The Foundation for Sarcoidosis Research is dedicated to the health and safety of our patients. Since the COVID-19 vaccines have been released for distribution, we have received a lot of questions. We continue to monitor this situation and want to provide you who the most up-to-date information.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have authorized emergency use of two COVID-19 vaccines in the U.S.
Currently available vaccines and Future Vaccines
As of January 11, 2021, the FDA, under the Emergency Use Authorization (EUA), has approved distribution of the Moderna,Inc. and the Pfizer/BioNTech vaccines Emergency Use Authorization (EUA)have been approved for distribution throughout the United States. The known and potential benefits of a COVID-19 vaccine must outweigh the known and potential risks of the vaccine for use under what is known as an Emergency Use Authorization (EUA). Both these vaccines have completed phase 3 trials and reported up to 95% efficacy in preventing COVID-19 disease in adults. The Pfizer/BioNTech vaccine received official FDA EUA approval for people age 16 and older. The Moderna COVD-19 vaccine received its official FDA EUA approval for people age 18 and older. The COVID-19 vaccines are not live vaccines and there is no risk of infection from the vaccine, even for those who are taking immune modulating drugs.
As part of Operation Warp Speed, the US government has been working to release the COVID-19 vaccines as soon as it was deemed safe. There are additional vaccines that are still in clinical trial. Clinical trials of all vaccines must first show they are safe and effective before any vaccine can be authorized or approved for use, including COVID-19 vaccines.
Distribution and Dosage
The CDC is overseeing the order, distribution, and tracking of COVID-19 vaccines. All vaccines are ordered from the manufacturer by the CDC and distributed to vaccine distribution centers.
Phase 1a: Healthcare personnel and long-term care facility residents
Phase 1b: Persons aged ≥75 years and non–healthcare frontline essential workers
Phase 1c: Persons aged 65–74 years, persons aged 16–64 years with high-risk medical
conditions, and essential workers not included in Phase 1b.
According to the CDC, there are two groups that fall within the high-risk medical condition category:
- People who are at increased risk and those who might be at increased risk for severe
illness from the virus that causes COVID-19.
- People who are immunocompromised from the use of corticosteroid or other immunosuppressant medications.
As more vaccines become available, the CDC will expand these recommendations to include other groups. Each individual state has developed guidelines for vaccine distribution. To learn more about distribution in your state visit your state’s or territory’s health department.
For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.
The FDA has issued a statement to remind the public that dosing recommendations for the vaccine should be followed “in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.” Additionally, without full dosage of the vaccine an individual may remain at increased risk for contracting COVID-19.
When you receive your vaccination, you should receive an information sheet providing you with an understanding of the risks and benefits of the vaccine. Additionally, you should receive a vaccine card that notes which vaccine you received, where you received your vaccine, and the date of your vaccination. The CDC recommends you “contact your doctor or healthcare provider if the redness or tenderness where you got the shot increases after 24 hours or If your side effects are worrying you or do not seem to be going away after a few days.”
For these types of vaccines, it is normal to have some minor side effects. This is the result of your body building up antibodies to resist the virus. Common side effects include arm pain, swelling at the injection site, fever, chills, headache, and tiredness.
Due to the potential for allergic reactions, all people who receive the vaccine should be monitored on-site. If you have had a severe allergic reaction to any ingredient in an mRNA COVID-19 vaccine, you should not get either of the currently available mRNA COVID-19 vaccines. If you had a severe allergic reaction after getting the first dose of an mRNA COVID-19 vaccine, CDC recommends that you should not get the second dose. Due to the potential for allergic reactions, all people who receive the vaccine should be monitored on-site. FSR’s Scientific Advisory Board Chair, Dr. Elliott Crouser, notes that “very few vaccinated patients have severe reactions, and those who are not vaccinated are at relatively high risk for severe complications of COVID-19. Only patients who have severe reactions to vaccines in the past should be advised against receiving the covid-19 vaccines at this time.”
FSR’s Resources and Recommendations
- We recommend that all individuals living with sarcoidosis continue to wear masks and practice social distancing.
- We recommend that all individuals living with sarcoidosis speak with their healthcare provided to determine if the vaccine is right for them. The CDC states that immunocompromised individuals may receive COVID-19 vaccination if recommended by their medical provider. Due to the fact that current vaccines have not been tested on immunocompromised individuals, those living with sarcoidosis should discuss the unknown safety profile of the vaccine with their medical provider, as well the risk for potential for reduced immune responses which may require continue diligence with safety protocols even after vaccination.
- We have heard concerns about whether getting vaccinated is appropriate if you are receiving immunosuppressive medications. We recommend those on these medications get the vaccine, if recommended by their healthcare providers. As Dr. Crouser notes, “while on immunosuppressive medications, the vaccine may be less effective (e.g., shorter duration of protection, probably fewer will achieve immunity), but in many cases it will likely provide some degree of protection.”
- We encourage you to view FSR’s COVID-19 webinar with Dr. Divya Patel. During this webinar, Dr. Patel answered questions and address concerns raised by the sarcoidosis community.