Adjuvant

New Data for AREXVY, GSK’s RSV Vaccine, Show Potential to Help Protect Adults Aged 50 to 59 at Increased Risk for RSV Disease

Retrieved on: 
Wednesday, October 25, 2023
Seniors, Biotechnology, Pharmaceutical, Health, FDA, Infectious Diseases, Consumer, Clinical Trials, RSV, COPD, Headache, Ageing, Food, Respiratory syncytial virus vaccine, III, Conditional sentence, US Foods, Safety, Heart, Diabetes, Stockholm Environment Institute US Center, Infection, Pneumonia, Chronic kidney disease, CDC, Chronic liver disease, Risk, Asthma, ACIP, GSK plc, GSK, Hospital, Pain, Chronic obstructive pulmonary disease, Fatigue, Vaccine, Pharmaceutical industry, Adjuvant

The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.

Key Points: 
  • The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.
  • The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial.
  • Tony Wood, Chief Scientific Officer, GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
  • Immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk of RSV disease was assessed (n=570).

Inimmune Collaborates with Boston Children'S Hospital to Develop Novel Adjuvants

Retrieved on: 
Tuesday, October 24, 2023
Infection, Faculty, Allergic rhinitis, Vaccine, BCH, NIAID, PVP, Boston Children's Hospital, Research, Pediatrics, Messenger, Immunotherapy, NIH, Adjuvant, Hospital, Bangladesh Technical Education Board, MD, Chemistry

MISSOULA, Mont., Oct. 24, 2023 /PRNewswire/ -- Inimmune Corporation, a clinical-stage biotechnology company focused on creating and developing innovative immunotherapeutics, announced that it has entered a research collaboration with Boston Children's Hospital (BCH) to develop novel and innovative small molecule vaccine adjuvants.

Key Points: 
  • MISSOULA, Mont., Oct. 24, 2023 /PRNewswire/ -- Inimmune Corporation, a clinical-stage biotechnology company focused on creating and developing innovative immunotherapeutics, announced that it has entered a research collaboration with Boston Children's Hospital (BCH) to develop novel and innovative small molecule vaccine adjuvants.
  • Inimmune prioritizes research into new classes of adjuvants and immunotherapies for vaccines and stand-alone indications and has a deep pipeline of rapidly advancing programs.
  • "At Inimmune, we continue to identify and develop novel and unique immunotherapeutics," said Dr. Juhienah Khalaf, Ph.D., Director of Chemistry and sub-principal investigator on the project at Inimmune.
  • "By leveraging the drug discovery expertise and resources of Inimmune, PVP researchers will have the opportunity to maximize the potential therapeutic value of their novel adjuvants."

Lilly Announces Details of Presentations at ESMO Congress 2023

Retrieved on: 
Friday, October 6, 2023
Congress, Selpercatinib, Eli Lilly and Company, ID, NYSE, NSCLC, RET, Risk, Adjuvant, MTC, Lilly, The Monarch School, Triple-negative breast cancer, Recurrence, Everolimus, CEST, Oncology, ESMO, LLY, EMBER, EBC, Transfection, ET, Vandetanib, European Society for Medical Oncology, Patient, Poster, Cabozantinib, Pharmaceutical industry, Vaccine

In a late-breaking oral presentation, Lilly will share five-year results, an established benchmark for adjuvant breast cancer trials, from a preplanned interim analysis of the Phase 3 monarchE study.

Key Points: 
  • In a late-breaking oral presentation, Lilly will share five-year results, an established benchmark for adjuvant breast cancer trials, from a preplanned interim analysis of the Phase 3 monarchE study.
  • A separate poster presentation will provide data on the impact of dose reductions on efficacy for patients treated in monarchE.
  • In two late-breaking oral presentations that will be featured as part of the Presidential Symposium 1 on Saturday, October 21, Lilly will share interim analysis results from the Phase 3 LIBRETTO-431 and LIBRETTO-531 clinical studies.
  • In a mini oral presentation, Lilly will share clinical data on imlunestrant as a single agent and in combination therapy.

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023
EUA, Heart, Pregnancy, Pharmacy, Caregiver, Tell, Arthralgia, Vaccination, Chills, Rite Aid, Infection, Fever, COVID-19, Center for Biologics Evaluation and Research, Coronavirus, Skin, Drug testing welfare recipients, Woman, COVID, Inflammation, Fact sheet, CVS Pharmacy, Government, CDC, Myalgia, Vomiting, Formula, Allergy, Physician, Child, XBB, Korea Disease Control and Prevention Agency, Immune system, USE, VAERS, Nausea, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, FD, Food, World Health Organization, Fatigue, Pericarditis, Vaccine, Pharmaceutical industry, Birth control, Medical device, Mobile phone, Novavax COVID-19 vaccine, Hypoesthesia, Adjuvant, Novavax

