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Your team at Oncology Consultants is excited about the arrival of the COVID-19 vaccine and wanted to share our thoughts and recommendations. The two COVID-19 vaccines have been granted authorization by the FDA and administration has started. The results of the research study, which was a very large trial including 43,548 people, were recently published in the New England Journal of Medicine. While it is not yet available to the general public, it will hopefully become available in the next few months. Our physicians, who will be receiving the vaccine in the coming weeks, feel confident in its safety and efficacy. We recommend consulting with your provider about receiving the vaccine in your specific case should you have concerns:

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FOR IMMEDIATE RELEASE

Dec. 23, 2020

SITC Statement on SARS-CoV-2 Vaccination

and Cancer Immunotherapy

 

The Society for Immunotherapy of Cancer (SITC) commends the global biomedical community for coming

together to develop and authorize safe and effective SARS-CoV-2 vaccines at unprecedented speeds. SITC

stands with the world in hoping that rapid vaccine deployment will help to end the global pandemic.

 

Representing leaders in the field of cancer immunotherapy, SITC recognizes that optimal patient care and

clinical trials must both continue and coexist with the dire need for global SARS-CoV-2 vaccination. Based

on the demonstrated efficacy and safety of the BNT162b2 (Pfizer Inc./BioNTech SE) and mRNA-1273

(Moderna Inc.) vaccines in healthy individuals across study demographics, and subsequent Emergency

Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA), SITC recommends the following

actions for all relevant stakeholders and patients concerning SARS-CoV-2 vaccination and cancer immunotherapy:

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• All cancer patients receiving approved or investigational immunotherapy as part of their treatment regimen, either as standard of care or as part of clinical trials and without a general contraindication to vaccination, should/could receive an FDA approved and/or authorized SARS-CoV-2 vaccination when made available to them;

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• At this point in time, the only known relevant contraindications based on available data are patient age as described within EUAs and/or history of anaphylaxis to similar/comparable vaccine components;

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• SITC does not recommend experimental and/or non-approved SARS-CoV-2 vaccination for patients being treated with immunotherapy outside of dedicated clinical trial settings at this time;

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• Immunosuppressed patients, e.g., those receiving corticosteroids or TNF blockers to manage immune-related side effects, patients with hematologic malignancies, or patients with B cell deficiency, may not mount a robust immune response against vaccines and/or may need additional booster vaccinations. SITC recognizes that this aspect has not yet been studied in clinical trials;

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• Given limited data, SITC acknowledges that possible interactions between cancer immunotherapies and SARS-CoV-2 vaccines are unknown at this time. As always, SITC believes the best medical judgment of risk/benefit of SARS-CoV-2 vaccination should be considered for each patient individually.

 

SITC’s current recommendations regarding SARS-COV-2 vaccination in patients being treated with immunotherapy are subject to change as more data are collected in real-world scenarios and in clinical trials. In addition, SITC may provide further recommendations as additional vaccine candidates gain approval and/or authorization. Given the paucity of data concerning the interactions between immunotherapy treatment and SARS-CoV-2 vaccination, SITC encourages healthcare professionals, industry sponsors, regulators, and academics to rapidly collect and report novel data relevant to unique aspects of cancer immunotherapy treatment. SITC recognizes that human immune responses are highly regulated and that immune-modifying therapies could positively or negatively impact SARS-CoV-2 vaccination efficacy and safety. As such, SITC believes continued data collection and research will help to address vital knowledge gaps that could clarify optimal protocols for SARS-CoV-2 vaccination in patients with cancer receiving immunotherapy. Critical aspects that must be further characterized include but are not limited to:

 

• Optimal sequence of SARS-CoV-2 vaccination and immunotherapy treatment, to preserve the efficacy and safety of both modalities;

 

• Determining effective dosage of SARS-CoV-2 vaccine for patients receiving immunotherapy;

 

• Monitoring of SARS-CoV-2 antibody and cellular immune response in patients receiving immunotherapy treatments following receipt of SARS-CoV-2 vaccines

 

• Impact and reporting of SARS-CoV-2 vaccination upon immune-related adverse events, and regulatory considerations for adverse event attribution in immunotherapy clinical trials;

 

• Development of standards for establishing theoretical risk factors that would support a delay in SARS-CoV-2 vaccination while administering cancer immunotherapy

 

In conclusion, SITC supports SARS-CoV-2 vaccination in cancer patients receiving immunotherapy, and looks forward to collaborating with the global community to address the above scientific questions while

simultaneously working to end the COVID-19 pandemic.

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SECOND DOSE
Many of you are about to have, or just had your second dose of the COVID-19 vaccine. There have been lots of questions about the increased chance of side effects. The first thing to know is there is a difference between an allergic reaction and a side effect. Side effects to the vaccine are typically mild and brief and might involve a sore arm, chills and a fever and last a day or two at most. An allergic reaction is more severe, happens very quickly and might require medical intervention. Those are still very rare. Here are some at a glance facts about the second dose and a story from the CDC on this topic. 

 

1. You may experience brief arm soreness, muscle pain, and fever within 24 hours after receiving the vaccine. This is normal. 

2. These symptoms may be a bit more common after the 2nd dose.

3. Local pain may be treated with cool compresses.

4. For other symptoms, you may take acetaminophen, ibuprofen, Aleve (assuming those are OK for you) as necessary.

5. You cannot get COVID-19 from the vaccine. Symptoms such as fever that lasts more than 24 hours, dry cough, loss of smell or taste, or diarrhea, should be evaluated for potential COVID-19 infection you may have contracted before receiving the vaccine.

6. Serious allergic reactions almost always occur immediately after the injection, during the time you are being observed.   These serious reactions are very rare. Symptoms would include shortness of breath, wheezing, throat tightness, passing out, dizziness, or low blood pressure. If you experience any severe side effects after you leave the observation room, please seek medical attention immediately which may include calling 911.   

7. If you have symptoms that are not an emergency but are either not any of the expected effects of the vaccine, or are more severe than would be expected.