COVID-19 Vaccine Information for Gaucher Patients

As of 1/6/2023. All information contained is provided with input from physicians on the NGF Medical Advisory Board.

Please remember that this website provides only general information about COVID-19. Your Gaucher specialist is the best person to advise you about your health.

Medical understanding of COVID-19 is evolving. To maintain your optimal health, follow your local guidance and CDC COVID-19 recommendations.

COVID-19 and Gaucher

You should continue all treatments and medical management of lysosomal disorders, including Gaucher disease. Before making any changes to your medical regimen, or if you need care for COVID-19-related illness, seek advice from both your Gaucher specialist and your primary care provider (PCP). Learn more about coronavirus and people with Gaucher disease.

COVID-19 Vaccines Available Now

The U.S. Food and Drug Administration (FDA) authorized or approved these vaccines:

These vaccines received emergency use authorization (EUA) from the FDA based on the initial data from each manufacturer. The FDA granted full approval to some vaccines after reviewing more detailed data.

Pfizer vaccine

On August 23, 2021, the FDA approved the Pfizer-BioNTech mRNA COVID-19 vaccine for people 16 years of age and older. The vaccine will be marketed as Comirnaty for the prevention of COVID-19 disease. This mRNA vaccine requires two doses, 3-8 weeks apart. On July 8, 2022, the FDA approved the Pfizer vaccine for ages 12-15.

This vaccine has an EUA for ages 6 months – 11 years, with children receiving an age-appropriate dose. The Pfizer bivalent booster also has an EUA.

Moderna vaccine

On January 31, 2022, the FDA approved the Moderna mRNA COVID-19 vaccine for people 18 years of age and older. The vaccine will be marketed as Spikevax.

This vaccine has an EUA for ages 6 months – 17 years, with children receiving an age-appropriate dose. The Moderna bivalent booster also has an EUA.

Novavax vaccine

This protein subunit vaccine has an EUA for a 2-shot primary series for ages 12 and older.

People who received 2 Novavax shots are eligible for Pfizer or Moderna boosters. In limited cases, people 18 years of age or older can get the Novavax vaccine as a first booster.

Johnson & Johnson vaccine

The J&J/Janssen vaccine initially had an EUA for ages 18 and older. However, the FDA limited the EUA in 2022 because of the risk of adverse events from the J&J/Janssen vaccine.

This vaccine has a risk of causing thrombosis with thrombocytopenia syndrome (TTS), a rare clotting disorder. Therefore, the updated EUA is for people 18 years of age and older who are unable or unwilling to get a different type of COVID-19 vaccine.

Vaccine primary series

A primary series is the initial dose of a vaccine. For some vaccines, the primary series is a single shot, while for others the primary series may be 2 or more shots given over time.

For vaccines that require two doses, it is important to get both doses within the recommended timeframe.

The primary series includes an additional shot for people who are immunocompromised. Read more about vaccines for people who are moderately or severely immunocompromised.

COVID-19 boosters

Immunity from vaccines declines over time. How long immunity lasts varies by vaccine. For example, people need to get a flu shot each year, while tetanus boosters are recommended every 10 years. A booster is a shot given after the primary series to prolong immunity.

COVID-19 boosters may be monovalent or bivalent. Monovalent boosters target one strain of the SARS-CoV-2 virus, typically the original strain. Bivalent boosters target multiple strains of the SARS-CoV-2 virus. The Pfizer and Moderna bivalent boosters target the original strain from 2019 along with Omicron subvariants BA.4 and BA.5.

Learn more about the CDC booster recommendations and discuss with your physician if you should have a booster.

Vaccine fast facts

Vaccine Type Approval by age Primary series* Booster timing Booster type
Pfizer mRNA · Full approval for ages 12+

· EUA for ages 6 months – 11 years

 2 shots given 3-8 weeks apart At least 2 months after primary series or last booster Bivalent
Moderna mRNA · Full approval for ages 18+

· EUA for ages 6 months – 17 years

 2 shots given 4-8 weeks apart At least 2 months after primary series or last booster Bivalent
Novavax Protein subunit EUA for ages 12+ 2 shots given 3-8 weeks apart At least 2 months after primary series or last booster Monovalent (limited eligibility)
J&J/Janssen Viral vector Limited authorization for ages 18+ 1 shot Limited authorization at least 2 months after primary series Monovalent (limited eligibility)

Who Can Receive a COVID-19 Vaccine?

CDC’s Interim Clinical Considerations indicate that the vaccines may be administered to persons with underlying medical conditions who have no contraindications to vaccination.

Answers to Other Questions About COVID-19 Vaccines and Gaucher

As more people become vaccinated and the COVID-19 pandemic continues to evolve, we will update this section. Meanwhile, here is what we know:

What are the benefits of the SARS-CoV-2 vaccine?

The COVID vaccine offers several major benefits. The vaccine:

  • Reduces the severity of COVID-19 if contracted and significantly reduces the risk of dying from COVID-19.
  • Protects others around you by reducing prevalence of the SARS-CoV-2 virus among the general population.
  • Lowers (but does not eliminate) your odds of getting COVID-19.

