Trials and Vaccine - Clinical Research Informer

Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial

Bio Pharma Dive

SEPTEMBER 17, 2020

The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial.

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Vaccine Vaccination Trials Development

CanSino, Canada abandon plans for a coronavirus vaccine trial

Bio Pharma Dive

AUGUST 27, 2020

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

Vaccine

Vaccine Vaccination Trials

FDA lifts pause on Novavax flu vaccine trials

Bio Pharma Dive

NOVEMBER 11, 2024

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

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Vaccine Vaccination Trials

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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine

Pharmaceutical Technology

NOVEMBER 12, 2024

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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Vaccine Vaccination Trials

J&J says single dose of coronavirus vaccine 66% effective in large trial

Bio Pharma Dive

JANUARY 29, 2021

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.

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Vaccine Vaccination Trials

Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

SEPTEMBER 15, 2020

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.

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Vaccine Vaccination Trials

Novavax says vaccine 90% effective against COVID-19 in large trial

Bio Pharma Dive

JUNE 14, 2021

Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.

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Vaccine Vaccination Trials

Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

SEPTEMBER 22, 2021

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

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Vaccine Vaccination Trials

Merck stops coronavirus vaccine development in surprise setback

Bio Pharma Dive

JANUARY 25, 2021

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

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Vaccine Vaccination Development Trials

Moderna follows Pfizer in beginning trial of omicron vaccine

Bio Pharma Dive

JANUARY 26, 2022

New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine. The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant.

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Vaccine Vaccination Trials

Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

FEBRUARY 10, 2023

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

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Vaccine Vaccination RNA Trials

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).

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Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

Bio Pharma Dive

SEPTEMBER 15, 2020

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

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Vaccine Vaccination Manufacturing Trials

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.

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Vaccine Vaccination Development Clinical Trials

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.

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Moderna close to having results from key coronavirus vaccine trial

Bio Pharma Dive

NOVEMBER 12, 2020

has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results. Coronavirus' fast accelerating spread in the U.S.

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Vaccine Vaccination Trials

Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

Bio Pharma Dive

MARCH 8, 2021

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.

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Vaccine Vaccination Trials

FDA fast tracks Sanofi’s mRNA vaccine for chlamydia

Pharmaceutical Technology

MARCH 26, 2025

Sanofi will commence a Phase I/II trial with its vaccine candidate in the next few days to start generating immunogenicity data.

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Vaccine Vaccination Trials

Trial success for 2 coronavirus vaccines backs up early research bets

Bio Pharma Dive

NOVEMBER 17, 2020

Positive results from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but critical questions remain.

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Vaccine Vaccination Research Trials

Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

Bio Pharma Dive

OCTOBER 20, 2020

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

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Vaccine Vaccination Trials

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.

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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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Vaccine Vaccination Development Clinical Trials

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.

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Moderna vaccine safe and spurs immune response in kids, company says

Bio Pharma Dive

OCTOBER 25, 2021

The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.

Immune Response

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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%.

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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.

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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.

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FDA delays testing of Inovio's coronavirus vaccine

Bio Pharma Dive

SEPTEMBER 28, 2020

The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.

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New coronavirus vaccine data back up Pfizer, BioNTech claims of strongly effective shot

Bio Pharma Dive

NOVEMBER 18, 2020

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just 8 for those who were vaccinated.

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Vaccine Vaccination Trials

UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age.

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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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Moderna mpox mRNA vaccine shows early promise in monkey study

Pharmaceutical Technology

SEPTEMBER 5, 2024

Moderna is currently running a Phase I/II trial of the mRNA mpox vaccine mRNA-1769 in healthy participants.

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Vaccine Vaccination Trials

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.

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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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Moderna reveals first study results for seasonal flu vaccine

Bio Pharma Dive

DECEMBER 10, 2021

Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.

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UK to start study testing Pfizer, AstraZeneca vaccines together

Bio Pharma Dive

FEBRUARY 4, 2021

The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.

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Vaccine Vaccination Trials

As trials progress, FDA weighs COVID-19 vaccine authorizations for children

Bio Pharma Dive

JUNE 11, 2021

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.

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Vaccine Vaccination Trials

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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Vaccine Vaccination Protein Clinical Trials

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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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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Vaccine Vaccination Gene Therapy Antibody

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.

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Vaccine Vaccination Development Immune Response

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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Vaccine Vaccination Protein Clinical Trials

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.

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Vaccine Vaccination Genetic Engineering Clinical Trials

Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. In June 2022, Pfizer acquired 8.1%

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Vaccine Vaccination Bacteria Protein

Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial

CanSino, Canada abandon plans for a coronavirus vaccine trial

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FDA lifts pause on Novavax flu vaccine trials

Webinars

FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine

J&J says single dose of coronavirus vaccine 66% effective in large trial

Pfizer says coronavirus vaccine study still on track for October readout

Novavax says vaccine 90% effective against COVID-19 in large trial

Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Merck stops coronavirus vaccine development in surprise setback

Moderna follows Pfizer in beginning trial of omicron vaccine

Pfizer begins plan to challenge Shingrix with an mRNA vaccine

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

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

How did pharma develop a vaccine so quickly?

Studies of AstraZeneca coronavirus vaccine put on hold for safety review

Moderna close to having results from key coronavirus vaccine trial

Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

FDA fast tracks Sanofi’s mRNA vaccine for chlamydia

Trial success for 2 coronavirus vaccines backs up early research bets

Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

Moderna gets $1.5B from US for coronavirus vaccine supply

BioNTech targets infectious diseases for vaccine development

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

Moderna vaccine safe and spurs immune response in kids, company says

GSK sets high bar with trial results for RSV vaccine

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

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

FDA delays testing of Inovio's coronavirus vaccine

New coronavirus vaccine data back up Pfizer, BioNTech claims of strongly effective shot

UK MHRA approves Takeda’s dengue vaccine Qdenga

Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

Moderna mpox mRNA vaccine shows early promise in monkey study

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

Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope

Moderna reveals first study results for seasonal flu vaccine

UK to start study testing Pfizer, AstraZeneca vaccines together

As trials progress, FDA weighs COVID-19 vaccine authorizations for children

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

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

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

Merck and Moderna partner to develop and sell cancer vaccine

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

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

Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

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