What vaccines are currently available in the United States?

There are currently 2 vaccines for COVID19 that have received emergency use authorization (EUA) by the FDA and are being distributed across the country.

  • One vaccine is made by Pfizer and BioNTech and requires that it be kept at extremely cold temperatures ( -94F) until shortly before its administration. 85,800 doses have been allocated to North Carolina and are being given now to front line health care workers and custodial staff that are in the hospital caring for patients infected with COVID-19. The second dose of this vaccine will be available to these individuals in 21 days.
  • A second vaccine made by Moderna in association with the NIH (National Institutes of Health) requires only refrigeration and will be distributed to residents of nursing homes and other long term care facilities in North Carolina through contracts with Walgreen and CVS. Pharmacists are being trained to travel to these facilities and administer them on site. The second dose of this vaccine is given at 28 days.

 

How do these 2 vaccines work?

This is a new type of vaccine that unlike many prior vaccines does not include a live or inactivated virus. The vaccines contain only a small piece of information (mRNA) that allows our cells to make the S (spike) protein found on the surface of the SARS CoV2 virus that causes COVID19.  The mRNA enters the outer cytoplasm of cells but not the nucleus and does not alter your genetic material.  It 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. The clinical trials have demonstrated 90-95% efficacy within 1-2 weeks of receiving the second (booster) injection.  Other types of vaccines are also being studied but clinical trials on these vaccines have not yet been completed.

 

Are there side effects associated with this vaccine?

Like many other vaccines, it is not uncommon for the mRNA vaccine to cause low grade fever, muscle and joint pain as well as headache for up to several days with the first and/or second dose. Although unpleasant this is not harmful to you and is not indicative of an allergic reaction. 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.  As of the date of this posting (12/28/2020) we are aware of only a single patient with a history of severe allergies to shellfish who developed an anaphylactic like reaction to the Moderna vaccine. He used his Epi-pen and was transferred to an urgent care facility where his symptoms rapidly cleared without further adverse events.

  

Who should not receive the vaccine?

  • 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. Please discuss further with your rheumatologist for additional information as there may be unique scenarios where vaccine would be indicated such as a prior reaction to an i.v. antibiotic and current risk for COVID 19 infection is quite high.
  • 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) should also not receive the vaccine.
  • Dr Anthony Fauci has recommended that the vaccine not be given to individuals who have had Guillain barre syndrome (GBS) in the past because of concern that it could trigger another episode. However, there has been strong pushback on this from neurologists who specialize in treating patients with GBS. They feel that there is currently no reason to not receive the vaccine. ( gbs-cidp.org). If you have had GBS we suggest that you consult with your healthcare provider.

 

What about the safety of the vaccine for other special groups?

  • 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 proceed with 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 plans to offer more detailed guidance by the first Quarter of 2021. Here is a link to the information posted by the ACR which is current as of 12/21/2020. (https://www.rheumatology.org/Portals/0/Files/ACR-Information-Vaccination-Against-SARS-CoV-2.pdf ).
  • Pregnant women and those who are breastfeeding: Pregnant women and those who are breastfeeding 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 a trial in children under the age of 12 that might have clinical results to submit to the FDA for approval by late 2021.
  • Prior COVID19 infection: You should still get this vaccine if you already have had COVID19 but it is recommended that you wait at least 30 days from when you tested positive. We do not know for certain how long immunity/protection from re-infection lasts but a just-published study in the New England Journal of Medicine strongly 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)

 

Will I still need to wear a mask and practice social distancing once I get the vaccine?

After receiving the vaccine you will still need to wear a mask in public and practice social distancing since we don’t know if the vaccine prevents transmission to other individuals although it has a 90-95 % likelihood of preventing you from developing the infection.

 

When will it be my turn to receive the vaccine?

A timeline for distribution and where you are in line for the vaccine will depend on which state you reside in.  The CDC is providing general guidance as to how the vaccine should be prioritized including adults who are definitely at increased risk as opposed to those who might be at increased risk  (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html)  but it is up to the states to determine the specifics.  Determining where in line people should be is complex and requires considerations of which individuals are most vulnerable as well as the value of their occupation to a functioning society. For a more detailed discussion of this debate see this link  https://www.nytimes.com/2020/12/24/magazine/who-should-get-the-covid-vaccine-next.html?referringSource=articleShare

 

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

 

These links will be updated as more information is provided.

