COVID-19 FAQs, Vaccines, Boosters, & Antivirals

The latest updates and information on COVID-19 for myeloma patients: Vaccines, boosters, anti-viral treatments, and answers to FAQs

Frequently Asked Questions (FAQ)
COVID-19 Vaccines & Boosters

For Moderately or Severely

Immunocompromised Individuals

(Updated as of November 3, 2022)

Source: CDC

Who are considered as moderately or severely immunocompromised?

Individuals who are moderately or severely immunocompromised have a weakened immune system and are at increased risk of severe illness from COVID-19 or death. Additionally, their immune response to COVID-19 vaccines may not be as strong as those who are not immunocompromised. 

According to the CDC:

People are considered to be moderately or severely immunocompromised due to several types of conditions and treatments, including:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts less than 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory

If you or someone you live or spend time with is immunocompromised, it is important to have a COVID-19 plan to protect yourself from infection and prepare for what to do if you get sick. 

What do you need to know if you are moderately or severely immunocompromised?

According to the CDC updates as of 10/24/2022:

  • If you are moderately or severely immunocompromised (have a weakened immune system), you are at increased risk of severe COVID-19 illness and death. Additionally, your immune response to COVID-19 vaccination may not be as strong as in people who are not immunocompromised.
  • As with vaccines for other diseases, you are protected best when you stay up to date with your COVID-19 vaccines as described below.
  • CDC recommends everyone ages 5 years and older get an updated COVID-19 booster to help restore protection that has decreased since your last vaccine. One updated booster is recommended for all people ages 5 years and older, regardless of whether or not they are immunocompromised.
  • CDC recommends that people who are moderately or severely immunocompromised to get an extra primary dose series if receiving the Moderna or Pfizer-BioNTech series.
  • Use CDC’s COVID-19 booster tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines.
  • You can self-attest to your moderately or severely immunocompromised status, which means you do not need any documentation of your status in order to receive COVID-19 vaccine or booster doses you might be eligible to receive.
  • You may also be eligible for Evusheld, a medicine given by your healthcare provider every six months to help prevent you from getting COVID-19.
As a myeloma patient, should I get the COVID-19 vaccine?

The IMF strongly recommends that patients with multiple myeloma (MM), smoldering multiple myeloma (SMM), or monoclonal gammopathy of undetermined significance (MGUS) get vaccinated either with the Pfizer-BioNTech COVID-19 vaccine or Moderna vaccine, whichever is available. These vaccines offer excellent benefits, and in general, have very limited and brief side effects or toxicities. Currently, the efficacy of these vaccines far outweighs any toxicity concerns.

Should I consult with my doctor before getting the COVID-19 vaccine?

Before getting the COVID-19 vaccine, it’s best to consult with your doctor first to discuss your medical condition in order to address questions and concerns which may arise before planning for your vaccination.

Vaccination for children ages 6 months to 4 years who are moderately or severely immunocompromised

For Pfizer-BioNTech COVID-19 Vaccine:

  • 3 doses are required to be considered up-to-date (3 doses of the primary vaccine series )
  • 2nd dose should be given 3 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 8 weeks after 2nd dose

Up to Date: 2 weeks after 3rd dose in primary series, since boosters are NOT recommended for this age group at this time

For Moderna COVID-19 Vaccine:

  • 3 doses are required to be considered up-to-date (3 doses of the primary vaccine series)
  • 2nd dose should be given 4 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose

Up to Date: Children 6 months to 4 years are up to date two weeks after completing the 3rd dose of their primary series. 

Vaccination for children ages 5-11 who are moderately or severely immunocompromised

For Pfizer-BioNTech COVID-19 Vaccine:

  • 4 doses are required to be considered up-to-date (3 doses of the primary vaccine series + 4th dose of booster)
  • 2nd dose should be given 3 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of updated bivalent booster should be given at least 2 months after the 3rd dose (Note: For children aged 5 years, only Pfizer-BioNTech updated bivalent booster may be administered.)

Up to date: Immediately after receiving the most recent booster recommended for you.

For Moderna COVID-19 Vaccine:

  • 3 doses are required to be considered up-to-date (3 doses primary vaccine series)
  • 2nd dose should be given 4 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of updated bivalent booster should be given at least 2 months after 3rd dose (Note: For children aged 5 years, only Pfizer-BioNTech updated bivalent booster may be administered.)

Up to Date: Children 5 years of age who received a Moderna primary series are up to date immediately after they have received the most recent booster recommended for them. For children ages 6-11, immediately after you have received the most recent booster recommended for you.

 

Vaccination for ages 12 and older who are moderately or severely immunocompromised

In order to stay up to date on COVID-19 vaccinations, immunocompromised individuals aged 12 years and older should receive the following doses:
 


For Pfizer-BioNTech COVID-19 Vaccine:

(Ages 12-17 years)

  • 4 doses are required to be considered up-to-date (3 doses of the primary vaccine series + 4th dose of UPDATED bivalent booster)
  • 2nd dose should be given 3 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of UPDATED bivalent booster should be given at least 2 months after the 3rd dose or last booster 

Up to date: Immediately after receiving the most recent booster recommended for you

(Ages 18 and older)

  • 4 doses are required to be considered up-to-date (3 doses of the primary vaccine series + 4th dose of UPDATED bivalent booster)
  • 2nd dose should be given 3 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of UPDATED bivalent booster should be given at least 2 months after the 3rd dose or last booster 

