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SoG responds to latest MHRA guidance on the AstraZeneca vaccine

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Wednesday 07 April 2021

Today Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee for Vaccination and Immunisation (JCVI) have both reported an extremely rare adverse event of thrombosis (blood clots) and thrombocytopenia (low platelet count) following vaccination with the first dose of AstraZeneca ChAdOx1 nCoV-19 vaccine (AZD1222).

Dr Nicola Brink, Director of Public Health said:

'Of importance is the fact that vaccines are the Bailiwick's be9st way out of this pandemic and provide strong protection against COVID-19.

As of the 31 March MHRA reported 20.2 million doses of the COVID-19 Vaccine AstraZeneca had been given in the UK with an estimated overall risk of these blood clots is approximately 4 people in a million who receive the vaccine.

So, whilst the number of cases of blood clots show that the circumstances in which they happen are extremely rare, they must, of course be taken seriously.

The MHRA has recommended that, as a precaution, administration of COVID-19 Vaccine AstraZeneca in people of any age who are at higher risk of blood clots because of their medical condition should be considered only if benefits from the protection from COVID-19 infection outweighs potential risks.

In light of the MHRA data, the JCVI made a precautionary recommendation today, that adults aged 18-29 with no underlying medical condition that puts them in a high-risk group for vaccination should receive an alternative vaccine to Astra Zeneca at present.

With regards to the second dose, the MHRA are recommending that anyone who experienced cerebral or other major blood clots occurring with low levels of platelets after their first vaccine dose of COVID-19 Vaccine AstraZeneca, acknowledging that this is a very rare complication, should not have their second dose. Anyone who did not have these side effects should come forward for their second dose when invited.

We have been closely monitoring the data regarding the clotting issue and have been invited to observe various meetings of the Joint Committee on Vaccination and Immunisation (JCVI) over the Easter weekend to understand fully the risks of clotting compared to the benefits of receiving the AstraZeneca vaccine.

As a precautionary measure, and whilst we have continued to investigate these cases, we have advised anyone with a headache that lasts for more than 4 days after vaccination or bruising beyond the site of vaccination after a few days, to seek advice from their GP or, if urgent, the Emergency Department.'

Alex Hawkins-Drew, COVID-19 Vaccination Programme Lead, added:

'We have been aware of the reports of blood clots for a few weeks and have been closely following the data provided by the MHRA and the guidance of the JCVI, whilst the situation was investigated further.

In anticipation of an update from the MHRA a precautionary decision was made late last week to rearrange all vaccination clinics for those 50 years of age or younger so that they were given the Pfizer-BioNTech over the Easter weekend. Now we have the update from the MHRA and the new JCVI guidance, as an extra cautionary measure, we will continue to ensure that anyone under 30, with no underlying health risk, will receive the Pfizer-BioNTech vaccine (or the Moderna Vaccine when available) when they are invited to make their vaccine appointments.

I know a number in our community will be concerned as they have already received the AstraZeneca vaccine and they are in the age range impacted by this decision. If they haven't suffered from a headache that lasted for more than 4 days after vaccination or bruising beyond the site of vaccination after a few days and were generally well during the 7 to 14 days after they received the dose of vaccine, they are very unlikely to experience these side-effects. The data from the MHRA suggests that all reported adverse incidents of this type have been associated with the first dose of vaccine to date.

Those under 30 who are due to receive a second Astra Zeneca vaccine will continue to be administered with it - this approach is supported by the JVCI.'

Public Health Services staff are liaising with our colleagues in Alderney and Sark to understand the impact of the MHRA decision on the vaccination programmes in our sister islands. All vaccinations to date in Alderney and Sark have used the AstraZeneca vaccine due to logistical restrictions around the movement of the Pfizer-BioNTech vaccine following its arrival in Guernsey.

Unless you are in the group identified by the MHRA who should not receive the vaccine, or there is any other clinical reason why you shouldn't receive the AstraZeneca vaccine, we are unable to offer patients a choice over which vaccine they receive. It is important that you receive both doses of the vaccine offered with the agreed gap between doses (6 weeks for Pfizer-BioNTech and 10 weeks for AstraZeneca).

Further information can be obtained here:

https://www.gov.uk/government/publications/use-of-the-astrazeneca-covid-19-vaccine-jcvi-statement/jcvi-statement-on-use-of-the-astrazeneca-covid-19-vaccine-7-april-2021

https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots

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