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AstraZeneca COVID-19 vaccine fine for use, says EU regulator

The benefits of the COVID-19 vaccine developed by AstraZeneca PLC (LON:AZN)/Oxford University outweigh risks of side effects, said the European Medicines Agency (EMA).

Sabine Straus, chair of the Pharmacovigilance Risk Assessment Committee (PRAC), said “vaccination is extremely important” at a press conference on Wednesday afternoon.

READ: AstraZeneca vaccine should not be offered to healthy under 30s, UK government says

Blood clots should be listed as possible “very rare” side effects of the vaccine, the committee concluded.

Specific factors such as age, gender and previous medical history have not been identified.

The PRAC carried out a review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.

No specific risk factors could be identified, based on the current data, so the PRAC is not recommending any specific measures to reduce the risk.

A possible explanation is the patient’s immune disease reacts to the jab, as observed in cases of heparin-induced thrombocytopenia.

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) and Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday that those who are aged 18 to 29, and don’t have any underlying issues making them vulnerable to the virus, should be offered another vaccine.

–Adds UK decision–

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