Few Side Effects of COVID-19 Vaccine Seen in Patients in Small Study
Parkinson’s disease patients don’t appear to be at an increased risk for side effects after getting the COVID-19 vaccination compared with the general population, and reported having fewer reactions to it than healthy participants in a small study.
“Our data showed few [adverse events] reported after the administration of Gam-COV-Vac and Pfizer-BioNTech vaccines in patients with Parkinson’s disease … Additionally, the frequency of [adverse events] in the population with Parkinson’s disease was significantly lower than in the control group,” the researchers wrote.
The study, “Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson’s Disease and Multiple Sclerosis: A Longitudinal Study,” was published in Vaccines.
Evidence has suggested a higher risk of severe COVID-19 infection and subsequent mortality among Parkinson’s patients than the general population. While it’s recommended that people with Parkinson’s receive an approved COVID-19 vaccine, more data is needed about the prevalence of side effects to it.
Researchers at the University of Bologna, conducted a study in the Republic of San Marino — an enclave in central Italy — to evaluate the safety profiles in people with Parkinson’s disease and multiple sclerosis (MS) who received the Gam-COVID-Vac (Sputnik V) or the PFizer-BioNTech vaccines compared with those of healthy people serving as controls.
Sputnik V contains small amounts of the part of the SARS-CoV-2 virus that causes COVID-19 infection, while the Pfizer-BioNTech vaccine provides the body with a template to make that part of the virus itself. Both vaccines are administered in two doses, three weeks apart, and are designed to prompt the body to mount an immune response against the virus.
Participants were asked to complete questionnaires about their symptoms the week after the first and second doses. All symptoms were graded on a scale of 1 to 4, with a higher grade indicating more severe symptoms.
A total of 34 people with Parkinson’s and 82 healthy participants were vaccinated and completed both questionnaires. All the healthy participants received the Sputnik V vaccine, while 28 Parkinson’s patients received Sputnik V and six the Pfizer-BioNTech vaccine.
In the week after the first dose, 26% of Parkinson’s patients and 68% of healthy participants reported having side effects.
Among patients, 15% reported local reactions at the injection site, pain being the most common, and 21% had systemic symptoms, such as fatigue, joint pain, and headache. All symptoms were graded a 1, or mild.
In healthy participants, 43% reported local reactions and 49% reported systemic reactions, most of which were grade 1.
More side effects were reported after the second dose, with 29% of Parkinson’s patients experiencing them. Local symptoms were again reported by 12% of these patients and systemic symptoms by 21%, and were similar to those after the first dose. A majority of healthy controls (78%) had reactions, with local side effects in 62% of cases and systemic ones in 57%. The majority of these were a level 1 or 2.
There was no significantly higher or lower risk of side effects for Parkinson’s patients after the first dose, the researchers reported, while a “significantly lower” risk was seen in these patients compared with controls after the second dose.
The team also evaluated side effects in 48 people with MS and found their rate to be similar to healthy participants.
“Even though our sample size was quite small, our findings showed that [Parkinson’s] and MS diagnosed participants reported fewer or similar [adverse events] compared to the control group, and almost all of them were graded 1 or 2 in intensity and/or duration. This was even more evident in the [Parkinson’s] group,” the researchers wrote.
Few participants received the Pfizer vaccine, which prevented a direct comparison of side effects between the two vaccines, the researchers noted.
The “cognitive deficits … frequently observed” in Parkinson’s patients may also have limited their ability to complete questionnaires or communicate side effects to caregivers, posing another study limitation, they said.
Still, these results suggest that Parkinson’s and MS patients are not at greater risk of side effects from the vaccines. Future studies with larger sample sizes will be needed to validate these results, the researchers noted.