Although the CDC has provided specific recommendations for the order in which people should receive the vaccine, individual states have the ability to modify the order.  Because of a significant surge in the number of reported cases of COVID19 in North Carolina, on Thursday 1/14/2021 the state announced a revised distribution plan in an attempt to speed up the number of people who can receive the vaccine.  This recommended plan would make the vaccine available now to all individuals 65 years of age and older and simplifies the number of groupings and the order in which the groups will receive the vaccine. However, a number of counties in North Carolina have indicated that they do not have enough vaccine to activate this new plan and instead plan to continue to vaccinate their residents based on the original schedule until more doses are made available to them. In contrast, vaccination plans announced by both Novant Health and Atrium Health care systems would appear to adhere to this newly revised schedule although it is not clear as of the date of this update (1/15/2021) whether patients who are enrolled in either Novant or Atrium will actually receive their vaccine any earlier.  For example a patient over age 75 on 1/11/2021 received an appointment for the first dose of the vaccine on 3/25/2021.  We suggest that you contact both the public health department of the county you reside in (listings are provided below) and Novant and/or Atrium Health if you are enrolled as a member of either healthcare system.

Residents of North Carolina will find information below for specific counties that correspond to where most AOCC patients reside. In addition, both Atrium Health and Novant Health have established enrollment procedures and vaccine clinics for their patients. (It appears that if you are not yet a patient in one of these 2 health care organizations you may also enroll.)

 

South Carolina residents who are patients in Atrium Health or Novant Health can also enroll or may register with the state of South Carolina to receive the COVID19 vaccine when it becomes available.

 

NORTH CAROLINA Revised Distribution Plan Announced 1/14/2021

  • Group 1:
    • Health care workers
    • Residents and staff of long-term care facilities including skilled nursing facilities, adult, family, and group homes.
  • Group 2: everyone 65 years of age and older ( currently able to register for the vaccine)
  • Group 3: frontline essential workers as defined by CDC include: first responders such as firefighters and police officers; education and childcare workers such as teachers and support staff; corrections officers; food and agricultural workers; manufacturing workers; US Postal Service workers; grocery store workers; public transport workers.)
  • Group 4: adults at increased risk of severe illness and adults at high risk for exposure. In the following order:
    • People 16-64 years of age with one chronic condition that puts them at risk of severe disease as defined by the CDC (cancer, chronic kidney disease, COPD, serious heart disease, immunocompromised state from organ transplant and medications to prevent graft rejection, obesity ( BMI > 30), pregnancy, smoking, Type 2 diabetes, sickle cell disease)
    • Anyone in a close living setting such as prisons, homeless shelters, migrant or fishery housing not previously vaccinated
    • Other essential workers including government employees who have not yet been vaccinated. As defined by the CDC this would include the following: people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety and public health staff who are non from line healthcare workers
  • Group 5: everyone else

Children younger than 16 years of age (when a vaccine is approved for children; Pfizer vaccine is approved for those who are 16 and older; Moderna vaccine is approved for those 18 and older)

NORTH CAROLINA Original Distribution Plan:

  • Phase 1a:
    • Health care workers fighting COVID-19 including those who are caring for patients with active COVID19 infection, those who clean areas used by patients and those giving vaccines to these workers
    • Residents and staff of long term care facilities including skilled nursing facilities, adult, family and group homes.
  • Phase 1b:
    • Group 1: everyone 75 years of age and older
    • Group 2: health care and frontline essential workers 50 yrs. of age and older
    • Group 3: health care and frontline essential workers of any age.

(Front line essential workers defined by CDC  as including the following groups: first responders such as firefighters and police officers; education and childcare workers such as teachers and support staff; corrections officers; food and agricultural workers; manufacturing workers; US Postal Service workers; grocery store workers; public transport workers.)