Up to date: Immediately after receiving the most recent booster recommended for you

For Moderna COVID-19 Vaccine: 

(Ages 12-17 years)

  • 4 doses are required to be considered up-to-date (3 doses of the primary vaccine series + 4th dose of UPDATED bivalent booster)
  • 2nd dose should be given 4 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of UPDATED bivalent booster should be given at least 2 months after the 3rd dose or last booster 

Up to date: Immediately after receiving the most recent booster recommended for you

(Ages 18 and older)

  • 4 doses are required to be considered up-to-date (3 doses of the primary vaccine series + 4th dose of UPDATED bivalent booster)
  • 2nd dose should be given 4 weeks after the 1st dose
  • 3rd dose of primary series should be given at least 4 weeks after 2nd dose
  • 4th dose of UPDATED bivalent booster should be given at least 2 months after the 3rd dose or last booster

Up to date: Immediately after receiving the most recent booster recommended for you

For J&J Janssen COVID-19 Vaccine:  

(Ages 18 to older) 

  • 3 doses are required to be considered up-to-date (2 doses of the primary series + 3rd dose of UPDATED bivalent booster)
  • 2nd dose of the primary vaccine series should be given at 4 weeks after 1st dose and should be Pfizer-BioNTech or Moderna
  • 3rd dose of the UPDATED bivalent booster shot should be given at least 2 months after the 2nd dose or last booster 

Up to date: Immediately after receiving the most recent booster recommended for you    

For Novavax COVID-19 Vaccine:

(Ages 12 -17 years) 

  • 3 doses are required to be considered up-to-date (2 doses of the primary vaccine series + 3rd dose of UPDATED bivalent booster)
  • 2nd dose of the primary series should be given 3 weeks after the 1st dose and should be Novavax
  • 3rd dose of the UPDATED bivalent booster shot should be given at least 2 months after the 2nd dose 

Up to date: Immediately after the most recent booster recommended for you 

(Ages 18 and older) 

  • 3 doses are required to be considered up-to-date (2 doses of the primary vaccine series + 3rd dose of UPDATED bivalent booster)
  • 2nd dose of the primary series should be given 3 weeks after the 1st dose and should be Novavax
  • 3rd dose of the UPDATED bivalent booster shot should be given at least 2 months after the 2nd dose 
  • A monovalent Novavax booster is available in limited situations. 

Up to date: Immediately after the most recent booster recommended for you 


         


 

COVID-19 Vaccination

General questions about COVID-19 vaccines and boosters

(Updated as of November 1, 2022)

Sources: CDC and CBS News

When are you up to date with COVID-19 vaccines?

According to CDC:

You are up to date with your COVID-19 vaccines if you have completed a COVID-19 vaccine primary series and received the most recent booster dose recommended for you by CDC. 

COVID-19 vaccine recommendations are based on three things: 

  • Your age 
  • The vaccine you first received, and 
  • The length of time since your last dose

People who are moderately or severely immunocompromised have different recommendations for COVID-19 vaccines. 

You are still up to date if you receive all COVID-19 vaccine doses recommended for you and then become ill with COVID-19. You do not need to be immediately revaccinated or receive an additional booster. 

Visit the CDC website for more FAQs about COVID-19 vaccination.

Who are eligible for the updated COVID-19 bivalent boosters?

As of October 12, 2022, the FDA has authorized the emergency use (EUA) of Moderna and Pfizer-BioNTech bivalent boosters as  a single booster dose in younger age groups.

The Moderna COVID-19 bivalent booster is "authorized for administration at least 2 months following completion of primary or booster vaccination in children down to 6 years of age."

The Pfizer-BioNTech bivalent booster is "authorized for administration at least 2 months following completion of primary or booster vaccination in children down to 5 years of age."

"With [Wednesday's] authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older," states the FDA.

For more information on the FDA's most recent EUA, visit the FDA website. 

With the FDA's latest EUA, the CDC followed through with an update:

"Today, CDC’s Director Rochelle P. Walensky, M.D., M.P.H., signed a decision memo expanding the use of updated (bivalent) COVID-19 vaccines to children ages 5 through 11 years. This follows the Food and Drug Administration’s (FDA) authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years, and from Moderna for children and adolescents ages 6 through 17 years.

For people ages 12 years and older, the only authorized mRNA booster is the updated (bivalent) booster. People ages 12 years and older can no longer get the original (monovalent) mRNA booster.

According to CBS News, the updated COVID-19 bivalent boosters are "to be used as a booster for anyone who's already had their primary vaccination series" from any of the vaccines that have been authorized/approved by the FDA and recommended by the CDC. 

What makes the COVID-19 mRNA bivalent boosters different?

According to the CDC:

The updated (bivalent) boosters are called “bivalent” because they protect against both the original virus that causes COVID-19 and the Omicron variant BA.4 and BA.5.

Previous boosters are called “monovalent” because they were designed to protect against the original virus that causes COVID-19. They also provide some protection against Omicron, but not as much as the updated (bivalent) boosters.

The virus that causes COVID-19 has changed over time. The different versions of the virus that have developed over time are called variants. 

Two COVID-19 vaccine manufacturers, Pfizer and Moderna, have developed updated (bivalent) COVID-19 boosters.
 

 

When should I get an updated COVID-19 bivalent booster shot?

