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Vaccines 

Vaccine update 1st February 2021

Following the initial vaccines to complete trials (Pfizer, Moderna and AstraZeneca), the high case numbers of COVID have resulted in further vaccines being able to give information on the protection offered vs placebo.  The additional vaccines (Valneva, Novovax, Jannssen) will probably not be available until later this year, if approved by the MHRA (the medicines regulator).  These vaccines, like those already licenced are made up of components of the virus and an immune stimulator and none of them are live vaccines, so all are safe for those with impaired immunity.

Valneva vaccine

The Valneva vaccine is an inactivated whole virus vaccine. Clinical trials, which began in December, are taking place at four National Institute for Health Research sites in Bristol, Southampton, Birmingham and Newcastle and results are expected by April.  If the results look promising larger tests will take place in April with more than 4,000 UK volunteers taking two doses.  The vaccine is stable in a normal fridge.  The UK has ordered 60 million doses of this vaccine and it could be available by the end of 2021.

Valneva vaccine begins manufacturing at Livingston plant - BBC News

Novovax vaccine

The Novovax vaccine will be given as two doses.  The vaccine comprises an artificial form of the spike protein (recombinant protein) and a special immune stimulator (adjuvant) to boost the immune response. Novavax is stable for up to three months in a normal fridge.  It has been shown to be 89.3% effective at preventing COVID-19 in participants in its Phase 3 clinical trial in the UK, and around 86% effective at protecting against the new UK variant. This vaccine needs approval from the MHRA and is hoped it will be available later this year.  The UK has secured 60 million doses of this vaccine.

Covid-19: Novavax vaccine shows 89% efficacy in UK trials - BBC News

Jannssen (Johnson and Johnson) vaccine

This is a single dose vaccination and uses a common cold virus that has been engineered to make it harmless.  This approach is similar to that used by the University of Oxford and AstraZeneca. This vaccine can be stored at a fridge temperature so it will be easier to roll out. The results that show that this vaccine gives 66% protection against COVID based on clinical trials involving nearly 44,000 people. The UK has ordered 30 million doses of this vaccine.

Covid vaccine: Single-dose Johnson & Johnson jab is 66% effective - BBC News

Vaccine FAQS

Q. What is being done to develop treatments and a vaccine against COVID-19 and how long is this going to take?

A. Research is happening at breakneck speed with collaborative efforts being forged between companies, laboratories and researchers around the world.

There is an “adaptive” protocol national trial called ‘RECOVER’, which changes as new treatments emerge.  There are trials of anti-virals and trials of potential vaccines are already in place.  Several companies are developing or testing currently available anti-virals against the COVID-19 virus, this includes testing those that were found to be effective against the SARS virus and EBOLA. Another research avenue is synthetically engineering antibodies that could be able to block the virus infecting human cells.  You can find out how the trials are progressing worldwide using this New York Times COVID vaccine tracker.  This BBC film is also helpful in explaining the process of vaccine development and how close we are to a vaccine being launched.

Q. Should I contact my immunology centre or GP about getting the COVID vaccination?

A. No, all services are over stretched. Wait to be contacted by the NHS, your NHS number is being used to track people wherever you are vaccinated. In some areas you will be contacted by a Hub not your own GP, but they will contact you. Your immunology centre will not have any vaccine and will not have a means to liaise with the vaccination hubs.

Q. Who will let me know when I can get the COVID vaccine?

A. The NHS is working through a priority list as set out by the Joint Committee on Vaccination and Immunisation (JCVI). You SHOULD NOT contact the NHS or your local GP surgery about the COVID vaccination. The NHS will let you know when it is your turn to have the vaccine.  This will be in the form of a letter/email from your GP or the NHS. It will include all the information you need to book appointments, including your NHS number.
Do not respond to texts, emails or messages that are not from your GP/NHS or that ask for personal details including bank details. There are a number of scams using COVID vaccination to get peoples' details. You will either be sent an appointment or there will be a web booking system, but you will not have to enter personal details.

 

Q. What do I need to bring with me to the vaccination centre?

A. If you are taking medication, please bring a list of these with you to the vaccination centre. Do not bring the medicines themselves.

If you are taking a blood thinner called 'warfarin' you will also be going for regular blood tests to monitor the thickness of your blood using a test called INR. The INR test result is a number (for example 2.5). Please make sure you know your latest INR reading and when that was last checked.  If you don't know this, you can get if from your GP surgery.

Q. Are there any side effects?

A. Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, lasting no longer than a week, and not everyone gets them. These may include: a sore arm where the needle went in; feeling tired; a headache; feeling achy; feeling or being sick.

You can take painkillers, such as paracetamol, if you need to. If you have a high temperature you may have coronavirus or another infection. If your symptoms get worse or you are worried, call 111.

