COVID-19 FAQ Vaccines, Testing, and Treatment for the PH Community2021-03-04T15:36:03-05:00

FAQ for the PH Community on Vaccines

(March 3, 2021) On Dec. 11 the U.S. Food and Drug Administration (FDA) gave emergency approval for the first vaccine to prevent COVID-19 in people at least 16 years old. The vaccine, manufactured by Pfizer-BioNTech, is available under an Emergency Use Authorization (EUA). On Dec. 18 the FDA approved an EUA for the ModernaTX Inc. vaccine for individuals within the U.S. ages 18 years and older. The third COVID-19 vaccine from Janssen Inc., a division of Johnson & Johnson, received an EUA approval from FDA with a Centers for Disease Control and Prevention (CDC) recommendation for individuals at least 18 years old. Discuss with your PH healthcare team about all your medical conditions and whether the Pfizer, Moderna or Janssen Inc. vaccine are right for you.

Multiple COVID-19 vaccines are advancing through clinical trials, but none has received full FDA approval. The Pfizer-BioNTech and Moderna vaccines require two doses administered several weeks apart. The Janssen COVID-19 vaccine is administered in a single dose. Details about implementing vaccination will be determined at the state and local level. COVID-19 is a rapidly emerging situation. Visit the FDA and CDC websites for the most up to date information.

Throughout the vaccine approval and distribution process, the Pulmonary Hypertension Association (PHA) will address related questions and concerns from the pulmonary hypertension (PH) community. We will update this information as scientific and medical knowledge about COVID-19 and vaccines emerges. In the meantime, we urge everyone to:

COVID-19 Vaccines

Q: When will I as a PH patient be able to get a COVID-19 vaccine?2021-03-02T10:45:24-05:00

A:  That depends on where you live and how many vaccines ultimately are approved. Multiple vaccines are in clinical development. However, demand initially is expected to exceed supply even if more than one COVID-19 vaccine receives Emergency Use Authorization from the FDA. Due to the limited amount of vaccine doses, vaccination will be prioritized for specific groups of people and occur in stages. The CDC has prioritized health care providers and residents and employees of long-term care facilities.

On Dec. 20 the CDC Advisory Committee on Immunization Practices (ACIP) recommended the CDC adopt the following recommendations:

  • Phase 1a for COVI-19 vaccination for healthcare providers and those in long-term care facilities.
  • Phase 1b prioritizes people 75 years and older and for frontline essential workers.  Frontline essential workers may include first responders, those in education, food and agriculture, manufacturing, correction workers, U.S. postal service, public transit workers and grocery store workers.
  • Phase 1c prioritization includes people with pulmonary hypertension.  Phase 1c includes:
    • People between 65 and 74 years old.
    • Individuals 16 to 64 years old with high risk medical conditions. Pulmonary hypertension falls under the CDC identified high-risk medical conditions of heart disease and other cardiovascular and cerebrovascular diseases. For more information on high-risk medical conditions, visit the CDC website.
    • Other essential workers who are not included in phase 1b.

Visit the CDC website to link to the health department for your state or territory for more information about getting the COVID-09 vaccine.

Q: COVID-19 vaccines are being developed very fast. How will I know they are safe and effective for me?2020-12-17T05:45:16-05:00

A: The shorted timetable doesn’t mean scientists or regulatory agencies are taking shortcuts when evaluating the science, safety and efficacy of COVID-19 vaccines. Usually, the process of moving a vaccine through clinical trials takes years. But several factors led to a significantly shorter-than-usual approval process for the COVID-19 vaccine:

Some clinical trials combined Phase 1 and Phase 2 studies so researchers could quickly evaluate safety and efficacy in a larger population of people at one time. Millions of people were infected worldwide and available to participate in Phase 3 studies.

Distribution began soon after approval because many companies and the U.S. government ramped up manufacturing capabilities before clinical trials were completed. Usually, manufacturing doesn’t begin until all clinical studies are completed, and FDA has reviewed and approved the vaccine.

Learn more about the vaccine development process from Johns Hopkins University.

Q: What vaccines are currently available?2021-03-03T12:37:16-05:00

A: All of the COVID-19 vaccines currently approved for Emergency Use Authorization (EUA) have been shown to be safe and effective:

To learn about the Pfizer-BioNTech vaccine read the FDA’s COVID-19 FAQ about this vaccine.

For information about the ModernaTX Inc. COVID-19 vaccine see the FDA fact sheet.

On Feb. 27, the third COVID-19 vaccine from Janssen Inc., a division of Johnson & Johnson, received an EUA approval from FDA with CDC recommendation for allocation. For more information visit the FDA’s website .

