What we know about the COVID-19 vaccines (from CDC 8/16/2021)

There are currently 3 vaccines for COVID19 that have received emergency use authorization (EUA) by the FDA and are being distributed across the country.

• There are 2 mRNA vaccines. Both require an initial injection and then a second injection (booster) at a later date.
  • The vaccine developed by Pfizer and BioNTech requires that it be kept at extremely cold temperatures ( -94º F) for 2 hours before its administration. The second dose of this vaccine is given at 21 days. The Pfizer vaccine is approved for those who are 12 years of age and older.
  • The vaccine developed by Moderna in association with the NIH (National Institutes of Health) requires only refrigeration .The second dose of this vaccine is given at 28 days. The Moderna vaccine is approved for those 18 years of age and older.
• A 3^rd vaccine from Johnson & Johnson (J&J) requires only regular refrigeration and is given as a single injection. A booster dose (2^nd shot) is not required.  The J&J vaccine is approved for those who are 18 years of age and older.

• The J&J vaccine is similar to traditional vaccines that use an inactivated virus which can enter muscle cells but not replicate. The virus has been designed to carry the genetic material (DNA) that makes a protein (S or spike protein) that is found on the surface of the SARS-CoV-2 virus. This DNA is then injected into the cell nucleus which makes the mRNA that moves to the cytoplasm where the S protein is made and released. This triggers an immune response so the body will make antibodies and instruct other cells to recognize this foreign protein if you were to become infected with the SARS CoV-2 virus in the future. For more information about how this vaccine works please see this excellent article from the New York Times :https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html
• The Pfizer and Moderna vaccines: This vaccine does not use DNA and also does not include a live or inactivated virus to introduce the genetic information into our cells. Instead, these 2 vaccines package the genetic information in the form of messenger RNA (mRNA) in a small sphere of lipids (liposomes) which enter our muscle cells. The mRNA genetic information contained in the liposomes does not need to enter the cell nucleus. This information is translated in the outer cell cytoplasm to make the S (spike) proteinfound on the surface of the SARS-CoV-2 virus that causes COVID19. Similar to the J&J vaccine it then triggers an immune response so your body will make antibodies and instruct other cells to recognize this foreign protein if you were to become infected with the SARS -CoV-2 virus in the future. For more information about how this vaccine works please see this excellent article from the New York Times :https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html

Like many other vaccines, it is not uncommon for vaccines to cause low grade fever, muscle and joint pain as well as headache for up to several days. Although unpleasant this is not harmful to you and is not indicative of an allergic reaction. Some individuals may experience more prominent side effects following the second dose of the Pfizer or Moderna vaccine.

Aside from these more general side effects they are several rare side effects that have been identified with the COVID19 vaccines. These include the following:

• central venous thrombosis and increased risk for clotting involving other veins and arteries: Administration of the J& J vaccine but not the Pfizer or Moderna vaccines was found to be associated with a very small but increased risk of  cerebral venous thrombosis (also called cerebral venous sinus thrombosis or CVST). This disease has also been seen in individuals in Europe who were given the AstraZeneca vaccine which has some similarities to the J&J vaccine but which is not approved in the US. Most cases have been seen in women ages 16-48 with symptoms appearing within 6-13 days of receiving the J& J vaccine. Almost all also had a low platelet count and several had clots that formed at other sites.

CVST is an uncommon condition that previously was seen in no more than 1 person out of 100,000 -200,000. It is felt to be due to the formation of blood clots in the veins that blocks drainage of blood from the brain and can lead to headaches, stroke, seizures, confusion and/or coma. That the condition has only been observed in women of child bearing potential and associated with low platelets suggests an underlying defect in blood clotting. Although the mechanism is not known there is speculation that it could be associated with generation of autoantibodies to phospholipids or more common in those with a pre-existing hypercoagulable state possibly linked to use of oral contraceptives or other estrogen compounds.  A statement by the director of the Center for Biologics Evaluation and Research (CBER) at the FDA also alerted individuals to be aware of “shortness of breath, pain in the legs, pain in the abdomen”. These are not typical symptoms of CVST but could be seen if clotting occurred in other parts of the body such as the legs, lung or abdomen. Clots at other locations were rarely seen with the J&J vaccine.

