EU medicines regulator backs safety of AstraZeneca vaccine

The regulator has said there is "no indication" that suggests it increases chances of blood clots

Author: Sophie ParsonsPublished 16th Mar 2021
Last updated 24th May 2022

The EU medicines regulator has stressed that there is "no indication" that the AstraZeneca Covid-19 vaccine is associated with causing reported blood clots.

Speaking at a virtual press conference, executive director of the European Medicines Agency (EMA), Emer Cooke, emphasised that there was no evidence to support this claim, highlighting that the number of blood clots among those who have received the AstraZeneca vaccine was no higher than in the general population.

"No indication" that the vaccine causes blood clots

Ms Cooke said: “I want to also stress at present there is no indication that vaccination has caused these conditions.

“They have not come up in the clinical trials and they are not listed as known side events with this vaccine.

“In clinical trials, both vaccinated people and people who received the placebo have shown some very small number of blood clot developments.

“The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.”

She added that the benefits of the vaccine in protecting people against Covid-19 far outweigh the risk of potential side effects.

Her comments come following the news that countries around Europe have taken the "precautionary measure" to temporarily suspend use of the AstraZeneca vaccine.

France, Spain, Italy and Germany are among the countries to halt using the vaccine despite advice from the World Health Organisation to continue with the rollout of the AstraZeneca jab.

These countries await results from further safety assessments carried out by the EMA, who are expected to deliver their report on Thursday.

Experts strongly reject claims that the jab causes blood clots

The move to suspend the vaccine based on claims it is linked to blood clots has been deemed "baffling" by leading health experts.

The UK's medicine regulator has confirmed that the evidence "does not suggest" the AstraZeneca jab has any link to causing blood clots.

Meanwhile, AstraZeneca highlighted that the number of blood clots among those who have received the jab in both the UK and Europe are "much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines."

Here's everything you need to know about the Covid-19 vaccines:

What is the Pfizer-BioNTech vaccine?

The Pfizer-BioNTech vaccine was approved for use in the UK on 2 December 2020. Britain was the first country in the world to approve the jab, which offers up to 95% protection against Covid-19. Pfizer is an American pharmaceutical firm while BioNTech is a German biotechnology company. The vaccine is very delicate and has to be stored at -70 degrees, limiting the number of sites that can administer the jab.

What is the Oxford/AstraZeneca vaccine?

A vaccine developed by Oxford University and pharmaceutical company AstraZeneca became the second vaccine approved for UK use on 30 December 2020. This vaccine was considered "the way out" of the pandemic in the UK, thanks to the fact it is easier to store than the Pfizer jab, making it well equipped for mass roll out. GPs and vaccination centres across the country began administering the jab in early January 2021. Under 30's in the U.K. were given the option to choose a different vaccine to this due to small risks of very rare blood clots. Instead, under-30s would typically choose the Pfizer jab or later, the moderna jab.

What is the Moderna vaccine?

The third vaccine approved for UK use on 8 January 2021 was developed by American firm Moderna. 24-year-old Elle Taylor from Wales became the first person in the UK to receive the Moderna jab in April. The Moderna vaccine is similar to the Pfizer jab in how it works but is even easier to roll out as it can be stored at -20 degrees rather than -70.

What is the Johnson & Johnson vaccine

The fourth vaccine to be be approved in the UK was Johnson & Johnson's vaccine, released under the name Janssen. Notably, It is also the first single shot vaccine in use during this vaccine rollout.

Who was the first person to receive the Pfizer vaccine?

90-year-old Margaret Keenan became the first patient in the world to be vaccinated against Covid-19 outside a clinical trial. She received her jab on 8 December 2020 at Coventry's University Hospital. Mrs Keenan, who lives in Coventry, became somewhat of a fashion influencer after the charity t-shirt she wore to her vaccination appointment sold out. Profits went towards buying Christmas presents for hospital patients. The grandmother advised everyone who was offered the vaccine to take it, saying "If I can have it at 90, then you can have it too."

Who was the first person to receive the Oxford vaccine?

Meanwhile, Brian Pinker from Oxford was first to receive the AstraZeneca jab outside of a clinical trial at the age of 82. Mr Pinker, who was vaccinated on 4 January 2021, praised the medical teams administering the vaccine, saying it would allow him to "really look forward" to celebrating his 48th wedding anniversary with wife Shirley later on in the year.

When will I receive the vaccine?

Vaccines were offered according to vulnerability levels. First to be offered the jab were people in care homes and their carers, followed by those over 80 and health and social care workers. People aged 65 and above were next on the priority list and then high-risk adults under the age of 65 followed by moderate risk adults under 65. The vaccine was then rolled out by age group.

How will I know when it's my turn to get vaccinated?

When it is your turn to receive the vaccination, you will be informed by the NHS. You should only attend vaccination sites if you have been told to do so. Vaccines are provided for free by the NHS and they will never ask for bank details. Find out more about vaccine scams here.

What is a vaccine passport?

The Government debate the idea of a vaccine passport as proof of full vaccination required to enter venues like nightclubs. Health Secretary Sajid Javid later "ditched" the idea and ensured clubbers that they no longer need to be double jabbed by the end of September 2021 to get into Nightclubs or big events.

Do I need a booster jab?

Pfizer/BioNTech booster jabs are rolled out as part of the Government's winter covid plan. Shots can be given to people aged 50 and over, those in care homes and frontline health and social care workers. All those who are clinically extremely vulnerable and anyone aged 16 to 65 in an at-risk group for Covid will also be eligible for a jab. There must be at least 6 months between a 2nd vaccine dose and a booster jab.
Oxford jab scientist Sarah Gilbert says booster jabs are "not needed for all" and that they should instead go to countries with low vaccination rates.

Will children be vaccinated?

The government have also made vaccines available to children aged between 12-15 as part of the country's winter Covid plan.

What about five to 11-year-olds getting vaccinated?

All 5 to 11-year-olds in England can now receive a coronavirus jab, following advice from the JCVI and the same decision being made in Scotland and Wales. Northern Ireland is also expanding their vaccination programme to include the 5-11 age range. It means almost six million children in the UK will be offered the Covid-19 vaccination.

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