CORONAVIRUS VACCINATION - QUESTIONS AND ANSWERS – JANUARY 2021

Covid Vacciantion 19 FAQs

Why are you postponing second doses?

The UK Chief Medical Officers have agreed a longer timeframe between first and second doses so that more people can get their first dose quickly which will save more lives.

  1. The level of protection at 2 weeks after first dose is 90%, this rises to 95% after second dose, so the short term benefit of protection from just the first dose is extremely high and minimally improved by the second dose.
  2. The second dose is to give lasting protection and for most vaccines this is given 3 months after the first dose (as with the Astra Zeneca Vaccine) and not 3 weeks . It is thought that delaying the second dose to 3 months will actually give better lasting protection than at 3 weeks that was done in the Pfizer drug trials .

 This decision will allow us to get the maximum benefit for the most people in the shortest possible time and will help save lives.

We recognise for some people a longer wait might be worrying. Getting both doses remains important so we would urge people to return for it at the right time.

Are there any groups that shouldn’t have the vaccine?

Anybody with a history of immediate onset anaphylaxis to any vaccine/vaccine ingredient  (not food, medicine or insect sting  - this guidance has now been removed)   should not have either  vaccine

Individuals with a history of immediate onset-anaphylaxis to multiple classes of drugs or an unexplained anaphylaxis should not be vaccinated with the Pfizer BioNTech.

Anybody with symptoms proven by test to be due to covid or symptoms in the last 28 days.

The MHRA have updated their guidance to say that pregnant women and those who are breastfeeding can have the vaccine but should discuss it with a clinician to ensure that the benefits outweigh any potential risks.

Can I choose which vaccine I have?

No, the vaccine is allocated to vaccination centres and patients are invited depending on the risk and given the vaccine that is available at that time.

Both the Pfizer/BioNTech and Oxford/AstraZeneca COVID-19 vaccines are now available. Both vaccines have been shown to be safe and offer high levels of protection, and have been given regulatory approval by the MHRA.

The Government has in principle secured access to seven different vaccine candidates, across four different vaccine types, totalling over 357 million doses. This includes:  

•           40 million doses of the BioNTech/Pfizer vaccine 

•           100m doses of the Oxford/AstraZeneca vaccine.

•           7 million doses of the Moderna vaccine, which is also being assessed by the MHRA.

Who gets the vaccine first? 

The Joint Committee for Vaccination and Immunisation (JCVI) published its final advice on 2 December which can be found here: https://www.gov.uk/government/publications/prioritygroups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-2-december2020/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-2-december-2020

Practices have advised that vaccination centres should strictly adhere to this guidance

 Priority Group 1 : Care Homes and Carers

2: > 80yrs and frontline staff   -  health and social care workers at high risk     see appendix below or here

                          3: >75 yrs

                          4: > 70 yrs and all clinically “extremely vulnerable” –  See appendix below or here

                          5: >65yrs

6:  Existing Health Care conditions in the “at risk “ or “vulnerable” group –   See appendix below  here

                         7: >60 yrs  

  8: > 55yrs,

  9: > 50yrs 

Where will I have my vaccine?

You may have had an invitation telling you that you can have your Covid vaccination in Bournemouth, Christchurch, Bristol or at a Pharmacy that isn't local.

We would like to reassure you that you can still have your vaccine at Fordingbridge, simply wait for the surgery to contact you when it is your turn to book an appointment.

Please do not phone the surgery to ask when your appointment is likely to be, please leave the phone lines free for those that need to get through.

If you are 80 and over and haven't had your vaccine, please call the surgery and press option 5.

Is one better than the other?  

The important point for any vaccine is whether the MHRA approves it for use – if it does then that means it’s a worthwhile vaccine to have and people should have it if they are eligible. Data from clinical trials does suggest the Pfizer vaccine offers marginally more protection, but both are classed as highly effective.

Is the NHS confident the vaccines are safe? 

Yes. The NHS will not offer any Covid-19 vaccinations to the public until independent experts have signed off that it is safe to do so.  

The MHRA, the official UK regulator, have said that both of these vaccines have good safety profiles and offer a high level of protection, and we have full confidence in their expert judgement and processes.  

As with any medicine, vaccines are highly regulated products. 

There are checks at every stage in the development and manufacturing process, and continued monitoring once it has been authorised and is being used in the wider population.   

I am concerned I may be allergic to the vaccine ?

These vaccines are safe and effective for the vast majority of people – they have been tested on tens of thousands of people and assessed by experts. 