• Guillain Barre syndrome (GBS): Administration of the J&J vaccine but not the Pfizer or Moderna vaccines has been associated with a small but possible increased risk of this autoimmune neurologic disease in which the myelin coating the nerves is attacked. This can result in damage to the nerves sending signals to the brain leading to numbness, weakness and occasionally paralysis.  As of 7/12/2021 there had been approximately 100 reports of GBS that followed 12.8 million doses of the J&J vaccine mostly in men ages 50 and older. GBS was felt to be severe in most requiring hospitalization with 1 death reported.  Although quite rare, GBS appears to occur 3-5 times more frequently in those receiving the J&J vaccine when compared to the general US population.
• pericarditis and myocarditis: Administration of the Pfizer and Moderna but not J&J vaccines has been associated with inflammation of the heart muscle ( myocarditis) and/or the outer lining of the heart ( pericarditis). Most reported cases were mild with rapid recovery and did not need hospitalization. Confirmed cases mainly occurred in young males 16 years of age and younger. Most cases occurred within several days of the second vaccine dose. Since April 2021 there have been approximately 1,000 (unconfirmed) cases of GBS with over 177 million people receiving at least 1 dose of the vaccine.

All people who receive the vaccine should be monitored for 15 minutes at the location where they receive the vaccine.  If you have had severe allergic reactions to foods such as shellfish or medications it has been suggested that you be monitored for 30 minutes. If you carry an Epi pen or similar device it may be prudent to bring it with you when you are vaccinated.

• For all 3 vaccines currently available: Individuals who have had severe allergic reactions to vaccines and other injections in the past including anaphylaxis that lead to trouble breathing and may have required hospitalization.
• For the mRNA ( Pfizer and Moderna) vaccines:
  • Individuals who experienced a severe allergic reaction to the first COVID19 vaccine should not receive the booster vaccine.
  • Individuals with a known allergy to polyethylene glycol (PEG) or polysorbate (which may cross-react with PEG)

• Individuals with autoimmune rheumatic diseases with or without a compromised immune system who are on medication(s) to treat their disease:  There does not appear to be a contraindication to being vaccinated at this time (aside from what is posted above) and AOCC providers are recommending that you obtain the vaccine when it becomes available to you. Please refer to the last section of this document for specific recommendations regarding possible changes to the dosing of your medication at the time you receive your vaccine.  The American College of Rheumatology also recommends that most patients with autoimmune rheumatic disease obtain the vaccine (https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf)
• Pregnant women and those who are breast feeding: Pregnant women and those who are breast feeding“and are part of a group recommended to get the shots — for instance, health-care workers — might want to consider talking with their medical providers beforehand. Pregnant people have been excluded from coronavirus vaccine trials, so there is no data on the safety of the vaccines for them, or its effects on the breastfed infant. The American College of Obstetricians and Gynecologists says a conversation with a clinician may be helpful but should not be required. Pregnant people who get infected with the coronavirus are at greater risk of death and severe illness than those who are not pregnant, even as the overall risk remains small. The Pfizer-BioNTech and Moderna vaccines do not contain live virus, or any enhancers to boost an immune response, and are not thought to be a risk to the breastfeeding infant. They do not alter human DNA in the people who get it and cannot cause any genetic changes. Also, this type of vaccine breaks down quickly and doesn’t enter the nucleus of the cell. Pfizer said it is planning to report to the FDA by the end of the year on a developmental and reproductive toxicity study in animals that could help clarify any risks.”(https://www.washingtonpost.com/health/interactive/2020/covid-vaccines-what-you-need-to-know) .  For additional helpful information the CDC website has a page dedicated to women who are pregnant or trying to conceive (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html ).
• Children under the age of 12: Not recommended at this time. It is not known if the dose of the vaccine and timing of the second booster vaccine should be different or whether there should be more than 2 doses given.
  • Pfizer is currently conducting 2 dose trials in children ages 6 months – 2 years ages 2- under 5 using a 3 mcg dose and ages 5-11 using a 10 mcg dose. (The dose for those 12 and older is 30 mcg. ) Initial data on these trials are expected to be available by later this year.
  • Moderna is currently conducting trials in children ages 6 months-2 years and 2 years-12 years using a variety of doses.  It is not known when initial trial data will be available.  (Moderna has completed a trial in children ages 12-17 showing efficacy in 100% after 2 doses. This was submitted to the FDA approval in June 2021)
  • J&J has just started a small study in adolescents ages 16 and 17 exploring dosing ranges. A trial for children 12-17 is planned for the fall of 2021.
• Prior COVID19 infection: We do not know for certain how long immunity/protection from re-infection lasts but a study in the New England Journal of Medicine suggests that it is a minimum of 6 months. (https://www.reuters.com/article/uk-health-coronavirus-reinfection/covid-19-reinfection-unlikely-for-at-least-6-months-study-finds-idUKKBN28015E) . You should still get this vaccine if you already have had COVID19 but it is recommended that you wait at least 30 -90 days from when you tested positive. Some studies suggest that in those who have had prior COVID19 infection the second (booster) dose of the mRNA vaccine, leads to a negligible increase in antibody levels compared to the first dose. Nevertheless, most public health officials still recommend that you receive both doses of the mRNA vaccine if you have been previously infected with COVID19.  Several recent studies suggest that those who have the best protection from COVID19 are individuals who have been previously infected and then received the COVID19 vaccine.