  • Phase 2: adults at increased risk of severe illness and adults at high risk for exposure. In the following order:
    • Group 1: Adults 65 years of age and older
    • Group 2: People 16-64 years of age with one chronic condition that puts them at risk of severe disease as defined by the CDC (cancer, chronic kidney disease, COPD, serious heart disease, immunocompromised state from organ transplant and medications to prevent graft rejection, obesity ( BMI > 30), pregnancy, smoking, Type 2 diabetes, sickle cell disease)
    • Group 3: Anyone in a close living setting such as prisons, homeless shelters, migrant or fishery housing not previously vaccinated
    • Group 4: Other essential workers including government employees who have not yet been vaccinated. As defined by the CDC this would include the following: people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety and public health staff who are non from line healthcare workers
  • Phase 3:
    • college students
    • High school students 16 years of age and older
    • Essential workers at lower risk for exposure
    • Children younger than 16 years of age (when a vaccine is approved for children; Pfizer vaccine is approved for those who are 16 and older; Moderna vaccine is approved for those 18 and older)
  • Phase 4: everyone else who wants the COVID19 vaccine

Timeline and location for vaccine distribution:  We currently have some information as to when and where the vaccine will be available. We are unsure at this time if AOCC will be a center to administer the vaccine for those in later phases of the rollout. We hope to provide more information and update this site when it becomes available.

  • Mecklenburg County: Vaccinations start at 8:30 AM Wednesday 1/6/2021 at Bojangles Coliseum off E Independence Blvd.  You must first sign up for an appointment. You can begin doing that at 8 AM Tuesday 1/6/2021 through the County’s website.
  • Gaston County: Starting Friday 1/8/2021 at the Gastonia Farmer’s Market for Gaston county residents. Pre-registration is required. For more information go to GastonSaves.com . The County has set up a hotline for residents to call to begin the pre-registration process for the vaccination clinic. That number is 704-866-3170. County employees will staff the hotline beginning Tuesday morning at 8 a.m. and will be available each day until 5 p.m.*
    • If all operators are busy, residents can leave a voicemail, and a county staffer will return their call to begin the registration process.
    • *The county sent out an alert Tuesday morning saying it is experiencing issues with its phone system for the COVID-19 Vaccine registration hotline. Officials said the IT department is working with their phone provider to fix the issue and are asking for the public’s patience. The county will send out another alert once the issue has been resolved and the phone opens for registration.
    • Gaston County plans to continue hosting vaccination clinics each Friday at the Gastonia Farmer’s Market as doses are made available. All future dates will be listed on the Gaston County Saves webpage as they are confirmed.
  • Union County: call 292.2550 Monday through Friday between the hours of 9:00 a.m. and 5:00 PM to be registered for a vaccination appointment. Vaccinations will be scheduled by appointment only, based on vaccine availability. For updated information please visit this website: https://www.unioncountync.gov/departments/health-services/covid-19-coronavirus-vaccines
  • Iredell County: will be offering the vaccine at various drive-thru sites throughout the community. To register to be notified please see more information here: http://www.co.iredell.nc.us/1441/COVID-19-Vaccine#:~:text=The%20Iredell%20County%20Health%20Department,Iredell%20County%20Health%20Department%20Office.
  • Catawba County: Starting January 5, Catawba County residents may schedule an appointment for vaccination one of the following ways:
    • Patients of Catawba Valley Medical Group (CVMG) can check the website https://www.catawbavalleyhealth.org  or call the Catawba Valley Health System Vaccine Line at 828-326-3993 for vaccine information. CVMG vaccination administration will begin the week of January 11.
    • Individuals who have an independently-owned provider, do not have a regular medical provider or prefer to receive the vaccination through Public Health may call Catawba County Public Health’s COVID-19 Vaccination Appointment Line at 828-695-6650 to set up an appointment. The appointment line will be available weekdays from 8 a.m. to 5 p.m. beginning January 5
    • For updated information please see this link: http://www.catawbacountync.gov/county-services/public-health/coronavirus-19
    • The Cabarrus Health Alliance (CHA) released its vaccine clinic dates:
      • *Clinic dates will be released as they are scheduled.
      • Phase 1B – Group 1:
        • Anyone 75 years or older, regardless of health status or living situation.
        • Individuals who would like to receive the vaccine are asked to do the following:
          • Print and bring the completed registration form that can be accessed here.
          • Bring a copy of their insurance card (front and back).
          • Bring proof of ID that qualifies them as being in Phase 1A or Phase 1B – Group 1 (75 years or older)
        • Please visit here for vaccine information. Individuals can direct questions to Cabarrus Health Alliance at 704- 920-1213.
  • Lincoln County: The Lincoln County Health Department advises residents to call the COVID-19 vaccination schedule information and appointment line at 704-479-2202. The LCHD will be taking appointments for the current priority groups Monday through Friday each week from 9am until 4pm.
  • Rowan County: Starting Jan. 11, the Rowan County Health Department will be providing vaccines at the West End Plaza Monday thru Friday from 9:30 a.m. until 3:30 p.m. No appointments are necessary. Vaccines will only be given to individuals who qualify and will be drive-thru. For this system, citizens will typically drive up, respond to screening questions to verify their age, fill out paperwork on paper or a tablet, and provide insurance cards if they have them, then proceed to the next area to receive their vaccine in their vehicle. They will be directed to wait for 15 minutes if they choose to monitor for any allergic response. After that, they are free to be on their way with their vaccine card that lets them know when to come back to receive the second dose. The vaccine is free to everyone. They are asking for insurance cards for administrative costs. Please know, however, that there is no cost to you, regardless of insurance.
  • Alexander County: The Alexander County Health Department will begin distributing the COVID-19 vaccine on Wednesday, Jan. 6. Vaccination clinics are scheduled for Wednesday, Thursday and Friday at the Health Department and on Thursday at the Alexander Senior Center. Appointments are required to receive the free vaccination. A new COVID-19 vaccine hotline (828-352-7724) has been established to allow the public to make appointments more easily. If there is no answer, citizens should leave a message with their name and phone number, and a staff member will return their call as soon as possible to arrange an appointment date and time.
  • Burke County: The Burke County health department advises individuals not to call to ask about the vaccines or to make an appointment. They will send out more information about the next group of vaccinations as soon as the current vaccination Group has been completed.

