Clinical Trials, Vaccination and Vaccine - Clinical Research Informer

Studies of AstraZeneca coronavirus vaccine put on hold for safety review

Bio Pharma Dive

SEPTEMBER 8, 2020

A participant in a clinical trial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.

Vaccination

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

DECEMBER 29, 2020

OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year.

Vaccine

Vaccine Vaccination Development Clinical Trials

BioNTech targets infectious diseases for vaccine development

Pharmaceutical Technology

MARCH 28, 2023

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer. In response to the lower vaccine sales forecasts, BioNTech shares opened at 3.9%

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Moderna gets $1.5B from US for coronavirus vaccine supply

Bio Pharma Dive

AUGUST 11, 2020

has already invested heavily in Moderna's vaccine, having previously committed $1 billion to fund clinical trials and manufacturing scale-up.

Vaccination

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

Vaccination

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ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

Clinical Trials

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India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine

Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. It is formulated to permit intranasal delivery via nasal drops.

Vaccination

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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

Vaccination

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Ten key clinical trials to watch in the first half of 2021

Bio Pharma Dive

JANUARY 11, 2021

Study results could come soon for several coronavirus vaccines, as well as experimental medicines from Amgen, Vertex and Sage Therapeutics.

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China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Pharmaceutical Technology

SEPTEMBER 5, 2022

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version.

Vaccination

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Health Canada approves Novavax’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

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BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines

Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

Vaccination

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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 The vaccine variant […]

Vaccination

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Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Bio Pharma Dive

NOVEMBER 22, 2021

Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

Vaccination

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Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Pharmaceutical Technology

JULY 15, 2022

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada.

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Breakthrough Vaccine Shows High Protection Against Drug-Resistant Superbug in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 1, 2024

Scientists have developed a vaccine against a notorious drug-resistant superbug, targeting molecules on its surface that are also found on other bacteria and fungi.

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT News

JANUARY 18, 2023

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. Read the rest…

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Consumers fall into three COVID-19 vaccine adoption segments

World of DTC Marketing

DECEMBER 11, 2020

(Mckinsey) Much of the prevailing market research on COVID-19 vaccination frames sentiment as “likely,” “unlikely,” or “neutral.” McKinsey’s research is designed to uncover a more granular continuum of sentiments and to account for the fact that many consumers may take a “wait and see” approach to their decision about vaccination.

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Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

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SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

Vaccination

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Radical Vaccine Strategy Could Help Quash Parasite Afflicting Millions

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 11, 2024

Using viruses that infect bacteria to detect proteins sprouted by a notorious parasite, scientists have honed in on possible vaccine targets for schistosomiasis, a neglected tropical disease that currently affects an estimated 600 million people worldwide, causing 280,000 deaths per year.

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Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 8, 2023

The World Health Organization has approved a new vaccine that scientists argue will be a game-changer in the fight against malaria, which kills half a million people in Africa every year.

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Race for universal flu vaccine ramps up as Osivax kicks off Phase IIa trial

Pharmaceutical Technology

JUNE 16, 2023

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs).

Vaccination

Vaccination Vaccine Trials Immune Response

The TB Vaccine Mysteriously Protects Against Lots of Things. Now We Know Why

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2022

When babies in the African countries of Guinea Bissau and Uganda were given the tuberculosis vaccine, something remarkable happened.

Vaccination

Vaccination Vaccine Bacteria Research

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

Vaccination

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GSK sets high bar with trial results for RSV vaccine

Bio Pharma Dive

OCTOBER 13, 2022

With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.

Vaccination

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

Vaccination

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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

DECEMBER 2, 2022

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.

Vaccination

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Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine

BioSpace

AUGUST 16, 2021

Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.

Clinical Trials

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BioNTech Founders Predict Cancer Vaccine Is Only Years Away

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2022

The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade.

Vaccination

Vaccination Vaccine RNA Development

NIH clinical trial for universal influenza vaccine begins

Pharma Times

SEPTEMBER 20, 2023

The universal vaccine could protect people against more strains of flu - News - PharmaTimes

Clinical Trials

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Landmark Melanoma Vaccine Could Be Available in Just 2 Years

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2023

Moderna CEO Stephane Bancel told AFP his company’s experimental vaccine against melanoma could be available in as little as two years, in what would amount to a landmark step against the most serious form of skin cancer. Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.

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Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2024

That’s how many vaccines a man in Germany claims to have received for COVID-19 in just 29 months – and his body isn’t reacting the way some scientists thought it would. Two hundred and seventeen. The 62-year-old male from the city of Magdeburg made headlines a few years ago for his private and risky decision […]

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India’s success story in pediatric vaccination program should be further replicated in adult vaccination: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 28, 2023

India’s success story in pediatric vaccination programme should be further replicated in the form of adult vaccination programme, experts recommended on the occasion of the 2nd edition of the India Vaccine Leaders Conclave (IVLC) held between August 22 and August 23, 2023 under the theme “Building Resilient Vaccine Ecosystems” in Mumbai.

Vaccination

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NHS platform announced to accelerate personalised cancer vaccine clinical trials

Pharma Times

MAY 31, 2024

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

Vaccination

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Pfizer, after delay, completes enrollment in Lyme vaccine trial

Bio Pharma Dive

DECEMBER 5, 2023

The announcement ends a lengthy setback that began when the company and partner Valneva accused a clinical trial site operator of study misconduct.

Trials

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Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Bio Pharma Dive

FEBRUARY 24, 2021

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

Clinical Trials

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Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca

BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

Clinical Trials

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ICON partners with US Government for clinical trials of Covid-19 vaccines

Pharmaceutical Technology

SEPTEMBER 14, 2023

ICON will conduct Phase IIb clinical trials for the US BARDA-selected Covid-19 vaccine candidates as part of ‘Project NextGen’.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

COVID-19: Some ignored facts

World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.

Vaccination

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Studies of AstraZeneca coronavirus vaccine put on hold for safety review

How did pharma develop a vaccine so quickly?

Webinars

Trending Sources

BioNTech targets infectious diseases for vaccine development

Webinars

Moderna gets $1.5B from US for coronavirus vaccine supply

Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll

India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine

Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Ten key clinical trials to watch in the first half of 2021

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Health Canada approves Novavax’s Covid-19 vaccine for adolescents

US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines

Merck and Moderna partner to develop and sell cancer vaccine

SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Breakthrough Vaccine Shows High Protection Against Drug-Resistant Superbug in Mice

HIV vaccine being developed by Johnson & Johnson fails clinical trial

Consumers fall into three COVID-19 vaccine adoption segments

Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

Radical Vaccine Strategy Could Help Quash Parasite Afflicting Millions

Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope

Race for universal flu vaccine ramps up as Osivax kicks off Phase IIa trial

The TB Vaccine Mysteriously Protects Against Lots of Things. Now We Know Why

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

GSK sets high bar with trial results for RSV vaccine

WHO grants emergency use listing to SK bioscience’s SKYCovione

India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine

BioNTech Founders Predict Cancer Vaccine Is Only Years Away

NIH clinical trial for universal influenza vaccine begins

Landmark Melanoma Vaccine Could Be Available in Just 2 Years

Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

India’s success story in pediatric vaccination program should be further replicated in adult vaccination: Experts

NHS platform announced to accelerate personalised cancer vaccine clinical trials

Pfizer, after delay, completes enrollment in Lyme vaccine trial

Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca

ICON partners with US Government for clinical trials of Covid-19 vaccines

COVID-19: Some ignored facts

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