Letter From the Chair

By now, you might be among the millions of people who have received COVID-19 vaccinations. At press time, three vaccines were available in the United States: the Pfizer-BioNTech for people 16 and older, the ModernaTX for those 18 and older and a vaccine from Janssen Inc., a division of Johnson & Johnson, for people 18 and older. The three approved for emergency use haven’t received full Food and Drug Administration approval but have been shown to be safe and effective.

Meanwhile, other COVID-19 vaccines from AtraZeneca and Novavax are advancing through clinical trials. Novavax anticipates FDA clearance in May for its vaccine.

As the pandemic rages on, the Pulmonary Hypertension Association offers Frequently Asked Questions about the vaccines at PHAssociation.org/COVID-19. Here are some excerpts:

When can PH patients get COVID-19 vaccines?

That depends on the rollout in your state or region. Initially, demand exceeded supply. Because of limited doses available, vaccination is prioritized for specific groups of people. Distribution continues in stages. People with pulmonary hypertension are included in a prioritized group, but when you can receive it depends how many doses are available where you live and your state’s distribution plan.

The Centers for Disease Control and Prevention recommends the following prioritization plan:

Phase 1a: Healthcare providers and residents in long-term care facilities.

Phase 1b: People 75 years and older and frontline essential workers. Essential workers include first responders, educators, and people employed in food and agriculture, manufacturing, corrections, postal service, public transit, and grocery stores.

Phase 1c includes: • People between 65 and 74. • People 16 to 64 with high-risk medical conditions, including PH, and other cardiovascular and cerebrovascular diseases. Visit CDC.gov for more information. • Essential workers not included in Phase 1b.

How do COVID-19 vaccines work?

Vaccines work by triggering the body’s immune system to produce proteins called antibodies that fight infection and prevent the virus from spreading throughout the body. Several different strategies are being used for COVID-19 vaccines.

In one type of vaccine, the virus is inactivated (killed) so it can’t multiply. But it can still trigger an immune response. type of vaccine 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. The SARS-CoV2 virus attaches to spike, or S protein, and infects human cells.

A third type, 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 can infect human cells. The action triggers an immune response but won’t cause a severe reaction.

None of the vaccines cause COVID-19.

Anna Hemnes, M.D., Vanderbilt University

Are there side effects or allergic reactions to the COVID-19 vaccines?

Pain, redness and swelling at the injection site have been reported for all three vaccines. Other common side effects include headache, extreme tiredness, muscle aches, nausea and fever. There is a remote chance the vaccines could cause severe allergic reactions within a few minutes to an hour after getting the vaccine. Learn more at FDA.gov.

How long do COVID-19 vaccine protections last? Can the vaccines prevent me from transmitting the virus to others?

Not enough information exists about how long vaccine protections last. Many vaccines, such those for the flu, periodically need to be re-administered.

Over time, scientists will learn more about longterm protection. People might need multiple doses of COVID-19 vaccines for broader protection. People who are vaccinated, although protected from getting

Murali Chakinala, M.D., FCCP, Washington University

sick, still might be able to transmit the virus to others.

Because vaccine doses initially were limited, it will take time to vaccinate a large percentage of the general population. Children and certain high-risk populations won’t receive vaccines until scientists collect more data. Continue to wear masks and practice physical distancing to prevent further spread of COVID-19.

Do people who already had COVID-19 need the vaccine?

The COVID-19 vaccine will be provided whether or not someone has been infected. Scientists don’t know how long people might be protected from reinfection after contracting COVID-19. Some people have been reinfected, so more studies are needed. Visit CDC.gov for more information.

What does the COVID-19 vaccine cost?

The U.S. government is providing the vaccines at no cost to the public. Vaccination providers can charge administration fees for giving the shot, but the government and private insurance companies will reimburse those providers. The Health Resources and Services Administration’s Provider Relief Fund will reimburse administration fees for shots administered to people without insurance.

As vaccines advance, PHA urges you to stay safe by wearing masks, washing hands and maintaining physical distance from others. Talk with your PH health care team about whether the COVID-19 vaccine is right for you.

Visit PHassociation.org/COVID-19 and FDA and CDC websites for the latest information about 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.

The shortened timetable doesn’t mean that scientists or regulatory agencies took shortcuts when evaluating the science, safety, and efficacy of the vaccines.

Researchers didn’t start from the beginning when studying SARS-CoV-2, the virus that causes COVID-19. SARS-CoV-2 is one of many coronaviruses.

Coronaviruses cause the common cold, as well as the epidemics Severe Acute Respiratory Syndrome (SARS) in 2002 and Middle East Respiratory Syndrome (MERS) in 2012. Scientists have been studying coronaviruses for many years, leading to findings about the biology and structure of coronaviruses.

Researchers discovered the genomic sequence of SARS-CoV-2 in January 2020, shortly after the first patient with COVID-19 was identified. That research led to worldwide scientific collaboration to develop treatments and vaccines.

Government agencies partnered with private biotechnology and pharmaceutical companies to provide funding to accelerate clinical development of COVID-19 vaccines.

In the U.S., Operation Warp Speed partnered with the National Institutes of Health and the Centers for Disease Control and Prevention to develop, manufacture and distribute COVID-19 vaccines. The European Commission and the UK Government Vaccine Taskforce funded research and development of potential vaccines.

Some COVID-19 vaccine 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. As the pandemic grew, millions of people worldwide were infected and could 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 the FDA approves a vaccine.

Toward the end of 2020, the pandemic landscape rapidly changed when two COVID-19 vaccines received emergency approval from the Food and Drug Administration (FDA).

Collaboration of scientists and clinicians globally because of the pandemic led to advances in vaccine research. As vaccines become available through emergency and ultimately full FDA approval, the CDC will monitor safety and collect additional safety data outside of clinical trials in real-life settings.

Speeding Up the Process Feeling Fine

About Sore Arms and Side Effects

Since the start of the pandemic, Marilyn Hanft of St. Marys, Georgia, prayed for a vaccine. Her prayers were answered Jan. 29 when she received her first dose of the Moderna vaccine.

Marilyn, a retired registered nurse with intensive care and emergency room experience, was diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) in 2011.

She was hesitant to take the vaccine when she first heard about it because she thought there hadn’t been enough testing. Once she read about the test results and the methods used, she was impressed.

Shortly after her first shot, Marilyn felt fine. A few days later, she began to have side effects. During the day, she felt fatigued. At night, she developed dizziness, hot flashes, nausea and diarrhea.

Despite a couple days of not feeling well, Marilyn “definitely plans” on receiving her second dose.

“Getting vaccinated not only protects yourself, it protects others,” she says. “This vaccine has no virus in it at all. So while you may have side effects or an allergic reaction, you cannot get COVID-19 from the vaccine.”

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Similarly, Alberta Wright of Detroit, Michigan, had a sore arm for a couple days after her first dose of the Pfizer vaccine. After her second dose, Alberta developed flu-like symptoms. She had body aches, a headache and nausea, and she felt like someone threw bricks on her stomach, she says.

Alberta, who has pulmonary arterial hypertension (PAH), says her doctors recommended she receive the vaccine because of her rare disease. Although there could be side effects, Alberta says it’s important people get COVID-19 vaccines to protect themselves and others.

“I made the best decision to get vaccinated to keep myself healthy,” she says. “Eventually, with everyone getting vaccinated, it will slow down the spread of the virus.”

‘Best decision’