What you wanted to know about the vaccine

Frequently Asked Questions and Answers

Download this information as a pdf here.

 

361 staff responded to our survey in which we asked: What would you find helpful to know about the vaccine before having it? Below we have compiled the most frequently asked questions and answers, which we have drawn together from information published by the NHS.UK website, Public Health England and the Medicines and Healthcare products Regulatory Agency (MHRA).  At the end of this document is a list of key leaflets and sources of further information. This FAQ was last updated on 6 Jan 2021, in line with changing national guidance.

 

FAQ list

 

 

 

1.Which vaccine will I be offered?

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised two vaccines for deployment across the UK:

At the moment, UHP only has supplies of the Pfizer/BioNTech vaccine. We will let colleagues know when we receive delivery of the Astra Zeneca vaccine.

 

 

2.What are the side effects – type and incidence of?

 

Pfizer vaccine

Public Health England advises[i]: Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, and not everyone gets them. Even if you do have symptoms after the first dose, you still need to have the second dose. Although you will get some protection from the first dose, having the second dose will give you the best protection against the virus.

 

Very common side effects include:

  • having a painful, heavy feeling and tenderness in the arm where you had your injection. This tends to be worst around 1-2 days after the vaccine
  • feeling tired
  • headache
  • general aches, or mild flu like symptoms
  • Although feeling feverish is not uncommon for 2 to 3 days, a high temperature is unusual and may indicate you have COVID-19 or another infection.
  • You can take the normal dose of paracetamol (follow the advice in the packaging) and rest to help you feel better. Do not exceed the normal dose.

 

These symptoms normally last less than a week. If your symptoms seem to get worse or if you are concerned, call NHS 111. If you do seek advice from a doctor or nurse, make sure you tell them about your vaccination (show them the vaccination card) so that they can assess you properly.

You can also report suspected side effects of vaccines and medicines online through the Yellow Card scheme or by downloading the Yellow Card app.

 

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[ii]The Medicines and Healthcare products Regulatory Agency (MHRA) advises that: Like all vaccines, COVID-19 mRNA Vaccine BNT162b2 can cause side effects, although not everybody gets them. Most side effects are mild or moderate and go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.

Side effects may occur with following frequencies:

Very common: may affect more than 1 in 10 people

  • pain at injection site
  • tiredness
  • headache
  • muscle pain
  • chills
  • joint pain
  • fever

Common: may affect up to 1 in 10 people

  • injection site swelling
  • redness at injection site
  • nausea

Uncommon: may affect up to 1 in 100 people

  • enlarged lymph nodes
  • feeling unwell
     

Further reading
MHRA  further information for healthcare practitioners (more detailed info)

 

3. Is it safe?

 

The NHS UK site says[iii]: The vaccine approved for use in the UK was developed by Pfizer/BioNTech. It has met strict standards of safety, quality and effectiveness set out by the independent Medicines and Healthcare products Regulatory Agency (MHRA).

Any coronavirus vaccine that is approved must go through all the clinical trials and safety checks all other licensed medicines go through. The MHRA follows international standards of safety.

Other vaccines are being developed. They will only be available on the NHS once they have been thoroughly tested to make sure they are safe and effective.


The Medicines and Healthcare products Regulatory Agency gives more detail on specific groups and the safety profile:[iv]

Paediatric population: The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age have not yet been established.
 

Summary of safety profile
The safety of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older. In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of COVID19 mRNA Vaccine BNT162b and 21,728 participants 16 years of age or older received placebo. Out of these, at the time of the analysis, 19,067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536 placebo) were evaluated for safety 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2.

Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA Vaccine and those who received placebo. Overall, among the participants who received COVID-19 mRNA Vaccine BNT162b2, 51.5% were male and 48.5% were female, 82.1% were White, 9.6% were Black or African American, 26.1% were Hispanic/Latino, 4.3% were Asian and 0.7% were Native American/Alaskan native.

The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used.

 

4. Is it effective?

 

Public Health England says[v]: The COVID-19 vaccination will reduce the chance of you suffering from COVID-19 disease. Like all medicines, no vaccine is completely effective and it takes a few weeks for your body to build up protection from the vaccine. Some people may still get COVID-19 despite having a vaccination, but this should lessen the severity of any infection

The vaccine has been shown to be effective and no safety concerns were seen in studies of more than 20,000 people.

Can you catch COVID-19 from the vaccine?
You cannot catch COVID-19 from the vaccine but it is possible to have caught COVID-19 and not realise you have the symptoms until after your vaccination appointment. Please continue to have the regular screening tests that your employer arranges.

