What was the initial concern regarding Vaxigrip Tetra and SKYCellflu Quadrivalent?

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Initial Concerns Regarding Vaxigrip Tetra and SKYCellflu Quadrivalent Resolved

The initial concern surrounding the influenza vaccines Vaxigrip Tetra and SKYCellflu Quadrivalent stemmed from reports of deaths associated with these products in South Korea. This led to an advisory from the Malaysian Health Ministry on October 28, recommending medical practitioners temporarily halt the administration of these two specific vaccine brands. The discontinuation was a precautionary measure taken to allow for a thorough investigation into the reported fatalities.
Reports of Deaths in South Korea Triggered Review

The primary apprehension that prompted the temporary suspension of Vaxigrip Tetra and SKYCellflu Quadrivalent was the emergence of reports linking deaths to their use in South Korea. These reports necessitated a detailed risk assessment by the Malaysian Health Ministry, undertaken by the National Pharmaceutical Regulatory Agency (NPRA). This assessment drew upon data from the Korean Disease Control and Prevention Agency (KDCA), as well as local and international safety reports and regulatory bodies.
Korean Authorities Conclude Low Probability of Vaccine Link to Deaths

Subsequent investigations by the KDCA, as of October 31, concluded that the probability of the influenza vaccine being the cause of the reported deaths is very low. A review of 72 out of 83 death cases (with 11 still under investigation) indicated that the fatalities were attributed to pre-existing illnesses or other causes unrelated to the influenza vaccine. Furthermore, the KDCA confirmed that no specific brands, manufacturers, or vaccine batch numbers could be identified as being connected to these deaths.
Malaysian Health Ministry Conducted Comprehensive Evaluation

In parallel with the Korean investigations, the Malaysian Health Ministry also conducted its own thorough evaluation. This included assessing the quality of the Vaxigrip Tetra and SKYCellflu Quadrivalent products and reviewing adverse event following immunisation (AEFI) reports, both locally and globally, to examine the safety profile of all influenza vaccines. This comprehensive review aimed to ensure the safety and efficacy of vaccines available in Malaysia.
No Vaccine-Related Deaths Reported in Malaysia

During the evaluation period, Malaysia confirmed that no deaths had been reported following the administration of any influenza vaccine within the country. The adverse effects that were noted were identified as common side effects, consistent with documented reactions to immunisations. This finding, alongside the KDCA's conclusions, supported the decision to allow the resumption of use for Vaxigrip Tetra and SKYCellflu Quadrivalent.

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What was the initial concern regarding Vaxigrip Tetra and SKYCellflu Quadrivalent?

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