1.Any person with a history of immediate-onset anaphylaxis to the ingredients contained in the vaccines should not receive them. A second dose of the Pfizer/BioNTech vaccine should not be given to those who have experienced anaphylaxis to the first dose of Pfizer/BioNTech vaccination

2.Following close surveillance of the initial roll-out, the MHRA has advised that individuals with a history of anaphylaxis to food, an identified drug or vaccine, or an insect sting CAN receive any COVID-19 vaccine, as long as they are not known to be allergic to any component (excipient) of the vaccine. All recipients of the Pfizer BioNTech COVID-19 vaccine should kept for observation and monitored for a minimum of 15 minutes. Facilities for management of anaphylaxis should be available at all vaccination sites.’

3.Individuals with a history of immediate onset-anaphylaxis to multiple classes of drugs or an unexplained anaphylaxis should not be vaccinated with the Pfizer BioNTech vaccine. The AstraZeneca vaccine can be used as an alternative (if not otherwise contraindicated)’

Everybody will also be screened for potential allergic reactions before getting vaccinated. All vaccinators will have the training they need to deal with any rare cases of adverse reactions, and all venues will be equipped to care for people who need it – just like with any other vaccine.

Checking for allergies is a routine part of the process before giving any vaccine or new medicine. Having these conversations – as well as being able to deal with allergic reactions in the rare case they do happen, is a central part of training for vaccinators. But these are new vaccines and so the NHS and the MHRA are being extra vigilant and responding quickly to ensure everyone across the NHS is totally clear on these requirements. 

Are there any side effects? 

These are important details which the MHRA always consider when assessing candidate vaccines for use. 

For these vaccines, like lots of others, they have identified that some people might feel slightly unwell, but they report that no significant side effects have been observed in the tens of thousands of people involved in trials. 

All patients will be provided with information on the vaccine they have received, how to look out for any side effects, and what to do if they do occur, including reporting them to the MHRA.

More information on possible side effects can be found at https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

Why are healthcare workers amongst the first groups to receive the vaccine?

The JCVI have put patient-facing health and social care staff into a priority group because of their heightened risk of exposure to the virus. Healthcare workers are not the top priority though, and with limited vaccine available up to now, employers have been asked to offer the vaccine to the most at risk healthcare workers first. With many more doses now expected over the coming weeks, employers will be widening this out and protecting staff as soon as possible.

The NHS is experienced in vaccinating hundreds of thousands of staff quickly and safely – we do it every year for the flu vaccine – and all local NHS employers will be responsible for ensuring that 100% of eligible staff have the opportunity to take it up over the coming weeks and months.

Why aren’t all healthcare workers getting vaccinated right now?

The Government have confirmed that the vast majority of vaccinations administered by the NHS in this initial phase will be prioritised for those 80 years of age and over and care home residents and workers.

Up to now some staff have been vaccinated to avoid doses going to waste, with employers asked to identify those who can benefit most to go first using the risk assesment framework to identify those at greatest risk. Over the following days and weeks as we get more supplies this will continue to be rolled out.

How will healthcare workers get the vaccine? See our information here about local arrangements.

The NHS will offer vaccinations using different models. For healthcare workers, dozens of NHS trusts will act as hospital hubs where NHS staff can get vaccinated on site.

Women who are pregnant

There is no known risk associated with giving non-live vaccines during pregnancy. These vaccines cannot replicate, so they cannot cause infection in either the woman or the unborn child.

Although the available data does not indicate any safety concern or harm to pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy.

JCVI advises that, for women who are offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines, vaccination in pregnancy should be considered where the risk of exposure to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2) infection is high and cannot be avoided, or where the woman has underlying conditions that put them at very high risk of serious complications of COVID-19. In these circumstances, clinicians should discuss the risks and benefits of vaccination with the woman, who should be told about the absence of safety data for the vaccine in pregnant women.

Vaccination of Children

Recommendations on vaccinating children with other underlying conditions will be reviewedafter the initial roll-out phase by which time additional data on use of the vaccines in adults  should allow a better assessment of risks and benefits.

Women who are breastfeeding

There is no known risk associated with giving non-live vaccines whilst breastfeeding. JCVI advises that breastfeeding women may be offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines.

Can any member of the public be vaccinated? Can they just walk in to a service?

People will be offered vaccinations in line with recommendations from the independent JCVI – see above listing different priority groups.   The NHS will contact people when it is their turn.  People will need an appointment to get their vaccine; most people will be invited by letter from their GP practice or the national programme.

Should people who have already had Covid get vaccinated?  

Yes, if they are in a priority group identified by JCVI. The MHRA have looked at this and decided that getting vaccinated is just as important for those who have already had Covid-19 as it is for those who haven’t. Their vaccination should be delayed until 4 weeks after their symptoms have settled.

Will the vaccines work with the new strain?