 

5. Is it safe for those with pre-existing conditions?  e.g I am on immunosuppressants, is it safe to have the vaccine?

 

The MHRA advises[vi]: Talk to your doctor, pharmacist or nurse before you are given the vaccine if you have:

  • had a serious allergic reaction to a previous vaccine, medicine or food
  • had any problems following previous administration of COVID-19 mRNA Vaccine BNT162b2 such as allergic reaction or breathing problems
  • a severe illness with high fever
  • However, a mild fever or upper airway infection, like a cold, are not reasons to delay vaccination.
  • a weakened immune system, such as due to HIV infection, or are on a medicine that affects your immune system
  • a bleeding problem, bruise easily or use a medicine to inhibit blood clotting

As with any vaccine, COVID-19 mRNA Vaccine BNT162b2 may not fully protect all those who receive it. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
 

6. Is it safe for Women of childbearing age, pregnant, planning a pregnancy or breastfeeding?

 

The NHS advises[vii]: There’s no evidence the COVID-19 vaccine is unsafe if you’re pregnant or breastfeeding. But more evidence is needed before you can be routinely offered the vaccine.

 

The JCVI has updated its advice to recommend you may be able to have the vaccine if you're:

 

  • pregnant and at high risk of serious complications of Coronavirus
  • if you're breastfeeding
  • Speak to a healthcare professional before you have the vaccination. They will discuss the benefits and risks of the COVID-19 vaccine with you.

 

You do not need to avoid pregnancy after vaccination. The vaccine cannot give you or your baby COVID-19.

Read the latest COVID-19 vaccine advice if you're pregnant, may get pregnant or are breastfeeding on GOV.UK

 

Note from UHP: If you are a member of staff who falls into this category, please note you will be able to have access to a doctor when you attend the vaccination clinic to discuss your circumstances in more detail.

 

 

7. What is the dosage needed and when?

 

Both the Pfizer/BioNTech and the AstraZeneca vaccines are given in two doses. The Joint Committee on Vaccination and Immunisation (JCVI) changed its guidance on the maximum time between the two doses of both the Pfizer-BioNtech and AstraZeneca vaccines from 21 and 28 days respectively, to up to 12 weeks.

 

Public Health England explains[viii]: You should have a record card with your next appointment, which should be between 3 and 12 weeks later. It is important to have both doses of the same vaccine to give you the best protection.

 

In a short statement on 31 December, the Joint Committee on Vaccination and Immunisation (JCVI) wrote[ix]: “Given the epidemiology of COVID-19 in the UK in late 2020 there is a need for rapid, high levels of vaccine uptake amongst vulnerable persons.

“The Committee supports a two-dose vaccine schedule for the Pfizer-BioNTech and AstraZeneca vaccines. Given the data available, and evidence from the use of many other vaccines, JCVI advises a maximum interval between the first and second doses of 12 weeks for both vaccines. It can be assumed that protection from the first dose will wane in the medium term, and the second dose will still be required to provide more durable protection.”

 

8. What is in the vaccine?

 

The MHRA outlines[x]:

What COVID-19 mRNA Vaccine BNT162b2 contains:

  • The active substance is BNT162b2 RNA.

After dilution, the vial contains 5 doses, of 0.3 mL with 30 micrograms mRNA each.

  • This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159

The other ingredients are:

  • ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
  • ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • 1,2-Distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol
  • potassium chloride
  • potassium dihydrogen phosphate
  • sodium chloride
  • disodium hydrogen phosphate dehydrate
  • sucrose
     

NHS.UK is clear that:[xi] The COVID-19 vaccine does not contain any animal products or egg.

 

9.Does it help reduce spread?
 

Public Health England states:[xii] The vaccine cannot give you COVID-19 infection, and a full course will reduce your chance of becoming seriously ill. We do not yet know whether it will stop you from catching and passing on the virus, but we do expect it to reduce this risk. So, it is still important to follow the guidance in your local area to protect those around you.

 

 

10. Do I have to have the vaccine if I’m offered it?

 

No, it is not mandatory but if you are offered the vaccine, we would encourage you to take up the offer.

 

 

 

11. Should people who have already had?COVID?get vaccinated?

 

Yes, if they are in a priority group identified by the Joint Committee of Vaccination and Immunisation. 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. 

