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New restrictions for AZ/Oxford COVID-19 vaccine despite EMA endorsement

Regulators in Canada and Germany have reportedly placed new restrictions on vaccine

Regulators in Canada and Germany have reportedly restricted the use of AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine in certain age groups, despite the European Medicines Agency (EMA) reconfirming the safety of the jab.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) met yesterday as part of an ongoing review into ‘very rare’ cases of blood clots with low numbers of platelets in people vaccinated with the AZ/Oxford vaccine – which has now been given the brand name Vaxzevria in the EU.

The EU regulator said that the review has currently not identified any specific risk factors, including age, gender or previous medical history of clotting disorders for the very rare blood clot events.

‘A causal link with the vaccine is not proven, but is possible and further analysis is continuing,’ added the EMA.

The EMA also reconfirmed that it believes the benefits of the vaccine continue to outweigh the risk of side effects.

Despite the EMA endorsement, a number of countries have placed further restrictions on the use of the jab, limiting it for only certain age groups.

According to CNBC, Germany has halted use of the AZ/Oxford vaccine in people under the age of 60 years old, after 31 cases of rare blood clots in the cerebral veins – also known as sinus vein thrombosis or cerebral venous sinus thrombosis – following vaccination.

In 19 of those cases, low levels of platelets were also reported, with nine people in total dying.

Germany’s medical regulatory body – the Paul Ehrlich Institute – said that the majority of the 31 cases involved women aged 20 to 63 years, with only two men aged between 36 to 57 years affected.

In Canada, health authorities have also suspended use of the vaccine for those under the age of 55, due to the blood clot concerns.

Shelley Deeks, vice-chair of Canada’s National Advisory Committee on Immunization said that “there is substantial uncertainty about the benefit of providing AstraZeneca Covid-19 vaccines to adults under 55 given the potential risks”.

Health Canada reported that, to date, it has not received any reports of blood clots in Canada, although it added that the vaccine has not been used in large numbers in the country.

France and Spain have also restricted use of the AZ/Oxford COVID-19 vaccine, according to Reuters.

Article by
Lucy Parsons

1st April 2021

From: Regulatory



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