Patient and Clinician information for immunosuppressed patients about COVID 19 Vaccines
COVID 19 Vaccinations Q & A with Dr Maheshi Ramasamy, Consultant Physician and Clinician Scientist , Oxford Vaccine Group, University of Oxford
8 January 2021
Dr Ramasamy is an Investigator at Oxford University for the Oxford /Astrazeneca COVID19 Vaccine clinical trials. Dr Ramasamy has recently authored a publication in the Lancet about the safety of the Oxford/AstraZeneca COVID Vaccine in older adults.
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About the Vaccines
Q1 Who is assessing the safety and effectiveness of the various COVID vaccines in the UK?
There are a number of independent bodies who evaluate information from the trials. The Medicines and Healthcare porducts Regulatory Agency (MHRA) is the regulatory body in the UK for all new drugs. The MHRA assesses all the clinical data including safety information from the trials and make a decision to approve vaccines. The government policy on vaccines is provided by the Department of Health and Social Care together with Public Health England and is informed by the Joint Committee on Vaccines and Immunisations (JCVI). Vaccination information for clinicians about the COVID vaccines is published in the Green Book1.
Q2 What does immunity against COVID 19 mean?
We can measure immune responses to the vaccine by measuring antibody or T cells. COVID-19 is a new virus, we don't yet know what exact level of immune response protects a patient. However, in clinical trials, all the vaccines that have now been approved (Pfizer/BioNTech, Oxford/AstraZeneca and Moderna) have also been shown to protect participants from COVID disease.
If a large proportion of the population is vaccinated then it is likely to reduce transmission of infection through the population, meaning that individuals are protected. Preliminary data from the Oxford/Astra Zeneca trials suggests that vaccination reduces transmission of infection.
Q3 Are any of the vaccines live viruses?
The mRNA vaccines contain a part of the genetic code for the spike protein of the COVID-19 virus, wrapped in a thin layer made of lipid. Our own cells then produce the protein encoded and we mount an immune response to it.
The Oxford/AstraZeneca vaccine contains a harmless cold virus which cannot replicate or cause disease in humans. This contains a stretch of genetic code for the spike protein of the COVID19 virus. Again, our own cells produce the protein encoded and we mount an immune response to it.
None of the vaccines available in the UK have the ability to cause COVID 19 infection because they do not contain the COVID19 virus itself, only a part of it. For this reason, they are safe in immunosuppressed patients.
There are several other adenoviral vector vaccines which are in phase 3 trials. Several other vaccine platforms are also being investigated, including inactivated COVID 19 virus vaccines and protein vaccines.
Q4 What is an adjuvanted vaccine ?
Some vaccines need an added boost to make a high quality, sustained immune response in the human body. This additional compound within a vaccine is called an adjuvant . The Oxford/Astra-Zeneca, and Pfizer/BioNTech vaccines do not contain adjuvant. At this time, only the Novavax vaccine which is currently in clinical trials contains adjuvant.
Q5 If a vaccine is 95% effective, does that mean there is still a 5% chance of not being protected?
While no vaccine offers complete protection from disease, both approved vaccines provide protection from severe disease and hospitalisation due to COVID. What is really important, however is good coverage – as many people in the population are vaccinated as possible. This is what will drive down transmission and infection rates in the country.
About the vaccines and immunosuppressed people
Q6 Did the COVID 19 vaccine trials study the effect of the vaccine on immunosuppressed patients?
When studying a new vaccine it is usual for the first clinical trial to be in healthy volunteers to establish that the vaccine is safe . Although some patients with autoimmune diseases were studied (including uveitis), patients on immunosuppressant treatments were generally excluded from these early vaccine trials. There are several studies underway looking at the way that immunosuppressed patients, such as HIV positive patients, respond to the COVID 19 vaccine.
Q7 Are immunosuppressed patients capable of making memory B &T cells against the virus?
We all have different types of immune cells. Both memory B and T cells are responsible for a successful immune response against viruses as they ‘remember' being exposed to the virus. Memory B cells sit in the bone marrow and make antibodies against the virus and memory T cells prevent the virus spreading infection between cells.
We don't yet have data about how long the immune responses to vaccine will last for, but are continuing to follow up the trial participants to understand this better. Ongoing studies are also comparing memory cell responses to COVID19 in healthy and immunosuppressed individuals.
We hope the vaccine will offer good levels of protection from the COVID-19 virus in immunosuppressed patients. Even if the levels of protection are less than for healthy people, the degree of protection given may reduce severity of infections . Also, if a large enough part of the population takes the vaccine, it will reduce transmission of the virus, protecting everybody.
Q8 Should someone who takes immunosuppressants agree to take a COVID vaccine?
The Joint Vaccination Immunisation Committee and Public Health England recommend that patients on immunosuppressant medication are vaccinated against COVID-19 as they consider patients who are on immunosuppressants within an at-risk group.
