2 flu vaccines linked to deaths in South Korea are safe for use: MOH review

SINGAPORE — Healthcare providers and medical practitioners can resume the use of two influenza vaccines – SKYCellflu Quadrivalent and VaxigripTetra – said the Ministry of Health on Saturday (Oct 31). 

The MOH said that these vaccines have been assessed to be safe for use following a “thorough review of the information” from South Korean health authorities as well as Singapore’s Health Sciences Authority’s (HSA). 

On Oct 25, the MOH had issued an advisory to medical practitioners to temporarily cease the use of these two vaccines, which were among seven brands of influenza vaccines linked to nine deaths in South Korea. 

In its statement on Saturday, MOH said that based on information release by South Korean health authorities on Oct 29, the likelihood of a causal link between influenza vaccination and the deaths reported was determined to be low. 

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, said MOH.

It added that HSA has also reviewed the reports of patients locally having adverse reactions, as well as the global safety data of the two vaccines. 

Several patients in Singapore who were given the vaccines experienced mild symptoms, such as nausea or rash, after receiving the jab.

“The reported adverse events for the two vaccines are consistent with the known safety profile of influenza vaccines,” said MOH. 

“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.”

It added that 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, it said.  

In rare instances, an individual may experience high fever or allergic reactions such as breathing difficulty, wheezing and swelling around the eyes.

Immediate medical attention should be sought in these instances, said MOH. 

It also strongly advised vulnerable groups such as the elderly, the young, pregnant women and those with certain pre-existing medical conditions, to receive their influenza vaccinations for their health and well-being. 

In a statement on Nov 1, Sanofi Pasteur, the manufacturer of VaxigripTetra, said it has always stood by its influenza vaccine.

"All batches of VaxigripTetra are manufactured in full compliance with high-quality international standards and processes of Sanofi Pasteur; they all undergo rigorous internal quality control testing and are controlled in France by an independent Official Medicine Control Laboratory acting on behalf of the European Medicines Agency before importation to Singapore," the company said.