• COVID-19 vaccination will prevent you from getting a severe case of COVID-19 that could lead to hospitalization, ICU admission and/or potential death
• COVID-19 vaccination is a safer way to help build protection as compared to getting the infection which can cause serious illness and even death. Additionally, some patients with initially mild infections have developed long term/chronic symptoms that can significantly impair normal daily activities.
• COVID -19 vaccinations are an important tool to help stop the pandemic and limit the spread of variants of concern including the Delta variant.

• “You can resume activities that you did prior to the pandemic.
• You can resume activities without wearing a mask or staying 6 feet apart, except where required by federal, state, local, tribal or territorial laws, rules, and regulations, including local business and workplace guidance.
• If you travel in the United States, you do not need to get tested before or after travel or self-quarantine after travel.
• You need to pay close attention to the situation at your international destination before traveling outside the United States.
  • You do NOT need to get tested before leaving the United States unless your destination requires it.
  • You still need to show a negative test result or documentation of recovery from COVID-19 before boarding an international flight to the United States.
  • You should still get tested 3-5 days after international travel.
  • You do NOT need to self-quarantine after arriving in the United States.
• If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.
  • However, if you live or work in a correctional or detention facility or a homeless shelter and are around someone who has COVID-19, you should still get tested, even if you don’t have symptoms.

• You will still need to follow guidance at your workplace and local businesses.
• If you travel, you should still take steps to protect yourself and others.
• Masks are required on planes, buses, trains, and other forms of public transportation traveling into, within, or out of the United States and in U.S. transportation hubs such as airports and stations. Travelers are not required to wear a mask in outdoor areas of a conveyance (like on a ferry or the top deck of a bus). CDC recommends that travelers who are not fully vaccinated continue to wear a mask and maintain physical distance when traveling.
• Fully vaccinated international travelers arriving in the United States are still required to get tested 3 days before travel by air into the United States (or show documentation of recovery from COVID-19 in the past 3 months) and should still get tested 3-5 days after their trip.
• You should still watch out for symptoms of COVID-19, especially if you’ve been around someone who is sick. If you have symptoms of COVID-19, you should get tested and stay home and away from others.
• People who have a condition or are taking medications that weaken the immune system, should continue to take all precautions recommended for unvaccinated people until advised otherwise by their healthcare provider.

• You should speak with your provider at AOCC for individualized recommendations based on your medical condition, current medications and other factors.
• Your provider has a great deal of experience dealing with these concerns and will be able to talk to you in a non-judgmental manner

After months of a phased role out of the vaccine for specific groups at high risk for exposure and/or high risk for infection, the vaccine is now available for all individuals 12 years of age or older.

We have provided links here for information that is currently available for:

• North Carolina https://covid19.ncdhhs.gov/vaccines
• South Carolina https://scdhec.gov/index.php/covid19/covid-19-vaccine

North Carolina residents:

• Atrium Health: https://atriumhealth.org/about-us/coronavirus/covid-19-vaccine
• Novant Health: https://care.novanthealth.org/vaccine
• select CVS pharmacies : https://www.cvs.com/immunizations/covid-19-vaccine
• select Harris Teeter pharmacies: https://www.harristeeterpharmacy.com/rx/covid-vaccine
• select Publix pharmacies: https://www.publix.com/covid-vaccine
• select Walgreens pharmacies: https://www.walgreens.com/findcare/vaccination/covid-19
• your county public health department ( see below for listings of select counties where many of our patients reside)
  • Mecklenburg County: https://www.mecknc.gov/covid-19/pages/vaccine.aspx
  • Union County: https://www.unioncountync.gov/departments/health-services/covid-19-coronavirus-vaccines 
  • Iredell County: https://www.co.iredell.nc.us/1455/Vaccine-Information
  • Catawba County: http://www.catawbacountync.gov/county-services/public-health/coronavirus-19
  • Gaston County: GastonSaves.com
  • Lincoln County: https://www.lincolncounty.org/2355/COVID-19-Vaccination-Information
  • Cabarrus County: https://www.cabarrushealth.org/605/COVID-19-Vaccine-Information
  • Rowan County: https://www.rowancountync.gov/1561/COVID-19
  • Anson County: http://www.co.anson.nc.us/DocumentCenter/View/553/Covid-Vaccine-Flyer
  • Stanley County: https://stanlyhealth.com/
  • Alexander County: https://alexandercountync.gov/covid/
  • Burke County: https://www.burkenc.org/2494/COVID-19-Vaccine-Schedule 