Q: Can I spread the COVID-19 virus after receiving a COVID-19 vaccine? Will I need to wear a mask and stay physically distant from family and friends once I am vaccinated?2020-12-17T05:49:01-05:00

A:  Yes. Initially, only limited vaccine doses will be available so not everyone will receive vaccines right away. People who are vaccinated, although protected from getting sick, might be able to transmit the virus to others. Until a large percentage of the general population is vaccinated, we must be vigilant, wear masks and practice physical distancing to prevent the spread of COVID-19. Furthermore, some children and high-risk populations, won’t receive vaccines until scientists collect more data about safety and efficacy.

Q: How long will the vaccine protect me from COVID-19?2020-12-17T05:52:09-05:00

A:  There isn’t enough information yet about how long a vaccine’s protection against COVID-19 will last. Many vaccines, such those for the flu, need to be periodically readministered. Over time, scientists will learn more about long-term protection. People might need multiple doses of a COVID-19 vaccine for broader protection.

Visit the CDC website for more information.

Q: Will I need a vaccine if I already had COVID-19?2020-12-17T09:56:43-05:00

A: Talk to your health care provider. It’s unknown how long people are protected from re-infection after contracting COVID-19. Some people have been re-infected, so more studies are needed.

Learn more.

Q: Will I have side effects or allergic reactions to a COVID-19 vaccine?2021-03-02T13:01:24-05:00

A: All three vaccines report similar common side effects of pain, redness and swelling at the injection site and general sides effects of may include headache, feeling very tired, muscle aches, nausea and fever. There is a remote chance that the vaccines could cause a severe allergic reaction within a few minutes to one hour after getting the vaccine dose.

Learn more at the FDA website.

Q: What types of vaccines are being developed for COVID-19, and how do they work?2020-12-17T06:02:02-05:00

A: More than 10 vaccines are in development to fight COVID-19. The vaccines trigger the immune system in various ways to produce proteins called antibodies. The antibodies fight infection and prevent the virus from spreading throughout the body. None of these vaccines will cause COVID-19. Several types of COVID-19 vaccines are in development:

  • In one type, the virus is inactivated (killed) so it can’t multiply but still can trigger an immune response. That type is used for polio, hepatitis A and flu vaccines.
  • Another type uses only part of the virus to trigger an immune response. For COVID-19, the vaccines target a protein on the surface on the virus called the spike protein.
  • A third type, known as a viral vector vaccine, uses part of the virus to trigger an immune response. For the COVID-19 vaccine, the spike protein is inserted into another virus. That virus can infect human cells and trigger an immune response but doesn’t cause a severe reaction.

Learn more.

Q: How does the vaccine approval process work?2021-01-04T13:18:02-05:00

A:    New vaccines in the U.S. must undergo a thorough FDA approval process. The CDC makes recommendations for use. These processes are deeply rooted in science and data and are independently assessed for safety and efficacy to protect the public.

  • An independent advisory panel of experts called the Vaccine and Related Biological Products Advisory Committee met Dec. 10 to assess data from clinical trials about the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine.
  • The CDC adopted recommendations from the Advisory Committee on Immunization Practices about access and allocation of COVID-19 vaccines. The committee voted Dec. 12 for to approve the EUA for the Pfizer-BioNTech COVID-19 vaccine.
  • The FDC, CDC and other federal agencies will monitor long-term effects of the vaccine on public health. Learn more about vaccine safety monitoring.

FDA approved an EUA for the Moderna COVID-19 vaccine Dec. 18, 2020, for adults 18 years and older. For more information, see the FDA fact sheet.

Q: What is an Emergency Use Authorization (EUA)?2020-12-17T06:08:52-05:00

A: An EUA permits rapid response during a health crisis, such as the COVID-19 pandemic. An EUA allows the FDA to approve medical products to diagnose, treat or prevent life-threatening conditions when no approved alternative is available. FDA scientists review safety, effectiveness, quality control and manufacturing data to confirm that known benefits outweigh potential risks.

Additional data and clinical trial results are needed before the FDA fully approves a vaccine. Researchers continue to study safety and efficacy data in additional populations, such as in young children. Researchers also will track long-term safety and efficacy after vaccination.

Q: Will I have to pay for the COVID-19 vaccine?2021-01-08T14:48:24-05:00

A:   Vaccine doses purchased by the U.S. government will be provided to the American people at no cost, according to the CDC. Vaccination providers can charge administration fees for giving shots, but the federal government and private insurance companies will reimburse them for the fees. For uninsured patients, the Health Resources and Services Administration’s Provider Relief Fund will reimburse providers for the fees.

COVID-19 Testing

Q: What types of tests are available for COVID-19?2020-12-17T06:17:58-05:00

A:  There are multiple types of COVID-19 tests.

