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ELY PCNs – JCVI and MHRA AZ announcement.

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The UK vaccination programme has been very successful with more than 30 million people vaccinated and more than 6,000 lives already saved.

We have played an important part in the UK vaccination programme so far in Ely North and South PCNs with over 34,000 vaccines delivered, and over 90% of those delivered in our area. We are and should be truly proud of our achievements with our staff, volunteers and wonderful patients.

Late on the 7th of April we received an announcement regarding Astra-Zeneca vaccine and a rare clotting disorder. You will have been aware of media discussions for the last two weeks.

What is the concern?

Recently there have been reports of a very rare condition involving blood clots and unusual bleeding after vaccination. This is being carefully reviewed but the risk factors for this condition are not yet clear. Although this condition remains extremely rare there appears to be a higher risk in people shortly after the first dose of the AstraZeneca (AZ) vaccine. Around 4 people develop this condition for every million doses of AZ vaccine doses given.

This is seen slightly more often in younger people and tends to occur between 4 days and 2 weeks following vaccination. This condition can also occur naturally, and clotting problems are a very common complication of COVID-19 infection, so this is also important to consider. An increased risk has not yet been seen after other COVID-19 vaccines but is being carefully monitored.

What are the risks and benefits of vaccination?

The benefits of vaccination to both catching and transmitting COVID-19 still massively outweigh the risks of the clotting problems highlighted. That benefit still is significantly higher for those having the second dose and is important for all.

However, the benefit starts to be less for those individuals aged less than 30 when the rates of transmission of COVID-19 are low, and hence the change to offer an alternative vaccination from AZ if it is available for the first dose.

The side effects now to consider are;

Very common

  • sore arm
  • feeling tired
  • headache
  • general aches
  • flu like symptoms

Extremely rare

  • clotting problems

A really useful visual representation of potential benefits and harm is available in this link.

 

So what can we do?

Over 50 years of age or with underlying medical conditions JCVI Cohorts 1-9 (inc 18-29 cohorts 1-9)

All older adults (including health and social care workers over 50 years of age), care home residents, health and social care workers, unpaid carers and family members of those who are immunosuppressed, adults with certain medical conditions are being prioritised in the first phase of the programme because they are at high risk of the complications of COVID-19. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) advises that they should still receive any of the available COVID-19 vaccines. The benefits of vaccination in protecting them against the serious consequences of COVID-19 outweigh any risk of this rare condition. Patients should complete the course with the same vaccine they had for the first dose. If their first dose was with AZ vaccine without suffering any serious side effects, they should have the second dose on time as they may still be at high risk of the complications of COVID-19. Having the second dose will give them higher and longer lasting protection.

Healthy person over 30 to 50 years of age JCVI Cohorts 10-12 Phase 2 vaccination

The MHRA and the JCVI advises that all adults in this age group (including health and social care workers) should still receive any of the available COVID-19 vaccines. The benefits of vaccination in protecting patients and populations against the serious consequences of COVID-19 outweigh any risk of this rare condition. The completion of the vaccination course should be with the same vaccine.

Healthy younger person aged 18 to 29 (not cohort 1-9)

This is where the significant change has been announced.

The MHRA and the JCVI continue to monitor the benefits and safety of the AZ vaccine in younger people. They should carefully consider the risk to both themselves, family and friends of contracting and transmitting COVID-19 before making a decision*. Currently JCVI has advised that it is preferable for people under 30 to have a vaccine other than AZ. If they choose to have another COVID-19 vaccine they are likely to need to wait to be protected. They may wish to go ahead with the AZ vaccination after they have considered all the risks and benefits to them, their family, contacts and friends.

*Administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome should be only be considered when the potential benefit outweighs any potential risks. Patients who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca.

If after discussion individuals would like to go ahead with AZ that is fine and will be made available. If an individual chooses to have another first dose vaccine arrangement will be put in place by NHSE with PCN led LVS, hospital hubs etc. We are still awaiting guidance on how this will work.

National booking service patients will be cancelled and asked to contact their General practice sites.

What about the second dose?

If they have already had a first dose of AZ vaccine without suffering any serious side effects they should complete the course. This includes people aged 18 to 29 years who are health and social care workers, unpaid carers and family members of those who are immunosuppressed. It is expected that the first dose of the vaccine will have given you some protection, particularly against severe disease. At present choosing an alternative vaccine is not an option. It is important to remember the risks are exceedingly small and even more unlikely with the second dose.

What should I look out for after vaccination?

Although serious side effects are very rare, if patients experience any of the following from around 4 days to 4 weeks after vaccination, they should seek medical advice urgently.

  • a new, severe headache which is not helped by usual painkillers or is getting worse
  • a headache which seems worse when lying down or bending over or
  • an unusual headache that may be accompanied by: – blurred vision, nausea and vomiting – difficulty with your speech – weakness, drowsiness or seizures
  • new, unexplained pinprick bruising or bleeding
  • shortness of breath, chest pain, leg swelling or persistent abdominal pain

 

Thank you for your help and understanding. This is fresh information to all of us and still subject to change. We are trying our best to keep on top of it. Please remember that vaccination protects those most vulnerable and 126,000 people have died so far from COVID-19 infection in the UK alone. The risk associated with infection remains significant. We have used the government-released information to put this communication together. We are happy to share it with patients, social media and websites.

Please stay safe and continue with COVID-19 security measures. This terrible indiscriminate disease is still circulating locally and nationally.

 

Useful Links.

Slides showing the potential benefits and harms of the AZ vaccine

MHRA and JCVI announcement regarding AstraZeneca Vaccine and next steps

Information for healthcare professionals on blood clotting following COVID-19 vaccination

Patient-facing leaflet about COVID-19 vaccination and blood clotting