Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
and Francesco Paolo Bianchi 1
Round 1
Reviewer 1 Report
The manuscript titled “Post-marketing active surveillance of adverse reactions following influenza cell-based quadrivalent vaccine: an Italian prospective observational study” is a perspective observational study evaluating, through a post-marketing active surveillance program developed during 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) happened in the 7 days after immunization with Flucelvax Tetra, which is a cell-based quadrivalent vaccine. This is an important field of study as active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups. The manuscript has been written very well and shows the importance of active surveillance program in defining the safety profiles of a given vaccine.
Minor Comments:
- Please include the age group/gender of the HCW that were part of this study.
- Please break down the data based on age groups/Gender. This may indicate if the AEFI’s were higher in certain age groups/certain population.
- Please increase the font size of Figure 1. In the current form it is very difficulty to read the figure data.
Author Response
A1. Revided
A2. Revised
A3. Revised
Reviewer 2 Report
This is a well-written paper addressing an interesting topic. My interest is enhanced by the fact that the almost identical study could be applied for the different COVID-19 vaccinations. I am particularly impressed by the response rate.
My only negative comment relates to Figure 1. The scale on the horizontal axis is not consistent. The time span for the first 2 12 hour points is identical to the subsequent one-day time marks. This affects the shape of the curves.
a minor point at line 43. provided not providec.
Author Response
A1. Revised
A2. Revised