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023
EUA, Heart, Pregnancy, Pharmacy, Caregiver, Tell, Arthralgia, Vaccination, Chills, Rite Aid, Infection, Fever, COVID-19, Center for Biologics Evaluation and Research, Coronavirus, Skin, Drug testing welfare recipients, Woman, COVID, Inflammation, Fact sheet, CVS Pharmacy, Government, CDC, Myalgia, Vomiting, Formula, Allergy, Physician, Child, XBB, Korea Disease Control and Prevention Agency, Immune system, USE, VAERS, Nausea, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, FD, Food, World Health Organization, Fatigue, Pericarditis, Vaccine, Pharmaceutical industry, Birth control, Medical device, Mobile phone, Novavax COVID-19 vaccine, Hypoesthesia, Adjuvant, Novavax

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023
EUA, SARS-CoV-2, Centers for Disease Control and Prevention, Allergy, Medicine, Completeness, Arthralgia, Vaccination, Hospital, COVID-19, Chills, Section, Fever, Immunodeficiency, Coronavirus, Myocarditis, Pericarditis, COVID, History, Person, Immunocompetence, Messenger, CDC, Emergency Use Authorization, Myalgia, Research and development, Development, Hypoesthesia, Anaphylaxis, XBB, VAERS, NVAX, FDA, Headache, Death, Paresthesia, MIS, FD, Pharmaceutical industry, Vaccine, Novavax COVID-19 vaccine, Adjuvant, Novavax, Research

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023
EUA, SARS-CoV-2, Centers for Disease Control and Prevention, Allergy, Medicine, Completeness, Arthralgia, Vaccination, Hospital, COVID-19, Chills, Section, Fever, Immunodeficiency, Coronavirus, Myocarditis, Pericarditis, COVID, History, Person, Immunocompetence, Messenger, CDC, Emergency Use Authorization, Myalgia, Research and development, Development, Hypoesthesia, Anaphylaxis, XBB, VAERS, NVAX, FDA, Headache, Death, Paresthesia, MIS, FD, Pharmaceutical industry, Vaccine, Novavax COVID-19 vaccine, Adjuvant, Novavax, Research

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use

Retrieved on: 
Thursday, July 20, 2023
Post-exposure prophylaxis, Biologics license application, Emergent BioSolutions, Partnership, Biomedical Advanced Research and Development Authority, DARPA, Office of Inspector General, U.S. Department of Health and Human Services, EBS, Human services, Public, National Institute of Allergy and Infectious Diseases, U.S. Department of Defense Strategy for Operating in Cyberspace, Infection, Person, Bangladesh Technical Education Board, Government, Science, Trial of the century, Bacillus anthracis, Administration, Development, Anthrax, Administration for Strategic Preparedness and Response, AVA, NIAID, FDA, Anthrax vaccine adsorbed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, NYSE, Food, Safety, Disease, Pharmaceutical industry, Vaccine, Emergent, Adjuvant

The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

Key Points: 
  • The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
  • “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities.
  • “The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security.
  • In December 2018, CYFENDUS™ vaccine was the subject of a pre-emergency use authorization package submitted to the FDA.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023
EUA, Autumn, Use, Centers for Disease Control and Prevention, Allergy, Medicine, Civil service commission, Arthralgia, Vaccination, Hospital, Completeness, Chills, Section, Fever, COVID-19, Immunodeficiency, European Directive on Traditional Herbal Medicinal Products, Coronavirus, Myocarditis, Pericarditis, COVID, History, Marketing, Person, Immunocompetence, CDC, Committee, Myalgia, Messenger, Hypoesthesia, Emergency Use Authorization, Anaphylaxis, European, VAERS, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Paresthesia, MIS, FD, Multisystem inflammatory syndrome, Food, European Commission, Safety, Financial Services and Markets Authority (Belgium), Vaccine, Pharmaceutical industry, EU, Novavax COVID-19 vaccine, Adjuvant, Novavax

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023
EUA, Autumn, Use, Centers for Disease Control and Prevention, Allergy, Medicine, Civil service commission, Arthralgia, Vaccination, Hospital, Completeness, Chills, Section, Fever, COVID-19, Immunodeficiency, European Directive on Traditional Herbal Medicinal Products, Coronavirus, Myocarditis, Pericarditis, COVID, History, Marketing, Person, Immunocompetence, CDC, Committee, Myalgia, Messenger, Hypoesthesia, Emergency Use Authorization, Anaphylaxis, European, VAERS, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Paresthesia, MIS, FD, Multisystem inflammatory syndrome, Food, European Commission, Safety, Financial Services and Markets Authority (Belgium), Vaccine, Pharmaceutical industry, EU, Novavax COVID-19 vaccine, Adjuvant, Novavax

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.