The BNT162b2 (BioNTech, Pfizer) COVID-19 vaccine proved just as safe and effective among patients with neuromuscular disorders (NMDs) as people without NMDs, according to study findings published in Frontiers in Immunology.
Researchers in Japan conducted a prospective, multicenter, observational cohort study comparing the immunological response following COVID-19 vaccination of 11 patients (7 males, 4 females), aged 12 years or older, with NMDs such as spinal muscular atrophy (SMA; n=9) and Duchenne muscular dystrophy (DMD; n=2) who were wheelchair-bound or bedridden to 346 Nagoya Memorial Hospital employees (60 males, 286 females), aged 21 years or older, who did not have NMDs.
All study participants provided blood samples at baseline and 2 weeks after each COVID-19 vaccination dose to assess the number of antibodies against the spike protein of the COVID-19 virus. All participants received 2 doses of the BNT162b2 (Pfizer) vaccine).
Anti-COVID antibody titers (U/mL) between the 2 groups remained similar at baseline (<.40 vs. <.40; P = 1.000), 2 weeks after the first vaccine dose (145±258 vs. 103±1192; P =.909), and 2 weeks after the second vaccine dose (1528±1265 vs. 1429±944; P =.736).
Males with NMDs demonstrated higher antibody titers after the first vaccine dose compared with males in the control group (203±312 vs. 26±29; P <.001). In contrast, the researchers did not observe any significant difference after the first vaccine dose between females in the NMD group and females in the control group (P =.998). After the second vaccine dose, antibody titers were not significantly different between either males (P =.886) or females (P =.230) in both groups.
Within the control group, females demonstrated a higher immunological response following the second vaccine dose than males (Females: 1486±991 vs. Males: 1167±633; P =.0176), but females did not demonstrate significantly higher antibody titers than males within the NMD group after the second vaccine (Females: 2091±1646 vs. Males: 1206±990; P =.287).
Both groups demonstrated comparable rates of adverse reactions higher than grade 1 following both first and second vaccinations. Injection site reactions and analgesic use were similar between groups after the first vaccination dose.
In contrast, participants in the control group experienced more injection site reactions and used more analgesics after the second vaccine than patients with NMDs (P <.0001; P =.0252, respectively).
“Antibody titers in patients with NMDs were similar to those of healthy controls and there was no difference in the percentage of adverse reactions to BNT162b2 between the NMDs group and healthy controls,” the researchers stated. They concluded that “Although BNT162b2 is administered by intramuscular injection, it appears to be effective and safe in patients with NMDs.”
Study limitations included small sample size of patients with NMDs, lack of confirmation of vaccination site via ultrasound, and short follow-up period.
Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Iwayama H, Ishihara N, Kawahara K, et al. Early immunological responses to the mRNA SARS-CoV-2 vaccine in patients with neuromuscular disorders. Front Immunol. Published online September 29, 2022. doi:10.3389/fimmu.2022.996134