Aug 24, 2021

NHF recognizes that people with bleeding disorders may have questions and concerns related to the variant coronavirus’ causing COVID-19 and the new COVID-19 vaccines, including any implications specific to their conditions. The following FAQs are therefore meant to address some of the most common questions from our community members. Please note that these answers were created for broad purposes and that affected individuals should engage closely with their healthcare provider to discuss the possibilities of disease signs and symptoms and vaccination, including potential contraindications (if any), and specific questions related to safety and efficacy. Given the nature of this virus, rapid developments in vaccines, and the ongoing transitions in our federal government, this continues to be a very fluid situation. If you have additional questions or need more information, please consult with your healthcare professional.

 

1. Have any of the vaccines been approved by the FDA?

One vaccine, the messenger RNA (mRNA) vaccine developed by Pfizer-BioNTech has been approved by the United States from the Food and Drug Administration on August 23, 2021, and will be marketed under the trade name of Comirnaty® (koe-mir’-na-tee). Comirnaty is indicated 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.

Comirnaty contains 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.

More information on prescribing Comirnaty can be found at https://www.fda.gov/vaccines-blood-biologics/comirnaty.

People seeking additional information on can find a vaccine information sheet for Comirnaty at https://www.fda.gov/media/144414/download

 

2. Vaccine’s emergency use authorization (EUA) in the United States

Three COVID-19 vaccines – two mRNA vaccines from Pfizer-BioNTech and Moderna and one recombinant, replication-incompetent human adenovirus serotype 26 (Ad26) vector vaccine from Johnson & Johnson/Janssen Biotech, have received emergency use authorization (EUA) in the United States from the Food and Drug Administration and are currently being administered to people in the US. The Pfizer-BioNTech vaccine has been approved by the FDA for the prevention of COVID-19 disease in individuals 16 years of age and older (see question 1 above) but remains available for those individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. There are several other vaccines that are in development but have not received EUA. NHF will keep the bleeding disorders community updated as new information becomes available.

The Pfizer-BioNTech COVID-19 Vaccine received emergency use authorization (EUA) on December 11, 2020 for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. The dosing regimen is two doses of 0.3 mL each, 3 weeks apart. The vaccine does not contain a preservative. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. On May 10, 2021, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. The vaccine was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age and was very effective in preventing COVID-19 disease. Furthermore, the vaccine elicited high levels of neutralizing antibodies demonstrating strong immunogenicity in a subset of adolescents one month after the second dose.

On December 18, 2020, the U.S. Food and Drug Administration issued an EUA for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. The vaccine contains a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. The dosing regimen is two doses of 0.5 mL each, one month apart. The vaccine does not contain a preservative. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Back in June, Moderna announced it would start “rolling submission” of data to the FDA for approval under a request for a Priority Review. This designation would call for the FDA to make a decision within six months rather than the typical 10-month waiting period.

The Janssen Biotech vaccine received emergency use authorization on February 27, 2021 from the U.S. Food and Drug Administration, the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.to prevent COVID-19. The vaccine contains a recombinant, replication-incompetent human adenovirus serotype 26 (Ad26) vector, encoding the SARS-CoV-2 viral spike (S) glycoprotein, stabilized in its pre-fusion form. The dosing regimen is a single dose of 0.5 mL, the vaccine does not contain a preservative. The most commonly reported side effects with this vaccine were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects occurred within 1-2 days following vaccination and were mild to moderate in severity and lasted 1-2 days. Johnson & Johnson has not started the approval process yet.

For more information on the COVID-19 vaccines and the regulatory process please visit the FDA website on COVID-19 vaccines.

 

3. Preparing for your COVID-19 vaccine

To learn more about vaccines including those to prevent COVID-19, you may want to visit www.vaccines.gov for more information and to receive email updates on the vaccines. This website is available in Spanish and has a vaccine finder to help you locate sites in your state or territory.

Before receiving a COVID-19 vaccine, you may be asked questions about your history of bleeding and your bleeding disorder. Below are some of the questions you may be asked, and an explanation as to why the people administering the vaccine might ask them. These questions should not deter anyone from receiving a vaccine. If you have a question about your specific situation, be sure to discuss it with your hematologist.

 

SCREENING QUESTIONS

Do you have a bleeding disorder or have any issues with bleeding?

A bleeding disorder neither increases the risk for getting coronavirus infection nor having a serious infection, being hospitalized, or dying if you are infected.

Likewise, having a bleeding disorder is not a reason to avoid getting the vaccine. Following precautions such as infusing with a factor replacement product prior to or right after the vaccination and applying pressure for 10 minutes after the vaccination should be considered. Contact your hematologist or healthcare professional to plan to safely receive the vaccine.

