The Ministry of Health (MOH) is advising that use of two influenza vaccines – SKYCellflu Quadrivalent and VaxigripTetra – should be temporarily ceased. This is a precautionary measure following reported deaths after influenza vaccination in South Korea. No deaths associated with influenza vaccination have been reported in Singapore to date. MOH and the Health Sciences Authority (HSA) are monitoring the situation closely.
2. HSA is in touch with the South Korean authorities for further information as they investigate to determine if the deaths are related to influenza vaccinations. Based on information released by the South Korean health authorities, seven brands of influenza vaccines were administered to the individuals involved in the deaths reported in South Korea. Of the seven brands, two are available in Singapore. They are SKYCellflu Quadrivalent, manufactured by SK Bioscience and locally distributed by AJ Biologics, and VaxigripTetra, manufactured by Sanofi Pasteur and locally distributed by Sanofi Aventis.
3. As a precautionary measure while HSA is assessing the implications of the reported deaths in South Korea, MOH has informed healthcare providers and medical practitioners to temporarily stop the use of these two vaccines. Healthcare providers and medical practitioners may continue to use the two other influenza vaccines that have been brought into Singapore for the Northern Hemisphere 2020/21 influenza season. MOH and HSA will assess the situation as more information becomes available and further advise on the use of the affected vaccines.
4. Persons recommended to receive the influenza vaccination, including those recommended under the National Childhood Immunisation Schedule (NCIS) and National Adult Immunisation Schedule (NAIS), may continue to receive their influenza vaccination using other brands of influenza vaccines. Influenza vaccination provides protection against seasonal influenza viruses, and is effective in reducing the risk of complications and deaths due to influenza. This is especially so for vulnerable groups such as the elderly, the young, pregnant women and those with certain pre-existing medical conditions.
5. Influenza vaccination is generally safe and well tolerated. Like any medicines, vaccines can cause side effects. Common side effects from influenza vaccination may include soreness and redness at the injection site, fever, headaches, muscle aches, fatigue and nausea. These side effects are generally mild and resolve on their own. In rare instances, a person may experience high fever or severe allergic reactions (such as breathing difficulty, wheezing and swelling around the eyes) and immediate medical attention should be sought.
6. Vaccines approved for use in Singapore have been evaluated by HSA to ensure that they meet the required international standards of quality, safety and efficacy. To ensure that the benefits continue to outweigh the risks, HSA monitors the safety of vaccines through an adverse event monitoring system. It draws on the network of local healthcare professionals and international regulatory counterparts to pick up adverse events suspected to be associated with the vaccines.
7. MOH and HSA will continue to monitor the situation closely for any concerns related to influenza vaccination and keep members of the public updated on new developments.
MINISTRY OF HEALTH
HEALTH SCIENCES AUTHORITY
25 OCTOBER 2020