Updated COVID-19 Guidance for Alphas
STATEMENT UPDATED: October 2021
Please note, this statement is specific to the United States. If you are an individual with Alpha-1 Antitrypsin Deficiency (Alpha-1) living outside the U.S., please see the specific statements from the health agencies and Alpha-1 organizations in your own country.
There are groups who are more likely to get severe disease, including those with lung disease, diabetes, and heart disease. In addition, age is a factor, with people who are older than 65 years of age more likely to develop severe disease and the risk of death increases with each decade above 60 years of age.
These are general recommendations provided to help avoid infection and prevent spreading infection to others. Medical decisions should be made for a patient’s particular circumstances in consultation with his or her physician.
- The best source for specific recommendations and answers to your questions is your own local physician or medical center.
The Centers for Disease Control and Prevention (CDC) is updating its website daily with the latest information and advice for the public. Visit the CDC website. If active contact tracing is taking place in your community please cooperate with individuals trying to track coronavirus cases. During the pandemic, public health workers follow-up and interview people who have had COVID-19 and their contacts. Contact tracing slows the spread of COVID-19. If you have been in close contact with a person who has COVID-19, a public health worker may call to let you know you’ve been exposed and ask you to stay at home and self-quarantine. Similarly, children, teenagers, and young adults may be told by their school or college that classmates were diagnosed with COVID-19 and quarantine might be recommended. Following these recommendations helps to keep you, your family, and your community safe.
REMEMBER TO TAKE THESE PREVENTATIVE ACTIONS:
Current CDC guidance has relaxed the recommendations regarding masking and social distancing. Still, we recommend that you remain vigilant about your own health and consider maintaining mask use and social distancing depending on the circumstances: When away from home stay at least 6 feet from other people in your immediate area and/or wear a mask if you are in a setting where the vaccination status of those around you is unknown, especially in indoor settings with large numbers of people.
The CDC and local regulations continue to recommend that people wear masks and social distance when traveling on public and mass transportation. When masks are worn, they are effective only when worn properly over both your nose and mouth. Medical masks may continue to be mandated on federal lands and in federal buildings or by specific businesses and schools. Surgical masks made of layers of paper filter material are more effective than cloth masks, especially in communities where highly infective coronavirus mutations are present. Face shields are not a substitute for a face mask. Do not shake hands or touch the skin of other individuals.
It is important to be aware of the prevalence of COVID-19 in your locality and the local recommendations in your locality, county, and state. Also, consider the additional health risks that the diagnosis of Alpha-1 can cause should you get COVID-19 and don’t hesitate to take additional precautions to protect your own health and that of your family.
Indoor family gatherings, whether to celebrate holidays or family events or to mourn the loss of a family member or friend, can still spread COVID-19 if unvaccinated visitors attend. Consider masks and social distancing if the vaccination status of participants is unknown or if participants have chosen not to be vaccinated against COVID-19. Large gatherings such as music and entertainment venues are likely to include unvaccinated individuals at the present time and should only be considered if social distancing is possible. Mask use should be strongly considered in these settings.
There are currently three vaccines available in the US to prevent COVID-19 infection. You can contact your state health department for more information on COVID-19 vaccinations.
To find a COVID-19 vaccine near you:
- Visit: VaccineFinder.org
- Check your local pharmacy’s website to see if vaccine appointments are available
- Contact your state health department
- Contact your physician
- Check your local news outlets
While vaccination is recommended to protect individuals from severe infection, hospitalization and death, it remains unknown if it will lead to the complete eradication of COVID-19 if low levels of virus continue to circulate seasonally in the community. Furthermore, the CDC and public health experts continue to monitor for variants of SARS-CoV-2 that could change transmission and virulence. While serious side effects from the vaccine are very rare, we now know that individuals with Alpha-1 have no greater risk of vaccine side effects than the general public.
The three vaccines approved in the U.S. include the Pfizer/BioNTek and Moderna vaccines which require two doses, 3 or 4 weeks apart, respectively, and the Janssen/Johnson & Johnson vaccine which requires only a single dose. The Pfizer/BioNTek vaccine is approved for individuals 12 years old and up and this age limit may be extended even lower in the near future. In addition, the Pfizer/BioNTek vaccine has received full approval from the U.S. FDA while the other two vaccines are still being used under Emergency Use Authorizations. The Moderna and Janssen/Johnson & Johnson vaccines are approved only for those 18 and older.
If you have received a transplant and have been vaccinated, we highly encourage you to ask your transplanr physician if you require additional doses of the vaccine. Please continue to follow all precautionary methods, such as facemasks and social distancing, until meeting with your physician or consulting your transplant team.