The evidence from the main clinical trials for COVID vaccines show that the vaccine is safe. There is no possibility of getting COVID infection from the Oxford/Astra Zeneca, Pfizer/BioNTech or Moderna mRNA vaccines because of the design of the vaccines. In the Oxford Astra Zeneca study, patients who had autoimmune diseases including uveitis didn't experience any flares of their autoimmune disease.
Q9 Should someone who takes immunosuppressants agree to be part of a Covid vaccine trial?
Every trial has strict inclusion criteria so if you meet these criteria and wish to take part in a COVID vaccine trial, you should do so. The investigators in a trial are there to answer questions so you are fully informed about the trial before you give consent. The research will advise us on the best way to protect patients who are on immunosuppressants
Q10 When will immunosuppressed patients get the vaccine?
There is a prioritisation list for the national vaccination program and patients with risk factors which can be viewed here. We expect the vaccine will be made available to patients aged 18-65 on immunosuppression in February 2021.
The timing of COVID vaccinations in patients who are about to start rituximab or have just taken it should be advised by their prescribing specialist.
Q11 What is the expected timescale for the vaccine between shots to be effective. Will the interval between shots be shorter / longer for patients on immune suppressants?
Good levels of protection are seen within 21 days of the first dose of both the Pfizer and the Oxford vaccines. For all individuals, the interval between the first and second dose will be between 4-12 weeks.
Q12 Would it be advisable to skip a dose of the immune suppressants in the week I get the vaccine jab?
We don't recommend skipping immunosuppressants as your immunosuppressant medication will still be active for several weeks even after stopping it. There is also the risk of triggering a flare up of inflammation in your eyes if you stop your medication.
Q13 I'm a frontline health care worker & therefore likely to be offered the vaccine fairly soon. If we are on immunosuppressants should we wait to be vaccinated?
The guidance from Public Health England and the Joint Committee on Vaccinations and Immunisations is that patients who are immunosuppressed receive the COVID-19 vaccine because they fall into an at-risk group and have been prioritised. They are not recommended to wait as the trials have shown that the vaccine is safe.
Patients with a history of allergy to the vaccine contents should not receive the vaccine.
Q14 Are the mRNA/viral vector vaccines less safe for patients with auto-immune diseases or immune suppressed people than the traditional vaccine preparations ? Should we wait until the more “old fashioned” vaccines are approved?
The results from the Pfizer and Oxford/Astra Zeneca vaccine trials have been carefully reviewed by the MHRA who have concluded that both vaccines are safe. Given the scale of the pandemic in the UK, it is essential that people are vaccinated as quickly as possible. If you are offered a vaccine as part of the NHS roll out, we advise you to take it.
Q15 Has being locked down meant immunosuppressed patients are at a disadvantage and less likely to benefit from the vaccine's immunity ?
There is no evidence that the vaccine is less likely to work if you have been shielding.
At present, we have not so far found that immunity against common cold viruses offers any protection against COVID-19. In fact, rates of flu and colds have gone down because of better hand hygiene, social distancing and masks so we should keep this up for now!
Q16 How long after having the virus do immunosuppressed people continue to shed the virus?
Immunosuppressed people do shed the virus for longer than non-immunosuppressed patients but we do not know if this means they are infective ( i.e they can spread infection) for longer.
General questions about the COVID 19 vaccine
Q17 Can someone who has had COVID-19 take the vaccine?
Some of the participants in the vaccine trials had previously had COVID 19 infections and the vaccine is safe in them.
Q18 Do we know that the vaccine is safe for pregnant women?
The trials did not include patients who were pregnant or wishing to get pregnant. At present, pregnant women are not advised to get the vaccine. However, in some circumstances a pregnant woman may be at particular risk due to high exposure or an underlying condition. In this circumstance she should discuss this with her GP
Q19 I'm finding it hard to understand why someone wouldn't get the vaccine? Is there any evidence yet that it causes problems for at- risk people?
There are no safety concerns for Pfizer/BioNTech mRNA, Moderna or Oxford/AstraZeneca COVID19 vaccines including in immunosuppressed patients. Some people have expressed the concern that vaccine development has been much quicker than for other vaccines. This is explained by the fact that the COVID 19 vaccine development has been nationally prioritised and extremely well- resourced. A large number of research staff have been deployed from their usual work to COVID 19 vaccine studies throughout the country and the various stages of vaccine development have happened without delays. There have been no shortcuts taken in the way the trials have been conducted. All the independent data safety committees , ethical reviews and a full regulatory authority (MHRA) inspection of the data have taken place exactly as they normally would.
Acknowledgements: Our sincere thanks to Dr Ramasamy for allowing us to interview her, Ms Charlotte Radovanovic and Professor Alastair Denniston for allowing us to use questions from a PinGU webinar in this interview and to uveitis patients for asking the questions!
- COVID-19: the green book, chapter 14a. https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a