Guidance for Bone Marrow Failure Patients to Protect Against Coronavirus (COVID-19)

• · Most healthcare facilities have resumed in-person medical appointments and/or have telehealth options available.  You may be required to wear a mask, and to follow extra precautions during your visit including a limit on the number of people who can attend appointments with you.  Please consult with your healthcare facility about these requirements.
• · While there are not blood shortages at the time of this publication, the blood supply can vary by country, region and state. If you require regular transfusions, it is important to communicate regularly with your healthcare provider(s) and you may need to go a bit longer between transfusions.
• · Some bone marrow failure patients are reported as having an incomplete or lower response to the available vaccines which makes them more susceptible to contracting COVID-19 and may necessitate a booster vaccine in the future.  Please consult with your treating hematologist/oncologist and follow their guidance to protect yourself from the COVID-19 virus.
• Patients who take immunosuppressive medications may be more susceptible to infections including COVID-19.  Your treating hematologist/oncologist will provide you with guidance as to how to protect yourself, however we recommend wearing a mask correctly, social distancing and other precautions.

These FAQs from the American Society of Hematology are geared toward healthcare providers but patients may find them useful:

• ASH Guidelines on Use of Anticoagulation in Patients with COVID-19: ASH has issued recommendations for the use of anticoagulation in critically and acutely ill patients for which the evidence will be re-evaluated in a continual fashion. This webpage will be updated as the evidence for recommendations are evaluated.   https://www.hematology.org/education/clinicians/guidelines-and-quality-care/clinical-practice-guidelines/venous-thromboembolism-guidelines/ash-guidelines-on-use-of-anticoagulation-in-patients-with-covid-19#acute
• Poster from the American Society of Hematology 2020 annual meeting: COVID-19 in Patients with Hematological Malignancies: High False Negative Rate with High Mortality https://ash.confex.com/ash/2020/webprogram/Paper138611.html

• ASH-ASTCT COVID-19 and Vaccines: Frequently Asked Questions:  https://www.hematology.org/covid-19/ash-astct-covid-19-and-vaccines

• COVID-19 and Vaccines:  https://www.hematology.org/covid-19/ash-astct-covid-19-and-vaccines

• COVID-19 and Resuming Clinical Visits:  https://www.hematology.org/covid-19/covid-19-and-resuming-clinical-visits

• COVID-19 and Myelodysplastic Syndromes:  https://www.hematology.org/covid-19/covid-19-and-myelodysplastic-syndromes

• COVID-19 and Aplastic Anemia:  https://www.hematology.org/covid-19/covid-19-and-aplastic-anemia

• COVID-19 and Acute Myeloid Leukemia: https://www.hematology.org/covid-19/covid-19-and-acute-myeloid-leukemia

• COVID-19 and Myeloproliferative Neoplasms: https://www.hematology.org/covid-19/covid-19-and-myeloproliferative-neoplasms

Other Trusted Resources

• Centers for Disease Control (CDC)
• Food and Drug Administration (FDA)
• Infectious Disease Society of America
• National Institutes of Health (NIH)
• World Health Organization (WHO) 

• March 13, 2020 Guidance for Bone Marrow Failure Disease Patients to Protect Against Coronavirus (COVID-19) Webinar
• March 20, 2020 COVID-19 Update - Focus on Aplastic Anemia and PNH Webinar
• March 21, 2020 COVID-19 Update - Focus on Pediatric Bone Marrow Failure Patients
• March 26, 2020 COVID-19 Update - Focus on  Bone Marrow Failure and Infectious Disease
• March 31, 2020 COVID-19 Update - Focus on High Risk MDS and Secondary AML
• March 31, 2020 COVID-19 Update - Focus on Pre/Post Transplant
• April 14, 2020 COVID-19 Update - Focus on Emotional Health and Wellness
• April 25, 2020 COVID-19 Update (as part of the AAMDSIF Spring Virtual Conference)
• April 28, 2020 COVID-19 Update - Focus on Low Risk MDS
• May 13, 2020 COVID-19 Update - Focus on MDS/MPNs Overlap
• May 22, 2020 Focus on COVID-19:  What We've Learned for Patient Care
• June 24, 2020 Focus on COVID-19:  Impact on Clinical Trials
• December 3, 2020:  AAMDSIF Global Update on COVID-19
• AAMDSIF Covid-19 Update: Returning To School Webinar
• NEW March 18, 2021: COVID-19 and Vaccinations Update

HealthWell Foundation:  COVID-19 Frontline Health Care Workers Behavioral Health:  
https://www.healthwellfoundation.org/fund/covid-19-front-line-healthcare-worker-behavioral-health/
Provides co-pay assistance for frontline healthcare workers for behavioral health services including prescriptions, counseling services, psychotherapy and transportation up to $6,000 per applicant. 