Patients receiving emicizumab may be vaccinated by intra-muscular injection at any time without receiving an additional dose of FVIII. Patients with von Willebrand disease or a rare bleeding disorders should consult with their hematologist regarding special precautions prior to receiving the vaccination. All rare bleeding disorder patients (including those with thrombocytopenia and/or platelet function disorders) should be vaccinated. Patients on warfarin should have prothrombin time testing performed within 72 hours prior to injection to determine international normalized ratio (INR); if results are stable and within the therapeutic range, they can be vaccinated intramuscularly.

 

Have you or are you currently receiving any monoclonal antibody treatments?
You may be asked this question before you receive the vaccine. Receiving emicizumab is not a reason not to receive a vaccine to prevent COVID-19 infection. Emicizumab is a monoclonal antibody that is used to prevent bleeding in people with hemophilia A. Other monoclonal antibodies have been and are being developed as treatments for COVID-19 infections. You can and should receive a vaccine even if you are taking emicizumab to prevent bleeding.

 

Are you taking any medications with one of the following ingredients……one of those ingredients being a PEG?
Polyethylene glycol (PEG) is a stabilizer that is used in many medications including plasma derived and recombinant factor products. Factor products that use PEG to extend the half-life of the factor product or any factor products are not a reason to not take a vaccine unless you have had a reaction to PEG. If you have a question about this please talk with your hematologist or healthcare professional.

 

FREQUENTLY ASKED QUESTIONS

What is an “Emergency Use Authorization” (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 in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions such as infection with the virus that causes COVID-19 disease when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

 

These vaccines were developed very fast. Are they safe?

It is true that the Pfizer/BioNTech, Moderna and Janssen Biotech vaccines have been developed very quickly. But the technology behind the Pfizer/BioNTech and Moderna vaccines is not new. They both are what are called mRNA vaccines, which function very differently than the types of vaccines used in the past. mRNA vaccines, rather than using a weak or ineffective sample of the virus to trigger antibodies – like in a flu shot – mRNA vaccines instruct your cells to create a harmless protein (called “spike” protein) that your body recognizes as foreign, creating an immune system response. Scientific papers describing this mRNA technology, discovered by Hungarian scientist Katalin Karikó (who oversees mRNA work for BioNTech) were first published in 2005. The Janssen Biotech vaccine uses a different mechanism of action, a recombinant, replication-incompetent human adenovirus serotype 26 (Ad26) vector, encoding the SARS-CoV-2 viral spike (S) glycoprotein. All three vaccines are designed to tell your body how to make the Spike protein, part of the SARS-CoV-2 virus.

 

Is it safe for a person with a bleeding disorder to receive the COVID vaccine?

If you have a bleeding disorder, there are no contraindications to being vaccinated with any of the three vaccines now available via EUA status for intramuscular administration. It should be noted that, immune tolerance therapy, treatment for hepatitis C, and HIV and other conditions including the use of immunosuppressive agents do not preclude a person from receiving the available vaccines. For patients in a clinical study, vaccination should be reported to the study investigators.

 

Is it safe for people with low platelets or ITP, or platelet function disorders to receive the COVID vaccine?

For those with pre-existing ITP (even if you don’t take medicine for your ITP and even if your platelet count is normal), consult your hematologist and obtain a platelet count prior to vaccination. Your hematologist may advise you as to whether and when your platelet count should be checked after the first and/or second vaccination in addition to the baseline value.

Patients with low platelet disorders like ITP should take extra precautions when receiving the vaccine to prevent hematoma formation. A fine gauge needle (25 or 27 gauge) should be used for the vaccination, followed by pressure on the site, without rubbing, for at 10 minutes.

For persons with other low platelet disorders or platelet function disorders (like Glanzmann thrombasthenia, Hermansky Pudlak syndrome, Grey Platelet syndrome), the recommendations for preparing for the vaccine may be similar or identical as those for persons with ITP. Persons with other platelet disorders should also consult with their hematologist prior to receiving the COVID-19 vaccine.

For persons with platelet disorders caused by medications (such as aspirin, clopidogrel, ticagrelor), follow the recommendations for persons with platelet function disorders (above). Always consult your hematologist or cardiologist for advice on how best to prepare for the COVID-19 vaccine.

Patients with ITP or other low platelet disorders should not hesitate to be vaccinated based on available information. Patients that are unsure about getting the vaccine should consult with their hematologist or another physician before proceeding.

 

Would I be in a priority group to receive the vaccine with a bleeding disorder?

