EMA adds new side effect of AstraZeneca

Italy limits AZ to over 60s, US tells J&J millions of doses can’t be used

New Age Desk | Published: 23:20, Jun 12,2021 | Updated: 00:41, Jun 13,2021

 
 

Europe’s drug regulator on Friday identified another very rare blood condition as a potential side effect of AstraZeneca’s Covid vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots, reports The Economic Times online.

The European Medicines Agency’s safety committee said that capillary leak syndrome must be added as a new side effect to labelling on AstraZeneca’s vaccine, known as Vaxzevria.

People who had previously sustained the condition, where fluids leak from the smallest blood vessels causing swelling and a drop in blood pressure, should not receive the shot, the EMA added.

The regulator first began looking into these cases in April and the recommendation adds to AstraZeneca’s woes after its vaccine was associated with very rare and potentially lethal cases of blood clotting that come with a low platelet count.

Last month, the EMA had advised against giving a second AstraZeneca shot to people with that clotting condition, known as thrombosis with thrombocytopenia syndrome.

Italy said Saturday it would restrict the AstraZeneca vaccine to the over-60s, with younger people who have already received one dose to complete the cycle with an mRNA jab, reports AFP.

The change follows an improvement in coronavirus infection rates in Italy, which has been devastated by the pandemic but will next week lift restrictions in much of the country following a sharp decline in cases.

The US Food and Drug Administration said Friday it had told Johnson & Johnson that millions of doses of Covid vaccine produced at a troubled plant can’t be used because of possible contamination issues.

In a statement, the FDA said ‘several’ batches of vaccine manufactured at the Emergent BioSolutions facility in the city of Baltimore are not suitable for use. Each batch is known to correspond to several million doses.

Neither the agency nor J&J revealed the precise number of doses, but The New York Times placed the number at 60 million, quoting people familiar with the matter.

‘These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,’ said FDA scientist Peter Marks.

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