Health
CORRECTING and REPLACING Medicago and GSK Announce Start of Phase 2/3 Clinical Trials of Adjuvanted COVID-19 Vaccine Candidate – Business Wire
QUEBEC CITY, Quebec & LONDON–(BUSINESS WIRE)–Please replace the release with the following corrected version due to multiple revisions.
The updated release reads:
MEDICAGO AND GSK ANNOUNCE START OF PHASE 2/3 CLINICAL TRIALS OF ADJUVANTED COVID-19 VACCINE CANDIDATE
The COVID-19 vaccine candidate will contain GSK’s pandemic adjuvant
Phase 3 part of clinical trial to enroll over 30,000 volunteers worldwide
Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK are pleased to announce the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results and the approval of Canadian regulatory authorities, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.
“Our Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.
Thomas Breuer, Chief Medical Officer GSK Vaccines said “This is the first of several GSK COVID-19 vaccine candidate collaborations to start Phase 2/3 clinical testing and an important step forward in our contribution to the global fight against the pandemic. We are delighted with the very promising Phase 1 results of Medicago’s COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant. Proven dose-sparing and a high immune response due to GSK’s adjuvant make us confident of delivering an efficacious vaccine with an acceptable safety profile in collaboration with Medicago.”
The Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).
The study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age and in elderly subjects aged 65 and over.
The Phase 2 trial part is a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It will be conducted in multiple sites in Canada and, upon FDA allowance, in the United States and on a population composed of healthy adults (18-64y) and elderly adults (over 65y). Each age group will have over 300 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate.
The Phase 3 part of the study should start before the end of 2020 and is an event-driven, randomized, observer-blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in over 30,000 subjects in North America, Latin America and/or Europe and within the same population, or – alternatively – amongst a broader one pending approval by regulatory authorities.
About Medicago
Medicago is a biopharmaceutical company and pioneer in plant-derived therapeutics. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.
Our mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global healthcare challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide. Our team includes over 450 scientific experts and employees in Canada and the United States and academic affiliations in Europe and South Africa.
Medicago has previously demonstrated its capability to be a first responder in a flu pandemic. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. In 2012, Medicago manufactured 10 million doses of a monovalent influenza vaccine candidate within one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense. In 2015, Medicago also demonstrated in principle that it could rapidly produce an anti-Ebola monoclonal antibody cocktail for the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
For more information: www.medicago.com
To learn more about our plant-based technology: Video / Website
About GSK and its commitment to tackling COVID-19
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase, and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.
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Interior Health says it delivered nearly 800,000 immunization doses last year — a number almost equal to the region’s population.
The released figure of 784,980 comes during National Immunization Awareness Week, which runs April 22-30.
The health care organization, which serves a large area of around 820,000, says it’s using the occasion to boost vaccine rates even though there may be post-pandemic vaccine fatigue.
“This is a very important initiative because it ensures that communicable diseases stay away from a region,” said Dr. Silvina Mema of Interior Health.
However, not all those doses were for COVID; the tally includes childhood immunizations plus immunizations for adults.
But IHA said immunizations are down from the height of the pandemic, when COVID vaccines were rolled out, though it seems to be on par with previous pre-pandemic years.
Interior Health says it’d like to see the overall immunization rate rise.
“Certainly there are some folks who have decided a vaccine is not for them. And they have their reasons,” said Jonathan Spence, manager of communicable disease prevention and control at Interior Health.
“I think there’s a lot of people who are hesitant, but that’s just simply because they have questions.
“And that’s actually part of what we’re celebrating this week is those public health nurses, those pharmacists, who can answer questions and answer questions with really good information around immunization.”
Mima echoed that sentiment.
“We take immunization very seriously. It’s a science-based program that has saved countless lives across the world and eliminated diseases that were before a threat and now we don’t see them anymore,” she said.
“So immunization is very important.”
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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.
The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.
“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement.
The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department says 33 herds have been affected to date.
FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”
The PCR lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University
“There is no evidence to date that this is infectious virus and the FDA is following up on that,” Jaykus said.
Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.
Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.
Matt Herrick, a spokesman for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.
Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.
To date, two people in U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Canada is about where it should be when it comes to childhood vaccines, but for adult vaccinations it’s a different story.
Dr. Vivien Brown of Immunize Canada says the overall population should have rates of between 80 and 90 per cent for most vaccines, but that is not the case.
She says most children are in that range but not for adult vaccines and ultimately the most at-risk populations are not being reached.
She says the population is under immunized for conditions such as pneumonia, shingles, tetanus, and pertussis.
Brown wants people to talk with their family physician or pharmacist to see if they are up-to-date on vaccines, and to get caught up because many are “killer diseases.”
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