The FDA has set the minimum wait time to 2 months. However, CDC advisers recommend to wait longer, with some advising at least 3 months while others advised 6 months for those who are NOT at high risk. An individual who recently got a COVID-19 monovalent booster shot already has more than enough virus-fighting antibodies in their system. (Source: CBS News)

Should I get an updated COVID-19 bivalent booster shot if I recently recovered from COVID-19?

According to the CDC:

If you recently had COVID-19, you may consider delaying your next vaccine dose (whether a primary dose or booster) by 3 months from when your symptoms started or, if you had no symptoms, when you first received a positive test.

Reinfection is less likely in the weeks to months after infection. However, certain factors, such as personal risk of severe disease, or risk of disease in a loved one or close contact, local COVID-19 Community Level, and the most common COVID-19 variant currently causing illness, could be reasons to get a vaccine sooner rather than later.

Are the updated COVID-19 bivalent boosters safe?

Basic ingredients used in both the omicron-targeting Pfizer-BioNTech and Moderna bivalent boosters are the same as the previous mRNA boosters. Human testing made by Pfizer and Moderna on their BA.1-targeting boosters proved to be safe; CDC advisers conclude that the added ingredients should be just as safe. (Source: CBS News)

How much more beneficial are these updated COVID-19 bivalent booster shots?

The extent of benefits is still unclear, given that this will be the first time that these updated COVID-19 bivalent boosters will be tested on humans. The FDA authorized the emergency use for these updated boosters based on "human studies of a similarly tweaked vaccine that's just been recommended by regulators in Europe. With BA.4 and BA.5 as the dominant omicron variants, the FDA ordered "an additional tweak to the shots—and tests in mice showed they spark an equally good immune response."

Currently, it is unknown "if antibodies produced by an omicron-matched booster might last longer than a few months." However, a booster is "supposed to strengthen immune system memory, adding to protection against serious illness from the ever-mutating virus." (Source: CBS News)

What if I prefer to wait before getting the updated COVID-19 bivalent booster?

Individuals who are at high risk of getting infected with COVID-19 are encouraged to get the updated COVID-19 bivalent booster when they're due for a booster shot. (Source: CBS News)

Why do I need to get a COVID-19 booster?

According to the CDC, "recent data suggest COVID-19 vaccine effectiveness at preventing infection or severe illness wanes over time, especially for certain groups of people,  such as people ages 65 years and older and people with immunocompromise."

Additionally, data show that mRNA boosters "increase the immune response, which improves protection against getting a serious COVID-19 infection."

Due to the emergence of COVID-19 variants, vaccination, boosters, and prevention efforts should be top of mind in order to ensure protection against COVID-19.

The CDC recommends COVID-19 vaccines for everyone ages 6 months and older, and boosters for everyone 5 years and older, if eligible.

Learn more about COVID-19 vaccine recommendations, including recommendations for people who are moderately or severely immunocompromised. Use CDC’s COVID-19 Booster Tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines.

Are there side effects after getting a COVID-19 booster?

After getting vaccinated, adults and children may experience some side effects including pain, redness or swelling at the injection site, tiredness, headache, muscle pain, chills, fever, and nausea. Serious side effects are rare, but may occur.

According to CDC:

  • Side effects after getting a COVID-19 vaccine can vary from person to person.
  • Some people experience a little discomfort and can continue to go about their day. Others have side effects that affect their ability to do daily activities.
  • Side effects generally go away in a few days.
  • Even if you don’t experience any side effects, your body is building protection against the virus that causes COVID-19.
  • Adverse events (serious health problems) are rare but can cause long-term health problems. They usually happen within six weeks of getting a vaccine.

 

Safeguards are in place:

  • Everyone who gets a COVID-19 vaccine should be monitored on site for at least 15 minutes after vaccination.
  • You should be monitored for 30 minutes if:
  1. You have had a severe allergic reaction called anaphylaxis due to any cause.
  2. You have had any type of immediate (within 4 hours) allergic reaction to a non-COVID-19 vaccine or injectable therapy.
  3. You had a severe allergic reaction to one type of COVID-19 vaccine (for example, an mRNA vaccine) and are now receiving another type of COVID-19 vaccine (for example, a viral vector). This vaccination should only be done in a health clinic, medical facility, or doctor’s office.
  4. You had an immediate (within 4 hours) allergic reaction that was not severe from a previous dose of that type of COVID-19 vaccine. This vaccination should only be done in a health clinic, medical facility, or doctor’s office.
What are some of the common side effects after a COVID-19 vaccination?

Side effects after a COVID-19 vaccination tend to be mild, temporary, and like those experienced after routine vaccinations. They can vary across different age groups.

6 MONTHS–3 YEARS

  • Pain on the leg or arm where the shot was given
  • Swollen lymph nodes
  • Irritability or crying
  • Sleepiness
  • Loss of appetite

 

4–17 YEARS
Side effects are more common after the second dose and can include:

  • Pain, swelling, and redness on the arm where the shot was given
  • Tiredness
  • Headache
  • Muscle or joint pain
  • Chills
  • Swollen lymph nodes

 

ADULTS 18 YEARS AND OLDER

On the arm where you got the shot:

  • COVID-19 vaccine vials
  • Pain
  • Redness
  • Swelling

Throughout the rest of your body:

  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Fever
  • Nausea
Are there side effects are getting a 2nd COVID-19 booster?

Reactions reported after getting a booster shot are similar to those after the two-dose or single-dose primary shots. Most side effects were mild to moderate.

