The Malta Independent 14 April 2021, Wednesday

‘Benefits of the AstraZeneca vaccine outweigh the risk of side effects' - Malta Medicines Authority

Thursday, 8 April 2021, 17:48 Last update: about 5 days ago

The Malta Medicines Authority has issued a statement on the Astrazeneca vaccine, addressing concerns.

The European Union's drug regulator recently said there was a "possible link" between the AstraZeneca vaccine and a rare clotting disorder while reiterating the vaccine is safe and effective. Regulators in the United Kingdom and the EU both stressed that the benefits of receiving the vaccine continue to outweigh the risks for most people, and the EU agency maintained its guidance that the vaccine can be used in all adults.

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In a statement, the Malta Medicines Authority said that it safeguards the safety, efficacy and quality features of medicines including the monitoring of vaccines. "As stated by the World Health Organization, WHO, on Wednesday, 7 April 2021, in extensive vaccination campaigns it is normal for countries to identify potential adverse events following immunization."

"The European Medicines Agency, EMA, has confirmed the position taken by the Malta Medicines Authority, in maintaining that the benefits of the AstraZeneca vaccine outweigh the risk of side effects, explaining that Covid-19 is a very serious disease. The UK Medicines Health and Regulatory Authority 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. Suspected Adverse Drug Reactions are to be reported using the Malta Medicines Authority Form and to be sent to Sir Temi Zammit Buildings, Malta Life Sciences Park, San Ġwann SĠN 3000, or online on http://www.medicinesauthority.gov.mt/adrportal, or to the Marketing Authorisation Holder or their local representatives.

"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, it said, adding that it 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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