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The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinicaltrial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.
A participant in a clinicaltrial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.
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%
WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinicaltrials of experimental vaccines against the coronavirus, and treatments for COVID-19. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.
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.
Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinicaltrial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. Read the rest…
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).
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.
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinicaltrials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 The vaccine variant […]
Moderna is expected to launch a human clinicaltrial 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.
The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinicaltrials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinicaltrial waiver subject to condition.
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.
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.
Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., The company’s.
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.
Health officials in Azerbaijan have granted approval for a clinicaltrial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinicaltrial, both precautionary steps against emerging strains.
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.
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 clinicaltrial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.
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.
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.
This webinar focused on the need for a coordinated clinicaltrials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.
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.
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.
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.
The biotech, best known for its vaccine research, said its clinicaltrial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.
Violations of study standards by a “third-party clinicaltrial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.
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.
Over the past decade, Germany’s share of global clinicaltrial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues. The country accounted for just 3.9%
Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinicaltrial industry were introduced. A few months later, the monkeypox outbreak showed the difficulty in accessing vaccines and antivirals despite a plan to stockpile them. Tracking the news.
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.
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
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.
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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