COVID-19 FAQ Vaccines, Testing, and Treatment for the PH Community2020-12-21T11:54:19-05:00

FAQ for the PH Community on Vaccines

(December 16, 2020) 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. Discuss with your PH healthcare team about all your medical conditions and whether the Pfizer or Moderna vaccine are right for you.

Multiple COVID-19 vaccines are advancing through clinical trials, but none has received full FDA approval. Distribution of Pfizer-BioNTech vaccine began Dec. 13 throughout the United States. The Pfizer-BioNTech vaccine requires two doses administered three weeks apart. Distribution of the Moderna vaccine began Dec. 20. The Moderna vaccine requires a second dose four weeks after the first dose. Details about implementing vaccination will be determined at the state and local level.

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?2021-01-04T12:58:52-05:00

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.

Learn more about vaccine distribution.

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?2021-01-04T13:01:15-05:00

A vaccine manufactured by Pfizer-BioNTech received Emergency Use Authorization from the FDA on Dec. 11. To learn more, read the FDA’s FAQ about this vaccine, which must be administered in two doses three weeks apart. Distribution of this vaccine to states began on Dec. 13.

On Dec. 18 the FDA approved an EUA for the ModernaTX Inc. vaccine for individuals within the U.S. ages 18 years and older. Distribution of the Moderna vaccine began Dec. 20. The Moderna vaccine requires a second dose four weeks after the first dose. For more information see the FDA fact sheet for the Moderna vaccine.

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?2021-01-04T13:14:37-05:00

A:  The most commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine are pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. Some side effects last several days. Some people experienced more side effects after the second dose of the vaccine. There is a remote chance the vaccine could cause a severe allergic reaction, according to the Pfizer-BioNTech EUA fact sheet for recipients and caregivers. Learn more at the FDA website.

The Pfizer-BioNTech vaccine is still in clinical trials, so scientists might learn of other side effects and more about their severity.

The most commonly reported side effects of the Moderna COVID-19 vaccine include injection site reactions: pain, tenderness, swelling and redness. Other side effects include swollen lymph nodes, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting and fever. There is a remote chance the vaccine could cause a severe allergic reaction. Learn more.

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.

COVID-19 Treatment

Q: Are treatments available for COVID-19?2020-09-01T13:16:47-04:00

A: There  are no antiviral medications recommended or licensed currently by the FDA for COVID-19. And there is no evidence that PH medications provide a protective or curative benefit for COVID-19.

However, scientists and pharmaceutical companies are developing and evaluating promising therapy and vaccines. Patient care and management of COVID-19 symptoms and complications continue to improve, including antiviral and steroid treatment regimens for hospitalized patients.

As with any non-prescription or over-the-counter medication, there is a high potential for interactions with PH medications. Or these agents could have a direct effect on the heart or lungs. See the latest COVID-19 information from the FDA here.

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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