  • The most common type analyzes samples from your respiratory tract for the presence of the COVID virus in your system. You might be asked to spit, or someone will swab the inside of your nose.
  • Real-time reverse transcription polymerase chain reaction (RT-PCR) tests detects the presence of viral genetic material, nucleic acid.
  • Antigen tests detect the presence of a specific viral protein or antigen. The antigen test for detecting the COVID-19 virus is relatively inexpensive and fast but generally is less sensitive than the RT-PCR test.

Test results may take hours to several days. The results show your infection level at the time the sample was collected. A negative result doesn’t mean you definitely are virus-free. A negative result can occur if you’re tested early after infection and there isn’t enough virus in your system to be detected. During that time, you can transmit the virus to others.

You can be infected with the COVID-19 virus even after receiving a negative test result for current infection, so it’s important to continue wearing a mask, keeping physical distance from others and frequently washing your hands.

An antibody test indicate whether you previously were infected with the COVID-19 virus. Antibodies are proteins that your body produces to help fight infections. The antibody test analyzes a blood sample for antibodies against COVID-19. It is unknown how long antibodies remain in your body after infection.

More research is needed to determine how long after infection antibodies can be detected. It is not known if a positive antibody test means that you will be protected from becoming reinfected by the COVID-19 virus or how long that protection will last.

Learn more about COVID-19 tests.

Johns Hopkins University has a COVID-19 testing tracker for monitoring changes in COVID-19 cases and testing capacity throughout the United States .

Q: How do I know if I should be tested for COVID-19?2020-12-17T06:20:24-05:00

A:  Testing is appropriate if you are experiencing symptoms of COVID-19 or if you know you were in contact with someone infected by the virus. Because some people don’t have symptoms, testing helps you know whether to isolate yourself and prevent infecting others.

Your city or state might have specific testing recommendations. In some areas with high infection levels, people are asked to quarantine and avoid health care facilities unless they experience severe symptoms. You might have to take a COVID-19 test before undergoing certain medical tests. Talk with your PH health care team to determine whether you should be tested for COVID-19.

Q: Where can I get tested for COVID-19?2020-12-17T06:23:43-05:00

A:    Testing sites differ in various localities. Some areas offer testing only in health care facilities, and others have community-based and/or drive-through sites. Visit the Department of Health and Human Services webpage to locate testing sites near you.

Q: As a PH patient, will I have to pay to get tested for COVID-19?2020-12-17T06:26:02-05:00

A:  Government and private insurance companies are required to cover the costs of COVID-19 tests under the Families First Coronavirus Response Act. While the law provides funds to cover costs accrued by uninsured patients, patients without health care insurance and those tested without orders from a health care provider might have out-of-pocket expenses.

Q: What do I do if I test positive for COVID-19?2021-03-02T10:36:21-05:00

A: Many people with COVID-19 have mild symptoms and can recover at home. If you tested positive for or think that you were exposed to COVID-19, contact your PH health care team for guidance. Follow these steps if you have COVID-19:

  • Stay in touch with your health care provider. Monitor your symptoms and follow instructions from your PH health care provider and local health department.
  • Stay at home and away from public areas.
  • Wear a mask over your nose and mouth.
  • Isolate as much as possible from others in your household, avoid sharing household items and frequently clean commonly touched surfaces.
  • Inform others with whom you have been in close contact about your illness.

If you have COVID-19, you can be with others after:

  • At least 10 days since symptoms first appeared and
  • At least 24 hours with no fever without fever-reducing medications and
  • Other symptoms of COVID-19 are improving.

The CDC  has a self-tracker tool to help you make decisions about seeking emergency medical care. Visit the CDC website for more information about what to do if you or a family member has COVID-19.

Q: What are COVID-19 variants? Are they more dangerous?2021-03-02T10:38:16-05:00

A: Viruses often undergo genetic changes or mutations over time, leading to new versions or variants of a virus. Multiple variants of the COVID-19 virus that appear to spread more easily and could cause more cases have been identified worldwide including in the U.S. (UK variant B.1.1.7, South Africa variant B.1.351 and Brazil P.1). The CDC has reported that the UK COVID-19 variant spreads more easily and quickly than other variants and may be associated with an increased risk of death. However, more studies are needed to confirm this finding.

Scientists and doctors are studying the new variants to understand how they spread from person to person, whether they cause more severe illness, how well current COVID-19 tests detect them, and the efficacy of current COVID-19 treatments and vaccines for these variants. While more investigation is needed, current COVID-19 vaccines are thought to be effective in reducing serious illness, hospitalization and death caused by these variants.

For the most up to date information on COVID-19 virus variants, visit the CDC website.

COVID-19 Treatment

Q: What treatments are available for COVID-19?2021-03-02T13:47:48-05:00

A: Veklury (remdesivir) is the first COVID-19 treatment the FDA-approved for hospitalized patients. Other medications are being studied as potential treatments for COVID-19. Ventilators, corticosteroids and convalescent plasma from people who recovered from COVID-19 may also be used on an emergency basis in the hospital.

