Sean M Fahey, MD

Undergraduate Education
University of North Carolina at Chapel Hill
Chapel Hill, NC

Graduate Education
Wake Forest University School of Medicine
Winston-Salem, NC

Internship
Carolinas Medical Center
Charlotte, NC

Residency
Carolinas Medical Center
Charlotte, NC

Fellowship
Medical University of South Carolina
Charleston, NC

Certifications
American Board of Internal Medicine – Rheumatology

Associations
American College of Rheumatology

COVID-19 Vaccine Information

Introduction

The SARS-CoV-2 virus which causes COVID-19 illness has changed our healthcare and our lives. Health experts agree that mask/face covering, physical distancing, frequent hand washing, and isolation when exposed to the virus or when experiencing symptoms of infection can help limit spread. Vaccines against the SARS-CoV-2 virus will be another way to decrease the number of cases and deaths and help bring an end to the pandemic. This information sheet is primarily for rheumatology patients with autoimmune disease and/or patients taking medications to suppress the immune system.

Testing and approval of Vaccines

There are currently more than 50 vaccines being tested in humans as well as more than a hundred others in other stages of development. While vaccines have been used in other countries, there are no FDA approved COVID vaccine in the US as of 12/15/20. However the FDA granted an Emergency Use Authorization (EUA) to the Pfizer/Biontech vaccine in December 2020 which will allow use during the pandemic related public health emergency. Even though the EUA process is quicker than the typical FDA approval there will be enough safety and effectiveness data to ensure the vaccine is appropriate for the general public

Types of vaccines

This section will be updated as new vaccines get close to EUA/approval.

Genetic material: This is a new vaccine technology. The vaccine puts some of the virus genetic sequence into cells in our body to cause an immune response. It is impossible for the vaccine to cause COVID illness. The Pfizer /Biontech vaccine which was granted EUA by the FDA uses this technology as does the Moderna vaccine candidate. The Pfizer/Biontech vaccine requires two injections separated by 21 days to be fully effective, and the Moderna vaccine candidate two injections separated by 28 days.  Early reports suggest more than 90% effectiveness after the series of injections and acceptable numbers of nonharmful side effects such as fever, arm pain at injection site, fatigue. The FDA will continue to monitor for adverse effects once the EUA allows for more widespread vaccination. We will not have direct head-to-head comparison between the two vaccines at the time of EUA.

Autoimmune disease questions

Have these vaccines been studied in patients with autoimmune disease? The Pfizer vaccine excluded patients being treated with immunosuppressive medications but there were 118 labeled as “rheumatic disease” patients. We hope there is more information released quickly.

Are the vaccines safe for patients with autoimmune disease? There are no live virus vaccines close to approval – these are off limits for patients on immunosuppressive medication. Some vaccines use an adjuvant (additive) to help stimulate the immune system to provide protection against the virus. There is theoretical concern that this immune stimulation could cause flare up of autoimmune disease but has not been the case with vaccines already approved.

Are the vaccines effective in patients with autoimmune disease? Being on immunosuppressive medication can sometimes decrease the effectiveness of the vaccines already approved since the medication can lower the overall immune system activity – we do not know yet about best timing of vaccine with immunosuppressive dosing for the COVID vaccines.

How long will the vaccine protection last?

Although unusual, some patients have been infected with SARS-Co-V-2 more than once. We do not yet know how long the protection from the vaccine will last. Volunteers in vaccines studies are still showing antibodies (evidence of protection) 3 months after dosing, but we are not certain what level of antibodies are required to maintain protection against infection.

When and where can I get the vaccine?

As you are probably aware the US government is providing COVID vaccine for free to patients regardless of insurance. The government is working with manufacturers on distribution of the vaccine through state and local health department and likely hospitals and pharmacy chains. There will be different phases of distribution with essential health care workers, other essential service providers, and patients at higher risk of COVID illness or complications allowed to receive the vaccine earlier than the general public. It is unlikely that your rheumatologist’s office will be administering vaccines.

Where can I get more information?

We realize this is a complicated issue. You can certainly schedule a virtual or in person appointment to discuss with your rheumatologist. You can discuss with other members of your health care team as well. There is a ton of information on the internet, some accurate and some inaccurate. Reliable sources include the CDC and the New York Times. As has been the case with much of the information about COVID-19 we anticipate that the vaccination recommendations will evolve quickly as we know more details. Stay tuned for updates.

 

Notice: This is for reference purposes only. It is intended to provide general guidance, is not legal advice and is not a statement regarding any standard of care. This document does not take into account every law or requirement of federal, state, or local authorities which may be applicable to you.