HealthWell Foundation:  COVID-19 Insurance Assistance Program Payment Assistance
https://www.healthwellfoundation.org/fund/covid-19-insurance-premium-payment-assistance/
Providers premium assistance for COBRA payments related to COVID-19 layoffs/unemployment, employee portion of insurance premium related to COVID-19 furlough. 

Bristol Myers Squibb Patient Support Program
https://www.bms.com/about-us/responsibility/coronavirus-updates.html#pspq
Telephone:  800.727.8909
BMS has expanded and extended their Patient Support Program to eligible unemployed patients in the United States, Puerto Rico and the US Virgin Islands who have lost health insurance due to the COVID-19 pandemic access to branded BMS medicines for free. Patients who are employed but cannot afford their prescribed BMS branded medications may be eligible for other BMS support programs available through the toll-free number or the website listed above. 

National Organization for Rare Diseases (NORD) COVID-19 Critical Relief Program
https://rarediseases.org/for-patients-and-families/help-access-medications/patient-assistance-programs-2/#toggle-panel-14
Telephone:  203.242.0497
Email:  COVID19assistance@rarediseases.org
Financial assistance of up to $1,000 for eligible patients. Please call or email for more information. 

Be The Match Patient Assistance Grant Program
https://network.bethematchclinical.org/transplant-centers/access-to-transplant/patient-services-and-grants/patient-assistance-grant-program/
One time financial assistance for medical and non-medical expenses of $500. There is no income limit on the program. Online application required.

Leukemia & Lymphoma Society Urgent Need Program (Pediatric and Young Adult Fund)
https://www.lls.org/support/financial-support/urgent-need-program
While the LLS COVID-19 Financial Assistance program is exhausted, they do offer a program to assist pediatric and young adult patients (up to age 39) who are in acute financial need.  You can apply online using the link above or by calling (877) 557-2672 between 8:30am and 5:00pm Eastern, Monday - Friday.

211:  Get Connected.  Get Help.
https://www.211.org/services/covid19
U.S. based residents can dial 211 and receive guided assistance through a number of COVID-19 related assistance programs including food, housing costs, or other essential services.  You can find your local 211 using the link above or simply dial 211. 

IRS Economic Impact Payments
https://www.irs.gov/coronavirus/economic-impact-payments
While the deadline has passed for the Economic Impact Payments, you may still be eligible for a payment under certain circumstances. Please consult the IRS website or your tax preparer who can answer any questions you may have. 

Disabled American Veterans COVID Unemployment Relief
https://thedav.wufoo.com/forms/q1078og50y99123/
The DAV provides a $250 grant to service-connected veterans that have lost employment as a direct result of the coronavirus including self-employed contractors and small business owners. The application is a simple online form. 

Please use this link to download the pdf version.

Guidance for Bone Marrow Failure Patients to Protect Against Coronavirus (COVID-19)

This content has been prepared in consultation with AAMDSIF Medical Advisory Board Chair Mikkael Sekeres MD, MS of Sylvester Comprehensive Cancer Center, University of Miami and Vice-Chair Olatoyosi Odenike MD of the University of Chicago with additional review by AAMDSIF Medical Advisory Board Members Amy DeZern, MD, Johns Hopkins and Carlos DeCastro, MD, Duke. (November 2022)

COVID-19 Concerns for Bone Marrow Failure Patients
Many U.S. states and other countries have relaxed or eliminated restrictions for business occupancy, social distancing guidelines and mask wearing. Patients living with bone marrow failure diseases and their families and caregivers should continue to practice social distancing, frequently wash and sanitize hands, wear masks around others, and encourage others to wear masks around you. Given the contagiousness of the Omicron variant, we also recommend strict precautions even among vaccinated patients or those who have been infected with COVID previously, as immunity to the Omicron variant is not as strong as it was to previous variants such as Delta.

As a person with a bone marrow failure condition, such as myelodysplastic syndromes (MDS), aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH), etc., you are already taking precautions to protect your compromised immune system. Patients with these diseases have been disproportionately affected by the COVID-19 pandemic with concerning mortality rates for patients who contract the virus and concerns about the efficacy of the available vaccines for bone marrow failure patients.

COVID-19 Vaccine Guidance
Patients with a bone marrow failure condition who have not yet been vaccinated, are encouraged to discuss getting a vaccination as soon as possible with their treating hematologist/oncologist. Two of the approved vaccinations available in the United States and much of the rest of the world are mRNA vaccines which do not contain live virus and should be safe for most patients with a bone marrow failure condition. While the efficacy of the vaccine may be lower in people with bone marrow failure conditions, side effects from receiving a vaccine are so low that most doctors recommend that you receive the vaccine.
Remember, some efficacy is always better than no efficacy, particularly as more contagious and possibly harmful COVID-19 variants are spreading. Please discuss this important topic with your treating hematologist/oncologist.

Some hematologists/oncologists have reported that a small number of PNH patients are experiencing an increase in hemolysis after vaccination, something that patients should discuss with their healthcare team and carefully weigh the benefits of vaccination against this risk. PNH patients should be carefully monitored after vaccination by their treating hematologist/oncologist.