 

 

 

12. If I have had COVID how long should I wait before getting my vaccine?

The Green book advises[xiii]: Vaccination of individuals who may be infected or asymptomatic or incubating COVID-19 infection is unlikely to have a detrimental effect on the illness. Vaccination should be deferred in those with confirmed infection to avoid confusing the differential diagnosis. As clinical deterioration can occur up to two weeks after infection, ideally vaccination should be deferred until clinical recovery to around four weeks after onset of symptoms or four weeks from the first confirmed positive specimen in those who are asymptomatic.

Having prolonged COVID-19 symptoms is not a contraindication to receiving COVID-19 vaccine but if the patient is seriously debilitated, still under active investigation, or has evidence of recent deterioration, deferral of vaccination may be considered to avoid incorrect attribution of any change in the person’s underlying condition to the vaccine.

 

 

13. Will I be given a certificate to say I have had the vaccine?

No

 

14. How long does protection last?

 

Public Health England advises[xiv]: As COVID-19 vaccines have only been given in clinical trials in recent months, there is currently no data available to describe how long protection from vaccination will last. Post-authorisation surveillance and continued follow-up of trial participants may indicate the need for booster doses but they are not currently recommended.

 

 

15. After I have the vaccine will I still need to follow all the infection control advice?

In its guidance for Healthcare workers, Public Health England says[xv]: The vaccine cannot give you COVID-19 infection, and 2 doses will reduce your chance of becoming seriously ill. No vaccine is completely effective and it will take a few weeks for your body to build up protection. So, you will still need to follow the guidance in your workplace, including wearing the correct personal protection equipment and taking part in any screening programmes.

 

 

16. Who is still excluded from having the vaccine?

The Patient Group Direction (PGD) states the following are currently excluded:

Individuals for whom valid consent, or ‘best-interests’ decision in accordance with the Mental Capacity Act 2005, has not been obtained.

Individuals who:

  • are less than 16 years of age
  • have had a previous systemic allergic reaction (including immediate onset anaphylaxis) to a previous dose of COVID-19 mRNA vaccine BNT162b2 or to any component of the vaccine or residues from the manufacturing process
  • have a history of immediate-onset anaphylaxis to multiple classes of drugs or unexplained anaphylaxis
  • are pregnant (though can be vaccinated if  high risk)
  • are suffering from acute severe febrile illness (the presence of a minor infection is not a contraindication for vaccination)
  • are participating in a clinical trial of COVID-19 vaccines
  • have received a dose of COVID-19 vaccine in the preceding 21 days
  • have completed a course of COVID-19 vaccination

 

 

 

[i] Source: Public Health England COVID-19 vaccination: guide for healthcare workers (Published 7 December 2020) Available at: https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-healthcare-workers/covid-19-vaccination-guide-for-healthcare-workers

 

[ii] Source: Medicines and Healthcare products Regulatory Agency (MHRA). Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Updated 10 December 2020) Available at: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine

 

[iii] Source: NHS website https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

 

[iv] Source: Medicines and Healthcare products Regulatory Agency (MHRA). Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine (Updated 10 December 2020) https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine

 

[v] Source: Public Health England COVID-19 vaccination: guide for healthcare workers (Published 7 December 2020) Available at: https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-healthcare-workers/covid-19-vaccination-guide-for-healthcare-workers

 

[vi] Source: Medicines and Healthcare products Regulatory Agency (MHRA). Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Updated 10 December 2020) Available at: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine

 

[vii] Source: NHS website (2021) Advice if you're of childbearing age, pregnant or breastfeeding  (Updated 31 December 2020) Available at: https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

 

[viii] Source: Public Health England COVID-19 vaccination: guide for healthcare workers (Published 7 December 2020) Available at: https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-healthcare-workers/covid-19-vaccination-guide-for-healthcare-workers

 

[ix] Source: JCVI Optimising the COVID-19 vaccination programme for maximum short term impact (Published 31 December) available at:

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103741

 

 

[x] Source: Medicines and Healthcare products Regulatory Agency (MHRA)

Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine

Updated 10 December 2020 Available at: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine

 

[xi]  Source: https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

 

 

[xii] Source: Public Health England COVID-19 vaccination: guide for healthcare workers (Published 7 December 2020) Available at: https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-healthcare-workers/covid-19-vaccination-guide-for-healthcare-workers

 

[xiii] Source: Green book (Dec 2020) https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a

 

 

[xiv] Public Health England COVID-19 vaccination programme: Information for healthcare practitioners

(Republished December 2020 Version 02.00) available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941236/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V2.pdf

 

[xv] Source: Public Health England COVID-19 vaccination: guide for healthcare workers (Published 7 December 2020) Available at: https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-healthcare-workers/covid-19-vaccination-guide-for-healthcare-workers

 

 

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