The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. The vaccine has been tested in animals and small numbers of people already.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

SEPTEMBER 23, 2020

Scientists around the globe are working on potential vaccines for coronavirus. The UK could be the first country in the world to carry out Covid “challenge trials” – where healthy volunteers are deliberately infected with coronavirus to test possible vaccines. How close are we to a coronavirus vaccine?

Virus 52

Virus Vaccine Government Trials 52

The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

MARCH 3, 2022

The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.

Virus 52

Virus Vaccine Clinical Trials Trials 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

SEPTEMBER 12, 2020

Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. On Tuesday, AstraZeneca said the studies were being paused while it investigated whether the adverse reaction was linked with the vaccine. Image copyright.

Vaccine 52

Vaccine Trials Virus Government 52

The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants.

Vaccine 52

Vaccine Virus Immune Response Clinical Trials 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

Agency IQ

MARCH 7, 2024

Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.

Vaccine 40

Vaccine FDA Virus Licensing 40

Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. For example, a site conducting only protocols involving mRNA may be able to leverage a generic SOP covering any mRNA protocol at that site.

Clinical Trials 52

Clinical Trials Engineering Trials Virus 52

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.

Vaccine 52

Vaccine Trials Virus RNA 52

SCIENMAG: Medicine & Health

OCTOBER 18, 2023

This study is conducted by the Jiangsu Provincial Center for Disease Control and Prevention, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Vaccines for Infectious Diseases of Xiamen University, China National Institutes for Food and Drug Control, and Xiamen Innovax Biotech Company.

Vaccine 52

Vaccine Laboratories Virus Science 52

The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Trials have resumed in the UK, Brazil and South Africa, but US trials remain on hold. Matt Fellows. Source link.

Vaccine 52

Vaccine Trials Science Regulations 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. 37, first identified in Peru (21%) and B.1.621,

Vaccine 52

Vaccine Trials Immune Response Virus 52

Codon

AUGUST 26, 2024

He also explains how they could be used to combat pandemics on “day zero,” well before vaccines are developed. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. Timelines for vaccine development are shrinking, but can it move even faster?

RNA 84

RNA Virus DNA Vaccine 84

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. There is hope that Moderna’s vaccine could be available by early 2021. .

Vaccine 90

Vaccine Immune Response Clinical Trials Virus 90

The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. vaccination efforts. The new vaccine remains stable for a time in the refrigerator. WEDNESDAY, Jan. 13 in the New England Journal of Medicine.

Vaccine 40

Vaccine Trials Clinical Trials Immune Response 40

The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September.

Vaccine 52

Vaccine Trials Virus Treatment 52

The Pharma Data

NOVEMBER 10, 2020

Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, The clinical trials resuming in Europe this week are phase 2 studies in Germany, the Netherlands and Spain, as well as a phase 1/2 study in Belgium, the company said. . Source link.

Vaccine 40

Vaccine Trials Clinical Trials Virus 40

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results.

Virus 40

Virus Trials Disease Hospitals 40

The Pharma Data

JULY 28, 2021

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., The seventh vaccine candidate is an inert protein subunit. and Troy Randall, Ph.D.,

Vaccine 52

Vaccine Virus Clinical Trials Science 52

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

Vaccine 52

Vaccine Virus Trials Immune Response 52

The Pharma Data

OCTOBER 20, 2020

20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. TUESDAY, Oct.

Trials 52

Trials Vaccine Virus Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 27, 2020

Vaccine development to cure coronavirus is at an all-time high after Pfizer and BioNTech announced they had success with a possible vaccine candidate. UK firm develops solution for identifying whether patients are actually infectious from a virus or not. Read on to for the full insight.

Virus 52

Virus Vaccine International Immune Response 52

The Pharma Data

DECEMBER 7, 2020

7, 2020 — Scientists say they may be getting closer to creating a universal flu vaccine. In an early-stage clinical trial with 65 volunteers in the United States, an experimental vaccine triggered strong immune responses to a wide range of flu virus strains and subtypes. MONDAY, Dec.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

The Pharma Data

AUGUST 17, 2020

More than 100,000 people have signed up to take part in future NHS trials of a coronavirus vaccine – but more volunteers are needed, researchers say. Kate Bingham, who chairs the UK’s vaccine taskforce, said: “These trials are safe, please sign up. Volunteers can register online. have blood tests.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52

The Pharma Data

NOVEMBER 23, 2020

Third COVID-19 Vaccine Shows Effectiveness. 23, 2020 — On Monday, AstraZeneca announced that late-stage clinical trials of its COVID-19 vaccine showed it to be 70.4 The trials were conducted in the United Kingdom and Brazil in collaboration with the University of Oxford. Professional. MONDAY, Nov. © 2020 HealthDay.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

SEPTEMBER 2, 2021

First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older. RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,

Clinical Trials 52

Clinical Trials Trials Vaccine Virus 52

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

Vaccine 52

Vaccine Virus Trials Regulations 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

NOVEMBER 23, 2020

. Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.

Vaccine 52

Vaccine Virus Trials Clinical Trials 52

The Pharma Data

AUGUST 9, 2021

Research by Lancaster University scientists to create a COVID-19 vaccine which can be administered through the nose has taken a significant step forward. The pre-clinical animal trials of the intranasal vaccine showed a reduction in both the impact of the disease itself and transmission of the virus.

Vaccine 52

Vaccine Virus Immune Response Disease 52