Should other vaccines become available, it is not recommended to get vaccinated with a live virus as this could cause problems for patients. Please consult your treating hematologist/oncologist about vaccinations and if you are pre or post-transplant, it is critically important to discuss this with your transplant team and to strictly adhere to their schedule for vaccinations.

The U.S. Food and Drug Administration has authorized a third dose ("booster") of COVID-19 vaccines from Pfizer Inc and Moderna Inc for people with compromised immune systems. Please check with your doctor to see if you should receive a third dose.

Recommended Precautions
These recommendations are for all patients but you should consult with your treating hematologist/oncologist for guidance specific to your health conditions:

Bone marrow failure patients should receive 3 mRNA shots, and a booster 4th dose is recommended for patients as follows:  

Bone marrow failure patients should receive 3 mRNA shots, and a booster 4th dose is recommended for patients as follows:  

• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. 
• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise. 
• A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise. 
• Patients who test positive should receive monoclonals such as regeneron to prevent serious infection.   

• A 5-day course of Paxlovid for people within the first 48 hours of developing symptoms to help prevent Covid-19 from becoming more serious. 
• Continue to wear a mask that covers your mouth and nose when outside your home. This includes going to work, shopping and going to medical appointments. While N-95 masks are best, surgical masks are a good second choice, followed by cloth masks. Masks with vents or “gaiters” are not recommended.
• Avoid close contact with people who are sick, do not attend large gatherings (even outdoors) with unmasked and/or unvaccinated people, and avoid shaking hands or embracing others who are not vaccinated.
• Well-spaced, outdoor activities are safest and most can be enjoyed without a mask provided that your companions are vaccinated and/or from your immediate household.
• Limit travel and travel companions and be sure to discuss best practices with your treating hematologist/oncologist before making plans. Your risk level may be higher or lower, depending on your specific situation.

International Travel Precautions
The CDC does not recommend that anyone travel until you are fully vaccinated, however we recognize that international travel poses additional risks due to the rapid spread of COVID-19 variants and the limited availability of vaccines in many countries. If you must travel internationally, please follow all safety precautions and consult with your treating hematologist/oncologist prior to scheduling your travel. Please be aware that you may be required to provide proof of vaccination and/or a negative COVID-19 test.

Specific Guidance for Patients Related to Treatments
•Most healthcare facilities have resumed in-person medical appointments and/or have telehealth options available.  You may be required to wear a mask, and to follow extra precautions during your visit including a limit on the number of people who can attend appointments with you.  Please consult with your healthcare facility about these requirements.
•While there are not blood shortages at the time of this publication, the blood supply can vary by country, region and state. If you require regular transfusions, it is important to communicate regularly with your healthcare provider(s) and you may need to go a bit longer between transfusions.
•Some bone marrow failure patients are reported as having an incomplete or lower response to the available vaccines which makes them more susceptible to contracting COVID-19 and
may necessitate a booster vaccine in the future. Please consult with your treating hematologist/oncologist and follow their guidance to protect yourself from the COVID-19 virus.
•Patients who take immunosuppressive medications may be more susceptible to infections including COVID-19. Your treating hematologist/oncologist will provide you with guidance as
to how to protect yourself, however we recommend wearing a mask correctly, social distancing and other precautions.

Returning to School/Work
Many people have worked or attended school remotely during the pandemic and are preparing to return to classrooms and workplaces. While each patient will have different factors to consider, generally:
•In remission + fully vaccinated: Can return to school/work with normal precautions
•In remission + not yet vaccinated:  Can return to school/work with mask + social distance. We recommend remote work/learning until vaccination.
•Undergoing treatment + fully vaccinated:  Can return to school/work with mask + social distance.  We recommend remote work/learning until remission is achieved or a doctor- approved status.
•Undergoing treatment + not yet vaccinated:  Remote work/learning only.

Other Trusted Sources:
•Centers for Disease Control (CDC):  https://www.cdc.gov/coronavirus/2019-ncov/
•Food and Drug Administration (FDA): https://www.fda.gov/emergency-preparedness-and-  response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
•National Institutes of Health (NIH):  https://www.nih.gov/coronavirus
•World Health Organization (WHO):  https://www.who.int/emergencies/diseases/novel-
coronavirus-2019

Guidelines from the American Society of Hematology (ASH)
ASH has released a number of guidelines that are geared toward healthcare providers but patients may find them useful and can be found at https://www.hematology.org/covid-19 including specific information for patients with aplastic anemia, MDS, AML and MPNs.

AAMDSIF Website Resources
AAMDSIF has a number of webinars about COVID-19 and the specific concerns of bone marrow failure patients available on our website along with updated guidance, financial resources and Frequently Asked Questions at:
www.aamds.org/education/covid-19

(Please refer to link for complete text of release)

For Immediate Release:
August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. 

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. 

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. 

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

(Please find full content here: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine)