In a statement by the Malta Medicines Authority about the safety and efficacy of the Astrazeneca vaccine, the Authority quoted the World Health Organization, WHO, who said that in extensive vaccination campaigns it was normal for countries to identify potential adverse events following immunization.
The Authority said that the European Medicines Agency, EMA, had confirmed the position taken by the Malta Medicines Authority – ie that the benefits of the vaccine outweigh the risk of side effects, and that COVID-19 was a very serious disease. It also referred to the UK Medicines Health and Regulatory Authority, MHRA, which confirmed that the benefits of vaccination continue to outweigh any risks.
The Malta Medicines Authority said that mild side-effects two or three days after the vaccine were normal.
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.
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.