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.

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DrugBaron

JANUARY 2, 2021

Over the past week a furious debate has broken out over the merits of delaying the second dose of the approved COVID vaccines, to increase the number of people who can be given a single dose. The case against doing so is clear: the labels of the approved vaccines are unambiguous that two doses should be given within a certain time window.

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The Pharma Data

JANUARY 25, 2021

Anaphylaxis Cases Reported Per Million COVID-19 Moderna Vaccine Shots. cases per million Moderna COVID-19 vaccine doses administered as of Jan. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. anaphylaxis cases per million Moderna COVID-19 vaccine doses administered). Professional.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. We are proud to deliver the first vaccine to help protect people in the U.S. 45 years ago.

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The Pharma Data

JANUARY 7, 2021

Anaphylaxis Cases/Million Doses of Pfizer-BioNTech COVID-19 Vaccine Reported. per million doses administered) after receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine in the United States, according to research published in the Jan. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

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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

JUNE 7, 2023

This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation. The vaccine was generally well tolerated.

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The Pharma Data

SEPTEMBER 5, 2021

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]). To date, AstraZeneca and its partners have supplied more than 1.1 Vaxzevria (ChAdOx1-S [Recombinant]).

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The Pharma Data

SEPTEMBER 5, 2021

million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 vaccines. The work is supported by the Centers for Disease Control and Prevention (CDC). “The world is relying on safe and effective vaccines to bring an end to the COVID-19 pandemic. . The total number of people evaluated was 6.2

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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. Centers for Disease Control and Prevention Director Robert R. The vaccine is administered in two doses three weeks apart. MONDAY, Dec. Redfield, M.D.,

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The Pharma Data

JANUARY 8, 2021

Moderna COVID-19 Vaccine Protection May Last Years, Company Claims. 8, 2021 — Moderna CEO Stéphane Bancel said the company’s COVID-19 vaccine may prevent infection for years, CBS News reported Thursday. Professional. FRIDAY, Jan. Natural immunity varies from person to person, CBS News reported. CBS News Article.

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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. We look forward to sharing initial results by year-end. ”. “

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keypoint

JULY 25, 2024

On September 10, 2024, Keystone Symposia will host a free ePanel event featuring the recipients of the Michelson Philanthropies & Science Prize for Immunology. The goal of the prize is to accelerate immunology advances with trans-disease applications towards vaccine and immunotherapy innovation.

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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

JANUARY 21, 2021

21, 2021 — Despite scattered media reports of severe allergic reactions to the Pfizer COVID-19 vaccine, a detailed analysis shows that such incidents are very rare, striking just 11 people for every million doses given. Tom Shimabukuro tracked data on reactions to the Pfizer vaccine soon after it was approved in December.

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The Pharma Data

JUNE 25, 2021

Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% “Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines.

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The Pharma Data

JULY 15, 2021

FreVAX is an innovative intramuscular needle free vaccine injection device for pigs around weaning until the end of nursery. to provide improved vaccination compliance and data management,” added Marius Leyhausen, Senior Global Brand Manager, Integrated Health Management at Boehringer Ingelheim Animal Health. The FreVAX app 2.0

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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 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 23, 2020

23, 2020 — The novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19, is well tolerated, especially among older adults, according to a study published online Nov. During the study period, 13 serious adverse events occurred, none of which were considered to be related to the study vaccine. MONDAY, Nov.

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 — A second COVID-19 vaccine is poised to be administered in the coming weeks after the U.S. Food and Drug Administration granted emergency use authorization (EUA) to the Moderna COVID-19 vaccine on Friday. The EUA allows for the vaccine to be administered to adults 18 years and older in two doses one month apart.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

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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., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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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

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.

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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.

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The Pharma Data

DECEMBER 8, 2020

The COVID-19 vaccine under development by China’s Sinopharm is showing efficacy of 86%, health authorities from the United Arab Emirates reported this morning. In August, the company reported the vaccine candidate triggered antibody-based immune responses in early and mid-stage trials. Source link.

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The Pharma Data

JANUARY 6, 2021

Rare Vaccination Side Effect in People Who Received Cosmetic Facial Fillers. Food and Drug Administration (FDA) noted that there have been a few reports of people who received cosmetic injections to smooth wrinkles or plump lips having unexpected swelling related to the COVID-19 vaccination. Here’s a look. An update from the U.S.

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The Pharma Data

JULY 28, 2021

Incidence of very rare thromboembolic events was far lower than in people diagnosed with COVID-19 infection. Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable. Furthermore, these very rare events can be managed when symptoms are identified and treated appropriately.

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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.

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

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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. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

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keypoint

FEBRUARY 17, 2023

On April 11, we celebrated the 2022 recipients of the Michelson Philanthropies & Science Prize for Immunology in this live ePanel event. This international prize focuses on transformative research in human immunology, with trans-disease applications to accelerate vaccine and immunotherapeutic discovery.

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

DECEMBER 8, 2020

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 The University of Oxford claims no vaccinated participants were hospitalized or suffered serious forms of the disease.

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