31st Oct 2020
The Ministry of Health (MOH) has advised healthcare providers and medical practitioners that the use of two influenza vaccines – SKYCellflu Quadrivalent and VaxigripTetra – can be resumed as the vaccines have been assessed to be safe for use. This follows a thorough review of the information from the South Korean health authorities as well as the Health Sciences Authority’s (HSA) further review of the quality and safety profiles of the two vaccines.
2. As a precautionary measure, MOH had on 25 October advised the temporary cessation of the use of the two vaccines while MOH and HSA assessed the implications of the reported deaths after influenza vaccination in South Korea. Based on information released by the South Korean health authorities on 29 October, the likelihood of a causal link between influenza vaccination and the deaths reported was determined to be low. South Korea’s investigations revealed that the causes of death for 71 of the 72 deaths reported were highly likely due to underlying diseases, while the remaining case is pending investigations. The South Korean health authorities also found that no vaccine from any particular manufacturer was associated with higher rates of reported deaths than the others.
3. HSA has reviewed the local adverse event reports as well as global safety data of SKYCellflu Quadrivalent and VaxigripTetra vaccines. The reported adverse events for the two vaccines are consistent with the known safety profile of influenza vaccines. In addition, HSA has reviewed the test reports of all batches of the two vaccines supplied in Singapore and based on the available data, the two vaccines distributed in Singapore meet the quality standards.
4. To date, there are no safety and quality concerns with all influenza vaccines available in Singapore for the Northern Hemisphere 2020-2021 influenza season – Fluarix Tetra, Influvac Tetra, SKYCellflu Quadrivalent and VaxigripTetra. MOH has informed healthcare providers and medical practitioners that they may continue to offer influenza vaccination using these vaccines.
5. Like any medicine, vaccines can have 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 allergic reactions (such as breathing difficulty, wheezing and swelling around the eyes) and immediate medical attention should be sought.
6. 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, those with certain pre-existing medical conditions. Those who are recommended to receive influenza vaccination are strongly advised to do so for their health and well-being.
7. Public health safety is of utmost importance, and MOH takes vaccine safety very seriously. MOH and HSA will continue to monitor for any concerns related to influenza vaccination.
MINISTRY OF HEALTH
HEALTH SCIENCES AUTHORITY
31 OCTOBER 2020