The most commonly reported side effects were:

  • Fever
  • Headache
  • Fatigue (tiredness)
  • Pain at the injection site
What should I do if I experience adverse effects from COVID-19 vaccines?

Adverse events, including severe allergic reactions, after COVID-19 vaccination are rare but can happen. For this reason, everyone who receives a COVID-19 vaccine is monitored by their vaccination provider for at least 15 minutes.

After leaving a vaccination provider site, if you think you or your child might be having a severe allergic reaction, seek immediate medical care by calling 911.

An allergic reaction, while rare, may occur after getting a COVID-19 vaccine. 

If you had an immediate allergic reaction (a reaction that started within 4 hours of getting vaccinated) to a COVID-19 vaccine, but the reaction was not considered severe by a medical professional, you likely can receive another dose of the same vaccine under certain conditions. Your doctor may refer you to an allergy and immunology specialist for additional care or advice.

A severe allergic reaction can cause:

  • difficulty breathing or wheezing,
  • a drop in blood pressure,
  • swelling of the tongue or throat, or
  • a generalized rash or hives, which may include mucus membranes.

Severe allergic reactions to vaccines are rare but can happen. If you get a COVID-19 vaccine and you think you might be having a severe allergic reaction after leaving the vaccination provider site, seek immediate medical care by calling 911.
 

If you had a severe allergic reaction after receiving a particular type of COVID-19 vaccine (either mRNA, protein subunit, or viral vector), you should not get another dose of that type of vaccine.

CDC recommends that people getting a booster get an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna). However, if you had a severe allergic reaction after a dose of an mRNA COVID-19 vaccine or if you have had a severe allergic reaction to any ingredient in an mRNA COVID-19 vaccine, you may be able to get the J&J/Janssen COVID-19 vaccine.

 

What if I get a rash on my arm after getting vaccinated for COVID-19?

According to CDC:

If you had a red, itchy, swollen, or painful rash where you got a COVID-19 shot, you should still get another shot at the scheduled date and time. This applies to second, additional, or booster shots. Your vaccination provider may recommend that you get your next COVID-19 vaccine in the opposite arm, if possible.

These rashes can start a few days to more than a week after your shot and are sometimes quite large. These rashes are also known as “COVID arm.” Tell your vaccination provider that you experienced a rash or “COVID arm” after your shot. Your vaccination provider may recommend that you get your next COVID-19 vaccine in the opposite arm if possible.

If the rash is itchy, you can take an antihistamine. If it is painful, you can take a pain medication like acetaminophen or a non-steroidal anti-inflammatory drug (NSAID).

About Evusheld

General questions about Evusheld™

Answers to common questions about Evusheld—(tixagevimab co-packaged with cilgavimab) for emergency use as pre-exposure prophylaxis for prevention of COVID-19. (Source: FDA FAQ Sheet last updated 10/20/2022.)

What does the FDA emergency use authorization (EUA) for Evusheld authorize?

The emergency use authorization (EUA) authorizes AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) for emergency use as pre-exposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and

                - Who are moderately or severely immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or

                - For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine  component(s). [See Warnings and Precautions 95.2)] 


Limitations of Authorized Use

• Evusheld is not authorized for use in individuals:
    - For treatment of COVID-19, or
    - For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.

• Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.

• In individuals who have received a COVID-19 vaccine, Evusheld should be administered at least two weeks after vaccination.

For any other limitations or conditions on use, please see the letter of authorized use.

How is Evusheld affected by the SARS-CoV-2 variants in the U.S.?

While Evusheld offers protection against many circulating variants, there are some new variants of SARS-CoV-2 that are not neutralized by Evusheld. This means that Evusheld may provide no protection against developing COVID-19 if individuals receiving Evusheld are exposed to those variants. Health care providers should inform their patients who receive Evusheld of the risk for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. If signs or symptoms of COVID-19 occur, individuals should test for COVID-19 and promptly seek medical attention, including starting treatment for COVID-19 as appropriate.

The frequency of the different SARS-CoV-2 variants is being monitored by the FDA, Centers for Disease Control and Prevention (CDC), and other stakeholders. Health care providers should review the Antiviral Resistance information in Section 12.4 of the authorized Fact Sheets for EVUSHELD for details regarding specific variants and resistance.

What is the initial dose of Evusheld?

The authorized Evusheld initial dose is 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular (IM) injections.

Is repeat dosing of Evusheld needed after the initial dose for ongoing protection?

Yes. If ongoing protection is needed, a repeat dose of 300 mg of tixagevimab and 300 mg of cilgavimab should be administered every 6 months.

If an individual already received the original, lower Evusheld dose, what should they do?

Individuals who have already received the previously authorized initial dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional Evusheld dose as soon as possible, with the dose based on the following criteria:

  • If the patient received their initial dose less than or equal to 3 months ago, the patient should receive a dose of 150 mg of tixagevimab and 150 mg of cilgavimab.
  • If the patient received their initial dose longer than 3 months ago, the patient should receive a dose of 300 mg of tixagevimab and 300 mg of cilgavimab.

Subsequent repeat dosing of Evusheld (300 mg of tixagevimab and 300 mg of cilgavimab) should be timed from the date of the most recent Evusheld dose.

Why did FDA revise the EUA to recommend repeat dosing every 6 months if ongoing protection is needed?

