Plant-Based COVID-19 Vaccine Candidate Starts Phase 3 TrialMarch 31, 2021
Medicago, the Quebec City-based biopharmaceutical company, and GlaxoSmithKline (GSK) have announced the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, as part of the ongoing Phase 2/3 study.
Medicago received approval from Canadian and US regulatory authorities to proceed with the enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. The vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) on February 17, 2021. Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo. The study will enroll up to 30,000 subjects initially composed of healthy adults (18y to 65y), followed by elderly adults (65y+), and adults with comorbidities. The trial will take place in 10 countries pending regulatory approvals, starting with Canada and the United States, and will enroll males and females from ethnically and racially diverse populations. Medicago's plant-derived COVID-19 vaccine candidate uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart.
For more details, read the media release from Medicago.
You might also like:
- Viable Vaccine Candidate for COVID-19 Developed Using Proprietary Plant-based Technology
- Medicago Announces Positive Results of Trials for its COVID-19 Vaccine Candidate
- Researchers in Spain Use Biotech to Produce SARS-CoV-2 Vaccine in Plants
Biotech Updates is a weekly newsletter of ISAAA, a not-for-profit organization. It is distributed for free to over 22,000 subscribers worldwide to inform them about the key developments in biosciences, especially in biotechnology. Your support will help us in our mission to feed the world with knowledge. You can help by donating as little as $10.
See more articles:
News from Around the World
- Biosafety and Varietal Release Authorities' Interaction Vital in Commercialization of GM Crops in Africa
- Newly Elected Leaders in Central Uganda Pledge Support for GM Crops
- Chickpea to Get Nutrition Boost from Hardy and Weedy Wild Relatives
- First Known Gene Transfer from Plant to Insect Reported
- Punjab Issues Schedule for Sowing of Registered Bt Cotton Varieties
- Biotech Experts to Tackle Impact of Agri-Biotech in Vietnam
- Study Reveals Plants Remember Drought
- Researchers Identify Where and How Plants Detect Potassium
- Mango Genome Sequence Leads to Candidate Genes for Fruit Quality
- ISAAA Webinar Puts Genome Editing in the Spotlight
- CRISPR-Cas12a Expands Genome Engineering with Six Novel Variants
- Plant-Based COVID-19 Vaccine Candidate Starts Phase 3 Trial
Read the latest:
- Biotech Updates (November 29, 2023)
- Gene Editing Supplement (November 29, 2023)
- Gene Drive Supplement (February 22, 2023)
Subscribe to BU: