AZ vax ‘remains authorised for all’: European regulator

Our Bureau Mumbai | Updated on June 15, 2021

Latest review is of adverse events relating to both AZ-Oxford and Bharat Biotech vaccine   -  LOIC VENANCE

The AZ vaccine has had fluctuating regulatory responses in different countries

The European Medicines Agency (EMA) has clarified that the AstraZeneca-Oxford University vaccine “remains authorised for all populations”. The clarification comes as reports suggested that the regulatory agency had banned the use of the vaccine in people over 60 years.

Rare blood clots

The AZ vaccine has had fluctuating regulatory responses in different countries, ranging from a pause to restrictions in certain age groups, following reports of rare blood clots. Recently, the EMA safety committee had said that people who previously had “capillary leak syndrome” should not be vaccinated with the AZ vaccine.

The committee also concluded that CLS be added to the “product information” as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk, said the EMA.

The AZ-Oxford vaccine is produced and marketed in India by Serum Institute under the Covishield brandname.

A person familiar with the development told BusinessLine that any labelling changes made by AZ were applicable to the vaccine being produced in India as well.

Capillary leak syndrome is a very rare and serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in swelling, mainly in the arms and legs; low blood pressure; thickening of the blood; and low blood levels of albumin (an important blood protein), the EMA explained.

Meanwhile, an AZ spokesperson pointed out that CLS cases were “extremely rare” and were reported in those who have been vaccinated with the AstraZeneca vaccine, “with a frequency less than 1 in 10 million vaccinated”.

The cases, some of which occurred in people with a previous history of CLS, occurred within four days of vaccination, the representative added.

Published on June 15, 2021

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