EMA launch investigation into J&J’s COVID-19 vaccine amid US blood clot reports
pharmafile | April 12, 2021 | News story | Sales and Marketing | COVID-19, EMA, J&J, JJ, Vaccine
The EMA is reviewing reports of rare blood clots in four people in the US who received Johnson & Johnson’s COVID-19 vaccine, one of whom has died.
Of the four serious cases of clotting and low platelets, three occurred in the US during the rollout of J&J’s vaccine from its Janssen pharmaceuticals unit, and the other was reported during clinical trials, the EMA confirmed on Friday.
The EMA said that these reports point to a ‘safety signal’, but that it is currently not clear whether there is a causal association between vaccination with J&J’s vaccine and these conditions.
The PRAC is investigating the cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.
J&J’s vaccine is currently only being distributed in the US, under an emergency use authorisation, and was authorised in the EU on 11 March, and it is expected to be rolled out in the coming weeks.
A spokeswoman for J&J said the company is working with regulators as more data come in and supports the “open communication” of any new findings with healthcare providers so they can monitor for risks.
She went on to say: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines. Our close tracking of side effects has revealed a small number of very rare events following vaccination.
“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”
The FDA is also investigating the cases, but has said it hasn’t found a causal relationship with vaccination.
The EMA has also expanded its inquiry into AstraZeneca’s COVID-19 vaccine to include reports of a bleeding condition, after having confirmed possible links between AstraZeneca’s jab and very rare blood clots in the brain and abdomen.
The EMA also said five cases of capillary leak syndrome in people who received AstraZeneca’s vaccine have been reported. The condition, in which blood leaks from the smallest of vessels into muscles and body cavities, is characterised by swelling and a drop in blood pressure.
Kat Jenkins
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