Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

Round 1

Reviewer 1 Report

I thank the authors for their time and energy that must have gone into behind the work. I read the manuscript with interest. But I could not fully understand the purpose/motivation of the authors behind the analysis of the VAERS data presented in it. Is the purpose to alert (scare) people not to take booster dose (because AEs [associated with booster shots] occur at a rate >50%)? This does not seem to be the case because the authors seem to be aware that an analysis like theirs might help "reduce skepticism and promote vaccination policy," as they say a line 56. But this motivation would not come out as such if they say that the AEs associated with booster doses occur at a rate >50%.

In lines 285 - 287, the authors conclude that "The findings of this research have implications for public health workers and scientists in other countries who intend to implement a mix-and-match strategy for COVID-286 19 booster vaccination." But this sentence does not clarify what implications those countries should take it away when it comes to administering booster doses in their populations.

Also, I wonder whether the authors should have analyzed their data on AEs by dividing it under two categories: non-life-threatening (e.g., local reactions, tiredness) and life-threatening (e.g., shortness of breadth) AEs. The reported overall rate of 52.2% might send a signal that booster doses do more harm than good. This may not be the case: booster doses can save lives.

A minor comment. The authors have refer to Table 1, Table 2 and Table 4 in the text. Where is Table 3? What was in it?

Author Response

Dear Reviewer,

Thank you for considering our manuscript (Vaccine-1780141) entitled “Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose”. We are grateful for the nice and detailed review from you and other reviewers. We have carefully revised our manuscript and responded to your comments. All changes with tracking-mark was also include for reference. We deeply appreciate your valuable comments, which stimulated a more thorough consideration of the paper and future studies as well.

Thank you very much, and we look forward to hearing from you.

Sincerely yours,

Yu-Chun Chen

Author Response File: Author Response.pdf

Reviewer 2 Report

This study explores the relevant topic of safety of COVID-19 vaccination. The paper sounds interesting, quite organized and comprehensive. Vaccination against COVID-19 has raised many concerns in public opinion. I think that it is a very relevant topic that must be addressed. The design of the study is good. I only have some minor suggestions:

-worsen outcome from vaccination was reported in people with COVID-19, in the female gender and after the second dose. This is in line with recent report that showed higher incidence of AEs in the female gender and after the first dose.

-the authors did not explore organ-specific involvement following vaccinations. What are the most feared AEs? What do they consider in the group “others”?

- The safety of vaccines is a very discussed topic and many papers have focused on the neurological consequences of vaccination. Are there any special population who should pay attention to vaccines? What about patients affected by autoimmune disease? Some considerations need to be discussed (i.e. Myasthenia gravis, CIDP, thyroid disorders, etc). Consider the role of vaccination in special populations and autoimmune disease such as myasthenia gravis. Read and cite recent papers on this topic (https://0-doi-org.brum.beds.ac.uk/10.3390/neurolint14020033).

-there are no relavant grammar mistakes. 

Author Response

Dear Reviewer,

Thank you for considering our manuscript (Vaccine-1780141) entitled “Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose”. We are grateful for the nice and detailed review from you and other reviewers. We have carefully revised our manuscript and responded to your comments. All changes with tracking-mark was also include for reference. We deeply appreciate your valuable comments, which stimulated a more thorough consideration of the paper and future studies as well.

Thank you very much, and we look forward to hearing from you.

Sincerely yours,

Yu-Chun Chen

Author Response File: Author Response.pdf

Reviewer 3 Report

The work by Po-Yu et al reports about the short term incidence rate of Adverse Effects following heterologous booster dose of Covid-19 vaccines.

The work is based on survey of over 7 thousand reports from vaccinees boosted with an heterologous regimen. The work is linearly conceived and clearly describe.

Although the results do not permit the evaluation of efficacy and durability of heterologous vaccination, nonetheless they are of interest to the readers being the concerns about short terms AE among the most relevant reasons for vaccine hesitancy.

However a few changes are needed to improve the quality of the manuscript .

line 70: the composition of the MVC-COV1901 should be described reporting the antigens included, their quantities and the adjuvants , as it is commonly used for other vaccines. See, as an example, https://secure.medicalletter.org/TML-article-1634a

lines 243-244 should be moved to the section Materials and Methods

Lines 254-257: What is the reason for mentioning here the Novavax vaccine for which no experimental data and no other mention is provided?

The table 2 , now  presented in two separated pages, has to be formatted so that it can be viewed in a single page.

Figure 2:  The data about MVC IR, commented in the legend at lines 184-187, are not shown int the figure (at least in the version I could see and download)

The final statement at lines  280-282   “ The reported population's IR is approximately identical to the overall population's rate. We believed that our research could still be a significant reference.”

Is not demonstrated

The sentences:  “No AEs items were utilized to guarantee survey anonymity and confidentiality” (lines 92-93);  “The IR of other AEs depends.”( at line 202);

“ In both homologous and heterologous COVID-19 227 booster vaccinations, the IRs of AEs within 7 days are identical.”(lines 227-228).

“To summarize, our study about AEs in booster doses is highly 247 credible and close to real-world data.” (lines 247-248);

“Third, representative bias was presented.” (Line 274)  

Seem  out of context and are incomprehensible to me: 

The acronym IR, for Incidence rate, is introduced in the abstract and then used throughout the text. For the sake of readability, any acronym should be recalled in the main text too.

The word “vaccinator” is consistently misused instead of “vaccinee”

Author Response

Dear Reviewer,

Thank you for considering our manuscript (Vaccine-1780141) entitled “Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose”. We are grateful for the nice and detailed review from you and other reviewers. We have carefully revised our manuscript and responded to your comments. All changes with tracking-mark was also include for reference. We deeply appreciate your valuable comments, which stimulated a more thorough consideration of the paper and future studies as well.

Thank you very much, and we look forward to hearing from you.

Sincerely yours,

Yu-Chun Chen

Author Response File: Author Response.pdf