Because people with bleeding disorders are not at a greater risk of contracting COVID-19 or developing a severe form of the disease, they are generally not considered a priority group. General selection rules will apply for those with a bleeding disorder. Bleeding disorder patients in the risk groups identified by age, state of health, health care or other essential worker will be vaccinated as a priority like others in the general population with the same risks. Priority groups will vary by state.

 

Is there a particular type of vaccine I should choose?

Currently there is no reason to choose a particular type of vaccine. If you are considering enrolling in a gene therapy clinical trial, you should avoid any vaccines that use a modified adeno-associated virus (AAV) since these viruses are used in gene therapy. No vaccinations currently authorized are using AAV vectors or viruses. The Janssen Biotech vaccine contains a type of a human adenovirus. Adenovirus is NOT used in hemophilia or any form of gene therapy and therefore is not a concern for our community including those who are considering receiving gene therapy in the future.  

 

Will I have a bleed if I receive the vaccination?

The vaccination is administered intra-muscularly but the smallest gauge needle should be used (25-27 gauge), if possible. Some vaccines must be administered using the accompanying needle–syringe combination, and so the use of an alternative needle may not be possible or desirable.

It would be preferable for you to infuse with a factor replacement product prior to or right after the vaccination and applying pressure for 10 minutes after the vaccination. Patients receiving emicizumab may be vaccinated by intra-muscular injection at any time without receiving an additional dose of FVIII. Patients with von Willebrand disease or a rare bleeding disorder should consult with their hematologist regarding special precautions prior to receiving the vaccination. All rare bleeding disorder patients (including those with thrombocytopenia and/or platelet function disorders) should be vaccinated. Patients on warfarin should have prothrombin time testing performed within 72 hours prior to injection to determine international normalized ratio (INR); if results are stable and within the therapeutic range, they can be vaccinated intramuscularly. Patients receiving other anticoagulants, such as enoxaparin, apixaban, dabigatran, rivaroxaban should consult their prescribing doctor or practitioner for advice on how to safely prepare for the COVID-19 vaccine.

Following the vaccination, the area should be monitored for hematoma formation immediately for 10 minutes to reduce bleeding and swelling and by self-inspection 2-4 hours later at home to ensure that there is no delayed hematoma. Discomfort at the injection site is to be expected. Discomfort in the arm felt for 1-2 days after injection should not be alarming unless it worsens and is accompanied by swelling.

Any adverse events should be reported to the physician and any allergic reactions need to be reported immediately to your physician or you need to go to the emergency room. To read more about vaccinations in general see NHF’s Medical and Scientific Advisory Council’s recommendation, Recommendations on Administration of Vaccines to Individuals with Bleeding Disorders.

 

 

Will the vaccines change my DNA?

mRNA vaccines do not interact with a person’s DNA or cause genetic changes because the mRNA does not enter the nucleus of the cell, which is where our DNA is kept.

The Janssen Biotech COVID-19 Vaccine is a viral vector vaccine, meaning it uses a modified version of a different virus (the vector) to deliver important instructions to our cells. Viral vector technology has been used by Janssen for other vaccine development programs.  Vaccines that use the same viral vector have been given to pregnant people in all trimesters of pregnancy, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes that affected the infant, were associated with vaccination in these trials.

 

Should I take the vaccination if I am pregnant or breastfeeding?

Getting vaccinated is a personal choice. Any of the currently authorized COVID-19 vaccines can be offered to people who are pregnant or breastfeeding. If you have questions about getting vaccinated, a conversation with your healthcare provider might help, but is not required.

Following an extensive evidence review, the American College of Obstetricians and Gynecologists recommends that COVID-19 vaccines should not be withheld from pregnant individuals. Similarly, COVID-19 vaccines should be offered to women who are breast feeding.

Currently, there is limited data on the safety of COVID-19 vaccines for women who are pregnant or breastfeeding, although studies are planned. The Centers for Disease Control and Prevention (CDC) and the FDA have safety monitoring systems in place to capture information about vaccination during pregnancy and will closely monitor reports. Individuals who are pregnant and considering vaccination for COVID-19 are encouraged to speak with their clinicians. According to the CDC, key considerations that should inform these conversations include likely exposure to the virus that causes COVID-19; risks of COVID-19 to the pregnant patients and their fetus; and current knowledge about available vaccines including efficacy, known side effects, and the lack of available data in this population. 

Additionally, mRNA vaccines do not interact with a person’s DNA or cause genetic changes because the mRNA does not enter the nucleus of the cell, which is where our DNA is kept.

The Janssen Biotech COVID-19 Vaccine is a viral vector vaccine, meaning it uses a modified version of a different virus (the vector) to deliver important instructions to our cells. Viral vector technology has been used by Janssen for other vaccine development programs.  Vaccines that use the same viral vector have been given to pregnant people in all trimesters of pregnancy, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes that affected the infant, were associated with vaccination in these trials. 

