Improving BNT162b2 mRNA vaccine tolerability without efficacy loss by Pidotimod supplementation Pidotimod in SARS-CoV-2 vaccination
Main Article Content
Keywords
immunostimulatory. SARS COV2, safety, Pfizer-Biontech, adverse events , Covid-19
Abstract
Background and objectives: A new pandemic has emerged across the world:Covid-19. Covid-19 has affected hundreds of millions of people globally. To stop the spread of the virus and gain a mass immunity several vaccines have been developed. BNT162b2-mRNA-vaccine has been shown to be largely effective and is widely administered. However the vaccine is not free from adverse events that could discourage vaccination in many people. The aim was evaluated adverse effect and immunological effect after second dose of BNT162b2-mRNA-vaccine in a healthcare population that take Pidotimod versus control subjects.
Methods: All nurses and doctors working in Covid-19 unit were proposed to participate, up to the enrollment of 30participants. 10 participants took Pidotimod 800mg bid orally fasting, from the fourth day before the second dose of the BNT162b2-mRNA-vaccine, for a total of six days. The remaining 20 participants did not take any therapy. We studied the differences in anti-SARS-CoV2 IgM and IgG levels and the difference of frequency of adverse events between the two groups
Results: Although there was no significant difference in IgG production between the two groups, we found a lower frequency of vaccine adverse events in the group supplemented with pidotimod.
Conclusions: This work demonstrates how pidotimod, despite not having a proven efficacy in increasing the production of antibodies, significantly reduces the adverse events described compared to people vaccinated without pidotimod supplementation. The results we described in this paper could encourage many more clinicians and people to vaccinate and gain the mass immunity needed to end this pandemic.
Downloads
Abstract 605
PDF Downloads 373
HTML Downloads 148
References
2. Lai CC, Chen CH, Wang CY, Chen KH, Wang YH, Hsueh PR. Clinical efficacy and safety of remdesivir in patients with COVID-19: a systematic review and network meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2021.
3. Goldberg E, Ben Zvi H, Sheena L, et al. A real-life setting evaluation of the effect of remdesivir on viral load in COVID-19 patients admitted to a large tertiary centre in Israel. Clin Microbiol Infect. 2021.
4. Katia F, Myriam DP, Ucciferri C, et al. Efficacy of canakinumab in mild or severe COVID-19 pneumonia. Immun Inflamm Dis. 2021.
5. Ucciferri C, Vecchiet J, Falasca K. Role of monoclonal antibody drugs in the treatment of COVID-19. World J Clin Cases. 2020;8(19):4280-4285.
6. D'Ardes D, Pontolillo M, Esposito L, et al. Duration of COVID-19: Data from an Italian Cohort and Potential Role for Steroids. Microorganisms. 2020;8(9).
7. Ucciferri C, Auricchio A, Di Nicola M, et al. Canakinumab in a subgroup of patients with COVID-19. Lancet Rheumatol. 2020;2(8):e457-ee458.
8. Ucciferri C, Barone M, Vecchiet J, Falasca K. Pidotimod in Paucisymptomatic SARS-CoV2 Infected Patients. Mediterr J Hematol Infect Dis. 2020;12(1):e2020048.
9. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615.
10. Fabiani M, Ramigni M, Gobbetto V, Mateo-Urdiales A, Pezzotti P, Piovesan C. Effectiveness of the Comirnaty (BNT162b2, BioNTech/Pfizer) vaccine in preventing SARS-CoV-2 infection among healthcare workers, Treviso province, Veneto region, Italy, 27 December 2020 to 24 March 2021. Euro Surveill. 2021;26(17).
11. Ucciferri C, Falasca K, Reale M, et al. Pidotimod and Immunological Activation in Individuals Infected with HIV. Curr HIV Res. 2021.
12. Abbasi J. COVID-19 and mRNA Vaccines-First Large Test for a New Approach. JAMA. 2020;324(12):1125-1127.
13. Li J, Huang DQ, Zou B, et al. Epidemiology of COVID-19: A systematic review and meta-analysis of clinical characteristics, risk factors, and outcomes. J Med Virol. 2021;93(3):1449-1458.
14. Skowronski DM, De Serres G. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2021;384(16):1576-1577.
15. Lamb YN. BNT162b2 mRNA COVID-19 Vaccine: First Approval. Drugs. 2021;81(4):495-501.
16. Giagulli C, Noerder M, Avolio M, et al. Pidotimod promotes functional maturation of dendritic cells and displays adjuvant properties at the nasal mucosa level. Int Immunopharmacol. 2009;9(12):1366-1373.
17. Ferrario BE, Garuti S, Braido F, Canonica GW. Pidotimod: the state of art. Clin Mol Allergy. 2015;13(1):8.
18. Tang MLK, Hsiao KC, Ponsonby AL, et al. Probiotics and oral immunotherapy for peanut allergy - Authors' reply. Lancet Child Adolesc Health. 2017;1(3):e1-e2.
19. Weinberger B. Vaccines for the elderly: current use and future challenges. Immun Ageing. 2018;15:3.
20. Borghi MO, Minonzio F, Fain C, et al. [Effect of pidotimod on the function of the human immune system: in vitro and ex vivo study]. Drugs Exp Clin Res. 1993;19 Suppl:37-43.
21. Trabattoni D, Clerici M, Centanni S, Mantero M, Garziano M, Blasi F. Immunomodulatory effects of pidotimod in adults with community-acquired pneumonia undergoing standard antibiotic therapy. Pulm Pharmacol Ther. 2017;44:24-29.
22. Burgio GR, Marseglia GL, Severi F, et al. Immunoactivation by pidotimod in children with recurrent respiratory infections. Arzneimittelforschung. 1994;44(12A):1525-1529.
23. Cogo R. Pidotimod activity in patients affected by COPD. Minerva Pneumologica 2014;53(1):21-26.