The COVID-19 vaccine race resumes as 3 Michigan medical centers are now involved in phase 3 clinical trials on 3 other candidate vaccines. The hope is that at least one of them will be effective in preventing the disease that has killed more people. 183,000 Americans.
Michigan Medicine on Tuesday announced its partnership with British pharmaceutical company AstraZeneca to test a COVID-19 vaccine created through researchers from the University of Oxford and its spin-off company, Vaccitech. The virus has been modified to include the complex genetic protein discovered in SARS-CoV-2.
A phase 3 trial is also underway at the Michigan Medical Research Center in Farmington Hills for the coronavirus vaccine created through Pfizer and German biotech company BioNTech. The vaccine uses messenger RNA, a copy of the SARS-CoV-2 genetic code, to induce the framework to create COVID-19 antibodies to fight infection.
Henry Ford Health System is in the midst of an mNR vaccine trial developed through Modern, based in Massachusetts, in collaboration with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
The purpose of the 3 trials will be to recruit another 30,000 people at various national sites to verify protection and immune responses to the vaccine.
President Donald Trump has said his purpose is to temporarily bring to market at least one effective coronavirus vaccine, potentially as soon as this fall. To achieve this purpose, he announced Operation Warp Speed, a public-private partnership to expand and deliver 300 million doses of a COVID-19 vaccine through January 2021.
“The importance of an effective vaccine opposing COVID-19 cannot be overstated,” said Dr. Marschall Runge, Dean of the U-M School of Medicine and Executive Vice President of Medical Affairs and Executive Director of Michigan Medicine.
“Ultimately, this kind of rigorous clinical trial with the commitment of Michigan Medicine and other protection sites will be a key step toward achieving a life-saving vaccine when it develops. “
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Michigan Medicine is recently recruiting volunteers for the placebo-controlled Phase 3 trial of the AstraZeneca COVID-19 vaccine.
Those who register must make seven visits to the Ann Arbor Health System over two years. A third of participants will get a placebo. Two-thirds will receive the vaccine. Injections will be given in two separate doses for 29 days and participants will be followed for two years.
To be eligible, you must be at least 18 years old and healthy or stable. Those with underlying medical situations can still participate in the trial if the disease is stable.
Participants also have or have already had COVID-19. For more information or to register, visit: https://www. uofmhealth. org/covid19-vaccine or email: AZVaccineTrial@med. umich. edu.
A simple-blind randomized controlled trial of the vaccine evaluated 1,077 adults over 18 in the UK and showed some success.
Each user won a double or single dose of the COVID-19 vaccine or a single dose of a conjugated meningococcal vaccine for control. He tolerated and generated “robust immune responses opposed to the SARS-CoV-2 virus in all participants evaluated,” AstraZeneca reported. .
A single dose of the vaccine resulted in a four-fold accumulation of antibodies directed against the PROTEIN complex of the SARS-CoV-2 virus in 95% of the participants one month after injection, as published in The Lancet.
Everyone who won the vaccine had a T-cell reaction that peaked on the 14th day after the injection, which was maintained for two months after the injection. There were no serious side effects.
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Dr. Mark Schlissel, president of the University of Michigan, said in a statement that the university is proud to promote “the remarkable legacy of UM excellence in vaccine trials with this vital association of clinical trials. We hope that one day, we will soon announce an effective vaccine. “opposed to COVID-19 and saving lives. “
The Michigan Medical Research Center is recruiting adults between the ages of 18 and 85 for their randomized, double-blind, placebo-controlled, randomized 3 trial of the Pfizer/BioNTech COVID-19 vaccine.
Half of the patients will get a placebo and the other side will get two doses of the BNT162b2 vaccine at an interval of 3 weeks or two months, said Dr. Steven Katzman, an intern who runs a trial in Michigan.
“So far, the observed tolerability has been phenomenal,” Katzman said of the few dozen patients who have already won injections as a component of the trial. “It’s very exciting”.
The trial will be closed for new patients on September 11. Katzman suggested that others, especially those from unrepresented communities, such as African-American, Hispanic and Asian populations, register quickly.
“These are communities that have been affected by the coronavirus,” he said.
Blood samples will be taken and monitored for two years.
To qualify, you will need to be in good physical shape and not pregnant. You should also not have COVID-19 or been diagnosed with a virus.
For more information or to register, please email FightCovid19@michmer. com or call 248-747-4383.
In a previous randomized phase I/2 trial of the vaccine, all those who won it developed an immune reaction and had antibodies opposed to SARS-CoV-2. No serious side effects were reported, some patients who won the vaccine reported fever, fatigue and cold.
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If the vaccine is through the U. S. Food and Drug Administration, the U. S. Food and Drug Administration is the only one who has been in the world toSome of the dosages will be manufactured at the Pfizer plant in Kalamazoo.
Henry Ford Health System is no longer recruiting patients in its randomized, placebo-controlled phase trial of the efficacy of modern mRNA-127 coronavirus (COVE).
The Detroit-based hospital formula is one of approximately 90 sites across the country involved in the double-blind complex and has recruited all the volunteers it needs.
Half of the enrolled patients won the vaccine and the other party won a placebo.
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Those who won the vaccine gained a two-dose injection of one hundred micrograms, spaced 28 days apart, and should be monitored for two years to see if the vaccine provides coverage opposed to the contraction of the virus or reduces the severity of the disease. Disease.
The effects of the Phase 1 trial recommend that this be possible. In this trial, initial knowledge published in the New England Journal of Medicine showed that two doses of the vaccine given to another forty-five people a month apart produced a “fast and robust” immune response.
Side effects of decreased vaccine doses were mild and included fatigue, chills, headaches or muscle aches. Some other people reported fever after receiving the current dose of the vaccine at levels.
Contact Kristen Shamus: kshamus@freepress. com. Follow her on Twitter @kristenshamus.
Editor’s Note: This story has been updated to include the main points of a Pfizer/BioNTech vaccine clinical trial at the Michigan Medical Research Center, as well as more data on the Modern Vaccine Trial at Henry Ford and the AstraZeneca trial at Michigan Medicine.