SOUTH CAROLINA 

  • Phase 1a: 
    • Residents and staff of long term care facilities
    • Hospitalized patients who are 65 years of age and older as long as they do not currently have COVID-19 and a provider feels it is indicated for them. 
    • Health care workers “at high risk for exposure and mission-critical to the overarching goal of preventing death”.  Employers are encouraged to reach out to their local hospitals no later than 1/15/2021 with a list of names and contact information of employees who want to be vaccinated.  Individuals in phase 1a to be vaccinated can also contact their local hospitals to request and schedule an appointment no later than 1/15/2021. They will be required to present proof of occupation at the time of vaccination.  Healthcare workers in Phase 1a include the following:  anesthesiology assistants, registered cardiovascular invasive specialists, and operating room staff; athletic trainers; American Sign Language (ASL) and other interpreters in healthcare facilities;  autopsy room staff, coroners, embalmers, and funeral home staff at risk of exposure to bodily fluids;  chiropractors;  dentists and dental hygienists and technicians; dietary and food services staff in healthcare facilities;  environmental services staff in healthcare facilities;  harbor pilots;  home health and hospice workers;  hospital transport personnel;  laboratory personnel and phlebotomists; licensed dietitians; medical assistants; medical first responders (paid and volunteer): EMS, fire department and law enforcement personnel who provide emergency medical care; nurses, nurse practitioners, and nurse’s aides/ assistants; opticians and optometrists and assistants/ technicians; persons providing medical care in correctional facilities and correctional officers; pharmacists and pharmacy technicians; physical and occupational therapists and assistants; physicians, including medical house staff (i.e., interns, residents, fellows), and physician assistants; podiatrists; public health healthcare workers who are frequently interacting with persons with potential COVID-19 infection; radiology technicians; respiratory care practitioners, such as respiratory therapists; speech language pathologists and assistants and audiologists; students and interns of the above categories
  • Phase 1b:
    • All people 75 years of age and older
    • Frontline essential workers: As defined by CDC including the following groups: first responders such as firefighters and police officers; education and childcare workers such as teachers and support staff; corrections officers; food and agricultural workers; manufacturing workers; US Postal Service workers; grocery store workers; public transport workers.
  • Phase 1c:
    • All people 65-74 years of age and older
    • People 16-64 years of age  with one chronic condition that puts them at risk of severe disease as defined by the CDC (cancer, chronic kidney disease, COPD, serious heart disease, immunocompromised state from organ transplant and medications to prevent graft rejection, obesity ( BMI > 30), pregnancy, smoking, Type 2 diabetes, sickle cell disease) 
    • Other essential workers including government employees who have not yet been vaccinated. As defined by the CDC this would include the following:  people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety and public health staff who are non from line healthcare workers
  • Phase 2: 
    • All other people who wish to be vaccinated. (We would assume this would not include people under the age of 16 for Pfizer vaccine and under the age of 18 for Moderna vaccine until approved for those age groups). 