There are different variants (and subvariants) of SARS-CoV-2. Currently, the Omicron BA.2, BA.2.12.1, BA.4, and BA.5 subvariants are circulating in the U.S. The available nonclinical data indicate that the neutralizing activity of Evusheld decreases approximately five-fold against the BA.2 and BA.2.12.1 variants, and 33- to 65-fold against the Omicron subvariants BA.4 and BA.5; despite the decrease in neutralizing activity with currently circulating variants, pharmacokinetic modeling suggests that sufficient activity against these subvariants may be retained for six months at drug concentrations achieved following a dose of 300 mg of tixagevimab and 300 mg cilgavimab.

The FDA continues to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will make further updates as needed.

Can people who have had a severe allergic reaction to a COVID-19 vaccine receive Evusheld?

Yes. People who have had a severe allergic reaction to a COVID-19 vaccine can receive Evusheld under the EUA. Evusheld contains polysorbate 80, which is in the Janssen COVID-19 Vaccine and is structurally similar to polyethylene glycol (PEG), an ingredient in the Pfizer-BioNTech and Moderna COVID-19 vaccines. Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to a COVID-19 vaccine.

For all individuals, Evusheld should be administered under the supervision of a health care provider with appropriate medical support to manage severe allergic reactions. In addition, everyone who receives Evusheld should be observed after injection for at least one hour to monitor for hypersensitivity reactions. Signs and symptoms of severe allergic reactions may include the following: dyspnea, chills, fatigue/asthenia, tachycardia, chest pain or discomfort, nausea/vomiting, angioedema, dizziness, urticaria, wheezing, pruritus, flushing, hyperhidrosis, myalgia, vaso-vagal reaction (e.g., pre-syncope, syncope), or throat irritation.

Is Evusheld approved by the FDA to prevent or treat COVID-19?

No. Evusheld is NOT FDA-approved to prevent or treat any diseases or conditions, including COVID-19. Evusheld is an investigational drug.

Are tixagevimab and cilgavimab monoclonal antibodies? What is a monoclonal antibody?

Yes. Tixagevimab and cilgavimab are monoclonal antibodies. Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on pathogens. Evusheld is designed to block viral attachment and entry into human cells, thus neutralizing the virus. 

Are there potential side effects from Evusheld?

Possible side effects of Evusheld include the following:

Allergic reactions can happen during and after injection of Evusheld. Reactions to Evusheld may include difficulty breathing or swallowing; shortness of breath; wheezing; swelling of the face, lips, tongue or throat; rash including hives; or itching. 

Everyone who receives Evusheld should be observed after injection for at least one hour to monitor for hypersensitivity reactions, and Evusheld should only be administered under the supervision of a health care provider with appropriate medical support to manage severe allergic reactions. Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction to a COVID-19 vaccine.

The side effects of getting any medicine by intramuscular injection may include pain, bruising of the skin, soreness, swelling, and possible bleeding or infection at the injection site.

Serious cardiac adverse events (such as myocardial infarction and heart failure) were infrequent in the clinical trial evaluating Evusheld for pre-exposure prophylaxis for prevention. However, more trial participants had serious cardiac adverse events after receiving Evusheld compared to placebo. These participants all had risk factors for cardiac disease or a history of cardiovascular disease before participating in the clinical trial. It is not clear if Evusheld caused these cardiac adverse events.

These are not all the possible side effects of Evusheld. Not a lot of people have been given Evusheld. Serious and unexpected side effects may happen. Evusheld is still being studied so it is possible that all of the risks are not known at this time.
 

Can I receive a COVID-19 vaccine if I was treated with a monoclonal antibody for COVID-19?

Patients and health care providers should refer to recommendations of the Advisory Committee on Immunization Practices regarding vaccination. 

Can I receive Evusheld if I recently got a COVID-19 vaccine?

Evusheld may reduce your body’s immune response to a COVID-19 vaccine. If you receive a COVID-19 vaccine, you should wait to receive Evusheld until at least two weeks after your COVID-19 vaccination.

Is Evusheld still an appropriate option for eligible patients?

Yes. FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants.

What are some medical conditions or treatments that may lead to an inadequate immune response to the COVID-19 vaccination?

Medical conditions or treatments that may result in moderate to severe immunocompromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies
  • Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
  • Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)
     
Are people who have received Evusheld eligible to receive COVID-19 treatments if they develop COVID-19?

There are several treatments – for example, Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir) – that are expected to retain activity against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether these treatments are right for their patients in the event the patient develops mild-to- moderate COVID-19.

FDA is closely monitoring the variants circulating in the United States that may impact the use of the available COVID-19 therapeutics, including Evusheld. The Agency will provide further updates as new information becomes available.

How can Evusheld be obtained for use under the EUA?

For questions on how to obtain Evusheld, please contact [email protected].

About COVID-19

General questions about COVID-19

Answers to common questions about the COVID-19 pandemic, including information about CDC COVID-19 guidance, symptoms and risk factors, prevention and self-care, and COVID-19 testing (Updated as of 10/26/2022).

 

    What are the symptoms of COVID-19?

    According to a 10/26/22 CDC update:

    People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. Anyone can have mild to severe symptoms.

    Possible symptoms include:

    • Fever or chills
    • Cough
    • Shortness of breath or difficulty breathing
    • Fatigue
    • Muscle or body aches
    • Headache
    • New loss of taste or smell
    • Sore throat
    • Congestion or runny nose
    • Nausea or vomiting
    • Diarrhea

    This list does not include all possible symptoms. Symptoms may change with new COVID-19 variants and can vary depending on vaccination status. CDC will continue to update this list as we learn more about COVID-19. Older adults and people who have underlying medical conditions like heart or lung disease or diabetes are at higher risk for getting very sick from COVID-19.

