Journal: Immunity, Inflammation and Disease

Article Title: Impaired immunity and high attack rates caused by SARS‐CoV‐2 variants among vaccinated long‐term care facility residents

doi: 10.1002/iid3.679

Figure Lengend Snippet: IgG levels to WT SARS‐CoV‐2 spike glycoprotein after vaccination with Comirnaty. (A) Receptor binding domain (RBD) and (B) full‐length spike glycoprotein (SFL) in binding antibody units (BAU)/ml. Dashed lines mark the threshold for positive result per antigen. Statistical significance measured with Wilcoxon rank‐sum test, significance level 0.05. IgG, immunoglobulin G; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus 2.

Article Snippet: In a recent study we conducted in another nursing home, we observed that while 7/7 nursing home residents had NAb to Delta, 2/7 did not have measurable NAb to either Beta or Omicron variant despite receiving a Pfizer/BioNTech Comirnaty booster 21–42 days prior.

Techniques: Binding Assay

Journal: Immunity, Inflammation and Disease

Article Title: Impaired immunity and high attack rates caused by SARS‐CoV‐2 variants among vaccinated long‐term care facility residents

doi: 10.1002/iid3.679

Figure Lengend Snippet: Geometric mean neutralizing antibody (NAb) titers (GMT [95% CI]) to wild‐type (WT), Alpha and Beta variants of SARS‐CoV‐2 and anti‐spike IgG concentrations (GMC [95%CI]) expressed in binding antibody units/ml. Vaccinated and noninfected (PCR‐) with Pfizer/BioNTech Comirnaty, COVID‐19 outbreaks in long‐term care facilities (LTCFs), 2021, Finland

Article Snippet: In a recent study we conducted in another nursing home, we observed that while 7/7 nursing home residents had NAb to Delta, 2/7 did not have measurable NAb to either Beta or Omicron variant despite receiving a Pfizer/BioNTech Comirnaty booster 21–42 days prior.

Techniques: Binding Assay, Variant Assay

Journal: Immunity, Inflammation and Disease

Article Title: Impaired immunity and high attack rates caused by SARS‐CoV‐2 variants among vaccinated long‐term care facility residents

doi: 10.1002/iid3.679

Figure Lengend Snippet: Peripheral blood mononuclear cell (PBMC) responses to stimulation with (A) SARS‐CoV‐2 recombinant spike glycoprotein or (B) SARS‐CoV‐2 recombinant nucleoprotein. The secretion of IFN‐γ, perforin‐1 or granzyme B into supernatants was measured after 6 days in infected or noninfected residents and healthcare workers (HCWs,) who all had received two doses of Comirnaty. Cytokine concentrations are presented as stimulation indexes. Dashed line marks the threshold for a positive result (stimulation index ≥3). IFN, interferon; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus.

Article Snippet: In a recent study we conducted in another nursing home, we observed that while 7/7 nursing home residents had NAb to Delta, 2/7 did not have measurable NAb to either Beta or Omicron variant despite receiving a Pfizer/BioNTech Comirnaty booster 21–42 days prior.

Techniques: Recombinant, Infection

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Covid-19 vaccines and treatments authorized by EMA and USFDA by 28 Feb 2022

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Vaccines, Recombinant

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Comparison between EMA and USFDA in number and type of Covid-19 MAs.

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Comparison

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Comparison between EMA and USFDA in approval timelines for Covid-19 MAs authorized by both authorities.

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Comparison

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Comparison between EMA and USFDA in Covid-19 MAs Approval Timelines and Pathways

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Comparison, Recombinant

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Continued USFDA Approval Timelines and Pathways for Covid-19 MAs Converted to Standard Approval

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques:

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Comparison between therapeutic groups of USFDA and EMA Covid-19 MAs.

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Comparison

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: Therapeutic groups, approved indications, accepted pivotal clinical trials, and post-authorization obligations for EMA and USFDA Covid-19 MAs

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: Vaccines, Virus, Binding Assay, Membrane, Recombinant, Concentration Assay, Infection, Medications

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: EU MA centralized procedure both for standard and implemented Covid-19 cases.

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques:

Journal: Therapeutic Innovation & Regulatory Science

Article Title: Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

doi: 10.1007/s43441-023-00574-6

Figure Lengend Snippet: US Procedures both for standard and implemented Covid-19 cases.

Article Snippet: EU , Pfizer- BioNTech COVID-19 Vaccine/[Comirnaty] , J07BX03 “Vaccines, other viral vaccines” , Active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older , 1 (C4591001) , Randomized, multinational, placebo-controlled, observer-blind , 44,000 , Ongoing , Completion of ongoing trials (as obligation for conditional authorization).

Techniques: