Safety and effectiveness of the booster dose of mRNA COVID-19 vaccines in people with multiple sclerosis: A monocentric experience.
Booster
COVID-19
Multiple sclerosis
SARS-CoV-2
Vaccine
mRNA
Journal
Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
19
10
2022
revised:
07
02
2023
accepted:
16
02
2023
medline:
11
4
2023
pubmed:
9
3
2023
entrez:
8
3
2023
Statut:
ppublish
Résumé
Long-term data on the effectiveness and safety of the booster dose of anti-SARS-CoV-2 vaccines in people affected by multiple sclerosis (pwMS) are lacking, hence a retrospective monocentric study exploring these issues was undertaken. PwMS who had received the booster dose of anti-COVID19 mRNA vaccines (either Comirnaty or Spikevax) according to the national regulation were included. The occurrence of adverse events or disease reactivation and SARS-CoV-2 infection were recorded up to last follow-up. Factors predictive of COVID-19 were explored using logistic regression analyses. A two-tailed p-value <0.05 was considered significant. One hundred and fourteen pwMS were included: 80 females (70%); median age at the booster dose 42 years (range 21 - 73); 106/114 patients (93%) were receiving a disease-modifying treatment at vaccination. The median follow-up after the booster dose was 6 (range 2 - 7) months. Adverse events were experienced in 58% of the patients, being mild to moderate in most cases; 4 reactivations of MS were observed, two of which occurring within 4 weeks after the booster. SARS-CoV-2 infection was reported in 24/114 (21%) cases, occurring a median of 74 days (5-162) after the booster dose and requiring hospitalisation in 2 patients. Six cases received direct antiviral drugs. Age at vaccination and time between the primary vaccination cycle and the booster dose were independently and inversely associated with the risk of COVID-19 (HR 0.95 and 0.98, respectively). The administration of the booster dose in pwMS showed an overall good safety profile and protected 79% of the patients from SARS-CoV-2 infection. The observed association between the risk of infection after the booster dose and both younger age at vaccination and shorter interval period to the booster dose suggest that unobserved confounders, possibly including behavioural and social factors, play a relevant role in determining the individual propensity to get infected with COVID-19.
Sections du résumé
BACKGROUND
BACKGROUND
Long-term data on the effectiveness and safety of the booster dose of anti-SARS-CoV-2 vaccines in people affected by multiple sclerosis (pwMS) are lacking, hence a retrospective monocentric study exploring these issues was undertaken.
MATERIALS AND METHODS
METHODS
PwMS who had received the booster dose of anti-COVID19 mRNA vaccines (either Comirnaty or Spikevax) according to the national regulation were included. The occurrence of adverse events or disease reactivation and SARS-CoV-2 infection were recorded up to last follow-up. Factors predictive of COVID-19 were explored using logistic regression analyses. A two-tailed p-value <0.05 was considered significant.
RESULTS
RESULTS
One hundred and fourteen pwMS were included: 80 females (70%); median age at the booster dose 42 years (range 21 - 73); 106/114 patients (93%) were receiving a disease-modifying treatment at vaccination. The median follow-up after the booster dose was 6 (range 2 - 7) months. Adverse events were experienced in 58% of the patients, being mild to moderate in most cases; 4 reactivations of MS were observed, two of which occurring within 4 weeks after the booster. SARS-CoV-2 infection was reported in 24/114 (21%) cases, occurring a median of 74 days (5-162) after the booster dose and requiring hospitalisation in 2 patients. Six cases received direct antiviral drugs. Age at vaccination and time between the primary vaccination cycle and the booster dose were independently and inversely associated with the risk of COVID-19 (HR 0.95 and 0.98, respectively).
CONCLUSIONS
CONCLUSIONS
The administration of the booster dose in pwMS showed an overall good safety profile and protected 79% of the patients from SARS-CoV-2 infection. The observed association between the risk of infection after the booster dose and both younger age at vaccination and shorter interval period to the booster dose suggest that unobserved confounders, possibly including behavioural and social factors, play a relevant role in determining the individual propensity to get infected with COVID-19.
Identifiants
pubmed: 36889098
pii: S2211-0348(23)00086-X
doi: 10.1016/j.msard.2023.104582
pmc: PMC9957336
pii:
doi:
Substances chimiques
COVID-19 Vaccines
0
RNA, Messenger
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104582Informations de copyright
Copyright © 2023 Elsevier B.V. All rights reserved.
Références
Mult Scler Relat Disord. 2022 Jan;57:103416
pubmed: 34847379
J Clin Immunol. 2013 Feb;33(2):388-96
pubmed: 23064976
Nat Immunol. 2022 Feb;23(2):186-193
pubmed: 35105982
BMJ. 2022 Feb 10;376:e069052
pubmed: 35144968
J Neurol Neurosurg Psychiatry. 2022 Apr;93(4):448-450
pubmed: 34408003
Ther Adv Neurol Disord. 2022 Oct 10;15:17562864221129383
pubmed: 36237201
J Neurol Sci. 2022 Mar 15;434:120155
pubmed: 35091386
J Neurol. 2022 Sep;269(9):4581-4603
pubmed: 35788744
Clin Microbiol Infect. 2022 Feb;28(2):202-221
pubmed: 34715347
Lancet Reg Health Am. 2022 May;9:100198
pubmed: 35187521
Vaccine X. 2022 Aug;11:100175
pubmed: 35692461
Arch Neurol. 2011 Oct;68(10):1267-71
pubmed: 21670384
Neurotherapeutics. 2022 Jan;19(1):325-333
pubmed: 34859382
Lancet Healthy Longev. 2022 Jul;3(7):e470-e480
pubmed: 35813279
Mult Scler. 2021 May;27(6):864-870
pubmed: 33856242
Eur J Neurol. 2021 Nov;28(11):3712-3721
pubmed: 34152073
J Neurol. 2022 Jun;269(6):2840-2847
pubmed: 35239006
Ann Neurol. 2011 Feb;69(2):292-302
pubmed: 21387374
Neurology. 1983 Nov;33(11):1444-52
pubmed: 6685237
Mult Scler. 2021 Dec;27(14):2280-2283
pubmed: 33870792
Ann Neurol. 2001 Jul;50(1):121-7
pubmed: 11456302
EBioMedicine. 2021 Oct;72:103581
pubmed: 34563483
Infect Drug Resist. 2022 Jul 29;15:4127-4136
pubmed: 35937784
Nat Med. 2021 Nov;27(11):1990-2001
pubmed: 34522051
Mult Scler. 2022 Oct;28(12):1937-1943
pubmed: 35723265
Neurol Neuroimmunol Neuroinflamm. 2020 May 1;7(4):
pubmed: 32358223