Read about the coronavirus vaccines at

https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

You can report side effects at Yellow Card Scheme - MHRA

Q. Can I do what I want after I have been vaccinated?

A. It is essential that everyone continues to stay at home whether they have had the vaccine or not.  We do not know how much protection people with certain types of immunodeficiency will have so it's absolutely essential that you continue to follow any shielding guidance you have been given.   It's tough but really important. Continue to follow social distancing guidance; wear a face covering and remember hands, face, space and cut down on your interactions with other people.

Q. Can I catch COVID from the vaccines?

A. You cannot catch COVID from the vaccines. But it is possible to have caught COVID and not realise you have the symptoms until after your vaccination appointment. If you have any of the symptoms of COVID, stay at home and arrange to have a test.  If you need more information on symptoms visit: www.nhs.uk/conditions/coronavirus-COVID-19/symptoms/

Q. Can I be vaccinated if I have had a severe allergy?

A. The Pfizer vaccine is not recommended for people who have had anaphylaxis (severe allergic reaction) to drugs or vaccines.  It is still recommended when there is a history of allergy without anaphylaxis, but this would be discussed with you.  Every person attending for vaccination will be asked. If you cannot have the Pfizer vaccine, you will be added to a wait list for the Astra-Zeneca vaccine.

Q. Do I need to be registered with a GP to get the vaccine?

A. To get the vaccine, you will need to be registered with a GP surgery. If you aren't you will have to get registered or wait until the vaccine is offered more widely at other locations.

Q. Can I have pay for a private COVID vaccination?

A. COVID vaccines will ONLY be available through the NHS.

Q.  Do I have a choice about what COVID vaccine I’ll receive?  

A.  The vaccine you will be offered will be dependent largely on the supplies available from the manufacturers and the logistics of the roll out of the COVID vaccine programme.  

Q. It is good news about the RNA based vaccine, developed by Pfizer and BioNTech indicates, but is this suitable for people with CGD and X-linked carriers?

A.  There is no reason to believe that people with CGD and X-linked carriers wouldn’t have a normal vaccine response but this vaccine represents a new class of vaccine which relies on translation of injected mRNA into SARS CoV 2 spike protein and for the protein to then be presented to the immune system by antigen presenting cells. Ultimately it will be important to have evidence of vaccine immunogenicity in patients with NADPH oxidase defects.

Q.  Are any of the vaccines being developed for COVID, live vaccines?

A.  None of the COVID vaccines being developed are live. It is important to emphasise that CGD patients, and carriers, where advised medically, should receive all vaccines except those specifically contraindicated (e.g., live BCG, live Salmonella). Particularly regarding the different types of COVID vaccine (and flu vaccines), they are not contraindicated.

Q.Would the pneumonia jab help me to avoid COVID secondary infections?  Is this the flu jab?

A.The flu and pneumonia jabs are different and are effective against different microorganisms. Pneumonia jab is effective against Streptococcus pneumoniae (pneumococcus) and the flu vaccine against different strains of the flu virus. See https://www.nhs.uk/conditions/vaccinations/how-flu-vaccine-works/

Q.  I have had the pneumonia vaccine. Does that give me any protection against COVID-19?

A. This vaccine specifically protects against infection with a bacterium called pneumococcus, which can cause a secondary bacterial chest infection in someone who has a viral pneumonia, but the vaccine does not protect against coronavirus itself.

Please note the vaccines for flu and pneumonia will not offer any protection against COVID.

Q. Does having a flu vaccine weaken an elderly immune system leaving you more vulnerable to COVID-19 infection?

A. There is no known link to flu vaccines "weakening" immune systems and no known link between COVID and influenza other than both are viruses and like many cough and cold viruses started circulating in the winter months.  The combination of COVID and flu in the elderly would likely be a very bad one, so we continue to encourage uptake of flu vaccine as a source of protection when possible.

Q.  How much do we know about the vaccines recently in the news?

A.  Pfizer/BioNtech and Moderna have recently announced highly successful interim results from their COVID-19 vaccines trials, and results from other vaccine trials are expected soon.

Interim findings from Pfizer/BioNtech indicate their RNA vaccine is 90% effective in preventing COVID-19. Two doses are needed to give protection.

The vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised. However, the data presented is not the final analysis as it is based on only the first 94 volunteers to develop COVID so the precise effectiveness of the vaccine may change when the full results are analysed. On the 23rd November the Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of this vaccine for a mass vaccination programme.

The Moderna trial involved 30,000 people in the US and the analysis was based on the first 95 to develop COVID-19 symptoms. Two doses are needed to give protection. Only five of the COVID cases were in people given the vaccine and 90 were in those given the placebo treatment. The company says the vaccine is protecting 94.5% of people. The data also shows there were 11 cases of severe COVID in the trial, but none happened in people who were immunised.

The Oxford University/AstraZeneca vaccine uses a modified, inactivated cold virus to carry the genetic information of COVID into the body to get the immune system to mount a response. Early data from the clinical trials suggests it is safe and could protect up to 70% of people. There is good data that it will work in elderly people.  The vaccine does not need to be shipped or stored in an ultra-cold environment, it is also considerably cheaper than the Pfizer/BioNtech and Moderna vaccines.