There is no evidence currently that the new strain will be resistant to the vaccines we have, so we are continuing to vaccinate people as normal. Scientists are looking now in detail at the characteristics of the virus in relation to the vaccines. Viruses, such as the winter flu virus, often branch into different strains but these small variations rarely render vaccines ineffective. 

Will you use the Oxford/AstraZeneca vaccine more because it’s cheaper and easier to store? 

The vaccines that the NHS uses and in what circumstances will be decided by the MHRA. Both vaccines are classed as being very effective. The Oxford/AstraZeneca is easier to store and transport, meaning we can deliver them in more places, and we expect to have more doses available as they are manufactured in the UK, so we would expect that most people are likely to receive this vaccine over the coming weeks and months. 

Do I need to leave a space between having the flu vaccine and having the Covid vaccine?

It is not essential to leave time between the flu and Covid vaccine but it is recommended that there should be a gap of a week.

We would always encourage anyone who is eligible but not yet taken up their flu jab to do so as soon as possible.

If a household has a priority group member, such as an NHS frontline worker or vulnerable person, will everyone living in that household be vaccinated together?  

These decisions are for the JCVI. Their current prioritisation plan does not include household members of NHS staff or clinically vulnerable people automatically – although in some cases family members may be eligible in their own right. 

Can I get one privately? 

No. Vaccinations will only be available through the NHS for the moment. Anyone who claims to be able to provide you with a vaccine for a fee is likely to be committing a crime and should be reported to the Police online or by calling 112.

When will you publish vaccine ingredients? 

A detailed review of the vaccines and their ingredients have been provided by the MHRA and can be found at the following links:

For the Pfizer/BioNTech vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

For the Oxford/AstraZeneca vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

The British Islamic Medical Association have produced a helpful guide for the Muslim community which can be found at https://britishima.org/pfizer-biontech-covid19-vaccine/

How effective are the vaccines?  How long do they take to work? 

The MHRA have said these vaccines are highly effective, but to get full protection people need to come back for the second dose – this is really important. 

To ensure as many people are vaccinated as quickly as possible, the Department for Health and Social Care now advise that the second dose of both the Oxford AstraZeneca and the Pfizer/BioNtech vaccine should be scheduled up to 12 weeks apart.

Full protection kicks in around a week or two after that second dose, which is why it’s also important that when you do get invited, you act on that and get yourself booked in as soon as possible. Even those who have received a vaccine still need to follow social distancing and other guidance. 

What happens if a person has the first jab but not the second? 

Both vaccines have been authorised on the basis of two doses because the evidence from the clinical trials shows that this gives the maximum level of protection.

To ensure as many people are vaccinated as quickly as possible, the Department for Health and Social Care now advise that the second dose of both the Oxford/AstraZeneca and the Pfizer/BioNtech vaccine should be scheduled up to 12 weeks apart.

The evidence doesn’t show any risk to not having the second dose other than not being as protected as you otherwise would be. We would urge everyone to show up for both of their appointments for their own protection as well as to ensure we don’t waste vaccines or the time of NHS staff. 

How will you monitor safety?  Are we using the yellow card system?

As will all vaccinations and medicines, patient safety is the NHS number one priority.  Public Health England have robust systems in place to monitor surveillance and will be following incident reporting protocols in the usual way.  

Were the trial participants reflective of a multi-ethnic population?

The Public Assessment Reports contain all the scientific information about the trials and information on trial participants.

For the Pfizer trial, participants included 9.6% black/African, 26.1% Hispanic/Latino and 3.4% Asian. 

For the Oxford/AstraZeneca vaccine 10.1% of trail recipients were Black and 3.5% Asian.

There is no evidence either of the vaccines will work differently in different ethnic groups.

Were the vaccines tested on high risk groups?

For both vaccines trial participants included a range of those from various ages, immune-compromised and those with underlying health conditions, and both found the efficacy of the vaccine translates through all the subgroups.

Details of trial participants for both vaccines are published online.

For the Pfizer/BioNtech vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

For the Oxford/AstraZeneca vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

Does the vaccine include any parts from foetal or animal origin?

There is no material of foetal or animal origin in either vaccine. All ingredients are published in healthcare information on the MHRA’s website.

For the Pfizer/BioNTech vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

For the Oxford/AstraZeneca vaccine information is available here: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

Can the vaccine alter your genetic material?

There is no evidence to suggest that individual genetic material will undergo an alteration after receiving the vaccine

How does the vaccine work?

The vaccine works by making a protein from the virus that is important for creating protection. 

The protein works in the same way they do for other vaccines by stimulating the immune system to make antibodies and cells to fight the infection.