     

    What should I do when I feel sick?

    If you are experiencing any of these symptoms, consider the following options:

    • Get tested for COVID-19
    • If you have already tested positive for COVID-19, learn more about CDC’s isolation guidance

     

    When should I seek emergency medical attention?

    Look for emergency warning signs* for COVID 19:

    • Trouble breathing
    • Persistent pain or pressure in the chest
    • New confusion
    • Inability to wake or stay awake
    • Pale, gray, or blue-colored skin, lips, or nail beds, depending on skin tone

    If someone is showing any of these signs, call 911 or call ahead to your local emergency facility. Notify the operator that you are seeking care for someone who has or may have COVID-19.

    *This list is not all possible symptoms. Please call your medical provider for any other symptoms that are severe or concerning to you.

    Can I get reinfected with COVID-19?

    The CDC has updated information on reinfections and COVID-19.

    According to the CDC:

    Reinfection with the virus that causes COVID-19 means a person was infected, recovered, and then later became infected again. After recovering from COVID-19, most individuals will have some protection from repeat infections. However, reinfections do occur after COVID-19. We are still learning more about these reinfections. Ongoing studies of COVID-19 are helping the CDC understand:

    • How often reinfections occur
    • Who is at higher risk of reinfection
    • How soon reinfections take place after a previous infection
    • The severity (how serious the infection is) of reinfections compared with initial (the first) infections
    • The risk of transmission to others after reinfection
    What are the factors that can raise the risk of getting very sick with COVID-19?

    Age

    Adults aged 50 and older are more likely to get very sick when infected with COVID-19 which means they are more likely to require hospitalization, intensive care, or a ventilator.

    Immunocompromised or a Weakened Immune System

    Immunocompromised individuals are more susceptible to getting very sick from COVID-19, even if up to date on vaccines. They may be eligible for Evusheld™—a pre-exposure prophylaxis that helps prevent being infected with COVID-19.

    Underlying Health Conditions

    Certain underlying health conditions (e.g., obesity, COPD, heart disease, etc.) can increase the risk of having severe symptoms from COVID-19. The more underlying health conditions, the higher the risk.

    What are the factors that lower or increase risk of transmission?

    Length of Exposure Time

    The longer the time you are exposed to COVID-19, the higher the risk of transmission. For example, being exposed to someone with COVID-19 for two minutes poses a lower risk as compared to 15 minutes. 

     

    Coughing or Heavy Breathing by the Infected Person

    If the individual infected with COVID-19 is coughing or breathing heavily, singing, or shouting the risk of transmission increases. 

     

    Infected Person Exhibiting Symptoms

    Being exposed to a symptomatic person infected with COVID-19 increases the risk of transmission.

     

    One-way or Two-way Masking

    • If both persons are not wearing masks, the risk of transmission is higher.
    • If one person is wearing a mask, the risk of transmission is moderate.
    • If both persons are wearing masks, the risk is substantially lower. 

    Risk is also lower if the mask or respirator provides greater protection, such as an N95 mask.  

     

    Ventilation and Filtration

    Staying outdoors decreases the risk of transmission as compared to being indoors (even with good ventilation and filtration). Being indoors with poor ventilation and filtration poses the highest risk of transmission.

     

    Distancing

    Proper distance decreases the risk of transmission. Avoid crowded settings as it raises the likelihood of getting infected.

     

    What are the factors that can provide protection from severe COVID-19?

    Vaccination

    To protect yourself and those around you from getting very sick, being hospitalized, or dying from COVID-19, stay up to date on COVID-19 vaccines—they are proven to be safe and effective. Boosters provide additional protection or can help enhance or restore protection that has diminished over time. However, while vaccines can reduce the risk, older adults with multiple underlying health conditions or those who are immunocompromised can still get very sick from COVID-19.

    Timely Testing and Treatment

    Free medications are available for those who are at an increased risk of getting severe symptoms from COVID-19. Getting tested quickly is imperative as most treatments need to be started within a few days of infection. Preparing a COVID-19 plan also helps, in case you are diagnosed with COVID-19. 

    Previous Infection

    If you were previously infected with COVID-19, it provides some level of protection from future illness. However, it is possible to still be reinfected or to get severe COVID-19, especially if your previous infection was from a different variant (e.g. Delta vs omicron). There are also risks of being repeatedly infected, including the potential of longer term symptoms or development of post-COVID conditions.

    Studies show that vaccinated people with previous infections are less likely to be hospitalized than those who were previously infected but are unvaccinated. Get vaccinated and boosted even if you have had a previous infection to increase protection against COVID-19. 

    What should I do if I was exposed to COVID-19?

    If you tested positive or are exhibiting symptoms of COVID-19, isolate immediately.

    If you were exposed to the virus that causes COVID-19 or have been advised by a healthcare provider or public health authority that you were exposed, do the following steps regardless of vaccination status or whether you had a previous infection. 

    After Being Exposed to COVID-19

    Start Precautions Immediately
    Wear a mask as soon as you find out you were exposed

    Start counting from Day 1

    • Day 0 is the day of your last exposure to someone with COVID-19
    • Day 1 is the first full day after your last exposure

    Continue Exercising Precautions for 10 Full Days
    You can still develop COVID-19 up to 10 days after you have been exposed.

