As of 1/11/21. All information contained is provided with input from physicians on the NGF Medical Advisory Board.
In December 2020, the FDA issued an Emergency Use Authorization (EUA) for two mRNA vaccines. One is produced by Pfizer & BioNTech and the other by Moderna. The CDC Interim Clinical Considerations indicate that the vaccines may be administered to persons with underlying medical conditions who have no contraindications to vaccination.
A panel of Gaucher specialists from Gaucher treatment centers have addressed the many questions regarding the new COVID-19 vaccines.
The following was authored 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, Neal Weinreb MD
It is highly recommended that everyone aged 16 or older receive the vaccine as per FDA emergency use authorization issued December 2020.
- COVID-19 can be a serious, highly infectious and unpredictable illness, and the risks of the infection far outweigh the risks associated with the vaccine. The disease is still spreading rapidly through communities in the United States and elsewhere.
- Careful trials of the vaccines indicate that they are safe and effective, and they have gone through a rigorous approval process. To the best of our collective knowledge, there is no reason why patients with Gaucher disease would have additional adverse events from the vaccines.
- Like most vaccines, the shot can cause mild side effects including a low-grade fever, pain or redness at the site, but these reactions go away after a few days.
- 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, we suggest that you do not get vaccinated on an infusion day.
- If you already had COVID-19, you can still get the vaccine 3 months after your infection.
The two vaccines currently being administered are what are called mRNA vaccines. The virus itself is not being injected into people. Instead, the mRNA clues the body to make the spike protein found on the outside of the virus. Then, the body’s own cells react to that protein, training one’s own immune cells to fight back any further infection.
Currently the two vaccines under the FDA’s EUA have only been approved for those over age 16. Clinical trials are underway in children, and approval is likely in the coming months.
Each state decides how they will distribute the vaccine. The official recommendations state that people over age 65 and those who have underlying health risks should get priority over the general population.
In our view, Gaucher disease is a chronic medical disorder, and thus our patients would be considered to have an underlying health problem.
That being said, our collective experience over the past months indicate that patients with Gaucher disease who do not have other serious health issues do not seem to be more susceptible to COVID-19, nor do they appear to be having more severe cases just because of Gaucher disease.
Many, many people have high-risk medical conditions (likely over 100 million people in the USA). Patients with Gaucher disease who are stable on treatment or who haven’t suffered complications from their disease generally fall into this large group.
However, if you have Gaucher disease and other serious risks, including, but not limited to, heart disease, kidney disease, obesity, chronic lung disease, coagulation or immune problems, you could fall into a higher risk group and you should discuss this with your doctor.
We feel that if given the opportunity, patients with Gaucher disease should get vaccinated as soon as they are able to. The faster the vaccines get into people, the sooner the pandemic will be halted. Meanwhile and after vaccination, continue to social distance, wear masks and wash those hands!
Most people experience mild symptoms from COVID-19 and do not require specialized treatment. However, people age 65 or older or who have certain chronic conditions are at an increased risk of developing complications from COVID-19.
So far, there is no evidence that Gaucher disease itself is an independent risk factor for getting COVID-19 or having a bad outcome if infected. To date, very few cases of COVID-19 have been reported among Gaucher patients. The few Gaucher patients that indeed developed more severe COVID-19 symptoms ALL had other co-morbidities known to increase COVID-19 symptom severity, i.e. obesity, hypertension, cardiac conditions, and diabetes mellitus. To date, the globally accessible numbers are considerably less than what was expected.
Medical understanding of SARS-CoV-2, known as COVID-19, is evolving. To maintain your optimal health, keep apprised of both your local as well as the CDC recommendations for Community Mitigation Strategies. Gaucher disease is one of many factors of your unique health. Seek advice from your Gaucher specialist as well as your PCP.
Additional Coronavirus Resources for Gaucher Patients
- Coronavirus Tips for Gaucher Patients
- What Precautions Should People with Gaucher Disease Take
- Coronavirus Glossary
The NGF requested and received feedback from the Medical Advisory Board regarding the recent press releases concerning the Israel Institute for Biological Research pre-peer reviewed paper on the possible use of analogues of eliglustat (brand name Cerdelga) and venglustat, a 3rd generation substrate inhibitor currently in clinical trials for Gaucher disease types 1 and 3, for either treatment and/or prevention of COVID-19 viral illness.