of COVID-19 Vaccines to Patients Receiving Galcanezumab
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging
virus that has caused the recent COVID-19 pandemic. Currently,
efforts are underway to develop vaccines against SARS-CoV-2 and these
vaccines are expected to be available in the coming months.1,2
Live vs Nonlive or Inactivated Vaccines
to current available information on SARS-CoV-2 vaccines being
developed, the majority are nonlive.3
However, this is an unprecedented and evolving situation, so it is
advisable to check for updated information. For the most up-to-date
information regarding each vaccine in development, including the type
of each vaccine, please check the World Health Organization and
European Medicines Agency at
of whether a specific vaccination is live vs nonlive/inactivated can
also be found in the manufacturer’s product labeling.
Prior to or During Therapy With Galcanezumab
use of a SARS-CoV-2 vaccine in patients treated with galcanezumab has
not been studied by Lilly.
Lilly and Company has not evaluated the safety and efficacy of
galcanezumab in combination with vaccines, including SARS-CoV2
on the mechanism of action and mechanism of elimination of
galcanezumab, there is no reason to expect an interaction with the
host immune system.
decision to administer a vaccination to a patient prior to, during,
or after galcanezumab treatment must be based on the clinical
judgment of the prescribing healthcare practitioner after careful
consideration of the patient's risk factors as well as the risks and
benefits of vaccination.
follow local guidance regarding vaccine schedules and
mAbs Have no Direct Specific Immunomodulatory Effect
CGRP mAbs have been engineered to bind to either the CGRP peptide or
receptor with high specificity and minimized interaction with the
As CGRP is not an immune system target, CGRP mAbs have no direct
use of galcanezumab is not associated with increased risk of
infections or immunosuppression, nor are such events identified as
important risks in the galcanezumab risk management plan.7,8
Dong Y, Dai T, Wei Y, et al. A systematic review of SARS-CoV-2
vaccine candidates. Signal Transduct Target Ther.
Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against
SARS-CoV-2 - preliminary report. N Engl J Med.
Draft landscape of COVID-19 candidate vaccines. World Health
Organization (WHO). November 12, 2020. Accessed December 4, 2020.
Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus
on calcitonin gene-related peptide for prophylactic migraine therapy.
Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what
headache specialists need to know. Headache.
Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for
the use of monoclonal antibodies in migraine. Headache.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
= calcitonin gene-related peptide
= coronavirus disease 2019
= Eli Lilly and Company
= monoclonal antibody
= severe acute respiratory syndrome coronavirus 2
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.