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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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.

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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.

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The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. My hunch is that AZ is going to need to collect more information.”. patients,” Gottlieb said. “My

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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.

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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.

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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.

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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.

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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. Further Support and Information on COVID-19.

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The Pharma Data

DECEMBER 21, 2020

The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. Additionally, how do you ensure that the vaccine distribution is equitable?

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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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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The Pharma Data

APRIL 14, 2021

We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. cases out of more than 6.8

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The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

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The Pharma Data

DECEMBER 17, 2020

Advisory Committee Votes to Recommend EUA for Moderna Vaccine. 17, 2020 — The Moderna COVID-19 vaccine received recommendation from a U.S. Food and Drug Administration advisory committee on Thursday, clearing the way for it to become the second COVID-19 vaccine to be granted emergency use authorization. More Information.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

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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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The Pharma Data

JANUARY 29, 2021

29, 2021 — Interim phase 3 data show that the COVID-19 vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson is 66 percent effective in preventing moderate-to-severe COVID-19 in adults, the National Institutes of Health announced today. The vaccine, known as Ad.26.COV2.S, The vaccine, known as Ad.26.COV2.S,

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The Pharma Data

DECEMBER 8, 2020

FDA Review Finds Pfizer COVID-19 Vaccine Effective After First Dose. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19. Further Support and Information on COVID-19. Professional.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Pharma Data

DECEMBER 11, 2020

70 Percent Efficacy Found for Oxford COVID-19 Vaccine. 11, 2020 — The ChAdOx1 nCoV-19 vaccine has an overall efficacy of 70.4 Participants in the vaccine group received two doses containing 5 x 10 10 virus particles (standard dose; SD/SD cohort); a subset in the U.K. The researchers found that vaccine efficacy was 62.1

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Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

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The Pharma Data

DECEMBER 14, 2020

14, 2020 — The Pfizer-BioNTech COVID-19 vaccine has received the first emergency use authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is administered in two doses three weeks apart. Researchers found the vaccine was 95 percent effective in preventing COVID-19. MONDAY, Dec. Redfield, M.D.,

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The Pharma Data

MAY 3, 2021

The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . Pfizer also shared antibody responses from the younger age group.

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The Pharma Data

DECEMBER 2, 2020

The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates. This License Agreement represents an important corporate milestone.

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The Pharma Data

DECEMBER 9, 2020

COVID-19 Vaccine Caution Issued by U.K. 9, 2020 — People with a “significant history” of allergic reactions should not receive the new Pfizer-BioNTech COVID-19 vaccine, U.K. mass vaccination program, the Associated Press reported. mass vaccination program, the Associated Press reported. Professional.

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The Pharma Data

JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

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The Pharma Data

FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages.

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The Pharma Data

JANUARY 4, 2021

4, 2021 — The mRNA-1273 vaccine has 94.1 from Brigham and Women’s Hospital in Boston, and colleagues conducted a phase 3 randomized trial at 99 centers across the United States. per 1,000 person-years), resulting in vaccine efficacy of 94.1 Further Support and Information on COVID-19. MONDAY, Jan. Baden, M.D.,

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The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however. FRIDAY, Dec.

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The Pharma Data

DECEMBER 30, 2020

Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine. 30, 2020 — Britain became the first country to give authorization to the COVID-19 vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Further Support and Information on COVID-19. WEDNESDAY, Dec.

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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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The Pharma Data

JANUARY 11, 2021

Two Billion COVID-19 Vaccine Doses From BioNTech Expected This Year. 11, 2021 — A boost in manufacturing should enable Germany’s BioNTech to produce 2 billion doses of its COVID-19 vaccine this year, the company says. BioNTech and partner Pfizer developed the first COVID-19 vaccination to be brought to market.

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The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,

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The Pharma Data

NOVEMBER 9, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. GAITHERSBURG, Md., Glenn, M.D., and globally.”.

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The Pharma Data

DECEMBER 15, 2020

COVID-19 Death Toll Hits 300,000 as Vaccine Rollout Begins. 15, 2020 — The number of Americans killed by COVID-19 topped 300,000 on Monday, the same day the country launched a massive vaccination campaign to curb the spread of COVID-19. KFF COVID-19 Vaccine Monitor. Further Support and Information on COVID-19.

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