We conducted a retrospective cohort study of Kaiser Permanente Northwest patients 18 years and older who were vaccinated with the COVID-19 bivalent vaccine between September 1, 2022 and March 1, 2023. We replicated the Vaccine Safety Datalink (VSD) rapid cycle analysis protocol to identify cases of ischemic stroke or transient ischemic attack (TIA) in the 21 days following vaccination using ICD-10-CM diagnosis codes in the primary position. The incidence of ischemic stroke or TIA was 34.3 per 100,000 (95 % CI, 17.7-59.9) in patients 65 years or older who received the bivalent Pfizer vaccine. Although a safety signal was detected in this study, further investigation is warranted to validate an association between COVID-19 vaccination and risk of ischemic stroke. Replication of the VSD case definition confirmed the exceptionally high positive predictive value in identifying ischemic stroke or TIA within 21 days of Pfizer bivalent vaccination in individuals 65 years and older. Two physician adjudication with chart review and confirmation of ischemic stroke cases allowed accurate absolute incidence estimates of stroke per 100,000 vaccine recipients and is helpful in calculation of net benefit for policy recommendations and shared decision-making.

2014-06-01·Vaccine3区 · 医学

Protective efficacy of intranasally administered bivalent live influenza vaccine and immunological mechanisms underlying the protection

3区 · 医学

Article

作者: Pyo, Hyun-Mi ; Zhou, Yan

Previously we reported the generation of a new potential live attenuated influenza vaccine (LAIV) named SIV/606 that expresses H1 and H3 HAs. We also demonstrated intratracheal vaccination of SIV/606 conferred protection against infections with both H1 and H3 swine influenza virus subtypes in pigs. Here we vaccinated pigs with SIV/606 intranasally, which is a more suitable route for LAIV, and evaluated vaccine efficacy. Intranasal vaccination of SIV/606 induced serum IgG antibody responses against both H1N1 and H3N2 SIVs and high titer of virus neutralizing antibodies against H1N1 SIV but not against H3N2 SIV. When we challenged the pigs with H1N1 and H3N2 SIVs, we observed marked reduction of lung lesions and viral titer in lung tissue in vaccinated pigs. Our analyses also showed that vaccinated pigs had more IFN-γ secreting cells in trachea-bronchial lymph nodes. Our studies demonstrated that intranasal vaccination of SIV/606 is efficacious for H1N1 and H3N2 SIVs infections. Moreover, our results may help explaining the protection from H3N2 SIV infection despite the low viral neutralizing antibody titer.

Developments in biological standardization

Dynamics and specificity of influenza virus antibodies as well as IgE values in serum and nasal fluid after repeated local application of live bivalent influenza vaccine.

Article

作者: Kuwert, E K ; Werner, J

A long term study with bivalent live influenza vaccine was carried out in 18 subjects with no previous history of egg protein hypersensitivity. Experimental conditions included a nine-fold vaccination schedule with collection of serum and nasal fluid. The parameters studied were determination of serum and local antibody formation as well as the demonstration of specific IgE antibodies in serum and nasal fluid. HI antibody response was observed in 100% of the vaccinees against vaccine related strains but not to antigenically remote isolates. NI antibodies could be demonstrated in serums and to some extent in nasal fluids. Special attention was given to induction of specific IgE antibodies to egg protein, however no indication for a vaccine induced sensitization could be detected when total and specific IgE concentrations of serum and nasal fluid were determined.

100 项与 Bivalent malaria vaccine (Novavax/CPL Biologicals/ICGEB) 相关的药物交易

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