Advice re Covid 19 / Coronavirus

Guidance on the “Covid 19 vaccine”

Revised to version 6 on 12 September 2021

Additional revision re third dose 16 Sept 2021 in green and blue in section below 

Please refer to this page for our best current opinion on vaccination which we have written in an FAQ style. This is aimed ONLY at patients of our office. It will be reviewed when new information is available.

Notes:

  1. We have had many calls about our stance on vaccination. About a quarter of the patients who talk to us express reservation about vaccination. Our stance is clear – we support vaccination of the population in a tiered fashion based on risk of a poor outcome from the virus.
  2. We are advising as best we can in line in line with the BSR and CRA advice. (Specifically, we do not fully agree with the initial (now changed) position of the National Advisory Committee on Immunization). We believe lack of data is not a reason to avoid vaccination, and that extrapolating our experience with other vaccines is sensible.
  3. This information is primarily aimed at patients with rheumatoid arthritis, psoriatic arthritis, and autoimmune diseases such as SLE, scleroderma, polymyalgia (i.e. patients likely to be on the medications listed below).

We are not in a position to advise on pregnancy and vaccination.

 

Which vaccines are available?

For the purpose of this page we consider these types of vaccine.

  • mRNA vaccines which are processed by the immune system to trigger a protective immune response.
  • Adenovirus vector vaccines –  The Oxford/AstraZeneca vaccine contains a live adenovirus vector but is non-replicating so cannot cause infection and is therefore safe for people who are immunosuppressed.

By the time you are offered a vaccine we will have safety data from many hundreds of thousands of people to reassure us.

If you wish to learn more about the science of these vaccinations please search elsewhere.

 

Which of our patients would be considered clinically vulnerable to Covid 19?

Patients on one or more immunosuppressive medications which include:

  • Methotrexate
  • Azathioprine
  • Leflunomide
  • Mycophenolate
  • Cyclophosphamide
  • Prednisone (dose and time related)
  • JAK inhibitors
    • Xeljanz
    • Rinvoq
  • Biologics
    • all anti-TNF drugs (eg etanercept, adalimumab, infliximab, golimumab, certolizumab and biosimilars of these);
    • Tociluzimab
    • Abatacept
    • Secukinumab
    • Sarilumab
    • See note below.

Hydroxychloroquine or Sulfasalazine either alone or in combination are not considered immunosuppressive though if you are on sulfasalazine you may still be a patient in an at risk group.

Patients with other conditions including but not limited to:

  • Age >70,
  • Diabetes Mellitus,
  • Pre-existing lung disease,
  • Renal impairment,
  • Heart Disease

Should I stop my medications to lower my risk of catching Covid?

No! The current best advice is that the risk of harm from stopping medications as “protection” against the virus is more harmful than good. Follow the public health advice in terms of shielding, hand washing, distancing, but do not stop medications.

If you have any active infection pause immunosuppressive drugs and seek advice from your doctor.

Prednisone should NOT be stopped suddenly and if you have any infection whilst on prednisone seek medical advice as this medication requires specific medical expertise.

Should patients continue their immunosuppressive therapy before and after vaccination?

We suggest in principle that where possible a patient holds their methotrexate for one week prior and  following the vaccine as this may allow a more efficient response from your immune system. If you are worried about stopping methotrexate it is safe to continue it. You may get marginally less protection. Evidence supporting these decisions is limitied

This advice does NOT apply to any other medications and if you reach a point where vaccination is planned we will be pleased to offer advice on whether to pause medications or not.

 

Will my medications prevent me from developing an adequate immune response? And should I get “the third vaccination”

We are not able to answer this, but our best thoughts are that you will still mount a meaningful response though possibly not as strong as a patient who is not on immunosuppressive drugs. It will still offer meaningful protection. In terms of a booster, at the time of updating this page  our feeling is that we have not seen compelling  published data to be able to recommend what is done. Remember expert opinion is useful, but what we need are good quality studies to inform us. 

