Adrian

I have passed your email onto the business area tasked with answering your request and asked them to contact you.

I should point out that as you did not ask for recorded information the request was not handled under FOI legislation. Nevertheless you should receive a response

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Adrian

Apologises for my email below. I am having problems with the email system this morning.

My last line should have read "...a response soon".

Again apologises

Regards

Jeff

Jeff Burns
Information Management Branch
Department of Health (NI)

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Adrian

Apologises. I have asked the business area dealing with your request again to contact you with a response.

Regards

Jeff

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Dear Adrian,

Thank you for your email of 28th December to the Department of Health. I apologise for the delay in replying - we have been receiving a large amount of emails.

As you will be aware, your initial request was not accepted under Freedom of Information legalisation. The request was not in accordance of the terms of the Act as it did not request us to supply recorded information held at the time (s1(4) FOIA).

Throughout the course of the Northern Ireland COVID-19 vaccination programme, we have been guided by the expert advice of the independent Medicines and Healthcare products Regulatory Agency (MHRA) and The Joint Committee on Vaccination and Immunisation (JCVI).

The JCVI is an independent expert advisory committee that advises United Kingdom health departments on immunisation, making recommendations concerning vaccination schedules and vaccine safety.

In the UK, vaccines are only approved and deployed for use following rigorous clinical trials and extensive analysis of the vaccine’s safety, quality and effectiveness by experts from the MHRA. A detailed review of the vaccines in use and their ingredients can be found at the following links:
• https://www.gov.uk/government/publicatio...
• https://www.gov.uk/government/publicatio...
• https://www.gov.uk/government/publicatio...

After reviewing data on booster responses from different combinations of COVID-19 vaccines, JCVI advises a preference for the Pfizer-BioNTech (BNT162b2/ Comirnaty®) vaccine to be offered as the third booster dose irrespective of which product was used in the primary schedule. There is good evidence that the Pfizer-BioNTech (BNT162b2/ Comirnaty®) vaccine is well tolerated as a third dose and will provide a strong booster response. Alternatively, individuals may be offered a half dose (50µg) of the Moderna (mRNA-1273/Spikevax®) vaccine, which should be well tolerated and is also likely to provide a strong booster response. A half dose (50µg) of Moderna (mRNA-1273/Spikevax®) vaccine is advised over a full dose due to the levels of reactogenicity seen following boosting with a full dose within the COV-BOOST trial. Where mRNA vaccines cannot be offered e.g. due to contraindication, vaccination with the AstraZeneca (ChAdOx1-S/Vaxzevria®) vaccine may be considered for those who received AstraZeneca (ChAdOx1-S/Vaxzevria®) vaccine in the primary course.

In connection to this advice, we are primarily using licensed Pfizer and Moderna stock, which are two vaccines currently being administered in NI, so although the emergency use authorisations (EUA) have not been formally withdrawn by MHRA, at this stage, in reality they are no longer relevant.

Comirnaty (Pfizer) obtained a conditional marketing authorisation from the EMA on 21 Dec 2020 and Spikevax (Moderna) obtained a conditional marketing authorisation from the EMA on 6 January 2021 - both authorisations apply in Northern Ireland, and the stock in use is deployed in line with these authorisations.

Vaxzevria (AZ) obtained a conditional marketing authorisation from the EMA on 29 January 2021, which also applies in NI - at this time the stock deployed here is still pre-commercial stock authorised under Reg 174, although very low numbers of the AZ vaccine are now being used here as JCVI have recommended that a mRNA vaccine (Pfizer or Moderna) is preferred for use as a booster dose. We understand, however that AZ plan to transition to commercial AZ stock in March / April of this year, which will be authorised in NI by the EMA authorisation.

You may wish to direct specific vaccine queries to MHRA, such as when the EUA will be withdrawn directly with the MHRA, as they are responsible for granting the EUA and would be better placed to advise on when they will withdraw it.

The MHRA operates the Yellow Card Scheme on behalf of the Commission on Human Medicines, collecting and monitoring information on suspected safety concerns or incidents. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The Yellow Card Scheme plays a central role in public health protection in the UK by the continuous monitoring of the safety of medicines and medical devices during normal clinical use.

Further information on vaccine safety can be found at the following link:

https://www.nidirect.gov.uk/articles/cor...

Regards,

Lynsey

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