July 24 Joint Committee Meeting Minutes

The meeting was held as a web conference from 2:00 p.m. to 5:00 p.m. on July 24, 2026, as a joint meeting of the 112th Adverse Reaction Review Committee of the Health Science Council's Immunization and Vaccine Subcommittee and the fourth Safety Measures Investigation Committee meeting of fiscal 2026 of the Pharmaceutical Affairs and Food Sanitation Council's Pharmaceuticals and Other Products Safety Measures Committee. Seven of the nine members of the Adverse Reaction Review Committee and all six members of the Safety Measures Investigation Committee attended, establishing a quorum.

The agenda covered the implementation status and safety follow-up of HPV vaccines; evaluations of suspected adverse reaction reports, death cases, suspected myocarditis and pericarditis, persistent symptoms, and literature concerning spike proteins for COVID-19 vaccines; the safety of vaccines other than COVID-19 vaccines; reporting criteria for respiratory syncytial virus vaccines; and revisions to evaluation methods and reporting forms.

Regarding COVID-19 vaccines, the meeting confirmed the assessment that no change to the current handling was necessary and that no serious safety concerns were identified for the products under review.

It was explained that linking the vaccination database with suspected adverse reaction reports and other data would enable analyses based on prior vaccination histories, clinical outcomes after reporting, medical histories, and comorbidities.

For HPV vaccines, cumulative initial vaccination rates by year of birth, including catch-up vaccination, were reviewed. The rates were 87.7% and 88.3% for those born in 1997 and 1998, respectively, and 54.8%, 53.1%, and 55.1% for those born in fiscal 2005, fiscal 2008, and fiscal 2009, respectively. The safety follow-up study was conducted at 87 cooperating institutions, and the number of newly attending patients remained at 10 or fewer.

For COVID-19 vaccines, suspected adverse reaction reports from January 1 to March 31, 2026, were aggregated by product. Comirnaty intramuscular syringe for people aged 12 and older had 12 cases reported by the marketing authorization holder and six cases reported by medical institutions, of which five were serious. Death cases and suspected myocarditis and pericarditis were confirmed and evaluated for each product, and no serious concerns were identified regarding reporting trends during the aggregation period.

In the survey of persistent symptoms after COVID-19 vaccination, patients and others who visited medical institutions from June 1, 2024, to December 31, 2025, were included. Responses were received for 42 cases from regional liaison offices, 56 cases from attending physicians, and 12 cases from the follow-up survey. In the attending physician survey, 31 of the 42 cases with confirmed outcomes had recovered or improved, while 10 had not recovered.

In the literature evaluation of vaccine-derived spike proteins and related substances, more than approximately 1,200 reports were initially extracted, and the set was narrowed to 29 reports detecting spike proteins or their derived mRNA in the bodies of vaccinated people. Following expert evaluation, no literature was identified at this time indicating that spike proteins pose a direct safety concern.

For the respiratory syncytial virus maternal immunization vaccine, the committee deliberated on adding Guillain-Barre syndrome to the suspected adverse reaction reporting criteria, following its addition to the package insert as a serious adverse reaction. The proposal to cover the period within 28 days after vaccination was approved, and it was scheduled that a draft ministerial ordinance amendment would be considered after public comments.

The evaluation method for suspected adverse reaction reports will retain the approach of combining individual and population-level evaluations, as well as the three categories of alpha, beta, and gamma. Their explanations will be revised so that alpha refers to cases where a relationship with vaccination is reasonably suggested, beta to cases where a relationship with vaccination is not recognized, and gamma to cases where the relationship is unclear due to factors other than the vaccine, insufficient information, or similar reasons. Previously evaluated cases will not be reclassified.

Following the start of operation of the vaccination database associated with the revised Immunization Act taking effect on June 1, 2026, the suspected adverse reaction reporting form was revised as of July 1, 2026. The revision included generating identifiers using insured person numbers and other data, preparing fields suitable for electronic processing, and reducing free-text fields. Data linkage is scheduled to begin during fiscal 2026, and deployment to all local governments is targeted for April 2028.