European regulator finds possible link between vaccine and blood clots

Matt Woodley

7/04/2021 3:08:57 PM

UPDATED: The European Medicines Agency says it has found a possible link between AstraZeneca’s COVID-19 vaccine and rare blood clotting issues in adults.

Female doctor giving COVID vaccine
Various investigations are attempting to determine whether blood clots among vaccine recipients are caused by the Oxford University/AstraZeneca candidate AZ1222. (Image: AAP)

This article was updated at 9.00 am on 8 April to reflect the announcement of the European Medicines Agency.

The European Medicines Agency (EMA) has confirmed a possible link between blood clots and the Oxford University/AstraZeneca vaccine.

The European regulator released a statement calling on health professionals and recipients of the vaccine to remain aware of the ‘possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination’.
It follows its head of vaccines, Marco Cavaleri earlier this week telling Italian publication Il Messaggero that, in his opinion, ‘it is clear there is a link with the vaccine … but we still do not know what causes this reaction’.

A spokesperson said the Australian Government has asked the Australian Technical Advisory Group on Immunisation (ATAGI) and the Therapeutic Goods Administration (TGA) to urgently look into the issue.

ATAGI has previously said a connection between the vaccine and reports of blood clots is ‘likely’. 
Department of Health Secretary Professor Brendan Murphy said earlier in the week that one case of blood clots among vaccine recipients in Australia is ‘not a strong signal’ of a connection.
‘We are working very closely with our counterparts in the UK who have now done well over 18 million doses of this vaccine, and in Europe, that have done many million, to look at the data that they’re getting from their signals and their regulatory body and their vaccine advisory committees,’ Professor Murphy said.
‘That’s what’s going to give us the true picture of whether this is a real problem, and whether it has any significance.
‘We’re having joint meeting with the Europeans and with the UK regulators and we are taking this matter very seriously at the moment.’
Professor Murphy said the current advice is that the Australian program continues and the benefit of vaccination outweighs any potential risk.
The World Health Organization (WHO), EMA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have also said people should continue receiving the Oxford University/AstraZeneca vaccine, as the benefits continue to outweigh any risks.

News of the possible link comes as the UK's vaccine advisory board, the Joint Committee on Vaccines and Immunisation (JCVI), said all people under the age of 30 will be offered alternative vaccines, including the Pfizer and Moderna jabs, due to a small number of blood clots linked to the AstraZeneca vaccine.
An Oxford University trial involving more than 200 children and adolescents aged 6–17 has also been paused as a precautionary measure while the MHRA and EMA investigations continue.
‘While there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopenia that have been reported in adults, before giving any further vaccinations in the trial,’ an Oxford University spokesperson said.
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Dr Gaston Hubert Marie Boulanger   8/04/2021 7:26:16 AM

That is not what I read this morning from the EMA: it is a very rare side effect. And AZ is changing the side effect profile on the leaflet.