 

Are the vaccines effective against the new variants of COVID-19?

All three vaccines currently having EUA in the US target the Spike protein and are designed to produce an immune response against the Spike protein in the SARS-CoV-2 virus. As the virus mutates or changes, these changes may be in the Spike protein causing the vaccines to be less effective against these mutated strains of the virus. A recent study from the New York Blood Center published in Science Magazine examined the efficacy of the Pfizer, Janssen Biotech and Moderna vaccines to combat variants of the virus. The data suggest that the three vaccines are probably effective against COVID-19 variants, however, the efficacy of the vaccines will need to be reexamined as new strains emerge.

 

When will the vaccine be available for younger children below age 12 years?

Research studies are currently underway to evaluate the safety, tolerability, and immunogenicity of the both the Pfizer-BioNTech and Moderna COVID-19 vaccines in children 6 months to 11 years of age. It’s too soon to predict the outcome of these studies and if or when they might be authorized for use in young children.

For more information on the COVID-19 vaccines and the regulatory process please visit the FDA website on COVID-19 vaccines.

 

Helpful resources:

CDC Pre-vaccine screening questionnaire

How COVID-19 Vaccines Work (CDC)

COVID-19: Mitigation, Treatment, and Vaccines (NHF Webinar)

MASAC Document 221 – Recommendations on Administration of Vaccines to Individuals with Bleeding Disorders.

Fact Sheet for Recipients and Caregivers – EUA of the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 in Individuals 16 Years of Age and Older

Fact Sheet for Recipients and Caregivers – EUA of the Moderna COVID-19 Vaccine  to Prevent Coronavirus Disease 2019 in individuals 18 Years of Age and Older

Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers (fda.gov)

COVID-19 Vaccination Considerations for People Who Are Pregnant (CDC)

https://pdsa.org/covid-19#covid-vaccine

ISTH Interim Guidance for the Diagnosis and Treatment on Vaccine-Induced Immune Thrombotic Thrombocytopenia

Frequently Asked Questions on Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) (ASH)

COVID-19 and Blood Clotting (National Blood Clot Alliance)

WFH-EHC April 12, 2021 Statement on COVID-19 Vaccinations

 

New and Updated COVID-19 Vaccine Resources

Information for Parents and Adolescents

  • New web page: COVID-19 Vaccines for Children and Teens provides information about the benefits of COVID-19 vaccines for adolescents aged 12 and older, how to find a vaccination provider for adolescents, and what to expect during and after vaccination.
  • New fact sheet: COVID-19 Vaccines for Preteens and Teens is a printable fact sheet for parents that explains the benefits of a COVID-19 vaccine for their children, safety information, and what to expect during and after vaccination.
  • New frequently asked questions: Two new FAQs have been posted to address questions about the safety and benefits of COVID-19 vaccination for adolescents aged 12 and older.
  • New myth-buster about menstrual cycles: Your menstrual cycle cannot be affected by being near someone who received a COVID-19 vaccine. This question and answer explains why.
  • Myth-buster about infertility: It is safe for people who would like to have a baby one day to get a COVID-19 vaccine. This question and answer explains why.
  • Key things to know: The web pages Key Things to Know about COVID-19 Vaccines and About COVID-19 Vaccines have been updated to include the recommendation that adolescents aged 12 and older get vaccinated.
  • Vaccine information for specific groups: The web page COVID-19 Vaccine Information for Specific Groups has been updated to help the public find information about vaccination for adolescents.

 

Information for Healthcare and Vaccine Providers

  • New pediatric toolkit: The Pediatric Healthcare Professionals COVID-19 Vaccination Toolkit provides materials to help healthcare providers give parents clear and accurate information about COVID-19 vaccines. The toolkit includes answers to common questions, an explanation of how mRNA vaccines work, and printable materials to give to parents.
  • New FAQs about consent for minors: FAQs have been posted on the Pfizer-BioNTech product page for providers with information about consent, prescreening questions, and other issues related to the vaccination of minors.
  • New sample patient letter: Healthcare providers can customize and send this sample letter to encourage their patients to get a COVID-19 vaccine. It includes the new recommendation that everyone aged 12 and up get a COVID-19 vaccination.
  • Recipient education page: The Vaccine Recipient Education page has been updated to include resources about COVID-19 vaccination for adolescents.

 

Information for Community Groups and Health Departments

 

Last revised: August 24, 2021

Stay connected with us! Subscribe to receive the latest news on treatments, clinical trials, advocacy issues, and NHF events.