COVID-19 vaccines in cancer patients. Evidence-Based Medicine answers to the most common questions

1. COVID-19 Vaccination
in Patients with Cancer:
Answers to The Most
Common Questions
Dr. Nabil Elhadi Omar
RPh, BSc Pharm, BCOP, PharmD, CBT-HMS, IPTeC
Date: March 16, 2021

2. Biography
● Graduated from College of pharmacy; Mansoura University, Egypt 2008.
● PharmD from College of pharmacy; Qatar University, 2016.
● American Board-Certified Oncology/Hematology Pharmacist (BCOP) 2013.
● One year Post graduate diploma in cancer biology and therapeutics from Harvard Medical School 2016-2017.
● Indiana Pharmacy Resident Teaching Certificate Program (IPTeC) from Purdue University and Butler University,
March 2020.
● Published 20 articles in highly ranked peer-reviewed journals.
● Presented 10 poster abstracts in international conferences.
● Presented more than 50 poster abstracts in national and regional conferences.
● Volunteered as peer reviewer for many international journals (Frontiers in immunology journal, cancer immunology
immunotherapy journal and cancer chemotherapy & pharmacology)
● Advanced Clinical Internship Preceptor, Doctor of Pharmacy Program, College of Pharmacy, Qatar University
● Currently working as clinical pharmacist specialized in oncology and palliative care at the National Center for
Cancer Care and Research, Hamad Medical Corporation, Qatar

3. Acknowledgment
● I would like to acknowledged Ph/ Rana Bassuni, PharmD candidate for her effort in the
preparation of this presentation

4. Disclosure
I have no conflicts of interest with the presented material in this presentation

5. Outline
Introduction
1
Review of vaccine development process
2
Summary of available COVID-19 Vaccines
3
Answers to the most common questions about the
use of the vaccine in cancer patients
4
Review of the guidelines
5
Summary and conclusion
6

6. Introduction
01

7. A Timeline
WHO was informed of cases of pneumonia of
unknown cause in Wuhan City, China
31 Dec. 2019
A novel coronavirus was identified as the cause by
Chinese authorities and was temporarily named
“2019-nCoV”
7 Jan. 2020
Rapid increase in the number of cases outside led
WHO to announce that the outbreak could be
characterized as a Pandemic
11 Mar. 2020

8. Current Knowledge
Definition:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the strain of coronavirus that causes
coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the COVID-19 pandemic
Clinical Features:
● Incubation period: 14 days
● Recovery time: 2 weeks for mild infections and 3-6 weeks for severe disease
Clinical Presentation:

9. Current Knowledge
Severity of Illness Definition
Asymptomatic or Pre-
symptomatic
✓ Test positive for SARS-CoV-2 using a virologic test
× No symptoms that are consistent with COVID-19
Mild ✓ have any of the various signs and symptoms of COVID-19
× Do not have shortness of breath, dyspnea, or abnormal chest imaging
Moderate ✓ Show evidence of lower respiratory disease during clinical assessment or imaging
✓ Have saturation of oxygen (SpO2) ≥94% on room air
Severe ✓ Have SpO2 <94% on room air respiratory frequency >30 breaths per minute, or lung
infiltrates >50%
Critical ✓ Have respiratory failure, septic shock, and/or multiple organ dysfunction

10. Current Knowledge
Complications:
Several complications of COVID-19 have been described:

11. Review of Vaccine
Development Process
02

12. Back to The Timeline
WHO was informed of cases of
pneumonia of unknown cause in
Wuhan City, China
December 2019
A novel coronavirus was identified
as the cause by Chinese
authorities and was temporarily
named “2019-nCoV”
January 2020
Rapid increase in the number of
cases outside led WHO to
announce that the outbreak could
be characterized as a Pandemic
March 2020
WHO and their partners launched
the ACT-Accelerator partnership
April 2020
FDA issued guidance on
Emergency Use Authorizations for
Vaccines to Prevent COVID-19
October 2020

