pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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Immune Response Vaccination Vaccine Trials 103

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

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Vaccination Vaccine Antibody Trials 293

XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Vaccination Vaccine Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.

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Vaccination Vaccine Immune Response Clinical Trials 147

XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals.

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Vaccination Vaccine Development Clinical Trials 96

BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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Immune Response Vaccination Vaccine Trials 105

BioPharma Reporter

MAY 17, 2021

Sanofi and GSK announced today that their COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase 2 trial.

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Immune Response Vaccination Vaccine Trials 56

Pharmaceutical Technology

JUNE 30, 2022

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer.

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Vaccination Vaccine Clinical Trials Clinical Trials 162

Pharmaceutical Technology

NOVEMBER 20, 2022

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease.

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Vaccination Vaccine Immune Response Protein 147

Drug Discovery World

SEPTEMBER 15, 2023

Replicate Bioscience has dosed the first participant in a Phase I trial of its RBI-4000 vaccine for the prevention of rabies. Rabies, RBI-4000 and the Phase I trial Rabies remains a public health threat in several geographical regions and is designated an NIAID Priority Pathogen.

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Vaccination Vaccine Trials Immune Response 52

pharmaphorum

FEBRUARY 25, 2021

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. A nasal delivery method will also produce an immune response at the point where the virus enters the body.

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Vaccination Vaccine Immune Response Trials 111

pharmaphorum

OCTOBER 11, 2022

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immune response to the virus. Other efforts to develop a nasally-delivered COVID-19 vaccine have met with greater success.

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Vaccination Vaccine Immune Response Development 116

BioPharma Reporter

JANUARY 25, 2021

Merck is shutting down the programs linked to its two COVID-19 vaccine candidates following early trial data indicating that they failed to generate immune responses comparable to a natural infection or existing vaccines.

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Vaccination Vaccine Immune Response Development 98

pharmaphorum

NOVEMBER 20, 2022

One standout success we have all benefitted from is vaccine development, with notable vaccines from Pfizer/BioNTech, AstraZeneca, and Moderna. New hurdles from COVID-19 vaccine development. Trials testing SARS-CoV-2 vaccines saw high enrollment, which reduced the time between each clinical trial phase.

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Vaccination Vaccine Development Clinical Development 97

BioSpace

NOVEMBER 7, 2022

Researchers from the University of Washington have developed an investigational vaccine that can safely elicit an immune response against the HER2 protein, a key marker in breast cancer.

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Immune Response Vaccination Vaccine Protein 87

Medical Xpress

JANUARY 30, 2023

A newly published paper in The Lancet shows that an experimental vaccine against Marburg virus (MARV) was safe and induced an immune response in a small, first-in-human clinical trial.

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Vaccination Vaccine Immune Response Allergies 104

Drug Discovery World

MAY 18, 2023

A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers at Duke University in Durham, North Carolina.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Vaccines predicated on neoantigens therefore elicit truly tumour-specific T cell responses.

Regulation 52

Regulation Vaccination Vaccine Trials 52

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

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Vaccination Vaccine Protein Immune Response 130

XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. These numbers do not reflect the efficacies of the vaccines, which have not been compared head-to-head in any trial yet.

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FDA Approval Vaccination Vaccine Life Science 108

Drug Discovery World

AUGUST 7, 2024

The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. It is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic HBV infection.

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Drug Trials Trials Drugs Antibody 59

The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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Immune Response Vaccination Vaccine Antibody 52

Drug Discovery World

MAY 15, 2024

Researchers have developed a new vaccine technology that can provide protection against a broad range of coronaviruses with potential for future disease outbreaks – including ones we don’t know about yet. Building protective vaccines before a pandemic emerges “We don’t have to wait for new coronaviruses to emerge.

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Vaccination Vaccine Immune Response Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 11, 2022

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine.

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Vaccination Vaccine Immune Response Protein 246

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. The vaccine works by inducing the body's immune response.

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Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. The vaccine works by inducing the body's immune response.

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Production Vaccination Vaccine Immune Response 100

BioSpace

AUGUST 13, 2020

A COVID-19 vaccine candidate developed by Chinese pharmaceutical company Sinopharm triggered antibody-based immune responses in early and mid-stage trials.

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Immune Response Vaccination Vaccine Antibody 132

VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

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Vaccination Vaccine Development Clinical Trials 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Vaccination Vaccine Trials Clinical Trials 59

BioPharma Reporter

FEBRUARY 13, 2023

Scancell has reported preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial: with the plasmid DNA based COVID-19 vaccine candidates inducing immune responses when delivered via needle-free tech.

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Immune Response Vaccination Vaccine DNA 97

pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The post Imugene HER2 vaccine hits target in stomach cancer trial appeared first on.

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Vaccination Vaccine Trials Antibody 119

XTalks

MAY 17, 2024

Every year on May 18th, the global community commemorates World AIDS Vaccine Day, also known as HIV Vaccine Awareness Day. Led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), World AIDS Vaccine Day emphasizes the importance of awareness and education in the fight against HIV/AIDS.

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Vaccination Vaccine Research Immune Response 52

pharmaphorum

NOVEMBER 25, 2021

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). Meanwhile researchers in Japan are also running preclinical studies of an intranasal tau vaccine.

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Vaccination Vaccine Trials Immune Response 96

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

The Pharma Data

NOVEMBER 10, 2020

Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. microgram or 15-microgram doses of the vaccine candidate, either alone or with an adjuvant.

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Immune Response Vaccination Vaccine Clinical Trials 40

pharmaphorum

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

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Vaccination Vaccine Trials Immune Response 105

Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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Vaccination Vaccine Immune Response RNA 52