IF YOU HAVE BEEN VACCINATED:
People are considered fully vaccinated:
- 2 weeks after their second dose in a dose-series, such as the Pfizer or Moderna vaccines, or
- 2 weeks after the single-dose vaccine, such as Janssen/Johnson & Johnson’s vaccine
If you don’t meet these requirements, you are NOT fully vaccinated. Keep taking all precautions until you are fully vaccinated.
There is some evidence that the full protection of the COVID-19 vaccines may decrease with time and so experts have suggested that a booster may be needed for some people. Studies have shown significant increase in immunity in people who are six to eight months since their last initial vaccine treatment. Currently, the FDA is recommending that boosters be given to individuals 65 years of age and older and to people who are at increased risk, such as transplant recipients. Many Alphas are considered at increased risk because of their lung or liver disease. Please discuss receiving a booster with your physician if you are in one of these groups. At the time of this update, the FDA has been considering suggesting that people who qualify for a COVID-19 vaccine booster might get a better response if they take a booster with one of the mRNA vaccines and choose the vaccine they didn’t receive previously.
DO VACCINES WORK?
There is doubt in some individuals whether COVID-19 vaccines are effective. This question comes up when an individual develops a COVID-19 infection, in spite of being vaccinated. This is called a break-through infection. Break-through infections do occur but fortunately, most are mild. It is a fact that greater than 90% people in the U.S. who die from COVID-19 are unvaccinated (more than 99% deaths are in unvaccinated people in some parts of the country).
Other concerns about vaccines include a wide range of suggested side effects and long-term consequences from taking COVID-19 vaccines and vaccines in general. While it is true that there can be side effects in some individuals after vaccination, the benefit to the individual being vaccinated and their community greatly outweigh the risks. Put plainly, the risk of serious disease or death from COVID-19 in the unvaccinated is far greater than the risk of side effects from the vaccine itself.
WHAT YOU SHOULD KEEP DOING:
For now, if you’ve been fully vaccinated:
- Although the CDC has recommended that fully vaccinated individuals can resume activities without a mask or staying 6 feet apart, except where required by federal, state, local, tribal, or territorial laws, rules and regulations, including local business and workplace guidance, the CDC continues to recommend that people who have a condition or are taking medications that weaken the immune system, should talk to their healthcare provider to discuss their activities.
- We are still highly recommending that all Alphas continue taking precautions to prevent COVID-19:
- You should still take steps to protect yourself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces. Take these precautions whenever you are:
- In public, especially indoors, when the vaccination status of the people in your immediate vicinity is not known.
- Visiting with an unvaccinated person who is at increased risk of severe illness or death from COVID-19 or who lives with a person at increased risk.
- You should still take steps to protect yourself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces. Take these precautions whenever you are:
- You should still avoid large-sized gatherings either indoors or outdoors, including sporting events.
- If you travel, you should still take steps to protect yourself and others. Currently, you are still required to wear a mask on planes, buses, trains, and other forms of public transportation traveling into, within, or out of the United States, and in U.S. transportation hubs such such as airports and stations. If you travel within the United States, you do not need to get tested before and after travel or self-quarantine after travel.
- You should still watch out for symptoms of COVID-19, especially if you’ve been around someone who is sick. If you have symptoms of COVID-19, you should get tested and stay home and away from others.
- You will still need to follow guidance at your workplace, school or public places.
ABOUT VARIANTS OF THE VIRUS THAT CAUSE COVID-19 (CDC)
The virus that causes COVID-19 is a type of coronavirus, a large family of viruses. Coronaviruses are named for the crown-like spikes on their surfaces. Scientists monitor changes in the virus, including to the spikes on the surface of the virus. Multiple variants of the virus that causes COVID-19 are circulating globally and within the United States.
Currently, the variant causing most of the disease in the world is the Delta variant. It is far more contagious than the original SARS-CoV-2 virus that was predominant during the initial months of the pandemic. Serious disease and death are still prevented by the existing vaccines and can be treated with usual COVID-19 therapies.
The appearance of new variant is being closely monitored and studied. For more information, click here to link to CDC: https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html
The CDC is closely monitoring these Variants of Concern (VOC). Click here to see updated proportions of variants of concern in your state: https://covid.cdc.gov/covid-data-tracker/#variant-proportions
MONOCLONAL ANTIBODIES AND COVID-19 ANTIVIRALS:
Monoclonal antibodies represent a novel method to protect individuals who have become infected with SARS-CoV-2 virus. Three products are currently approved for use, from Regeneron, from Lily and GSK . These therapies include antibodies against the coronavirus made in the lab and given by intravenous infusion. They are most effective when given within 72 hours of infection and has been shown to prevent hospitalization and death. They are indicated in patients early in the infection in individuals with risk factors for severe disease who do not have low oxygen and are not hospitalized. Beyond a week after a COVID-19 infection starts they are largely ineffective. Should you develop a COVID-19 infection, please contact your physician or local medical center immediately about whether you qualify for monoclonal therapy.