13. The Access to COVID-19 Tools (ACT) Accelerator
The goal of the ACT Accelerator is to end the COVID-19 pandemic as quickly as possible by reducing COVID-
19 mortality and severe disease through the accelerated development, equitable allocation, and scaled-up
delivery of vaccines, therapeutics and diagnostics to reduce mortality and severe disease. This will accelerate the
end of the health and economic crisis, restoring full societal and economic activity globally in the near term and
facilitating high-level control of COVID-19 disease in the medium term.
By the end of 2020, the Diagnostics, Therapeutics, Vaccine the Health Systems Connector pillars were
established. The vaccines pillar of the ACT-Accelerator is speeding up the search for an effective vaccine for all
countries
With a fast-moving pandemic, no one is safe, unless everyone is safe

14. Back to The Timeline
WHO was informed of cases of
pneumonia of unknown cause in
Wuhan City, China
December 2019
A novel coronavirus was identified
as the cause by Chinese
authorities and was temporarily
named “2019-nCoV”
January 2020
Rapid increase in the number of
cases outside led WHO to
announce that the outbreak could
be characterized as a Pandemic
March 2020
WHO and their partners launched
the ACT-Accelerator partnership
April 2020
FDA issued guidance on
Emergency Use Authorizations for
Vaccines to Prevent COVID-19
October 2020

15. Emergency Use Authorizations (EUA)
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical
countermeasures, including vaccines, during public health emergencies, such as the current COVID-19
pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of
approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or
conditions when certain statutory criteria have been met, including that there are no adequate, approved, and
available alternatives.
Manufacturers are required to submit an EUA request to the FDA for review

16. Comparing the Process of Developing a Vaccine
Regular Vaccine
Development
Developing Vaccine at
Speed (COVID-19 Vaccine)

19. Comparing the Process of Developing Vaccines

20. Summary of available
COVID-19 Vaccines
03

21. Back to The Timeline
WHO was informed of
cases of pneumonia of
unknown cause in Wuhan
City, China
December 2019
A novel coronavirus was
identified as the cause by
Chinese authorities and
was temporarily named
“2019-nCoV”
January 2020
Rapid increase in the
number of cases outside
led WHO to announce that
the outbreak could be
characterized as a
Pandemic
March 2020
WHO and their partners
launched he ACT-
Accelerator partnership
April 2020
FDA issued guidance on
Emergency Use
Authorizations for
Vaccines to Prevent
COVID-19
October 2020
EUA allows the Pfizer-
BioNTech COVID-19
Vaccine to be distributed
in the U.S.
11 Dec. 2020
EUA allows the Moderna
COVID-19 Vaccine to be
distributed in the U.S.
18 Dec. 2020

22. Ccurrently Available Vaccines
3 7 60 >200
Received EUA
from FDA
Rolled out in
countries across
three platforms
Included in clinical
trials
Vaccine
candidates in
development

23. Comparison Between Some of the Vaccines

24. Company Type Number of
doses
Time between
doses
Efficacy
mRNA
vaccine
21 days 95%
mRNA
vaccine
28 days 94.1%
Viral vector 28 days 63.09%
Viral vector - 66%
Viral vector 21 days 91.6%
Subunit vaccine 21 days 95.6%

34. Answers to The Most Common
Questions About The Use of
The Vaccine in Cancer Patients
04

35. General Rule:
Yes, vaccines are important for patients with cancer as they are at increased of serious
infection. Many of these infections are vaccine preventable.
All indicated vaccines should be given to adult cancer patients before initiation of
chemotherapy, before therapy with other immunosuppressive drugs, and before radiation or
splenectomy, when feasible.
Indicated inactivated vaccines should be given ≥2 weeks prior to chemotherapy and
indicated live-virus vaccines should be given ≥4 weeks prior to chemotherapy.
Q1 Shall cancer patients receive any vaccine?
A1

36. Patients with cancer currently receiving chemotherapy or other immunosuppressive therapy
should not receive live-virus vaccines because of the risk of vaccine-derived infections.
Patients with cancer currently receiving chemotherapy or other immunosuppressive therapy
should not receive inactivated vaccines because they may not be effective
Q1 Shall cancer patients receive any vaccine?
A1

