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MNHQ

Have you had the first dose of the AstraZeneca vaccine in the last 6 weeks?

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JustineBMumsnet · 26/05/2021 17:49

We’ve been asked by the Drug Safety Research Unit to find Mumsnet users who have had the first dose of the AstraZeneca COVID-19 vaccine in the last 6 weeks to take part in a project to monitor the effects of the vaccine. You can take part whether or not you’ve experienced any symptoms following the vaccine

Below you’ll find some information on the project from Dr Liz Lynn, Head of Scientific and Educational Development, Drug Safety Research Unit:

“Hi, I’m Liz, and I’m from an organisation called the Drug Safety Research Unit (DSRU). We’re an independent academic unit and registered charity, established in 1981 and based in Southampton. Whilst all medicines are subject to thorough testing for efficacy and safety before being made available, continued monitoring to gather information in ‘real life’ is always essential too. That’s where we come in.

We’re currently working on a project to monitor the Oxford-AstraZeneca COVID-19 vaccine. This study is supported by a consortium of doctors, pharmacists and scientists from 12 UK universities and NHS trusts. Data collected will be shared with the manufacturer, the UK’s regulating body, and the results will be publicly available too.

For the study, we’re asking anyone who has had their first dose of this vaccine within the last 6 weeks to sign up to this questionnaire-based study. The initial sign-up phase takes around 10 mins, and participants will then be contacted via chosen method (text, email or phone) for a few follow-up questions over the course of the next 18 months. Of course, opting out at any stage is possible.

People have stepped up to volunteer in so many ways during the course of the pandemic, but the fight continues and ongoing research is a vital part of this. We’ve been grateful to the thousands who have already signed up over the last few months but we need more! In total we’re looking for 20,000 UK volunteers to help us with the trial, before their short 6 week window has passed. Please help by signing up, or sharing with others who you know fit this description. You can sign up and find more information available here.

Thank you for playing your part!”

Please note this project is not being run by Mumsnet, and if you sign up you will be sharing your details with DSRU.

Thanks
MNHQ

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MNHQ

JustineBMumsnet · 27/05/2021 16:28

Hi all, in response to a few of the comments on this thread, here’s a bit more information from the study team at the DSRU:

"- The DSRU is an independent unit and registered charity, not a pharmaceutical company or a government agency. We are commissioned by a wide range of parties to run ‘at arms-length’ studies, where we hold responsibility as study sponsor, which is independent to the study funder role. Our studies are subject to the highest level of scrutiny and standards, both in methodologies used and governance

- Studies to look at what is happening once medicines/ vaccines have been approved for use (so called ‘post-authorisation studies’) are an essential component of every drug’s development, and are just one part of the ongoing monitoring process (other measures include schemes like the MHRA’s yellow card reporting system and also medicines manufacturers will also run their own post-approval studies)

- This particular study has been designed with the unique aspects of COVID-19 in mind, where we know speed of data collection is vital. The study is designed so that any concerns regarding safety or efficacy can be detected and acted upon quickly, in near-real time

- Since January we have encouraged people to register their interest for this study before they have received the first dose of COVID-19 vaccine (and before they know which vaccine they will receive). Throughout the study we have requested that people take part whether or not they have experienced any suspected side effects since their vaccination.

- There’s lots more information available on our website about our organisation and the study details – www.dsru.org. Apologies that we can’t provide everything on this thread! Thank you for helping to further our understanding of COVID-19 and the vaccine response."

MNHQ

JustineBMumsnet · 01/06/2021 17:30

Hi all, the DSRU has asked us to pass on the following, which outlines how this study differs from the Yellow Card scheme.

"The Yellow Card scheme is a well-established system for reporting suspected side effects of medicines in the UK (set up in 1964 by Dr Bill Inman, who subsequently established the Drug Safety Research Unit and became our first Director). It is the UK’s national system for spontaneous reporting, and as such requires the reporter to suspect that there is a link between the symptom and the medicine or vaccine. The Yellow Card scheme and post-authorisation studies like ours are two of several methods for monitoring the safety of a newly approved medicine or vaccine. Our study on the AstraZeneca vaccine is an example of active surveillance, where we ask participants for details of any symptoms they have experienced, without relying on the participant to suspect that there is a link between the symptom and the vaccine. Crucially this active surveillance approach allows us to collate data from a large number of vaccinees, which can reveal some rare side effects which were not previously linked to the vaccine or medicine. It is a legal requirement to conduct this type of monitoring under UK and EU Pharmacovigilance legislation. We invite volunteers to register for our study whether or not they have had symptoms after their Oxford-AstraZeneca vaccination. Those who have had symptoms can also submit information to the Yellow Card scheme. Thank you"

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