Pfizer COVID-19 Vaccine Continues to Show Real-World Safety in Multiple Sclerosis

Disease Spotlight | <b>Disease Spotlight: Multiple Sclerosis</b>

Of those who reported new or worsening neurological symptoms, 77.8% didn’t require any additional medication to treat their symptoms.

Using an anonymous survey, investigators from a tertiary multiple sclerosis (MS) center in Israel concluded that the BNT162b2 COVID-19 vaccine (Pfizer) has an overall safe profile for patients with MS and should be further confirmed in larger, prospective studies.

Lead author Itay Lotan, MD, department of neurology, Rabin Medical Center, and colleagues reported on real-life safety data of the Pfizer COVID-19 vaccine among 262 patients with MS who responded to the survey. Patients first answered general demographic and disease-related questions and were then questioned on if they received the vaccine, date of vaccination, presence, type of early reactions, and type and timing of new or worsening neurological symptoms following the vaccination.

The median age of the cohort was 42 years (range, 22-79 years), with 25.2% (n = 66) of participants reporting associated comorbidities. Disease-modifying therapy (DMT) use was reported in 198 participants (75.6%), while 17 participants received treatment with corticosteroids in the month proceeding the first vaccination.

A total of 239 participants (91.2% of responders) received the vaccine, 18 (7.5%) of which who received only 1 dose and 221 (92.5%) participants who received both doses. Following vaccination, 136 participants (56.9%) reported early adverse events (AEs), with pain at the injection site as the most reported AE by 111 participants (46.4%). Fatigue (38.1%), muscle pain (36.8%), headache (36.8%), chills (29.7%), fever (15.9%), and dizziness (12.6%) rounded out the other AEs.

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Among the 198 participants who were treated with DMTs, 100 (55.9%) reported AEs. In comparison, 36 of 57 participants (63.2%) who received the vaccine and were not treated with DMTs reported AEs (P = 0.0683). Sixty-nine of 127 participants (54.3%) treated with DMTs who were younger than 55 years of age experienced AEs, while 23 of the 52-patient cohort (44.2%) above 55 years of age on DMTs reported AEs. Notably, no association between the type of DMT and the frequency and type of AEs was found.

Investigators reported that 36 participants (15.1%) had new or worsening neurological symptoms following the vaccination. Of this group, 29 (80.5%) were women and 28 (77.8%) were treated with DMTs. Among those who received both doses of the vaccine, 3 participants (9.7%) reported new or worsening neurological symptoms only after the first dose and 18 (58.1%) reported new or worsening neurological symptoms only after the second dose. A total of 10 participants (32.2%) experienced new or worsening neurological symptoms after both doses of the vaccine.

Sensory disturbances such as numbness, tingling, and itching sensations were the most common new or worsening neurological symptoms, which occurred in 21 patients. Other common symptoms included muscle weakness (n = 17), pain (n = 13), gait instability (n = 12), walking difficulty (n = 9), visual symptoms (n = 6), and sphincteric problems (n = 5).

New or worsening neurological symptoms that occurred within the first 24 hours post-vaccination was reported in 61.1% (n = 22) of the cohort, while 27.8% (n = 10) of participants reported the occurrence of new or worsening neurological symptoms within a few days to 1 week after vaccination. Only 2 participants experienced new or worsening symptoms 1-month post-vaccination.

Of those who reported new or worsening neurological symptoms, 28 participants (77.8%) didn’t require any additional medication to treat their symptoms. Six participants (16.7%) required simple analgesics, 1 participant (2.8%) received benzodiazepines, and 1 (2.8%) was treated with corticosteroids.

REFERENCE
Lotan I, Wilf-Yarkoni A, Friedman Y, Stiebel-Kalish H, Steiner I, Hellman MA. Safety of the BNT162b2 COVID-19 vaccine in multiple sclerosis: early experience from a tertiary MS center in Israel. Eur J Neurol. Published online July 21, 2021. doi:10.1111/ene.15028