The Malta Medicines Authority safeguards the safety, efficacy and quality features of medicines including the monitoring of vaccines. As stated by the World Health Organization, WHO, on Wednesday, 7th 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 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. 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 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.