South Carolina residents:

• Atrium Health: https://atriumhealth.org/about-us/coronavirus/covid-19-vaccine
• Novant Health: https://care.novanthealth.org/vaccine
• select CVS pharmacies: https://www.cvs.com/immunizations/covid-19-vaccine
• select Harris Teeter pharmacies: https://www.harristeeterpharmacy.com/rx/covid-vaccine
• select Publix pharmacies: https://www.publix.com/covid-vaccine
• select Walgreens pharmacies: https://www.walgreens.com/findcare/vaccination/covid-19
• Most county public health departments in SC do not have specific vaccination programs. Instead, they are run through the state Department of Health and Environmental Control (DHEC). Please contact DHEC to schedule an appointment at  https://scdhec.gov/index.php/covid19/covid-19-vaccine or call DHEC appointment line at 855-472-3432
  • York County: https://www.yorkcountygov.com/CivicAlerts.aspx?AID=376

The American College of Rheumatology (ACR) recommendations were released in mid-February 2021 and can be viewed here: https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf

Based on our experience with other vaccines, AOCC providers are offering specific guidance regarding drugs where the dosing or timing of the injection might be altered to ensure optimal efficacy of the vaccine. Our recommendations differ slightly from those of the ACR when it comes to methotrexate, mycophenylate/Cellcept, JAK inhibitors, Orencia and Rituxan. Absent strong scientific data, AOCC is taking a more conservative approach to maximize the potential of a more vigorous antibody response to the vaccine. As more information becomes available we will update our recommendations accordingly.

• No changes need to be made for dosing or timing of the following oral medications:
  • Arava (leflunomide)
  • Azathioprine
  • NSAIDs ( non-steroidals) such as Advil/ibuprofen/Motrin, Aleve/naproxen/Naprosyn, celecoxib, diclofenac, etodolac, indomethacin, meloxicam, nabumetome, sulindac
  • Olumiant
  • Plaquenil (hydroxychloroquine)
  • Prednisone in doses of less than 10 mg daily. For patients on Prednisone in doses of 10 mg/day or higher please discuss this with your AOCC provider.
  • Rinvoq
  • Sulfasalazine
  • Xeljanz
• No changes need to be made for dosing or timing of the following injectable medications:
  • Actemra
  • Benlysta
  • Cimzia
  • Cosentyx
  • Enbrel
  • Humira
  • Simponi
  • Skyrizi
  • Taltz
  • Tremfya
• No changes need to be made for dosing or timing of the following infusion medications:
  • Actemra
  • Kevzara
  • Remicade or infliximab biosimilars Inflectra, Avsola, Renflexis
  • Simponi Aria
• METHOTREXATE: LIKELY WILL IMPACT RESPONSE TO COVID19 VACCINE. To avoid this, we suggest that you lower the dose to 7.5 mg a week for the 2 weeks following the vaccine and the booster if you are receiving the Pfizer or Moderna vaccine. If you are getting the J&J single vaccine, just lower the dose to 7.5 mg for 2 weeks after the vaccine. If you are on oral (pill) methotrexate that would be the equivalent of 3 pills and for the injectable methotrexate it would be 0.3 cc/ml. If you are taking a branded injectable methotrexate such as Rasuvo or Rheumatrex speak with your provider for specific guidance.
• INFUSIONS AND INJECTIONS OF ORENCIA (ABATACEPT): LIKELY WILL IMPACT RESPONSE TO COVID19 VACCINE.
  • iv Orencia:
    • If on 750 mg or 1000 mg of Orencia, reduce the dose to 500 mg for a single infusion in preparation for the vaccine
    • Wait at least 4 weeks after last Orencia infusion to receive the vaccine. Resume Orencia infusion 2 weeks after the 2^nd injection/booster (Pfizer or Moderna) or 2 weeks after the single vaccine injection ( J&J)
  • Injections of Orencia:
    • For Pfizer and Moderna vaccine: Hold Orencia 1 week prior to vaccine and resume 2 weeks after the vaccine. Do the same thing for the booster.
    • For J&J vaccine: Hold Orencia 1 week prior to vaccine and resume 2 weeks after the vaccine.
  • INFUSIONS OF RITUXIMAB (RITUXAN, TRUXIMA, RUXIANCE). LIKELY WILL IMPACT RESPONSE TO COVID19 VACCINE (assuming this is typically infused every 6 months or less frequently)
    • Your AOCC provider should order a blood test called the “lymphocyte enumeration panel” to determine the amount of CD19/CD20 B cells that are present. If the level is too low, attempts to vaccinate will likely result in failure to generate an antibody response. Lowering the standard dose of rituximab from 1,000 mg infusion given twice, 2 weeks apart to a single 1,000 mg infusion is now suggested in addition to monitoring the lymphocyte enumeration panel.  It may be necessary to wait 6 months or longer from your last rituximab infusion before one can successfully vaccinate.
    • After one is vaccinated, you should wait at least 2 weeks after the last vaccine dose before receiving your next rituximab infusion.
  • Mycophenylate/Cellcept: potentially could impact response to vaccine. There is evidence that this medication can affect the cells in the immune system that generate antibody responses to vaccines. For example, its effect on the pneumococcal vaccine has been studied in a small number of patients with lupus where it blunted the response in some individuals on 1500 mg or more daily. Its effect may be long lasting and stopping drug for an extended time could lead to flare of your disease. Some have recommended stopping drug for 1 week but we do not know if that is a sufficient time. Please discuss with your provider since recommendations here need to be individualized based on your age, dose of drug, other medications you may be on and the rheumatic disease for which you are being treated.

