COVID-19 Vaccine Information for Gaucher Patients

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.
• Decreases (but does not eliminate) your odds of developing Long COVID.

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

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.

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.

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.

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.

It takes 1-2 weeks for immunity to develop after you receive a vaccine. Studies show the COVID-19 vaccines are most effective in the first few months after vaccination. After approximately 3-4 months, immunity from the vaccines begins to wane. We also do not have information about how variable that immunity will be among individuals with or without GD.

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.

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.

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 mRNA COVID-19 vaccines developed in 2021 targeted the original SARS-CoV-2 strain. Those vaccines were less effective against the Omicron variant and its sublineages. That’s why Pfizer and Moderna created bivalent booster shots that target BA.4 and BA.5 in 2022. The original formulas and the bivalent boosters are no longer available in the U.S.

In the summer of 2023, when the FDA was deciding how to update the vaccines for the coming fall, the dominant variant in the U.S. was XBB.1.5. The updated 2023-2024 vaccines are monovalent, targeting this XBB lineage. As of January 2024, XBB has mostly been replaced by other variants in the U.S. The updated 2023-2024 vaccine formulas do provide protection against these new variants.

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.

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, Moderna, and Novavax vaccines have 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.

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.

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.