There are a number of antiviral medications that have been repurposed to treat COVID. Recently, a specific COVID-19 antiviral, taken by mouth, was tested by Merck and found to be effective in shortening the duration of disease in those with COVID-19 infection. It is set to receive and Emergency Use Authorization by the FDA within days or weeks of this update. Again, this drug only works if given very early in the infection.
- Get your seasonal flu shot.
- Consider avoiding air travel, cruise ships, public transportation, and traveling to areas with a high prevalence of infection, if possible.
- Avoid close contact with people with respiratory illnesses.
- While sick, limit contact with others as much as possible.
- Stay home if you are sick (self-isolation). Family members who live with you should follow the same restrictions as you.
- Follow local directives based on the prevalence of COVID-19 in your community.
- Cover your nose and mouth when you cough or sneeze. Best is to cover your mouth and nose with a tissue, immediately discard the tissue, and then wash your hands. Avoid touching your eyes, nose, and mouth with unwashed hands; germs spread this way. If you are in a public place and need to sneeze or cough, do not take off your face mask.
- Clean and disinfect surfaces and objects that may be contaminated with germs. The exact risk of infection from surfaces is thought to be low.
- Wash your hands often with soap and water for at least 20 seconds. If soap and water are not available, use an alcohol-based hand sanitizer with at least 60% alcohol, scrubbing all parts of your hands and fingers until dry.
What are specific recommendations for those with Alpha-1?
People with Alpha-1 are likely to be particularly vulnerable to the effects of the COVID-19 infection. Alphas with lung disease are most susceptible to serious complications if they become infected. It is likely that Alphas with liver disease are also at high risk for serious disease should they become infected. Those that have received a transplant and/or immunosuppressed patients are also more likely to get severe disease if infected with COVID-19.
The symptoms that can distinguish between a typical exacerbation of your lung disease versus COVID-19 are a fever that lasts for several days or a high fever of any duration, loss of smell or taste, fatigue, muscle aches, diarrhea, abdominal pain, and dropping oxygen levels. Early symptoms can be subtle. We encourage you to monitor your temperature and contact your physician for additional instructions should you find yourself feeling ill. Do not go straight to the hospital or urgent care without reaching out to your physician first. Hospitals are recommending that patients contact them first before arriving at an emergency room, if possible.
If you need to leave your house, bring a face mask with you to use in case you find yourself in a situation in which you need to protect your health. Medical face masks are the most protective; however, cloth face masks made with two layers of cloth while less effective, will still provide some protection. Face masks are only effective when worn properly over both your nose and mouth. Face shields are not a substitute for a face mask.
What should an individual with Alpha-1 do?
The medical team at the Alpha-1 Foundation and AlphaNet has come together to make some specific recommendations for those with Alpha-1. There is no information in the medical literature that relates specifically to COVID-19 and Alpha-1, therefore these recommendations should be considered expert opinions rather than based on direct scientific evidence.
The recommendations of the CDC and other federal and local authorities should be followed very strictly by every person with Alpha-1:
- As mentioned above, those with liver and lung problems due to Alpha-1 are more likely to develop serious complications from a COVID-19 infection compared to the general population.
- Individuals with severe deficiency (two abnormal genes for Alpha-1) but who do not have liver or lung disease are likely at no more risk of developing serious complications from COVID-19 than the general population, although we do not know this for sure at the present time.
- Similarly, individuals who are carriers of a single abnormal gene for Alpha-1 (MZ, MS, etc.) and who have no lung or liver disease, are likely not at increased risk for serious complications of COVID-19, beyond the above-mentioned risk factors.
For those receiving augmentation therapy:
- The Plasma Protein Therapeutics Association (PPTA) has issued a statement that there is no risk of transmission of COVID-19 through plasma product infusions. Thus far, there have been no augmentation supply delays as a result of COVID-19. PPTA information about plasma products can be found at pptaglobal.org.
- Maintain a 1-month supply of augmentation therapy at your home or infusion facility, if possible.
- If you are receiving supplemental oxygen via tanks or a liquid oxygen system attempt to receive additional supplies for your home by contacting your supplier. With reports of decreased availability of supplemental oxygen supplies in some states, it is advisable to acquire an oxygen concentrator, if possible.
- On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued temporary regulatory waivers and new rules amid concerns for the US Healthcare system during the COVID-19 pandemic. Within these regulations is a big victory for individuals with Alpha-1 Antitrypsin Deficiency who receive augmentation therapy. The choice of home infusions is now available for Alphas that usually receive infusions in a hospital or physician office setting. Patients need to be their own best advocate for their health care treatments by having transparent conversations with your health care providers about this choice and its cost. In order to receive infusions at home, Alphas and their physicians need to understand the choice and nuances of billing Medicare correctly. We encourage patients to understand the costs associated with switching from Medicare Part B to Medicare Part D if this is being recommended. Talk to your provider, specialty pharmacy and/or home care infusion company and have a transparent conversation about the costs. This provision has been extended through the end of 2021 and the Foundation is working to make these provisions permanent.