38. Yes, if they have no contraindications.
CDC: Immunocompromised individuals can receive COVID-19 vaccination if they have no
contraindications to vaccination. However, they should be counselled about the unknown
vaccine safety profile and effectiveness in immunocompromised populations, and the
potential for reduced immune responses and the need to continue to follow all current
guidance to protect themselves against COVID-19.
The JCVI: The committee’s advice is to offer vaccination to those aged 65 years and older
followed by those in clinical risk groups aged 16 years and older including cancer patients.
Q2 Are cancer patients eligible to receive COVID-19 vaccine?
A2

39. Contraindication to COVID-19 Vaccine
CDC considers a history of the following to be a contraindication to vaccination with
both the Pfizer-BioNTech and Moderna COVID-19 vaccines:
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine
or any of its components
Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any
of its components (including polyethylene glycol [PEG])
Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive
hypersensitivity with the vaccine ingredient PEG)

40. Yes, persons with immunocompromising conditions or who take immunosuppressive
medications or therapies might be at increased risk for severe COVID-19. Thus, they should
be prioritized to take the COVID-19 vaccine including those who are in remission.
The available evidence supports that patients with cancer, in particular with hematologic
malignancies, should be considered among the very high-risk groups for priority COVID-19
vaccination.
Q3 Do cancer patients need to be vaccinated?
A3

42. Not yet, despite several vaccine candidates being in phase 2/3 clinical trials, no current
clinical trial of a COVID-19 vaccine has enrolled immunocompromised patients. Thus, the
efficacy and safety of a SARS-CoV-2 vaccine has not been established in the different
immunocompromised patient populations.
Q4 Have the vaccines been tested on cancer patients?
A4

45. Yes, the FDA EUA recommends that immunocompromised individuals
and other subpopulations with specific comorbidities be studied in post-
authorization observational studies.
Are there any plans to do Phase 4 studies in immunocompromised patients?
Q3.1
A3.1

46. Q4 When should patients with cancer get the COVID-19 vaccine?
A4
Patients
undergoing
treatment
Cancer
survivors
Cancer
patients
already had
COVID-19
Offer vaccination in
between treatments
when the patient is least
immunosuppressed
Offer vaccination as
long as no
contraindications
Wait 90 days post
infection to start the
two injection vaccine
series

47. Q5 What are the expected side effects of the vaccines on cancer patients
and how to manage them?
A5
Common
Side
Effects
Side Effects Important for
Cancer Patients
Serious
Side
Effects

48. The following side effects were more commonly reported in younger vaccine
recipients and following the second shot of the 2-dose series:
➢ Pain or swelling at the injection site
➢ Fatigue
➢ Headache
➢ Fever
➢ Chills
➢ Muscle and joint pain
Common
Side
Effects

49. Side effects typically resolved after one to two days. Such side effects can be
managed by the following:
➢ To take pain relievers (like ibuprofen or acetaminophen) every 4–6
hours to manage headache or fever
➢ To drink plenty of fluids
➢ To rest throughout the day
➢ To soak in a bath to soothe aching muscles
➢ To use or exercise the arm
Common
Side
Effects

50. ➢ Anaphylaxis
It should be considered when signs or
symptoms are generalized (i.e., if there are
generalized hives or more than one body
system is involved) or are serious or life-
threatening in nature, even if they involve a
single body system (e.g., hypotension,
respiratory distress, or significant swelling of
the tongue or lips).
Serious
Side
Effects

51. If anaphylaxis is suspected, take the following steps:
1. Rapidly assess airway, breathing, circulation, and mentation (mental activity)
2. Call for emergency medical services (EMS)
3. Place the patient in a supine position with feet elevated, unless upper airway obstruction is present, or the
patient is vomiting.
4. Epinephrine is the first-line treatment for anaphylaxis and should be administered immediately.
• Epinephrine dose may be repeated approximately every 5-15 minutes if symptoms do not improve or if
they return while waiting for EMS. The number and timing of epinephrine doses should be recorded and
communicated to EMS.
Serious
Side
Effects