Please contact your AOCC provider. We have tested over 1000 of our patients and have identified specific medications (Rituxan and their biosimilars, Orencia, Methotrexate, Cellcept/mycophenylate) which may lead to negative results when looking for the presence of IgG antibodies to the S/spike protein. Although the COVID19 vaccine may induce other immune responses that are effective in preventing future infection and that we are currently unable to measure, there does appear to be specific threshold levels of antibody binding to the S/spike protein that correlate with more broader immune protection .

It is possible that the vaccine generated additional beneficial effects which we cannot currently evaluate for.  Until we know more, we would strongly recommend that you continue to practice all recommended COVID-19 safety measures including masking, frequent hand washing and avoiding small indoor/enclosed areas especially those with poor ventilation. Please contact your AOCC provider if you have not already done so to discuss next steps.

On 8/12 and 8/13/2021 the FDA and CDC recommended that an additional 3^rd vaccine dose be given now for certain immunocompromised patients previously vaccinated with the Pfizer or Moderna vaccine.  

On 8/17/2021 the Biden administration announced that all vaccinated individuals should receive a booster dose 8 months after their first vaccine course.

From our study of over 1000 patients AOCC has identified certain drugs that may prevent one from developing an antibody response to the first vaccine course and could also be problematic when you receive the 3^rd or booster dose.

• If you have already had an antibody test performed by your provider at AOCC and had a negative response (no antibodies detected):
  •  talk with your provider about potential changes to your medication dosing or timing before proceeding with the 3^rd vaccine dose.
  • Two weeks after getting the vaccine we should test you again to see if you responded to the vaccine.

• If you have NOT had an antibody test and you are on Rituxan, Truxima, Orencia, Cellcept, mycophenylate orprednisone in doses greater than 10 mg a day
  • you should have an antibody test here before proceeding with the 3^rd vaccine dose.
  • if the antibody test is negative , talk with your provider about potential changes to your medication dosing or timing before proceeding with the 3^rd vaccine dose.
  • Two weeks after getting the vaccine we should test you again to see if you responded to the vaccine.

• Some patients on Rituxan or Truxima will need to demonstrate a change in their B cell counts before a 3^rd vaccine dose would even work. Talk to your provider about this.
• Some patients on Cellcept/mycophenylate or iv Orencia may require changes in dosing and timing of drug in relationship to a 3^rd vaccine dose. Talk to your provider about this.
• Currently, patients who are immunocompromised because of the medication they are on can “self-identify” as being immunocompromised and do not require a note from their provider to receive the 3^rdvaccine dose.
  • You need to wait at least 28 days from the time of your first vaccine course (2^nd dose) before getting the 3^rd
  • If you received the Pfizer vaccine initially you should be able to receive the 3^rd dose using  either  the Pfizer or Moderna vaccine
  • If you received the Moderna vaccine initially  you should be able to receive the 3^rd  dose using either the Moderna or the Pfizer vaccine
  • This program does NOT currently allow for an additional vaccine dose for those who received the Johnson & Johnson vaccine.
• All other patients who have been previously vaccinated including those who received the Johnson and Johnson vaccine should soon be able to receive a booster dose of the vaccine if it has been 8 months from the time you received the first vaccine course.
• Please refer to the AOCC website for further updates as well as listings of hospitals, county health departments and pharmacies that are offering COVID19 vaccines.