UPDATE 14 Sept 2021

In response to evolving data around the transmissibility of the Delta variant, the Ontario government, in consultation with the Chief Medical Officer of Health is expanding eligibility for third doses of the COVID-19 vaccine to additional groups that face the highest risk of serious illness from the virus. This decision aligns with evidence and recommendations provided by the National Advisory Committee on Immunization (NACI).

A complete two-dose COVID-19 vaccine series provides strong protection against COVID-19 infection and severe outcomes, including against the Delta variant, in the general population. Third doses are being offered to specific high-risk groups to help provide sufficient protection based on a suboptimal or waning immune response to vaccines and increased risk of COVID-19 infection.

Based on the recommendation of the Chief Medical Officer of Health and in alignment with NACI’s recommendation, the province will begin offering third doses of the COVID-19 vaccine to additional vulnerable populations:

  • Those undergoing active treatment for solid tumors;
  • Those who are in receipt of chimeric antigen receptor (CAR)-T-cell;
  • Those with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome);
  • Stage 3 or advanced untreated HIV infection and those with acquired immunodeficiency syndrome; and
  • Those undergoing active treatment with the following categories of immunosuppressive therapies: anti-B cell therapies (monoclonal antibodies targeting CD19, CD20 and CD22), high-dose systemic corticosteroids, alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and other biologic agents that are significantly immunosuppressive.

Individuals in these groups can receive their third dose at a recommended interval of eight weeks following their second dose

On 16 th September the British society for rheumatology added to their guidance –

We advise that all patients on DMARDs (except HCQ and SSZ), biologics, JAK inhibitors, and those on prednisolone >10mg should have a third vaccine dose to enhance primary vaccination effectiveness.

Interpreting this for simplicity  if you are on methotrexate, leflunomide, rituximab or another biologic you are eligible for a third dose. If you are on higher doses of prednisone you should ask you primary care provider or our team for advice but doses > 10 mg seem to be a reasonable level at which a third vaccine is advice.

This is pragmatic advice and not fully evidence based

 

Will my disease flare after vaccination?

Whilst there are case reports of autoimmune diseases flaring after infections and vaccination, our current advice is that this very small risk is balanced by the individual and population benefits of vaccination. Vaccination is about protecting you, your loved ones, and the rest Ontario. As of late August 2021 we have seen about 25 to 30 flares of RA from a patient population of over 2000. So yes, we nbelieve the vaccine could trigger a flare, but we are learning month by month. We still feel this is not a reason to avoid protecting yourself and your family.

 

Do we know how long I will be protected for?

No – we have no reliable long-term data on the durability of response. Perhaps it is best to assume that the virus will act a little like flu, and annual vaccination may be needed. We cannot answer this. Nor do we know if having had a Covid 19 infection offers extra long-term protection. We will know more in another year of course.

 

How do I know the vaccine is safe…it was produced very quickly, and we have no long-term safety data?

We have decades of experience of vaccine use, and the currently available vaccines are based on far more robust long-term data than appears at first sight. Undoubtedly we have few long term data for these specific new vaccines, but we have very clear data of the tragedy of Covid 19 virus with ongoing potentially avoidable deaths. If we are to return to the life we had before Covid then vaccination of most of the population needs to be achieved.

Vaccine hesitancy.

We understand and respect many of the anxieties patients describe to us.  Our position is unambiguous – eventually if you are not vaccinated you should accept that you will probably get the virus. If you are vaccinated you are massively less likely to end up in the ICU or dead. But the data are indeed confusing and there are some strongly held opinions

You will not be surprised that many of our patients claim an expertise and level of knowledge that exceeds that of many scientists and our own….  and for these, we recommend they purchase the following:

 

Resources:

https://rheum.ca/wp-content/uploads/2021/04/FINAL-EN-Updated-Position-Statement-on-Covid-19-Vaccination-April-16_2021-For-Publication-1.pdf

https://rheum.ca/wp-content/uploads/2021/01/Updated-Position-Statement-on-Covid19-Vaccine_Jan_21.pdf

https://www.rheumatology.org.uk/practice-quality/covid-19-guidance

http://arma.uk.net/covid-19-vaccination-and-msk/