52. Axillary adenopathy (swollen/tender lymph nodes)
Some people have swelling or tenderness of the lymph nodes under the arm in which they got the injection. Axillary
adenopathy in women with an otherwise normal screening mammogram is a rare occurrence, reported in 0.02%-0.04% of
screening mammograms.
For patients receiving the Pfizer-BioNTech COVID-19 vaccine, lymphadenopathy was only reported as
an unsolicited adverse event with 58 more cases in the vaccine group than the placebo group (64 vs 6
respectively). Lymphadenopathy occurred in the arm and neck within 2-4 days of vaccination and
lasted for a mean of 10 days
For patients receiving the Moderna COVID-19 vaccine, axillary swelling or tenderness (i.e.,
lymphadenopathy) was a solicited adverse event reported in 11.6% of patients (vs 5.0% for
placebo) following dose 1 and 16.0% of patients (vs 4.3% for placebo) following dose 2
Side Effects Important for
Cancer Patients

53. Caution
Since the COVID-19 vaccine can cause swollen lymph nodes under the arm in which the
injection was given, it is recommended that people with breast cancer or a history of
breast cancer get the injection in the unaffected arm.
Management
➢ Consider a short term follow up exam in 4-12 weeks following the second vaccine
dose.
➢ If axillary adenopathy persists after short term follow up, then consider lymph node
sampling to exclude breast and non-breast malignancy
Side Effects Important for
Cancer Patients

54. Review of The
Guidelines
05

55. Guidelines To Be Reviewed
01
02
03

57. Guidelines To Be Reviewed
01
02
03

58. Therapy Specific
Recommendations
Hematopoietic stem cell
transplantation and cellular
therapy
Steroids Intravenous
Immunoglobulin
(IVIG)
Rituximab
Immune
Checkpoint
Inhibitors
(ICIs)
Disease Specific
Recommendations
Hematologic
Malignancies
Solid Tumors

59. Disease Recommendation
CLL
(special consideration of rituximab,
venetoclax, ibrutinib)
o Asymptomatic → Hold B-cell depleting therapy until one month after completion of vaccination
o Small molecule therapy in symptomatic patients → hold vaccination until 1 month after completion of
treatment, once there is evidence of B-cell recovery
B- or T-ALL
(Induction/maintenance therapy)
o Induction therapy for newly diagnosed disease should not be delayed for vaccination
o Vaccine should be given during the maintenance phase at a time patient displays evidence of
hematopoietic count recovery. It can also be considered during induction with less intense regimens
DLBCL and other aggressive
B-cell lymphoma
o Systemic induction therapy, including anti-CD20 antibodies, for newly diagnosed disease should in general
not be delayed for vaccination.
o Vaccine should be given after completion of therapy, assuming patient is in remission and no further
treatment is planned, once there is evidence of B-cell recovery from anti-CD20 depletion
Indolent lymphomas o Asymptomatic → Hold B-cell depleting therapy until one month after completion of vaccination
o Systemic therapy needed →treat with induction but without maintenance therapy, and vaccinating
following completion of therapy
T cell lymphomas o Therapy for newly diagnosed and progressive disease should not be delayed for vaccination purposes.
o Vaccine can be given during induction therapy, preferably following count recovery.
Lymphoma patients with
relapsed or refractory
disease
o Systemic therapy with the potential for therapeutic benefit should not be delayed for vaccination purposes
Hematologic Malignancies

60. Disease Recommendation
Myeloma o With the exceptions of lymphodepleting therapy administration there are no specific disease or
treatment related contraindications for vaccination in patients with myeloma.
o Patients treated with lymphodepletion, vaccination can be attempted once lymphocyte recovery is
observed
AML
(induction/consolidation therapy)
o Induction therapy for newly diagnosed disease should not be delayed for vaccination purposes.
o Vaccine should not be given during the induction remission phase but should be considered during
consolidation therapy.
o Patients with relapsed disease may be considered for vaccination.
Myelodysplastic syndromes o Patients on observation or active therapy should be considered for vaccination
Myeloproliferative Neoplasm o Patients on observation or active therapy should be considered for vaccination
CML o Patients receiving TKIs (with or without remission) should be considered for vaccination.
Hematologic Malignancies