New variants have diminished the vaccines’ effectiveness at preventing infections, but the vaccines remain highly effective at reducing severe disease or death.

Should I get the COVID vaccine if I have Gaucher disease?

Vaccination is an important tool to help manage the pandemic. Vaccines reduce the risk of infection and are effective at preventing serious illness even if you get COVID-19.

All vaccines have gone through a rigorous authorization process. Careful trials of the vaccines indicate that they are safe and effective.

As far as we know, these vaccines are as effective in GD patients as in everyone else. To the best of our collective knowledge, there is no reason why patients with Gaucher disease would have additional adverse events from the vaccines.

If you already had COVID-19, you can still get the vaccine. Check for the latest recommendations from the CDC and discuss with your physicians.

COVID-19 can be a serious, highly infectious and unpredictable illness. The risks of COVID-19 illness far outweigh the risks associated with the vaccine. The disease is still spreading rapidly through communities in the United States and elsewhere.

What are the vaccine’s side effects for people with Gaucher?

Like most vaccines, the shot can cause mild side effects. These reactions go away after a few days. Vaccine side effects may include:

  • Swelling, redness and pain in the injected arm
  • Fatigue, sometimes severe
  • Muscle and joint pain
  • Fever
  • Headache

Very rarely, predisposed allergic individuals could have an anaphylactic reaction. All individuals receiving vaccines are monitored for at least 15 minutes post-injection to reasonably assure no anaphylaxis.

There is a rare risk of myocarditis and pericarditis developing after the Pfizer, Moderna, and Novavax vaccines. This risk is higher in males ages 12-39. Extending the time period between the first and second dose of the primary vaccine series may reduce this risk.

The J&J/Janssen vaccine has a risk of thrombosis with thrombocytopenia syndrome (TTS), a rare clotting disorder, which is why the EUA was limited.

Additional and serious side effects are extremely rare in our relatively short-term post-vaccination experience.

As recommended for anyone receiving such vaccinations, persons with Gaucher disease who have previously had a major allergic reaction (anaphylaxis) to food, or to Gaucher or other medications should alert the healthcare facility providing the injection and should be closely monitored for at least 30 minutes after their injection.

If you receive enzyme replacement therapy, we suggest that you do not get vaccinated on an infusion day.

Can I still get COVID-19 if I’ve been vaccinated?

Yes. The vaccines reduce your risk of getting infected but do not completely prevent infection. People who are vaccinated tend to have less severe illness with fewer adverse effects.

Individuals can have asymptomatic infection after vaccination and, therefore, transmit the disease to others. It is important to continue to follow local and CDC mitigation guidelines after vaccination.

We do not yet know how long immunity to COVID-19 disease will last after infection or immunization. We also do not have information about how variable that immunity will be among individuals with or without GD.

How do the COVID vaccines work?

The vaccines teach your body to recognize the COVID-19 virus and mount its own defense against the virus. They work as follows:

  • mRNA vaccines: Messenger RNA tells the body to make the spike protein found on the outside of the virus. Then the body’s own cells react to that protein. The vaccine trains your own immune cells to fight back any further infection. The mRNA rapidly deteriorates, and your body disposes it as waste. The mRNA does not enter your cells’ nucleus and cannot change the makeup of your cells.
  • Protein subunit vaccine: This type of vaccine contains pieces of the virus’s spike protein. The body reacts to the foreign protein. The vaccine also has an ingredient called an adjuvant, which helps the immune system create antibodies against the spike protein.
  • Modified adenovirus vaccine: The vaccine uses a deactivated cold virus changed to include the spike protein on the outside of the SARS-CoV-2 virus. The modified virus can’t reproduce in your body. The vaccine travels to your cells, which “read” the protein and start making antibodies to the virus.

Do the vaccines protect against variants of COVID-19?

The SARS-CoV-2 virus, like other viruses, is mutating (changing) as it spreads in the human population worldwide. New variants have emerged from around the world, including variants of concern (VOC) such as Alpha, Delta, and Omicron.

The original mRNA vaccines are less effective against the Omicron variant and its sublineages, such as BA.4 and BA.5. That’s why Pfizer and Moderna created bivalent booster shots that target BA.4 and BA.5.

The BQ.1, BQ.1.1 and XBB subvariants are the most immune evasive variants thus far. BQ.1 and BQ.1.1 are descendants of BA.5, while XBB is a combination of BA.2 sublineages. We don’t know how well the bivalent boosters will work against these sublineages, but experts believe the boosters will continue to provide protection against severe disease and death.

Vaccination is still recommended to provide significant protection against the SARS-CoV-2 virus.

Can the vaccine give me COVID-19?

No. None of the vaccines can cause COVID-19. The vaccine does not inject the SARS-CoV-2 virus into people.