FDA has issued an Emergency Use Authorization (EUA) for monoclonal antibody therapy bamlanivimab to treat mild to moderate COVID-19 in patients at risk of severe illness or hospitalization.

On February 9, 2021, FDA issued an EUA for monoclonal antibody therapies bamlanivimab and etesevimab to be administered together for treatment of mild to moderate COVID-19 in adults and and children 12 years and older who test positive for COVID-19  and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for individuals 65 years and older or those with certain chronic medical conditions. High risk is defined as patients who have:

  • A body mass index (BMI) equal or great than 35.
  • Chronic kidney disease.
  • Diabetes.
  • Immunosuppressive disease or currently receiving immunosuppressive treatment.
  • 55 years or older with cardiovascular disease or hypertension or chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Between 12 and 17 years old with:
    • BMI equal or greater than the 85th percentile for age and gender.
    • Sickle cell disease.
    • Congenital or acquired heart disease.
    • Neurodevelopment disorders.
    • Medical-related technology dependence.
    • Asthma or other chronic respiratory disease that requires daily medication.

For more information about therapies to treat COVID-19, visit the CDC website.

Health insurance plans aren’t required to cover COVID-19 treatment. Out-of-pocket costs for treatment vary by insurance plan and by individual.

Be aware of products that falsely claim to diagnose, treat, prevent or cure COVID-19. To help patients protect themselves, the FDA lists warning letters sent to companies selling fraudulent products.

Q: What risks are associated with medication for pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) when infected with the COVID-19 virus?2020-09-01T13:19:05-04:00

A: The use of PAH and CTEPH medications hasn’t been studied in PAH or CTEPH patients who contract COVID-19. Stopping or modifying your medication isn’t recommended because that could make your PAH or CTEPH worse. Talk about medication concerns with your PH health care team.

Q: Should I worry about running out of medicine or supplies?2020-09-01T13:23:15-04:00

A: The CDC recommends that you maintain enough medicine and supplies for several weeks in case you need to stay home for prolonged periods of time. There is no indication that PAH prescriptions and refills will be disrupted.

PHA isn’t aware of any manufacturing disruptions of PH medication caused by COVID-19. Current information of the impact of COVID-19 on access to PH therapies, supplies, oxygen and lab tests can be found here.

There may be shortages throughout the United States of some supplies and other medications. Consult the FDA’s drug shortage database about specific medications. PHA is monitoring the PAH medication and supply availability throughout the pandemic.

Q: What do I do about routine tests for refills?2020-09-01T13:27:32-04:00

A: Certain PH medications may require blood and/or urine tests to refill your prescription. If you are concerned about going to the hospital for tests but are short on medication, contact your PH care provider and/or specialty pharmacy. Your specialty pharmacy might require home visits for some medications. Most have temporarily halted home visits, but speak to your healthcare provider and specialty pharmacy about changes in services.

Q: What about herbal or vitamin supplements?2020-09-01T13:29:16-04:00

A: Don’t take herbal supplements, high amounts of vitamin supplements or any “antiviral cures” without consulting your PH care team. Herbal therapies should be viewed as drugs and can be harmful.

Q: Can I use at home a pulse oximeter to accurately monitor my blood oxygen level?2021-03-02T13:21:26-05:00

A: A pulse oximeter is a device used to estimate the amount of oxygen carried in the blood and pulse rate. It can be helpful for COVID-19 patients to monitor their illness at home.

On Feb. 19, 2021 the U.S. Food and Drug Administration (FDA) warned about the limitations and risk of inaccuracy of pulse oximetry. Some circumstances include:

  • Poor circulation.
  • Skin pigmentation.
  • Skin thickness.
  • Skin temperature.
  • Tobacco use.
  • Use of fingernail polish.

The FDA suggests that changes or trends in oximeter measurements may be more relevant than relying on one single reading. Do not solely rely only on a pulse oximeter to assess your health condition or oxygen level. If you are monitoring your oxygen levels at home, pay attention to signs or symptoms of low oxygen levels, such as:

  • Bluish coloring in the face, lips, or nails.
  • Shortness of breath, difficulty breathing or a cough that gets worse.
  • Restlessness and discomfort.
  • Chest pain or tightness.
  • Fast or racing pulse rate.

If you are concerned about your pulse oximeter reading or if your symptoms are getting worse, contact your PH health care team.

Pulse oximeters cannot be used to diagnose COVID-19.  If you think you may have COVID-19, contact your PH care team or local health department about getting a diagnostic test for COVID-19.

Talk with your PH health care teams about your health risks and safety measures to protect yourself from COVID-19 infection.

For more information about how to stay safe and prevent infection during the pandemic, the symptoms of COVID-19, medical appointments and managing stress and anxiety, visit the COVID-19 FAQ for the PH Community.

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