    Take Precautions

    • Wear a high-quality mask or respirator (e.g., N95) any time you are around others inside your home or indoors in public*
    • Do not go places where you are unable to wear a mask, including travel and public transportation settings.
    • Take extra precautions if you will be around people who are more likely to get very sick from COVID-19.

    Watch for symptoms

    • fever (100.4°F or greater)
    • cough
    • shortness of breath
    • other COVID-19 symptoms


    If you develop symptoms:

    • isolate immediately
    • get tested
    • stay home until you know the result

    If your test result is positive, follow the isolation recommendations.

    Get tested on Day 6
    Get tested at least 5 full days after your last exposure. Test even if you don’t develop symptoms.

    If you already had COVID-19 within the past 90 days, see specific testing recommendations

    If you test negative**

    • Continue taking precautions through Day 10
    • Wear a high-quality mask when around others at home and indoors in public*. You can still develop COVID-19 up to 10 days after you have been exposed.

    If you test positive
    Isolate immediately


    [* Masks are not recommended for children under ages 2 years and younger, or for people with some disabilities. Other prevention actions (such as improving ventilation) should be used to avoid transmission during these 10 days.]

    [** As noted in the Food and Drug Administration labeling for authorized over-the-counter antigen tests, negative test results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.]
     

    When should I get tested for COVID-19?

    Key times to get tested:

    • If you have symptoms, test immediately.
    • If you were exposed to COVID-19 and do not have symptoms, wait at least 5 full days after your exposure before testing. If you test too early, you may be more likely to get an inaccurate result.
    • If you are in certain high-risk settings, you may need to test as part of a screening testing program.
    • Consider testing before contact with someone at high risk for severe COVID-19, especially if you are in an area with a medium or high COVID-19 Community Level.

    For guidance on using tests to determine which mitigations are recommended as you recover from COVID-19, go to Isolation and Precautions for People with COVID-19.

    What are Long COVID or Post-COVID conditions?

    The Center for Disease Control and Prevention (CDC) defines Post-COVID conditions as:

    "Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as post-COVID conditions (PCC) or long COVID.”

    “People call post-COVID conditions by many names, including: long COVID, long-haul COVID, post-acute COVID-19, post-acute sequelae of SARS CoV-2 infection (PASC), long term effects of COVID, and chronic COVID."

    What do you need to know about Post-COVID conditions?

    The Center for Disease Control and Prevention (CDC) elaborates on what you need to know about Post-COVID conditions

    • Post-COVID conditions can include a wide range of ongoing health problems which can last for weeks, months, or years.
    • Post-COVID conditions often occur in people who had severe COVID-19 illness, but anyone who has been infected with COVID-19 can experience post-COVID conditions, even people who had mild illness or no symptoms from COVID-19.
    • People who become infected with COVID-19 but are unvaccinated may also be at higher risk of developing post-COVID conditions compared to vaccinated people who had breakthrough infections.
    • There is no single test for post-COVID conditions. While most people with post-COVID conditions may have tested positive or have evidence of being infected by COVID-19, in some cases, a person with post-COVID conditions may not have tested positive for the virus or might not have known that they were infected.
    • CDC and its partners are working to understand more about whom are affected by post-COVID conditions and why; as well as whether groups who were disproportionately impacted by COVID-19 are at higher risk.
    What are the symptoms of Long COVID or Post-COVID conditions?

    According to the CDC, people with post-COVID conditions (or long COVID) may experience a wide-range of symptoms which can last for more than 4 weeks (or even months) after infection. Some symptoms may go away but come back again. 

    “Post-COVID conditions may not affect everyone the same way. People with post-COVID conditions may experience health problems from different types and combinations of symptoms happening over different lengths of time. Most patients’ symptoms slowly improve with time. However, for some people, post-COVID conditions may last months, and potentially years, after COVID-19 illness and may sometimes result in disability.”

    The most commonly reported symptoms from people who experience post-COVID conditions are:

    General symptoms

    • Tiredness or fatigue that interferes with daily life
    • Symptoms that get worse after physical or mental effort (also known as “post-exertional malaise”)
    • Fever

     

    Respiratory and heart symptoms

    • Difficulty breathing or shortness of breath
    • Cough
    • Chest pain
    • Fast-beating or pounding heart (also known as heart palpitations)

     

    Neurological symptoms

    • Difficulty thinking or concentrating (sometimes referred to as “brain fog”)
    • Headache
    • Sleep problems
    • Dizziness when you stand up (lightheadedness)
    • Pins-and-needles feelings
    • Change in smell or taste
    • Depression or anxiety

     

    Digestive symptoms

    • Diarrhea
    • Stomach pain

     

    Other symptoms

    • Joint or muscle pain
    • Rash
    • Changes in menstrual cycles
       
    Should I keep wearing a mask?

    According to a CDC update on September 9, 2022, wearing best-quality masks are still advisable at this time because they offer the best protection from COVID-19.  The CDC has also updated its information on Types of Masks and Respirators, with the following key messages still in place: 

    • Masking is a critical public health tool for preventing spread of COVID-19, and it is important to remember that any mask is better than no mask.
    • To protect yourself and others from COVID-19, CDC continues to recommend that you wear the most protective mask you can that fits well and that you will wear consistently.
    • Masks and respirators are effective at reducing transmission of SARS-CoV-2, the virus that causes COVID-19, when worn consistently and correctly.
    • Some masks and respirators offer higher levels of protection than others, and some may be harder to tolerate or wear consistently than others. It is most important to wear a well-fitting mask or respirator correctly that is comfortable for you and that provides good protection.
    • While all masks and respirators provide some level of protection, properly fitting respirators provide the highest level of protection. Wearing a highly protective mask or respirator may be most important for certain higher risk situations, or by some people at increased risk for severe disease.
    • CDC’s mask recommendations provide information that people can use to improve how well their masks protect them.
    Should I wear a mask in travel and public transportation settings?

