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European Medicines Agency again gives clean certificate for AstraZeneca vaccine

DUBLIN: The European Medicines Agency (EMA) has again issued a clean certificate for the controversial AstraZeneca vaccine over side effects.

The administration of AstraZeneca’s COVID-19 vaccine was suspended after several reports of blood clots in the brain. But as mentioned in the previous review, the EMA reiterated that the benefits of the vaccine outweigh all the side effects. However, the guidelines say that vaccine review will continue.

With the agency’s recommendation, it is estimated that the respective countries will now have to make individual decisions regarding the use of the AstraZeneca vaccine. Many countries in the European Union and around the world have limited the use of the vaccine, known as Vaxzevria. Denmark has stopped its use altogether, after blood clot issues were confirmed. It is in this context that EMA came out in support of AstraZeneca.

The EMA advises member states to adjust their vaccination strategies. They are of the opinion that the decision can be made according to the level of infection and the age of the people to be vaccinated.

According to the EMA’s analysis, only one in 100,000 people who are vaccinated is at risk for blood clots. The benefits of getting the vaccine have been shown to increase with age. The agency also points out that the recommendation may change as more information is gathered. This is because not all EU member states include the gender of vaccine recipients in their data.

The highest incidence of blood clots was reported in 40-year-olds who had been vaccinated. There were 2.1 cases per lakh people. Such incidents are also reported in 20-30 year olds. The agency conducted a risk-benefit analysis of each age group.

Side effects range from 1.1 per 100,000 people over the age of 50. The analysis also shows that it is declining to one in a million people over the age of 60.

Earlier this month, the EMA announced that it had found a link between the AstraZeneca vaccine and blood clotting. Johnson & Johnson also reported similar problems and as a result, countries are skeptical about whether to use the J&J vaccine as well.

But Peter Arlett, head of the EMA’s data analytics and methods task force, said the astraZeneca vaccine’s benefit risk balance was positive. “It’s preventing serious disease and saving lives,” he added.

The NIAC review of Johnson & Johnson vaccine use is also ongoing. The United States gave Johnson & Johnson vaccine a clean chit yesterday.

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