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This chart shows information about KESIMPTA and vaccinations.

Vaccination of infants born to mothers treated with KESIMPTA  during pregnancy1*

  • In infants of mothers treated with KESIMPTA during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts. Depletion of B cells in these infants may increase the risks from live or live-attenuated vaccines

  • Inactivated vaccines may be administered, as indicated, prior to recovery from B-cell depletion, but an assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted

Currently available COVID-19 vaccines on the market, by Pfizer/BioNTech, Moderna, and Janssen, are non-live vaccines.3

Any vaccine used in patients taking KESIMPTA should be administered in accordance with the KESIMPTA full Prescribing Information.


Immune response

  • B cells are part of a complex immune response to both viruses and vaccinations4,5

  • T cells are also involved and play a fundamental role in viral infections by helping B cells produce antibodies. They also orchestrate the response for other immune cells. Some T cells kill infected cells to reduce the viral burden4,5

  • Data from a relapsing MS clinical study also showed that T cells remained largely unaffected in KESIMPTA-treated patients. T cells are an important part of a response to viral infections, including COVID-195,6


KESIMPTA is a targeted and precisely delivered B-cell therapy

  • When delivered subcutaneously, KESIMPTA is thought to promote preferential depletion of B cells in the lymph nodes7

  • Preclinical evidence suggests that KESIMPTA may spare B cells in the spleen that help maintain immune function8

The precise mechanism by which KESIMPTA exerts its therapeutic effects is unknown.

KESIMPTA vaccine-related information brochure

Read more on KESIMPTA vaccine-related information

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*As of March 2021, KESIMPTA has not been studied with vaccines.

Post vaccination, an assessment of vaccine immune responses, including consultation with qualified specialists, should be considered to determine whether a protective immune response was mounted. It is unknown whether KESIMPTA may interfere with vaccine efficacy.

Data from Studies 1 and 2 indicate a median time to B-cell recovery to either LLN or baseline value of 24.6 weeks post treatment discontinuation. PK and PD modeling and simulation for B-cell repletion corroborate these data, predicting median time to B-cell recovery to LLN of 23 weeks post treatment discontinuation.

LLN, lower limit of normal; MOA, mechanism of action; MS, multiple sclerosis; PD, pharmacodynamic; PK, pharmacokinetic; SC, subcutaneous.


Contraindications: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema.

Warnings and Precautions

Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies....


KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults...

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References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. Centers for Disease Control and Prevention. Principles of vaccination. Updated August 18, 2021. Accessed November 7, 2023. 3. Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. Updated February 22, 2022. Accessed March 11, 2022. 4. Centers for Disease Control and Prevention. Understanding How COVID-19 Vaccines Work. Updated January 25, 2022. Accessed February 10, 2022. 5. Vabret N, Britton GJ, Gruber C, et al. Immunology of COVID-19: current state of the science. Immunity. 2020;52(6):910-941. doi:10.1016/j.immuni.2020.05.002. 6. Wiendl H, Fox E, Goodyear A, et al. Effect of subcutaneous ofatumumab on lymphocyte subsets in patients with RMS: analysis from the APLIOS study. LB129. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Paris, France; Virtual. 7. Torres JB, Roodselaar J, Sealey M, et al. Distribution and efficacy of ofatumumab and ocrelizumab in humanized-CD20 mice following subcutaneous or intravenous administration. P2.2-052. Poster presented at: 71st American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. 8. Theil D, Smith P, Huck C, et al. Imaging mass cytometry and single-cell genomics reveal differential depletion and repletion of B-cell populations following ofatumumab treatment in cynomolgus monkeys. Front lmmunol. 2019; 10:1340. doi:10.3389/fimmu.2019.01340