Study Supports Pfizer, Moderna COVID-19 Vaccines’ Safety in Patients With Multiple Myeloma

Study results showed that both the Pfizer-BioNTech and Moderna COVID-19 vaccines were safe and effective in patients with multiple myeloma, which investigators hope will improve vaccine hesitancy in the high-risk population.

Receiving 2 doses of either the Pfizer-BioNTech or Moderna messenger RNA (mRNA) vaccine against COVID-19 was found to be safe and immunogenic in a group of patients with multiple myeloma (MM), investigators of a recent study concluded.

During the study, which was published in BMC Cancer, patients with MM experienced mild reactions to both doses of the vaccines against SARS-CoV-2, the virus that causes COVID-19. Previously, patients with MM were largely left out of vaccine clinical trials, leading a lot of vaccine hesitancy among the MM population, who are considered to be at higher risk for severe COVID-19 complications.

“These findings can provide reassurance to MM patients who are hesitant to receive SARS‐CoV‐2 mRNA vaccines,” the investigators wrote.

Patients with MM have a 34% inpatient mortality rate due to COVID-19 complications. Because patients with MM and other immunocompromised populations were excluded from vaccine trials, data on the effects of mRNA COVID-19 vaccines are critical to patients and their providers.

The investigators used a social media campaign to recruit 44 patients with MM aged 18 years or older without a history of COVID-19. The study extended from December 17, 2020, to March 18, 2021. The median age of the patients was 64 years, and 68% of the cohort was women. Additionally, 39% were not on any therapies at baseline and 98% of the cohort was White. The Pfizer-BioNTech vaccine and the Moderna vaccine were distributed to 22 patients each.

The participants were given a questionnaire about local reactions, systemic reactions, and adverse events 1 week after receiving each dose. Local reactions included injection site pain, swelling, and erythema. Systemic reaction consisted of fatigue, headache, myalgia, chills, fever, diarrhea, and vomiting. Adverse events could include anaphylaxis, incident neurologic diagnoses, or infections.

Overall, 80% of local and 71% of systemic reactions were mild. The most common local reaction observed was injection site pain, occurring in 75% of the cohort after the first dose and 73% after the second dose. The most reported systemic reaction was fatigue, occurring in 39% after dose 1 and 64% after dose 2. That was followed by headache, which was reported in 32% of patients after dose 1 and 50% after dose 2, and myalgia, which was found in 32% of the cohort after dose 1 and 41% after dose 2. No participants were reported to develop anaphylaxis, SARS-CoV-2 infection, or incident neurologic diagnoses

The investigators noted that the rates of local and systemic reactions were in line with previous clinical trial data for the vaccines.

One month after administration of the second dose, the participants underwent SARS-CoV-2 antibody testing. Antibodies were detected in 41 (93%) of patients, of whom 25 were taking a therapy for MM and 16 were not. The 2 participants receiving MM therapy who did not have detectable antibodies were taking teclistamab or a combination therapy of lenalidomide and ixazomib.

The study’s small sample size was listed as a limitation. Additionally, the antibody assays had a low dynamic range, and monoclonal protein concentrations were not measured.

“Due to these limitations, we do not yet know the degree to which detectable antibody levels impact the clinical presentation and severity of COVID-19 in patients with MM….Future investigations should include larger samples, examine the role of specific medications in vaccine response, and examine cellular immunity,” the investigators suggested.

Reference

Greenberg RS, Ruddy JA, Boyarsky BJ, et al. Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. BMC Cancer. 2021;21:1354. doi:10.1186/s12885-021-09097-5