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Clean certificate for AstraZeneca; EMA says vaccination can continue

DUBLIN: The European Medicines Agency (EMA) certifies that AstraZeneca COVID-19 vaccine is safe and effective. The EMA also said that there is no risk of blood clots.

The efficacy and side effects of the vaccine were once again assessed following reports of blood clots in the brains of four young people who received the vaccine in Norway. AstraZeneca got another clean chit at the agency’s extraordinary meeting yesterday. The World Health Organization, EMA, and AstraZeneca have repeatedly stated that the vaccine is safe.

Head of the EMA, Emer Cooke said that the benefits of vaccination outweigh the risks. However, the link between these cases and the vaccine cannot be fully ruled out.

The EMA’s safety committee therefore recommended that the pamphlet with the vaccine should include details that draw attention to these possible rare cases. “What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information,” said Cooke.

Several countries across Europe, including Ireland, had suspended using the vaccine following a report by the Norwegian Medicines Agency. Irish authorities had said they have suspended the administration of vaccine as a precaution. Irish authorities had said that the suspension of the administration of vaccine was as part of precautionary measures.

Collaboration with MHRA

About 2,500 people die every day in the European Union from COVID-19 infection. A quick and thorough review of all available evidence in this case was crucial for the EMA. Therefore, this review was given the highest priority. Mr. Cooke explained that the review was conducted in collaboration with the UK’s health regulator the Medicines and Healthcare products Regulatory Agency (MHRA).

Vaccination will resume in Italy today, but will be delayed in Ireland

Italy says it will resume vaccination from today following the EMA’s decision. Meanwhile, Swedish health officials said it would take a few days to assess the verdict and therefore have been suspended.

The Health Products Regulatory Authority (HPRA) in Ireland said in a statement that it would continue to closely monitor reports of blood clotting disorders. The authority said more laboratory data and analysis of the evidence were underway. The MHRA has previously stated that there is no evidence that blood clots in veins are caused by the AstraZeneca vaccine.

The National Immunisation Advisory Committee (NIAC) will evaluate the advice from the EMA and provide guidance to NPHET, HSE said. NPHET will then make recommendations to the Health Minister.

HSE CEO Paul Reid said the first attempt would be to distribute the 30,000 jabs – that were delayed last week. 10,000 doses of AstraZeneca will arrive in Ireland next week. Taoiseach Micheál Martin has said that HSE will be restart vaccination once clear information is received from the EMA.

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