- If you receive home infusion from an infusion nurse, be diligent and be sure your infusion nurse is diligent in cleaning surfaces used for reconstitution, pooling, and administration of infusions before and after each treatment. Make sure that both your nurse and you follow all the instructions regarding personal protection from transmission including wearing face masks, vigorous hand washing and covering coughs and sneezes. Maintain Social Distancing as possible. Try to arrange that your nurse visits you first on the day of infusion to avoid bringing in infection from other homes.
- If you have concerns about receiving your augmentation therapy infusions, please understand that there are no significant withdrawal side effects from missing a dose. If you know you will be missing a dose, ask your physician about receiving a double dose of augmentation therapy prior to missing a dose. While receiving a double dose every two weeks is likely not as effective as a usual dose every week, it is better than missing a dose entirely.
- Should you develop symptoms of COVID-19 that require you to be admitted to a hospital or an intensive care unit (ICU), every effort should be made to continue your augmentation therapy in the hospital setting.
- Many clinical trials of novel therapies to treat Alpha-1 antitrypsin deficiency are now open and have been modified for the safety of study subjects during COVID-19. Please visit our website to learn with trials are active. http://www.alpha1.org/ct/
- Some individuals may be able to learn to self-infuse their augmentation therapy or have their spouse or another person in their household learn to do this. This would avoid the need to visit an infusion center or have a nurse come to your home each week. Such a decision should be discussed with your physician. Training is usually done by your own infusion nurse.
How to reduce the risk of COVID-19 infection during augmentation therapy infusions
Please note: If you have been diagnosed with COVID-19 or have symptoms of that might be caused by COVID-19, please notify your infusion center or infusion nurse before your next infusion.
If you receive your infusions at an infusion center:
- Be sure to wear a face mask the entire visit.
- Entry into the infusion facility should be distant from the entrance to the ER and COVID-19 screening areas.
- Ensure that personnel at the infusion center are not also working in areas of the hospital or physician office that screens or cares for COVID-19 patients.
- Expect all staff with patient contact to be wearing, at a minimum, gloves, and masks and that gloves are changed between patients with careful hand washing while changing gloves.
- All patients in the infusion center should also be wearing gloves and masks.
- Patients should be at least 6 feet apart from each other.
- Any patients with COVID-19 requiring infusions should be infused in a different area of the facility.
- The infusion facility should be scrupulously disinfected each morning and all surfaces in proximity of a patient should be disinfected after each patient completes their infusion and departs.
If you receive your infusions from a home infusion nurse:
- Expect the nurse to be wearing, at a minimum, gloves and a mask and that gloves are changed between patients with careful hand washing while changing gloves.
- The nurse should consider removing shoes and outwear before entering the home.
- You should also be wearing a face mask.
- You should also be wearing gloves and a mask.
- You should maintain social distancing from your nurse of at least 6 feet apart except for the actual sticking of your vein and start of infusion.
- The preparation area and area where infusion is given should be scrupulously disinfected before and after each infusion.
If you self-infuse your augmentation therapy:
You are absolutely fine in terms of risk as long as you disinfect the package of augmentation therapy and supplies before bringing them into your home.
For Alpha-1 patients who have received a lung or liver transplant:
- Transplant recipients take medications that suppress their immune system and therefore they are more susceptible to certain infections. It is reasonable to be concerned about an increased risk of complications including organ injury should a transplanted patient develop COVID-19 infection.
- Many respiratory viruses can be much more severe in lung transplants and they may be at greater risk due to immunosuppressant medications. These viruses have also been associated with, though not causal of acute and chronic rejection.
- At this point, the medical team at the Alpha-1 Foundation does not believe it is necessary for transplant recipients to take special precautions other than the many recommendations above to protect themselves from COVID-19 infection. However, please be particularly attentive to the virus prevalence in your local area, which may require you to self-isolate.
- Transplant recipients should contact their transplant center should they develop symptoms consistent with COVID-19 infection.
- Transplant recipients should contact their transplant center with any questions or concerns.
The Alpha-1 Foundation and AlphaNet are following the situation and will continue to keep the Alpha-1 community updated.
IF YOU FEEL SICK with fever, cough, or difficulty breathing, seek medical advice. Before you go to a doctor’s office, health facility, or emergency room, call ahead and tell them about any recent travel, exposures, and your symptoms. If you have concerns about any symptoms, get tested.
*Please continue to check the Alpha-1 Foundation website for continuous updates on the coronavirus and scheduled Foundation events.
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