 

When it comes time to get my vaccine should I do anything different with my medication?

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. 

  • No changes need to be made for dosing or timing of the following oral medications:
    • non-steroidals (NSAIDs
    • Plaquenil (hydroxychloroquine)
    • Arava (leflunomide), sulfasalazine
    • 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.
    • Azathioprine
    • Mycophenylate
    • Cellcept 
  • 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 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. 
  • Injectable Enbrel, Humira, Cimzia:  discuss with your AOCC provider. There is no clear data to guide us at this time. We currently do not recommend holding or altering the dose when receiving other vaccines such as influenza or H. zoster. 
  • Infusions of infliximab (Remicade, Inflectra, Avsola, Renflexis): obtain initial vaccine 2 weeks before your next infusion. If you are being dosed every 8 weeks, then try to receive the vaccine 6 weeks from your last infusion; if every 6 week infusion then try to receive the vaccine 4 weeks out from your last infusion; if every 4 weeks then 2 weeks from your infusion. With the vaccines currently available, a booster is required at 21 days for Pfizer vaccine and 28 days for the Moderna vaccine. Delaying the time you receive the booster is not recommended. Speak with you AOCC provider for specific recommendations on whether your subsequent infusion should be moved to another date. 
  • Infusions of Simponi Aria: (assuming this is typically infused every 8 weeks) Obtain the initial vaccine 2 weeks before your next infusion or at the 6 week mark. With the vaccines currently available, a booster is required at 21 days for Pfizer vaccine and 28 days for the Moderna vaccine. Delaying the time you receive the booster is not recommended. Speak with you AOCC provider for specific recommendations on whether your subsequent Simponi Aria infusion should be moved to another date.
  • INFUSIONS AND INJECTIONS OF ORENCIA (ABATACEPT): LIKELY WILL IMPACT RESPONSE TO COVID19 VACCINE. Please talk with your provider about dosing. 
  • Infusions of Actemra: It should be OK to continue without interruption. There is data that shows these 2 IL-6 inhibitors do not inhibit antibody responses to certain vaccines but no data are available for COVID19 vaccine or similar vaccines.  Alternatively, one could obtain the initial vaccine 2 weeks before your next infusion or at the 2week mark after your infusion (assuming this is typically infused every 4 weeks).  With the vaccines currently available, a booster is required at 21 days for Pfizer vaccine and 28 days for the Moderna vaccine. Delaying the time you receive the booster is not recommended. Speak with you AOCC provider for specific recommendations on whether your subsequent infusion should be moved to another date.
  • Injections of Actemra and Kevzara: it should be OK to continue without interruption. There is data that shows these 2 IL-6 inhibitors do not inhibit antibody responses to certain vaccines but no data are available for COVID19 vaccine or similar vaccines. 
  • INFUSIONS OF RITUXIMAB (RITUXAN, TRUXIMA, RUXIANCE).  LIKELY WILL IMPACT RESPONSE TO COVID19 VACCINE (assuming this is typically infused every 6 months or less frequently) The initial vaccine and booster at 21 or 28 days should be scheduled so that there is at least 2 weeks between your booster and your next rituximab infusion. For patients receiving rituximab every 6 months, plan to receive your first vaccination at 4 months to 4 months and 2 weeks after your last dose of rituximab. Your booster vaccine would then be given 21 days later (Pfizer) or 28 days later (Moderna) allowing at least 2 additional weeks before your next course of rituximab.  
  • Xeljanz: potentially could impact response to vaccine. Talk with your AOCC provider. 
  • Rinvoq : potentially could impact response to vaccine. Talk with your AOCC provider. 
  • Olumiant: potentially could impact response to vaccine. Talk with your AOCC provider. 
  • Cosentyx injections: no change needed in dosing or timing of injection.
  • Taltz injections: no change needed in dosing or timing of injection.

 

For more information: 

Lupus.org: COVID-19 Vaccine and Lupus

Creaky Joints: Can you get a COVID Vaccine if you are Immunocompromised?

COVID-19 Vaccine Information: North Carolina Department of Health & Human Services

AOCC is pleased to welcome Gordon K. Lam, MD, FACR.

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