Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-adapted bivalent vaccine. 5) AUTHORIZED USES .

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DM Clinical Research

APRIL 30, 2021

And while this means that most of us can get outside and enjoy the nice weather, it means something different to allergy sufferers. If you have seasonal allergies, then you know how painful and annoying your symptoms can be. Certain symptoms might have you wondering- is it allergies or COVID? Is it Allergies or COVID symptoms?

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XTalks

SEPTEMBER 8, 2020

The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.

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Manufacturing Vaccination Vaccine Allergies 83

Scienmag

MARCH 15, 2021

The first vaccine has been administered in a comparative adjuvant trial of DNA prime/protein boost HIV vaccine regimens in Kericho, Kenya Credit: U.S. Military HIV Research Program SILVER SPRING, Md.

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Vaccination Vaccine Trials DNA 68

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

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Scienmag

JUNE 15, 2021

Responsibility for the safety, integrity and scientific validity of the trials fell to 12 experts of the COVID-19 Vaccine Data and Safety Monitoring Board, who now have taken the unusual step of publishing details of their review process Credit: UAB BIRMINGHAM, Ala.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Scienmag

JUNE 27, 2021

Study points towards role of gut microbiome in vaccine effectiveness Credit: Image by Dr. Hiroshi Kiyono, CC BY 4.0 A new vaccine to protect against deadly cholera has been made by grinding up genetically modified grains of rice. The first human trial has shown no obvious side effects and a good immune response.

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Vaccination Vaccine Immune Response Trials 72

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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Pharmaceutical Technology

DECEMBER 16, 2022

Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. Novel therapeutics and vaccines for malaria. Apart from vaccines, other approaches for preventing malaria are also being studied.

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Scienmag

OCTOBER 5, 2020

Michael Houghton discovered hepatitis C virus and now is developing a vaccine Credit: Photo: Michael Holly Michael Houghton was awarded the 2020 Nobel Prize in Physiology or Medicine today in recognition of his discovery of the hepatitis C (HCV) virus.

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Medicine Vaccination Vaccine Development 86

Scienmag

OCTOBER 14, 2020

A prospective observational study testing the concept of trained immunity for protection from severe COVID-19 reported milder symptoms in COVID patients receiving MMR vaccination, as published in Allergy. Yet what if an existing vaccine […].

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Vaccination Vaccine Allergies Clinical Trials 59

Scienmag

SEPTEMBER 8, 2020

September 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) announced today that the Bill & Melinda Gates Foundation awarded close to 1.5 Following successful completion […].

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The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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Pharmaceutical Technology

JUNE 9, 2023

After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older. On 31 May, the FDA also approved Pfizer’s vaccine Abrysvo in the same patient population.

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Scienmag

NOVEMBER 18, 2020

Older adults are at a disproportionate risk of severe COVID-19 disease, so it is essential that any vaccine adopted for use against SARS-CoV-2 is effective in this group Peer-reviewed / Randomised Controlled Trial / People **There will be a UK Science Media Centre briefing at 10.15am UK time on Thursday 19th November about this study. […].

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The Pharma Data

AUGUST 24, 2020

The top US virus expert has warned against rushing out a Covid-19 vaccine before it has been proven to be safe and effective. Speaking to Reuters news agency, Dr Anthony Fauci also said doing so could hurt the development of other vaccines. Oxford coronavirus vaccine triggers immune response.

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Vaccination Vaccine Immune Response Allergies 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Fri, 07/08/2022 - 11:48.

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The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,

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Scienmag

OCTOBER 11, 2020

A largescale global trial designed to test the theory that the widely-used BCG vaccine could help protect against COVID-19 will soon recruit healthcare staff and care home workers in the UK.

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Scienmag

JULY 23, 2021

Intranasal vaccination is needle-free and elicits immunity at the site of infection, the respiratory tract Credit: UAB BIRMINGHAM, Ala. and Troy Randall, Ph.D., write […].

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Delveinsight

AUGUST 27, 2020

Moderna’s COVID-19 vaccine triggers an immune response in older adults. Moderna showed robust phase 1 results for its COVID-19 vaccine in adults up to 55 last month. The two drugs combined with radiation cleared the brain metastases in 75% of the animals, as reported in the journal Science Translational Medicine.

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Vaccination Vaccine Research Trials 53

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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Scienmag

FEBRUARY 19, 2021

The vaccine candidate was developed by Maryland-based Altimmune Inc. vaccine candidate that was tested preclinically at the University of Alabama at Birmingham last year is expected to […]. Preclinical tests at UAB last year showed potent systemic and mucosal immune responses in mice after a single intranasal dose.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

OCTOBER 29, 2021

Data published in PLOS Medicine demonstrated that the Johnson & Johnson (the Company) Ebola vaccine authority, Zabdeno ® (Ad26.ZEBOV) These data add to the growing body of substantiation supporting the precautionary use of the Johnson & Johnson Ebola vaccine authority to cover people at threat of Ebola.

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Scienmag

NOVEMBER 4, 2020

The finding provides a surrogate for testing the effectiveness of vaccine candidates Credit: Jennifer Jenks, Duke University School of Medicine DURHAM, N.C.

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Bioengineer

JULY 23, 2021

Intranasal vaccination is needle-free and elicits immunity at the site of infection, the respiratory tract. – There are many reasons that an intranasal vaccine against the SARS-CoV-2 virus would be helpful in the fight against COVID-19 infections, University of Alabama at Birmingham immunologists Fran Lund, Ph.D., Credit: UAB.

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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. About the Phase 1/2/3 Trial in Children. Fri, 07/08/2022 - 09:45.

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Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .

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XTalks

DECEMBER 7, 2020

Past Few Weeks Herald Good News on the Vaccine Front. First came the news from Pfizer and its German partner BioNTech that their mRNA vaccine was 90 percent effective in preventing symptomatic COVID-19 disease. In their trial, some 30,000 patients received either two doses of Moderna’s mRNA-1273 vaccine 28 days apart or placebo.

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The Pharma Data

MARCH 2, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. “For

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Scienmag

SEPTEMBER 4, 2020

The new paper reports the findings of two open-label, non-randomised phase 1/2 trials looking at a frozen formulation and a freeze-dried formulation of a two-part vaccine.

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The Pharma Data

JULY 12, 2021

Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. What Is the Janssen COVID-19 Vaccine?

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The Pharma Data

SEPTEMBER 23, 2020

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles.

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The Pharma Data

MARCH 22, 2021

79% vaccine efficacy at preventing symptomatic COVID-19. The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo.

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The Pharma Data

DECEMBER 2, 2020

Yet, despite the push, the UK is set to administer the first Western vaccine before the FDA’s vaccine review committee even meets, leaving an increasingly skeptical public wondering why. The Phase III trials that involve 44,000 patients (Pfizer) or 30,000 people (Moderna) aren’t adequate for a simple yes or no response.

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