There are some unknowns about the vaccines, for example, we do not know if the vaccine stops you spreading the virus although new data suggest that Oxford-AstraZeneca vaccine may reduce the spread of COVID. The data to be published formally in the journal Lancet, suggest that the vaccine may have a "substantial" effect on transmission of the virus.  It means the jab could have a greater impact on the pandemic, as each person who is vaccinated will indirectly protect other people too.  Information on the effect of all vaccines on virus transmission is being investigated as the vaccination programme continues to be rolled out.  Over time more information will be gained on whether the vaccines work equally well in high-risk elderly people. We also do not know how long the immunity will last and this question will only be answered by long-term follow up studies.

Q.  Have any of the vaccine trials involved people with CGD or other primary immunodeficiencies? 

A.  We do not know precisely the mix of people who have taken part in the clinical trials but people affected by immunodeficiency would not be eligible to take part in a vaccine trial in the way that they are conventionally set up.

Q.  Is there any evidence about the effectiveness of the RNA vaccines for primary immunodeficiency patients?

A.  In short, no, because these patients haven't been enrolled in the trials.  Our experience to date of COVID-19 infection suggests that the antibody response is at least as important as T-cell responses for clearing this virus. The pre-clinical vaccine trial data suggests that antibody is essential for preventing primary infection. There will be more research data available about this over the coming months.

Q.  How safe are the vaccines and who will monitor their safety?

A.  All vaccines undergo extensive safety testing and must meet exacting standards to progress through the different stages of clinical trials. Their use must be approved and licensed before their use through expert review of all trial data through the Medicines and Healthcare products Regulatory Agency (MHRA). They check that the trial meets the necessary efficacy and safety levels. You can find out more about this process at http://vk.ovg.ox.ac.uk/vaccine-development

Q.  When will we know if the vaccines are working for the general population?

A.  The government is keeping tabs on infection by age and location.  We should start to see a fall in cases and hospitalisation in those groups targeted by the vaccine first within 2 months of the vaccination roll-out.

Q.  How will the safety of the vaccines be monitored after the vaccination programmes start?

A.  The safety of the vaccines will be monitored on an ongoing basis, as with all licensed drugs. This is undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme. Reports of suspected side effects are sent to the MHRA by drug companies (who are obliged to pass on any reports of suspected side effects that are defined as serious), health professionals, and patients themselves.

The data are evaluated each week, and the reported side effects are compared against the expected side effects as detailed in the information sheet for the vaccine. If a previously unidentified reaction emerges, or the frequency of reactions is not in line with what is expected, then the MHRA will investigate carefully. What happens next depends on the kind of side effect identified, but options include insisting that details of the new side effect are given in the product information leaflet or giving out warnings identifying groups of patients who should not be given the vaccine. In rare circumstances, the vaccine may be withdrawn from use.

Q.  Who decides on the priority list for a COVID vaccination programme?

A.  The Joint Committee on Vaccination and Immunisation (JCVI) provides advice to the Government about this. They examine data on who suffers the worst outcomes from coronavirus and who is at highest risk of death.  More information can be found at https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-25-september-2020

Q.  Who will be prioritised for the COVID vaccination programme?

A.  Age is, by far, the biggest risk factor for COVID so older age groups will be targeted first.

The current JCVI guidance says the order of priority would be as below:

This priority list is as follows:

  • residents in a care home for older adults and their carers
  • all those 80 years of age and over and frontline health and social care workers
  • all those 75 years of age and over
  • all those 70 years of age and over and clinically extremely vulnerable individuals
  • all those 65 years of age and over
  • all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
  • all those 60 years of age and over
  • all those 55 years of age and over
  • all those 50 years of age and over

It is estimated that taken together, these groups represent around 99% of preventable mortality from COVID-19.

Q.  How long will it take for herd immunity to COVID-19 to develop within the UK population?

A.  Herd immunity usually requires 60-70% of the population to have had the infection or be vaccinated, so in the UK that is approximately 40 million people.

Q.  Will the vaccines stop the spread of COVID?

A.  It is unlikely that a vaccination programme will be able to fully stop the spread of the COVID virus unless we see high level uptake of a highly effective vaccine. The disease may well become endemic in the global population like flu and have to be managed on a yearly basis through vaccination programmes.  This means that everyone, and most importantly those clinically vulnerable should continue to take measures to protect themselves from catching the virus.

Q.  How can I find out more about the development of COVID vaccines and vaccination programmes?

A.  These websites may be helpful:

https://wellcome.ac.uk/news/how-can-we-develop-covid-19-vaccine-quickly

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

https://www.bma.org.uk/advice-and-support/covid-19/gp-practices/covid-19-vaccination-programme

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/about-vaccines.html 

Page updated 15th July 2021

Useful info/sites:

Video from Public Health England : 3 min video from PHE on vaccine process

UK Government site : COVID Vaccine

USA FDA (Food & Drug Administration) :  COVID Vaccines

Centre for Disease Control and Prevention : Facts about COVID Vaccines