61. Solid Tumors
Time first dose of vaccine to be given ≥ 2 weeks prior to initiation of
therapy
Patients planned for but not yet on
immunosuppressive cancer directed therapy
Patients with solid tumors should receive the COVID-19 vaccine, as stratified by factors such as age. There are
no additional stratification recommendations related to cancer type or stage of disease at this time.
Patients already on cytotoxic chemotherapy
Patients completing cytotoxic therapy
Patients undergoing cancer related surgery
Time first dose of vaccine in between chemotherapy cycles, and away
from nadir period
Time first dose of vaccine to be given after therapy complete and
nadir period resolved
No specific timing is recommended relative to surgery from a vaccine
efficacy standpoint

62. Therapy Specific Recommendations
Steroids
Intravenous
Immunoglobulin
(IVIG)
Rituximab
Immune
Checkpoint
Inhibitors
(ICIs)
Hematopoietic stem cell
transplantation and cellular
therapy

63. Treatment Timing of vaccine administration
Autologous HCT Vaccination may be initiated 2- 3 months after HCT
Allogeneic HCT
Conventional, no severe GVHD, no anti-CD20
antibodies
Vaccination may be initiated as early as 3 months post HCT
Ex-vivo T-cell depleted and post HCT Vaccination may be initiated around 6 months post HCT with
confirmed presence of B cells (>50) and CD4+ T-cells (>100)
CART cell therapy and receipt of antiCD20
antibodies
Vaccination may be initiated as early as 3 months if demonstrated
IVIG independence and B-Cell count ≥50
HSCT patients with GVHD So far, there is no data suggesting immune activation of
underlying conditions making the likelihood that COVID-19
vaccines will exacerbate GVHD low
Hematopoietic stem cell transplantation
and cellular therapy

64. • Severe, uncontrolled acute GVHD grades III – IV
• Recipients, who have received anti-CD20 antibodies during the last
six months and absolute B-cell count <50
• CAR T cell patients with B-cell aplasia (absolute B-cell count <50)
• Recent therapy with Anti-thymocyte globulin or alemtuzumab
When to postpone vaccination?
Q
A

65. Steroids
Patients treated with corticosteroids
should be vaccinated prior to therapy,
if feasible
Patients on ICI therapy should receive
the COVID-19 vaccine. Clinicians
should not pause ICI therapy for
vaccination (No specific timing is
recommended)
Immune Checkpoint
Inhibitors (ICIs)
It is recommended that patients
should be vaccinated prior to
initiation of therapy when feasible
Rituximab
COVID-19 vaccines may be administered
as these are unlikely to substantially
impair development of protective antibody
responses.
IVIG

68. Summary and
Conclusion
06

69. Review of Questions and Answers
Yes,
if no
contraindic
ations
Yes,
if no
contraindic
ations
Yes
Shall cancer patients receive any vaccine?
Are cancer patients eligible to receive COVID-19 vaccine?
Do cancer patients need to be vaccinated?

70. Review of Questions and Answers
When should patients with cancer get the COVID vaccine?
Patients
undergoing
treatment
Cancer
survivors
Cancer
patients
already had
COVID-19
offer vaccination in
between treatments
when the patient is least
immunosuppressed
offer vaccination as
long as no
contraindications
Wait 90 days post
infection to start the
two injection vaccine
series.

71. Review of Questions and Answers
What are the expected side effects of the vaccines on cancer patients?
Common
Side
Effects
Side Effects Important for
Cancer Patients
Serious
Side
Effects

72. References
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vaccination-advice-from-the-jcvi-2-december-2020

73. References Cont.
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2020;11(2):233-236.
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https://www.sbi-online.org/Portals/0/Position%20Statements/2021/SBI-recommendations-for-managing-axillary-adenopathy-post-COVID-vaccination.pdf
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articles/2021/01/22/19/27/vaccine-side-effects
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74. Thank you for listening
Questions?