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J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

Johnson & Johnson (J&J) is delaying the rollout of its one-dose COVID-19 vaccine in Europe after the US announced this week that it was pausing the rollout of the vaccine following concerns over rare blood clots in people who have received the jab.

In a statement issued yesterday, J&J said that it was ‘aware’ that a small number of people who had received its COVID-19 vaccine had developed rare blood clots.

In the US, the Food and Drug Administration (FDA) and Centers for Disease Control & Prevention (CDC) recommended pausing the rollout of the vaccine following six reported cases of a rare and severe type of blood clot – known as cerebral venous sinus thrombosis (CVST) – was observed in individuals who had received the vaccine.

In these cases, the rare blood clot type was seen in combination with low levels of blood platelets, known as thrombocytopenia.

Prior to the pause, as of 12 April, over 6.8 million doses of the J&J jab have been administered in the US.

While the CDC and FDA is reviewing the cases and assessing their ‘potential significance’, J&J has made the decision to 'proactively' delay the rollout of the vaccine in the EU.

The company added that it has been working ‘closely’ with medical experts and health authorities following the reported cases.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has also started a review into reports of people developing blood clots after receiving the J&J COVID-19 vaccine.

This includes four ‘serious cases of unusual blood blots with low blood platelets’ - one occurred in a clinical trial and three occurred during the US rollout of the vaccine.

The J&J blood clot reports follow similar reports associated with AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine.

FDA official Peter Marks told Reuters that it was “plainly obvious” the J&J vaccine cases were “very similar” to those reported with the AZ vaccine, adding that no similar blood clot cases had been reported among people who have received the Pfizer/BioNTech or Moderna vaccines, both of which are being widely used in the US.

However, last week the EMA said that there is no definite causal link between the AZ/Oxford vaccine and the reported cases of rare blood clots.

The regulatory authority went on to add that the unusual blood clots with low blood platelets should be listed as a very rare side effect of the AZ vaccine.

Emer Cooke, executive director of the EMA added that the EMA’s safety committee ultimately “confirmed that the benefits of the AstraZeneca vaccine in preventing COVID-19 overall outweigh the risks of side effects”.

Article by
Lucy Parsons

14th April 2021

From: Regulatory

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