How long will my vaccine be effective for?

We expect these vaccines to work for at least a year – if not longer. This will be constantly monitored.

Does the vaccine work on those taking immune suppressants?

Although the vaccine was not tested on those with very serious immunological conditions, the vaccine has been proven to be very effective and it is unlikely that the vaccine will have no effect at all on these individuals. 

There may be a very small number of people with very complex or severe immunological problems who can’t make any response at all – but the vaccine should not do any harm to these individuals. Individuals meeting these criteria may want to discuss the vaccine further with their specialist doctor.

 Appendix 1. Definition of clinically “extremely vulnerable groups”  also known as”shielded patients” and  “very high risk” offered Covid  Vaccine in Priority Risk Gp 4

These patients will have been identified by their GP or hospital Specialist. They will have received letter directly from the Health Secretary and from their GP advising them they are in the above groups . They are a relatively small group of patients at the very highest risk from Coronavirus

•solid organ transplant recipients

•people with cancer who are undergoing active chemotherapy

•people with lung cancer who are undergoing radical radiotherapy

•people with cancers of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at any stage of treatment

•people having immunotherapy or other continuing antibody treatments for cancer

•people having other targeted cancer treatments that can affect the immune system, such as protein kinase inhibitors or PARP inhibitors

•people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs

•people with severe respiratory conditions including all cystic fibrosis, severe asthma (requires continuous or repeated use of systemic steroids or with previous exacerbations requiring hospital admission ) and severe chronic obstructive pulmonary disease  = COPD (defined as  patients on triple therapy inhalers )

•people with rare diseases that significantly increase the risk of infections (such as severe combined immunodeficiency (SCID), homozygous sickle cell disease)

•people on immunosuppression therapies sufficient to significantly increase risk of infection (on two or more immunosuppressant  medicines or on Prednisolone 20mg/D or more)

•problems with your spleen, for example splenectomy (having your spleen removed)

•adults with Down’s syndrome

•adults on dialysis or with chronic kidney disease (stage 5)

•women who are pregnant with significant heart disease, congenital or acquired

•other people who have also been classed as clinically extremely vulnerable, based on clinical judgement and an assessment of their needs. GPs and hospital clinicians have been provided with guidance to support these decisions

https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19#cev

Appendix 2. Clinical Risk Groups “At moderate Risk” “Clinically vulnerable”

Chronic respiratory

Individuals with a  lung condition, including those with asthma , and chronic obstructive

pulmonary disease (COPD) including chronic bronchitis and emphysema;

bronchiectasis, interstitial lung fibrosis, pneumoconiosis and

bronchopulmonary dysplasia (BPD).

Chronic heart disease and vascular disease

Congenital heart disease, hypertension with cardiac complications, chronic

heart failure, individuals requiring regular medication and/or follow-up for

ischaemic heart disease. This includes individuals with atrial fibrillation,

peripheral vascular disease or a history of venous thromboembolism.

Chronic kidney disease

Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic

syndrome, kidney transplantation.

Chronic liver disease Cirrhosis, biliary atresia, chronic hepatitis.

Chronic neurological disease

Stroke, transient ischaemic attack (TIA). Conditions in which respiratory

function may be compromised due to neurological disease (e.g. polio

syndrome sufferers). This includes individuals with cerebral palsy, severe or

profound learning disabilities, Down’s Syndrome, multiple sclerosis,

epilepsy, dementia, Parkinson’s disease, motor neurone disease and related

or similar conditions; or hereditary and degenerative disease of the

nervous system or muscles; or severe neurological disability.

Diabetes mellitus Any diabetes, including diet-controlled diabetes.

Immunosuppression  HIV infection at all stages, or genetic disorders affecting the immune system (e.g.IRAK-4, NEMO, complement disorder, SCID).

Individuals who are receiving immunosuppressive or immunomodulating

biological therapy including, but not limited to, anti-TNF, alemtuzumab,

ofatumumab, rituximab, patients receiving protein kinase inhibitors or

PARP inhibitors, and individuals treated with steroid sparing agents such as

cyclophosphamide and mycophenolate mofetil.

Those with systemic lupus erythematosusand rheumatoid arthritis, and psoriasis who may require long termimmunosuppressive treatments.

Those with possible splenic dysfunction, such ashomozygous sickle cell disease, thalassemia major and coeliac syndrome.

Morbid obesity Adults with a Body Mass Index ≥40 kg/m².

Severe mental illness Individuals with schizophrenia or bipolar disorder, or any mental illness that causes severe functional impairment.

Adult carers Those who are in receipt of a carer’s allowance, or those who are the main carer of an elderly or disabled person whose welfare may be at risk if thecarer falls ill.