Self-Reported safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among Iranian people with multiple sclerosis

Figures & data

Table 1. Study variables and their measurement

Variable	Measurement
Primary outcome
1. Number of MS relapses	Count
Secondary outcomes
2. General post-vac symptoms	Categorical
3. Neurological post-vac symptoms	Categorical
4. Possible serious events	Count
5. Reason for vac-hesitancy	Nominal
Other
6. Duration since the first dose	Number of weeks
7. Age	Years
8. Sex	Female/male
9. Disease duration	Years
10. MS type	Relapsing-remitting/progressive
11. Disease-modifying therapy	Categorical
12. Number of Comorbidities	Count
13. Previous COVID-19	Binary

Abbreviations: vac, vaccination; MS, multiple sclerosis.

Figure 1. Study flow diagram.

Table 2. General characteristics of participants

General characteristics	Vaccinated(n = 517)	Unvaccinated(n = 174)	P
Mean age (SD) [years]	37.81 (8.74)	36.75 (10.20)	0.19
Sex (n, %) [female/male]	397 (76.79)/120 (23.21)	137 (78.74)/36 (21.26)	0.18
Comorbidities (n, %)			0.62
None	416 (80.46)	143 (82.18)
Hypertension	16 (3.09)	7 (4.02)
Diabetes	8 (1.55)	3 (1.72)
Smoking	5 (0.97)	2 (1.15)
Obesity	12 (2.32)	8 (4.59)
Autoimmune conditions	14 (2.71)	3 (1.72)
Thyroid dysfunction	38 (7.35)	9 (5.17)
Other	46 (8.90)	19 (10.92)
Median MS duration (Range) [years]	8 (29)	6 (20)	<.01
MS phenotype (R/P)	427/90	154/20	<.01
History of COVID-19 (n, %) [Yes/No]	208 (40.23)/309 (59.77)	28 (16.09)/146 (83.91)	0.07
DMTs (n, %)			0.05
No DMT	20 (3.87)	14 (8.04)
Interferons	161 (31.14)	50 (28.74)
Glatiramer Acetate	53 (10.25)	22 (12.64)
Dimethyl Fumarate	100 (19.34)	41 (23.56)
Teriflunomide	41 (7.93)	17 (9.77)
Fingolimod	48 (9.28)	14 (8.05)
Natalizumab	4 (0.77)	1 (0.57)
Rituximab	90 (17.41)	15 (8.62)	0.04*
Vaccination status (n, %)		NA
One dose	100 (19.3)
Two doses	417 (80.7)
Median vaccine-related ARP (Range) [weeks]	6 (4)

*The only significant post-hoc P-value with Bonferroni correction is reported.

Abbreviations: SD, standard deviation; R, relapsing; P, progressive; DMT, disease-modifying therapy; ARP, at-risk period; NA, not applicable.

Table 3. Post-accination symptoms of participants during the ARPs

Symptoms (n, %)	pwMS vaccinated with BBIBP-CorV
	After first dose (n = 517)	After second dose (n = 417)	Total (n = 517)
GENERAL SYMPTOMS
No symptoms	222 (42.9%)	228 (54.7%)	137 (26.5)
Fever	97 (18.8%)	56 (13.4%)	112 (21.66)
Headache	122 (23.6%)	78 (18.7%)	147 (28.43)
Myalgia	132 (25.5%)	84 (20.1%)	160 (30.95)
Fatigue	106 (20.5%)	66 (15.8%)	123 (23.79)
Hypersensitivity	55 (10.6%)	41 (9.8%)	70 (13.54)
Pruritus	19 (3.7%)	12 (2.9%)	22 (4.26)
Urticaria	3 (0.6%)	1 (0.2%)	3 (0.6%)
Gastrointestinal	7 (1.4%)	0	7 (1.4%)
Dyspnea	3 (0.6%)	0	3 (0.6%)
Dizziness	5 (1%)	0	5 (1%)
Other	15 (2.9%)	0	15 (2.9%)
NEUROLOGICAL SYMPTOMS
No symptoms	465 (89.94)	363 (87.05)	433 (83.7%)
Motor	19 (3.68)	25 (5.99)	32 (6.2%)
Sensory	11 (2.13)	10 (2.40)	12 (2.3%)
Diplopia	8 (1.55)	11 (2.64)	14 (2.7%)
Vision impairments	10 (1.93)	14 (3.36)	17 (3.3%)
Vertigo	13 (2.51)	19 (4.56)	23 (4.4%)
Other	10 (1.93)	15 (3.60)	19 (3.7%)

Abbreviations: pwMS, people with multiple sclerosis.

Table 4. Results of multivariable Poisson regression

Predictors	Multivariable Poisson regression (n = 691, outcome: MS relapse, Offset: ARP)
	B	SE	P
Age (per year)	−0.037	0.026	0.157
Sex
Male	(ref)
Female	−0.094	0.576	0.871
History of COVID-19
No	(ref)
Yes	0.404	0.564	0.473
MS type
Relapsing	(ref)
Progressive	0.160	0.723	0.824
MS duration (per year)	0.054	0.050	0.283
DMT
No DMT	(ref)
Injectables (IFN, GA)	−0.251	1.200	0.834
Orals (DMF, TFN, FNG)	0.565	1.116	0.612
Infused (RTX, NTZ)	0.541	1.214	0.656
Cohort
Unvaccinated	(ref)
Vaccinated	0.163	0.579	0.779

Abbreviations: MS, multiple sclerosis; ARP, at-risk period; ref, reference; DMT, disease-modifying therapy; IFN, interferons; GA, glatiramer acetate; DMF, dimethyl fumarate; TFN, teriflunomide; FNG, fingolimod; RTX, rituximab; NTZ, natalizumab.

Data availability statement

The anonymized data will be shared with any qualified investigator upon reasonable request.