Malta Medicines Authority recommends no changes in use of Oxford-AstraZeneca vaccine

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The Malta Medicines Authority has reaffirmed that the benefits of the AstraZeneca vaccine outweigh the risk of side effects, while encouraging vaccinated people and healthcare professions to be aware of any potential side effect and as such it recommended to continue to prevent serious harm and loss of life by using all the highly effective vaccines having an EU Marketing Authorisation.

European Union health ministers failed on Wednesday to agree common guidance on use of the shot. Regulators say its benefits outweigh risks.

Anglo-Swedish drugmaker AstraZeneca said it was working with regulators to list the possible brain blood clots as “an extremely rare potential side effect” on the vaccines labels.

As of April 4, the European Medicines Agency had received reports of 169 cases of a rare brain blood clot known as cerebral venous sinus thrombosis (CVST), after 34 million doses had been administered in the European Economic Area – the EU plus Norway, Liechtenstein and Iceland. Most cases were in women under 60 years of age.

Statement:

The European Medicines Agency, EMA, has confirmed the position taken by the Malta Medicines Authority in maintaining that the benefits of the vaccine outweigh the risk of side effects, explaining that COVID-19 is a very serious disease. The UK Medicines Health and Regulatory Authority, MHRA, confirmed that the benefits of vaccination continue to outweigh any risks.

The Malta Medicines Authority encourages vaccinated people and healthcare professionals to be aware of side effects, on any vaccine, especially when these call for immediate action. S

Side effects within 2 or 3 days following vaccination, the majority of which are mild and local in nature, are expected and common. However, individuals who experience any severe symptoms – such as shortness of breath, chest pain, leg swelling, persistent abdominal (belly) pain, neurological symptoms, such as severe and persistent headaches or blurred vision, tiny blood spots under the skin beyond the site of injection – from around 4 to 20 days following vaccination, should seek medical attention.

The Malta Medicines Authority is monitoring the rollout of all COVID-19 vaccines and will continue to work with other competent authorities and with the health vaccination team to manage potential risk and use science and data to drive response and recommendation. The recommendation is to continue to prevent serious harm and loss of life by using all the highly effective vaccines having an EU Marketing Authorisation.

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