher side effects, if the authors don't have sufficient supporting data which I had asked, (as they have declared) they need to mention it in the discussion section.

Reviewer #2: (No Response)

Reviewer #3: (No Response)

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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: Yes: Mohammadreza Azangou-Khyavy

Reviewer #2: No

Reviewer #3: No

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