Tag: Development of Vaccines

Development of vaccines can be simplified into two broad stages:
1. Pre-clinical development is research carried out in lab assays and on animals. It includes:
– Identification (discovery) of relevant antigens (e.g. screening)
– Creation of the vaccine concept
– Evaluation of vaccine efficacy in test tubes and animals
– Manufacture of the vaccine to Good Manufacturing Practice standards
2. Clinical development is when the vaccine is first tested in humans. It covers four stages over several years, from initial clinical trials in humans (phase I) right through to introduction and beyond (phase IV). Clinical development is built on rigorous ethical principles of informed consent from volunteers, with an emphasis on vaccine safety as well as efficacy.

MSD start clinical studies of its investigational polyvalent conjugate vaccine

merck
MSD (known as "Merck" in USA and Canada) announced that the company is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease.

Merck KGaA and Jenner Institute join forces to improve vaccine manufacturing

merck kgaa
Merck KGaA, a leading science and technology company announced a partnership with Oxford University’s Jenner Institute to develop more robust and scalable vaccine manufacturing processes.

Inovio started new partnership with CEPI

vaccine
Inovio Pharmaceuticals and the Coalition for Epidemic Preparedness Innovations (CEPI) announced a partnership under which Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome (MERS).

Vaxart will present its oral influenza vaccine development program

digital drug
Vaxart a clinical stage biotechnology company developing oral recombinant vaccines administered by tablet rather than by injection, completed the Phase 2 Challenge Study of its H1 influenza oral tablet vaccine.

Russian company starts phase 2 clinical trials of its meningococcal vaccine

clinical trials
NPO Microgen has begun phase 2 clinical trials of the first Russian polysaccharide meningococcal vaccine to prevent diseases caused by Neisseria meningitidis serogroups A and C, including meningitis and meningococcemia.

Indian Immunologicals launches a pentavalent vaccine

vaccine
Developed with the company’s research and development expertise, it will be made at the IIL’s vaccine manufacturing facility in Hyderabad for retail market as well as the national Universal Immunisation Programme.

GSK received approval for Shingrix vaccine in Europe and Japan

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GlaxoSmithKline announced that the European Commission has approved Shingrix for the prevention of shingles and post-herpetic neuralgia. The Japanese Ministry of Health, Labour and Welfare has also approved Shingrix.

Scientists from Australia and Wales developed a new vaccine production platform

microscope
A team led by Associate Professor John Miles from James Cook University and Cardiff University’s Professor Andrew Sewell describe how they engineered a new vaccine production platform and built a fully synthetic flu vaccine.

Clinical study of vaccine that blocks opioid dependence is going in Russia

drug development
The vaccine against opiate dependence is being developed by the National Scientific Center (NSC) of Narcology, the leading institution of the Russian Ministry of Health in that area.

BiondVax will conduct the clinical efficacy trial of Universal Flu Vaccine

influenza vaccine
BiondVax, an Israeli developer of the Universal Flu Vaccine candidate M-001, announced the signing of a Master Service Agreement with a contract research organization to conduct the first pivotal, clinical efficacy, trial.

ProJect Pharmaceutics expands its laboratory facilities

vaccine
ProJect Pharmaceutics, a German service provider of pharmaceutical formulations and lyophilisation processes, expands its service portfolio with laboratories for handling GMO S2 and BSL-2 biological products.

NIAID published a strategic plan for development of universal influenza vaccine

vaccine
Developing a universal influenza vaccine—a vaccine that can provide durable protection for all age groups against multiple influenza strains—is a priority for the US National Institute of Allergy and Infectious Diseases.

Prokarium received a $10 million funding for development of novel vaccine

vaccine manufacturing
Prokarium, the UK-based synthetic biology company that has developed Vaxonella, an oral, thermostable vaccine delivery platform, announced the completion of a $10 million investment round.

PharmaJet and Genexine will jointly develop DNA vaccine

dna
PharmaJet, the US maker of innovative, needle-free injection technology, announced a global license agreement with Genexine, a biotherapeutics company from South Korea, for the development of DNA vaccines for human applications.

Russian vaccine against TB is ready for Phase II trials

research
The funds have been already allocated to continue this work over the next two years. The program is financed from the state budget and provides for the allocation of about 60 million rubles in 2018 and about 30 million in 2019.

CureVac received two grants from Bill & Melinda Gates Foundation

vaccine
CureVac AG, a German biopharmaceutical company pioneering the field of mRNA-based drugs, announced the awarding of two new grants from the Bill & Melinda Gates Foundation.