Filtered By:
Management: Food and Drug Administration (FDA)
Vaccination: Vaccines
This page shows you your search results in order of date.
Order by Relevance | Date
Total 962 results found since Jan 2013.
COVID-19: An Overview of SARS-CoV-2 Variants-The Current Vaccines and Drug Development
Biomed Res Int. 2023 Aug 29;2023:1879554. doi: 10.1155/2023/1879554. eCollection 2023.ABSTRACTThe world is presently in crisis facing an outbreak of a health-threatening microorganism known as COVID-19, responsible for causing uncommon viral pneumonia in humans. The virus was first reported in Wuhan, China, in early December 2019, and it quickly became a global concern due to the pandemic. Challenges in this regard have been compounded by the emergence of several variants such as B.1.1.7, B.1.351, P1, and B.1.617, which show an increase in transmission power and resistance to therapies and vaccines. Ongoing researches are ...
Source: Biomed Res - September 7, 2023 Category: Research Authors: Narjess Bostanghadiri Pardis Ziaeefar Morvarid Golrokh Mofrad Parsa Yousefzadeh Ali Hashemi Davood Darban-Sarokhalil Source Type: research
In vitro and in vivo evaluation of immune response of poly(lactic acid) nanoparticles with different end groups
Int J Biol Macromol. 2023 Aug 31:126593. doi: 10.1016/j.ijbiomac.2023.126593. Online ahead of print.ABSTRACTPoly(lactic acid) (PLA) has excellent properties of biodegradability and biocompatibility, which is a US Food and Drug Administration (FDA) approved biopolymer for the preparation of safe and effective vaccines, drugs, and gene delivery systems. However, there still exists a great problem whether and how the end group affects the immune response of PLA vaccines. Therefore, the aim of this study was to evaluate the in vitro and in vivo of immune response of PLA nanoparticles (NPs) with carboxyl (COOH) and ester (COOR)...
Source: International Journal of Biological Macromolecules - September 2, 2023 Category: Biochemistry Authors: Yuan Gao Jun Yang Yaru Zhang Ying Zhao Xin Zhao Xining Zhang Jing Zhang Li Mao Hongjun Wang Huimei Wang Lianyan Wang Source Type: research
Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines
We describe simultaneous influenza and mRNA COVID-19 bivalent booster vaccine administration between August 31-December 31, 2022, among persons aged ≥6 months in the Vaccine Safety Datalink (VSD) by COVID-19 bivalent booster vaccine type, influenza vaccine type, age group, sex, and race and ethnicity. Of 2,301,876 persons who received a COVID-19 bivalent booster vaccine, 737,992 (32.1%) received simultaneous influenza vaccine, majority were female (53.1%), aged ≥18 years (91.4%), and non-Hispanic White (55.7%). These findings can inform future VSD studies on simultaneous influenza and COVID-19 bivalent booster vaccine ...
Source: Vaccine - August 20, 2023 Category: Allergy & Immunology Authors: Tat'Yana A Kenigsberg Kristin Goddard Kayla E Hanson Ned Lewis Nicola Klein Stephanie A Irving Allison L Naleway Bradley Crane Tia L Kauffman Stanley Xu Matthew F Daley Laura P Hurley Robyn Kaiser Lisa A Jackson Amelia Jazwa Eric S Weintraub Source Type: research
United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism
Expert Opin Drug Saf. 2023 Aug 18:1-6. doi: 10.1080/14740338.2023.2245748. Online ahead of print.ABSTRACTINTRODUCTION: Nuclear reactor incidents and bioterrorism outbreaks are concerning public health disasters. Little is known about US Food and Drug Administration (FDA)-approved agents that can mitigate consequences of these events. We review FDA data supporting regulatory approvals of these agents.AREAS COVERED: We reviewed pharmaceutical products approved to treat Hematopoietic Acute Radiation Syndrome (H-ARS) and to treat or prevent pulmonary infections following Bacillus anthracis (anthrax) exposure. Four drugs were a...
Source: Expert Opinion on Drug Safety - August 18, 2023 Category: Drugs & Pharmacology Authors: Charles L Bennett Peter Georgantopoulos Robert Peter Gale Kevin Knopf William J Hrushesky Chadi Nabhan James O Armitage Source Type: research
A review of criteria strictness in "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
Vaccine. 2023 Jul 31:S0264-410X(23)00918-0. doi: 10.1016/j.vaccine.2023.07.072. Online ahead of print.ABSTRACTTo assess safety in vaccine development, stricter grading scales, such as the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" issued by the U.S. Food and Drug Administration (FDA grading scale), are required. However, concern exists that their strictness may lead to an overestimation of some adverse events (AEs). We analyzed the details of AEs in a phase I clinical trial of a preventive vaccine for infectious diseases. In this trial, we observed th...
Source: Vaccine - August 2, 2023 Category: Allergy & Immunology Authors: Motoki Amai Masanori Nojima Yoshikazu Yuki Hiroshi Kiyono Fumitaka Nagamura Source Type: research
Vaccination has more to offer than direct clinical benefit: FDA's vaccine licensure process ignores population health and social determinants of disease
Am J Epidemiol. 2023 Jul 31:kwad161. doi: 10.1093/aje/kwad161. Online ahead of print.ABSTRACTThe current U.S. Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct non-clinical benefits. For example, COVID-19 vaccinations for school-aged children may prevent school absenteeism. Al...
Source: Am J Epidemiol - August 1, 2023 Category: Epidemiology Authors: Malia Jones Katelyn K Jetelina Source Type: research
