Table 1.

Summarized treatment and vaccination recommendations for various clinical scenarios

Clinical scenario	ICI recommendation	Vaccination recommendation*†‡
No comorbidities or AID	Treat with SOC or clinical trial* without delay	Vaccinate promptly with first-available approved option
Known history of AID	Use of clinical judgment is advised If deemed fit for ICI, prioritize treatment with SOC or clinical trial*. Consider delay if AID exhibiting active and clinically significant flare Consider approved longer interval of ICI doses§	Prioritize prompt vaccination with first-available approved option¶
High risk of COVID-19 severity or mortality (advanced metastatic cancer,22 poor performance status,21 elderly,12 active comorbidities,20 smoking history)13	Use of clinical judgment is advised If deemed fit for ICI, prioritize treatment with SOC or clinical trial* without delay Consider approved longer interval of ICI doses§	Prioritize prompt vaccination with first-available approved option
Contraction of COVID-19 infection while receiving, or prior to initiation of, ICI therapy	Recommend withholding ICI therapy regardless of symptoms On resolution of acute illness (if symptomatic) and meeting criteria to discontinue isolation, use of clinical judgment is advised. If deemed fit for ICI, prioritize treatment with SOC or clinical trial* without delay‡ Consider approved longer interval of ICI doses§	No treatment with monoclonal antibodies or convalescent plasma: Asymptomatic: prioritize prompt vaccination 14 days following positive test Symptomatic: vaccination recommended pending clinical judgment at 28 days from diagnosis or on symptom resolution, whichever is first** Temporary delay in booster dose appears to be reasonable in case of vaccine shortages Treated with monoclonal antibodies or convalescent plasma: Recommend at least 90-day delay from time of treatment to vaccine, regardless of vaccine series

*If enrolling in phase I trial involving investigational medicinal products with known or theoretical risk of cytokine release syndrome, as well as if administered in combination with ICI, consider waiting 2–4 weeks following completion of all COVID-19 vaccination(s) prior to the initiation of investigational treatment.132

†If two-dose vaccine provided, strongly recommend adherence to receiving second dose within timeframe of pivotal trials in attempts to optimize immunologic seroconversion.117 118 Deferral of vaccinations is ill advised and consideration to do so should be based on individual clinical context along with regional infectivity rates.

‡Clinical caution and shared decision-making are advised as provided recommendations are synthesized from available trial data that lack cancer and ICI-treated patients.

§Consider utilization of approved dosing of pembrolizumab and nivolumab at longer intervals of every 6 and 4 weeks, respectively, in attempts to enhance practices of social distancing and limit healthcare-related exposures.105 107

¶Vaccination is recommended regardless of use of immunosuppression. However, if immunosuppressive agent is temporary in patients with low risk of severe COVID-19 and adequately low regional infectivity rates, they may consider delaying vaccination until completion of immunosuppression in attempts to optimize immunologic seroconversion.133

**Vaccination appears safe in previously infected patients. Delay in vaccination is recommended in order to avoid both symptomatic transmission within healthcare facilities as well as misrepresentation of viral symptoms as adverse events to vaccine and advisable based on favorable immune profile of previously infected non-cancer patients.134

AID, autoimmune disease; ICI, immune checkpoint inhibitor; SOC, standard of care.