IMPACT OF KP.2 BNT162B2 COVID-19 VACCINE ON ACUTE SYMPTOMS AMONG U.S. ADULTS DURING THE 2024-2025 RESPIRATORY SEASON
Author(s)
Alon Yehoshua, PharmD1, Laura Lupton, MHA, MD2, Tianyan Hu, PhD1, Joseph C. Cappelleri, MPH, MS, PhD1, Manuela C. Di Fusco, PhD1, Meghan Gavaghan, MPH1, Santiago Lopez, MD1, Rachel Brathwaite, PhD2, Xiaowu Sun, PhD2;
1Pfizer, New York, NY, USA, 2CVS Health, Wellesley, MA, USA
1Pfizer, New York, NY, USA, 2CVS Health, Wellesley, MA, USA
OBJECTIVES: To assess the impact of the Pfizer-BioNTech BNT162b2 KP.2 COVID-19 vaccine on acute symptom burden during the first week of SARS-CoV-2 infection.
METHODS: Symptomatic adults testing positive for SARS-CoV-2 at a national pharmacy chain between October 24, 2024, and April 15, 2025, were enrolled (CT.gov: NCT05160636). Participants completed an online survey reporting demographics, clinical history, and vaccination status. Fourteen CDC-defined acute COVID-19 symptoms were self-reported daily and retrospectively recalled for pre-infection and worst moment prior to enrollment. Symptom severity was rated using an FDA-based 4-point scale (0-3) for most symptoms and a 3-point scale (0-2) for smell and taste. A composite symptom score (0-40, lower scores indicate less symptom severity) representing overall symptom burden was calculated for vaccinated and unvaccinated groups. Least-squares mean changes in composite scores from pre-infection were calculated via regression and compared between groups. A running average of daily survey means was calculated to estimate the average symptom burden from symptom onset through a median of 7 days post-infection.
RESULTS: Among 608 participants, 106 (17.4%) received the 2024-2025 KP.2 vaccine. Mean age was 45.8 years, 76.5% were female, 53.6% used antiviral treatment, and 57.7% had ≥1 comorbidity. Vaccinated participants had a mean (SD) time since vaccination of 167.2 (87.6) days. Median time from symptom onset to enrollment was 4 days. At survey day 3, corresponding to a median of 7 days from symptom onset, the running average change in composite score from pre-infection was 0.95 (SE: 0.41, P=0.020) lower in the vaccinated vs unvaccinated group, indicating reduced symptom burden for the vaccinated group compared to the unvaccinated group.
CONCLUSIONS: BNT162b2 KP.2 vaccine was associated with lower COVID-19 symptom burden during the first week of infection compared to no receipt of KP.2 vaccine. These findings support staying up-to-date with recommended COVID-19 vaccination.
METHODS: Symptomatic adults testing positive for SARS-CoV-2 at a national pharmacy chain between October 24, 2024, and April 15, 2025, were enrolled (CT.gov: NCT05160636). Participants completed an online survey reporting demographics, clinical history, and vaccination status. Fourteen CDC-defined acute COVID-19 symptoms were self-reported daily and retrospectively recalled for pre-infection and worst moment prior to enrollment. Symptom severity was rated using an FDA-based 4-point scale (0-3) for most symptoms and a 3-point scale (0-2) for smell and taste. A composite symptom score (0-40, lower scores indicate less symptom severity) representing overall symptom burden was calculated for vaccinated and unvaccinated groups. Least-squares mean changes in composite scores from pre-infection were calculated via regression and compared between groups. A running average of daily survey means was calculated to estimate the average symptom burden from symptom onset through a median of 7 days post-infection.
RESULTS: Among 608 participants, 106 (17.4%) received the 2024-2025 KP.2 vaccine. Mean age was 45.8 years, 76.5% were female, 53.6% used antiviral treatment, and 57.7% had ≥1 comorbidity. Vaccinated participants had a mean (SD) time since vaccination of 167.2 (87.6) days. Median time from symptom onset to enrollment was 4 days. At survey day 3, corresponding to a median of 7 days from symptom onset, the running average change in composite score from pre-infection was 0.95 (SE: 0.41, P=0.020) lower in the vaccinated vs unvaccinated group, indicating reduced symptom burden for the vaccinated group compared to the unvaccinated group.
CONCLUSIONS: BNT162b2 KP.2 vaccine was associated with lower COVID-19 symptom burden during the first week of infection compared to no receipt of KP.2 vaccine. These findings support staying up-to-date with recommended COVID-19 vaccination.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR200
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Infectious Disease (non-vaccine), STA: Vaccines