https://orcid.org/0000-0002-9953-7769
ABSTRACT
Dear Editor, We would like to reply to “Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5–11years: Correspondence” regarding our article entitled “Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNTech) vaccine in children aged 5–11years: Results from an active pharmacovigilance study in central Italy.”
Author’s reply
Dear Editor,
We would like to reply to “Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5–11 years: Correspondence” regarding our article entitled “Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNTech) vaccine in children aged 5–11 years: Results from an active pharmacovigilance study in central Italy.”
The first comment is regarding a history of previous diseases among children who have undergone COVID-19 vaccination. In Italy, information on health status of children, as for adults, was collected by health professionals through a standardized format and procedure before undergoing vaccination.Citation1 In case of significant uncertainties or specific health concerns, including dengue fever, the medical doctor would make the final decision amongst vaccination, exemption, rescheduling and possible consultation of other specialists. Of note, dengue fever is endemic in more than 100 countries in Africa, the Americas, South-East Asia, the Western Pacific, and the eastern Mediterranean, but generally in Europe only imported cases are reported by travelers returning from these areas.Citation2 Indeed, according to latest surveillance data from 2010 to present provided by the European Centre for Disease Control and Prevention,Citation2 in our country, including the Molise region, dengue fever may also occur as an imported disease.
With respect to the second comment regarding COVID-19 vaccination in asymptomatic subjects, according to the interim clinical considerations by the Centers for Disease Control and Prevention,Citation3 COVID-19 vaccination is recommended for everyone ages 6 months and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection, and it was proved to be safe considering different age population groups.Citation3,Citation4 In addition, there are no contraindications for subjects with previous SARS-CoV-2 infection (symptomatic or asymptomatic) to get vaccinated against COVID-19 according to both Italian Ministry of Health and Italian Medicines Agency,Citation5,Citation6 and it is possible to consider the administration of a single dose that should be preferably received within 6 months after infection diagnosis and not over 12 months of recovery. Since the information related to a previous SARS-CoV-2 infection is collected at time of vaccination through a self-certification model, it is recommended to have evidence of a documented SARS-CoV-2 infection. In the absence, it is recommended that the anamnestic information on a previous infection is collected in the most complete and detailed way. Anyway, viral testing for acute SARS-CoV-2 infection, or serologic testing to assess for prior infection, is not recommended for vaccine decision-making.Citation7
Lastly, with respect to the comment related to recipient genetic background connected to immunological responses, the paradigm of personalized medicine has been already applied in the study of SARS-CoV-2 to understand the large inter-individual clinical differences, in which host genetics factors were proven to contribute and modulate response to infection.Citation8,Citation9 Responses to vaccination could be also different, including adverse reactions or lack of responses, and these are thought to be influenced by host genetic factors because polymorphisms of the innate and adaptive immune system genes could theoretically influence the vaccines response.Citation10 Indeed, personalized approaches would contribute to identify genetic markers as predictors of SARS-CoV-2 infection and vaccine response, and could guide health-care providers in the process of selecting the best treatment, and the most suitable vaccine for an individual or a specific population group.
Ethics statement
For this study, ethical approval was not requested as no experimental procedure was applied, and the information were retrospectively provided by participants after signing an informed consent. Furthermore, all data presented were de-identified, coded and were analyzed anonymously in accordance with ethics guidelines.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Additional information
Funding
References
- Ministero della Salute. Guida alle controindicazioni alle vaccinazioni [accessed 2022 Dec 11] https://www.salute.gov.it/imgs/C_17_pubblicazioni_2759_allegato.pdf
- European Centre for Disease Prevention and Control. Autochthonous transmission of dengue virus in mainland EU/EEA, 2010-present. https://www.ecdc.europa.eu/en/all-topics-z/dengue/surveillance-and-disease-data/autochthonous-transmission-dengue-virus-eueea
- Ripabelli G, Sammarco ML, D’Amico A, De Dona R, Iafigliola M, Parente A, Samprati N, Santagata A, Adesso C, Natale A, et al. Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: results from an active pharmacovigilance study in central Italy. Hum Vaccin Immunother. 2022;18(6):2126668. doi:10.1080/21645515.2022.2126668.
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- Ministero della Salute. Aggiornamento indicazioni sulla Vaccinazione dei soggetti che hanno avuto un’infezione da SARS-CoV-2. Circolare n° 32884-21/07/2021-DGPRE- DGPRE-P. 2021. 1–4.
- Agenzia Italiana del Farmaco. FAQ Vaccine COVID-19 [accessed 2022 December 11]. https://www.aifa.gov.it/domande-e-risposte-su-vaccini-covid-19
- Centers for Diseases Control and Prevention (CDC). Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States [accessed 2022 Dec 12]. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html
- Traversi D, Pulliero A, Izzotti A, Franchitti E, Iacoviello L, Gianfagna F, Gialluisi A, Izzi B, Agodi A, Barchitta M, et al. Precision medicine and public health: new challenges for effective and sustainable health. J Pers Med. 2021;11(2):135. doi:10.3390/jpm11020135.
- Tamburro M, Ripabelli G, Salzo A, Sammarco ML. Public health, personalized medicine, and COVID-19 in the pre-vaccination phase: a narrative review of the literature on unfavorable prognostic factors in Italian patients. Epidemiol Prev. 2022;46(3):181–91. doi:10.19191/EP22.A450.027.
- Smatti MK, Alkhatib HA, Al Thani AA, Yassine HM. Will host genetics affect the response to SARS-CoV-2 vaccines? Historical precedents. Front Med (Lausanne). 2022;9:802312. doi:10.3389/fmed.2022.802312.