The mRNA vaccines (Pfizer-BioNTech and Moderna) tell the body to make the spike protein found on the outside of the virus. Then the body’s own cells react to that protein. The vaccine trains your own immune cells to fight back against any further infection. The mRNA rapidly deteriorates, and your body disposes it as waste. The mRNA does not enter your cells’ nucleus and cannot change the makeup of your cells.

The protein subunit vaccine (Novavax) uses small pieces of the spike protein to tell the body to create antibodies. These protein pieces are a fragment of one protein on the outside of the SARS-CoV-2 virus and cannot cause infection.

The modified adenovirus vaccine (Johnson & Johnson Janssen) uses a deactivated cold virus changed to include the spike protein on the outside of the SARS-CoV-2 virus. The modified virus can’t reproduce in your body. The vaccine travels to your cells, which “read” the protein and start making antibodies to the virus.

Can my child with Gaucher disease get the vaccine?

Most children 6 months of age and older can now receive a COVID-19 vaccine. Currently, COVID-19 vaccines have an EUA for babies and children. The Pfizer vaccine has full approval for ages 12 and older. Clinical trials are underway for full approval in younger children.

There have been reports of myocarditis and pericarditis in adolescents and young adults after COVID-19 vaccination. The CDC is monitoring these reports through VEARS, the Vaccine Adverse Event Reporting System.

Cases reported to VAERS have occurred:

  • Mostly in male adolescents and young adults age 16 years or older
  • More often after getting the second dose of one of these two COVID-19 vaccines than after the first dose
  • Typically within several days after COVID-19 vaccination
  • Most patients who received care responded well to medicine and rest and quickly felt better.

We do not know whether these vaccines will be as effective in GD patients as in everyone else, but there is no evidence to the contrary. To the best of our collective knowledge, there is no reason why patients with Gaucher disease would have additional adverse events from the vaccines.

Vaccination is an important tool to help manage the pandemic. Vaccines reduce the risk of infection and are effective at preventing serious illness even if someone gets COVID-19.

COVID-19 can be a serious, highly infectious and unpredictable illness. The risks of COVID infection far outweigh the risks associated with the vaccine. The disease is still spreading, rapidly through some communities in the United States and elsewhere.

More information is available from the CDC regarding COVID-19 vaccines for children and teens.

What about the possible use of substrate inhibitor analogues to treat COVID-19?

The Israel Institute for Biological Research shared news releases about a pre-peer-reviewed paper on the possible use of Gaucher medications to treat and/or prevent COVID-19 viral illness. The medications are analogues of eliglustat (Cerdelga®) and venglustat, a third-generation substrate inhibitor currently in clinical trials for Gaucher disease types 1 and 3.

The NGF requested and received feedback from the Medical Advisory Board regarding the recent press releases. In essence:

There is no evidence that existing Gaucher medicines have an effect on COVID-19.

Gaucher patients should continue their current treatment unless otherwise directed by their Gaucher specialists.

Are there publications regarding attitudes of Gaucher disease experts towards vaccination for patients with GD and the impact of the pandemic on their patients?

On July 5, 2021, the British Journal of Haematology published an article about a cross-sectional study conducted by surveying 19 Gaucher experts from 10 countries who collectively treated 1, 417 Gaucher patients.

The study “revealed overall support of the COVID-19 vaccination…specifically, the mRNA-based vaccines were favored…due to their overall efficacy, tolerance and safety profiles, as appears from clinical trials and world-wide experience.”

To note, the survey for the study was distributed when data was available for only one adeno-associated virus (AAV) vectored vaccine — the Oxford-AstraZeneca vaccine and, some responses were received prior to regulatory authorization. The only AAV vectored vaccine under Emergency Use Authorization (EUA) in the US is the Johnson & Johnson vaccine.

Read the article in its entirety:  Experts’ Views on COVID-19 Vaccination and the Impact of the Pandemic on Patients with Gaucher Disease.

Additional Coronavirus Resources for Gaucher Patients

Gaucher disease is one of many factors that uniquely affect your health. Seek advice from your Gaucher specialist as well as your PCP. Other resources that may interest you include:

Thank You to Our Advising Gaucher Specialists

A panel of Gaucher specialists from Gaucher treatment centers addressed the questions above regarding the new COVID-19 vaccines.

Information on this page was contributed by a panel of Gaucher specialists including: Manisha Balwani, MD; Deborah S. Barboth, MD; T. Andrew Burrow, MD; Robin Ely, MD; Edward I. Ginns, MD, PhD; Ozlem Goker-Alpan, MD; Gregory A. Grabowski, MD; Priya S. Kishnani, MD; Heather Lau, MD; Nicola Longo, MD, PhD; Grisel Lopez, MD; Gustavo Maegawa, MD, PhD; Pramod Mistry, MBBS, PhD; Seymour Packman, MD; Barry Rosenbloom, MD; Tamanna Roshan Lal, MB ChB; Raphael Schiffmann, MD; Ellen Sidransky, MD; and Neal Weinreb, MD.

Sources

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