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.

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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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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.

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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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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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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.

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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

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

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

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.

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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. If a vaccine is available, clinical personnel working with the IP should consider vaccination status.

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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

AUGUST 14, 2020

Professor Alexander Chuchalin has quit the Russian Health Ministry’s ethics council due to the quick approval process for the country’s coronavirus vaccine. Many countries have criticised Russia pursuit for a COVID-19 cure, which has skipped Phase 3 trials before giving the vaccine regulatory approval. Safety always comes first.

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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

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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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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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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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

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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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Eye on FDA

SEPTEMBER 10, 2020

Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. Scientifically, there was the big news that a vaccine trial had experienced a serious adverse event bringing a pause to bear in its continuation, likely throwing further cold water on the political side of the equation.

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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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Drug Target Review

JULY 18, 2024

Our recent Nature Medicine publication is a good example of where liquid biopsy data was used alongside T cell responses to make decisions during a dose escalation of a new cancer vaccine candidate, ELI-002 2P 1. In later stage trials, additional clinical trial designs are made possible by liquid biopsy. Reference 1 Pant, S.,

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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

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

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

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. Further Support and Information on COVID-19.

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The Pharma Data

OCTOBER 19, 2020

No Pfizer COVID-19 Vaccine Expected Before Election. 19, 2020 — Pfizer will not apply for emergency authorization of its COVID-19 vaccine before the third week in November, the company’s chief executive said in a statement posted to the Pfizer website on Friday. Further Support and Information on COVID-19.

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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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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

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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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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