"Chickenpox vaccine 'Sky Varicella Inj' is safe…"

"Precautions advised for immune-compromised individuals"

29 cases of shingles have been reported after vaccination…the reported rate for Sky Varicella Inj was 0.003%

"One case of reported death, but there is no causal relationship between the vaccine and the reported death"…will continue using the vaccine for national immunization

The KDCA posted the results of the investigation and analysis in collaboration with the MFDS

SK Chemical’s varicella virus vaccine, Sky Varicella Inj.

The Korea Disease Control and Prevention Agency (KDCA) reported on June 12th that experts and related agencies have conducted an investigation and analysis in response to an increased number of adverse reactions reported following vaccination with 'Sky Varicella Inj,' a varicella virus vaccine, and they confirmed that there are no safety concerns related to the vaccine.

 

According to the KDCA, cases of shingles have been recently reported following vaccination with Sky Varicella Inj.

 

From 2018 until May this year, 1,888,631 varicella virus vaccinations were given, and 29 cases of shingles were reported after the vaccination (reported rate: 0.0015%).

 

The reported rate of shingles after vaccination with SK Chemical’s varicella virus vaccine, Sky Varicella Inj, was 0.003%.

 

Consequently, the KDCA formed a public-private working group on April 26th following the decision by the Korea Expert Committee on Immunization Practices (KECIP).

 

The group conducted a comprehensive review, including the safety of the varicella virus vaccine and shingles cases after vaccination, and concluded that there are no safety concerns related to Sky Varicella Inj.

 

The public-private working group consisted of three pediatric infection experts, one virus experts, pharmacoepidemiology expert, and officials from the National Health Insurance Service (NHIS), KDCA, and the Ministry of Food and Drug Safety (MFDS).

 

The MFDS stated it had conducted a comprehensive evaluation of documents related to quality and non-clinical·clinical trials submitted during the approval of the varicella virus vaccine, reports of national lot release at every manufacturing stage, and cases of adverse reactions reported in South Korea and oversees.

 

The findings indicated no safety concerns related to the vaccine itself.

 

After investigating 29 cases of reported shingles following varicella vaccination, it was found that all 29 individuals experienced symptom improvement without any complications.

 

Additionally, analysis of NHIS big data showed no significant differences in severity, including hospitalization duration after shingles occurrence, following vaccination.

 

The KDCA explained, "The varicella vaccine is a live vaccine that uses weakened strains of bacteria or viruses.

 

It is known that the symptoms of shingles after vaccination are generally milder than when shingles occur in individuals who have not been vaccinated against chickenpox." During the investigation, there had been one case of reported death suspected to be related to the varicella vaccine.

 

However, the expert committee, including a blood cancer specialist, concluded that there is no causal relationship between the varicella vaccine and the reported death.

 

Consequently, based on these results, the KECIP decided to continue using Sky Varicella Inj in national immunization.

 

However, considering that the incidence of shingles after vaccination with Sky Varicella Inj is higher than with other vaccines, precautions will be advised for high-risk groups, such as prohibiting the administration of the vaccine to severe immune-compromised patients and pregnant women.

 

The KDCA strongly advocated for vaccination, stating the significant preventive effect of the varicella vaccine, citing that the incidence of chickenpox among the unvaccinated group, based on those born in 2022, is nearly ten times higher than that of the vaccinated group.

 

They also emphasized that Sky Varicella Inj’s preventative effect against smallpox is 78.9%, which is higher than that of other varicella vaccines.

 

The KCDC said, "We urged the medical community to actively report cases of adverse events, such as shingles, after receiving the varicella vaccine." They added, "Enhanced surveillance of the safety of the varicella vaccine will be implemented, including conducting additional diagnostic tests when reporting adverse events." If any adverse reactions, such as high fever, rash, and shingles, occur after the vaccination in young children, report to the NIP internet website (https://nip.kdca.go.kr) or the monitoring system for vaccines (https://is.kdca.go.kr).

 

For other inquiries, including the report process, contact the call center ☎1339 or the nearest public health center.