    According to a CDC update on September 8, 2022, wearing a high-quality mask or respirator is still recommended for everyone ages 2 years and above when indoors on public transportation and at transportation hubs. It is especially important to wear a mask:

    • During times when public transportation or transportation hubs are crowded
    • In areas that are poorly ventilated.
    • Examples of poorly ventilated areas include: small, enclosed spaces, such as airport jetways; public transportation during periods when the ventilation system is off and windows are closed (e.g., when the engine is turned off on an airplane); during international travel and in transportation hubs that serve international travelers
    • If you are at high risk for getting very sick from COVID-19, or if you live with or have social contact with someone at high risk
    • When the COVID-19 Community Level in the area you are located in is high (applies to US locations only)
       
    Should I wear a mask in indoor spaces?

    Most businesses have their own rules regarding masking. If the establishment requires customers to wear masks, then it will be best to abide by their policy. If wearing a mask is optional, three things need to be considered: the space, the crowd, and the airflow. 

    Dr. Bromage advises to ask yourself these following questions:

    • How high are the ceilings?
    • Is the air moving?
    • Can I create my own little buffer of space? 

    For small, crowded spaces, wearing a mask is still recommended. 

    What if I have the sniffles?

    Remember that COVID-19 is not the only virus floating around and infecting people. 30,000 Americans die from the flu virus during a typical season, and most are elderly people or are immunocompromised. To avoid transmitting any kind of virus if you’re feeling sick, either stay home or if you must go outside, wear a mask. 

    What type of mask should I wear? 

    For the best protection, high-quality masks are still advised by experts, even if you’re one-way masking. N95, KN95 and KF94 masks provide the best protection — just make sure that you’re not buying counterfeit ones. Cloth masks don’t provide as much protection while surgical masks often gape. 

    What is a Self-Test or At-Home Test?

    Self-tests or at-home tests can be taken regardless of your vaccination status or whether you’re experiencing symptoms or not. Self-tests and at-home tests can be taken anywhere and give results in minutes, unlike laboratory-based tests which may take days. However, self-tests and at-home tests cannot detect antibodies (which may suggest a previous infection). They are also unable to measure immunity levels. 

    When should I take a COVID-19 Self-Test or At-Home Test?

    If you’re experiencing COVID-19 symptoms, a self-test or at-home test should be taken immediately. 

    If you are attending an indoor event or gathering, you are advised to take a self-test or at-home test immediately, or as close to the date or time of the event as possible, especially if you’re attending a gathering with unvaccinated young children, older adults, immunocompromised individuals, individuals at risk of severe disease or those who are not up to date with their COVID-19 vaccines. 

    Where can I get a Self-Test or At-Home Test for COVID-19?

    Currently, free tests can be ordered at COVIDtests.gov or through your local health departments. COVID-19 self-tests and at-home tests may also be purchased online, or in retail stores and pharmacies. For a list of authorized tests, visit FDA.gov.

    How do I use a Self-Test or At-Home COVID-19 test?

    Before using a self-test or at-home COVID-19 test, make sure to read the complete manufacturer’s instructions to get an accurate result. Wash your hands before doing the test, collect a nasal specimen, then do the test. 

    What do the COVID-19 test results mean?

    If you test POSITIVE for COVID-19, it means the test has detected the virus and that you have an infection. You are advised to:

    -    Stay home for at least 5 days and isolate from other members of your household. 
    -    Inform your close contacts about your positive result
    -    Wear a well-fitting mask (a N95 or KN95 respirator is recommended), especially when around others.
    -    Watch out for symptoms and emergency warning signs
    -    Seek emergency medical attention if you experience the following:

    • trouble breathing
    • persistent pain or pressure in the chest
    • new confusion
    • inability to wake or stay awake
    • pale, grayish, or bluish skin, lips, or nail beds

    If you test NEGATIVE for COVID-19, it means the test did not detect the virus. However, it does not rule out the possibility of an infection. Some tests are designed to be taken as a series. You may repeat the test 24 to 48 hours later. Multiple negative tests give the assurance that you do not have an infection.
     

    When should I get a COVID-19 vaccine if I was recently infected ?

    From the CDC: "People who have COVID-19 should wait to receive any vaccine, including a COVID-19 vaccine, until after they recover and complete their isolation period."

    "Additionally, people who recently had COVID-19 may consider delaying their next vaccine dose (primary dose or booster) by 3 months from when their symptoms started or, if they had no symptoms, when they first received a positive test. Reinfection is less likely in the weeks to months after infection. However, certain factors, such as personal risk of severe disease, local COVID-19 community level, and the most common COVID-19 variant currently causing illness, could be reasons to get a vaccine sooner rather than later."

    COVID-19 News relevant to myeloma patients and care providers
    COVID-19 Latest News and CDC Guidelines

    The latest COVID-19 news updates and CDC guidelines for myeloma patients and care providers. 

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