Single shot may be enough for AZ vaccine see more
Britain’s health chief says a new study showing that a single dose of the COVID-19 vaccine developed by Oxford University and AstraZeneca provides a high level of protection for 12 weeks supports the government’s strategy of delaying the second shot so more doses can be delivered to more people.
Health Secretary Matt Hancock’s comments came after Oxford released a study showing the vaccine cut transmission of the virus by two-thirds and prevented severe disease. The study has not been peer-reviewed yet, but it was greeted with excitement by U.K. officials under pressure to justify their decision to delay the second dose.
“That reduction in transmission, as well as the fact there is no hospitalizations, the combination of that is very good news. And it categorically supports the strategy we’ve been taking on having a 12-week gap between the doses,” Hancock told Sky News on Wednesday.
One of the lead researchers on the project, Dr. Andrew Pollard of Oxford University, said Oxford scientists believe the vaccine will continue to offer protection against new variants of COVID-19, although they are still waiting for data on this.
Even if the virus adapts, “that doesn’t mean that we won’t still have protection against severe disease.’’
“If we do need to update the vaccines, then it is actually a relatively straightforward process it only takes a matter of months, rather than the huge efforts that everyone went through last year to get the very large-scale trials run,” he told the BBC.
MUSC partners with AstraZeneca, IQVIA in chase for vaccine for COVID see more
As researchers from across the globe race to find a vaccine for the coronavirus, the Medical University of South Carolina has entered as a key player in that fight. Along with AstraZeneca and IQVIA, MUSC was selected to be part of a Phase III trial of a vaccine that has shown promise in battling COVID-19.
“The science behind it looks good,” said MUSC emergency medicine physician Gary Headden, M.D., who will be leading the trial. “So, I’d say I’m optimistic.”
MUSC and Charleston will be part of the first wave of locations across the United States to test the vaccine. In total, manufacturers and researchers hope to enroll and collect data on 30,000 people across 20 cities in the U.S., with as many as 1,500 of those being from right here in Charleston.
For context: Once a pharmaceutical company thinks it has a promising vaccine on its hands, it begins clinical trials. According to the U.S. Food and Drug Administration, these trials consist of three phases:
- Phase 1, also referred to as initial human studies, is performed on small groups and focused on safety and the recipient’s immune response to the vaccine.
- Phase 2, which are usually administered on hundreds of people, are still focused on safety and fine-tuning the dosage and treatment regimen required.
- Phase 3 typically enrolls thousands of individuals and focuses on the safety and efficacy (how well it works) in a population.
If successful, the manufacturer can then submit an application to the FDA for approval.
Because of the unique world we’re living in, the U.S. government has implemented “Operation Warp Speed,” which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. In other words, a process that often takes years is being compressed into mere months. To facilitate this process, the government is speeding up all aspects that can safely be sped up and is pumping billions of dollars into the pharmaceutical industry. AstraZeneca, the company that has manufactured the vaccine being tested at MUSC, received $1.2 billion alone.
According to Amanda Cameron, Trial Innovation Network manager at MUSC and a key figure in bringing the trial to the university, even with Operation Warp Speed in play, this is one of few Phase III vaccine trials out there.
“For us to get to bring a trial here to MUSC is incredible, but the fact that it’s one that researchers are optimistic about is even more exciting,” she said.
Recently, Russia claimed to have a vaccine ready. U.S. researchers believe it has effectively only cleared Phase I, so to roll it out so quickly could prove to be reckless, Headden said.
This week, MUSC will go live with a webpage, officially opening the trial to applicants. The hopes are that soon thereafter, the study's first patients will be seen at the Clinical Sciences Building on MUSC’s downtown campus. Several hundred have already expressed interest in participation, and MUSC clinical research manager Ashley Warden said the team would love to get as many people involved as possible.
“This is a really important research opportunity,” Warden said. “We need to have a therapy that can bring this pandemic into control. It would be best that those that participate in this trial are representative of our region.”
The trial – which will be double-blind, randomized and placebo-controlled in a 2:1 ratio, meaning that for every two people who get the active vaccine, one will get the placebo – will require the participants to come in at Day 1 and Day 29 to receive their vaccines or the placebo.
Researchers and doctors hope each of these two visits will last about 90 minutes, during which time the participants will undergo a physical examination that includes having their medical histories reviewed, blood drawn for testing and a nasal swab test for COVID-19. The vaccine will then be administered.
All subjects will be monitored over a period of two years. During this time, those who show any signs of illness that could be due to COVID-19 will undergo additional testing. Compensation will be provided for participants’ time.
“This is a big study with an aggressive time frame, which is expected of a trial of this importance,” Headden said. “As for the science behind it, it’s totally solid. Put it this way: I would let my family take this vaccine.”
To learn more about the trial or to enroll, visit https://research.musc.edu/clinical-trials/coronavirus-clinical-trials.
Vikor Scientific names new CSO see more
CHARLESTON, S.C. (PRWEB) AUGUST 07, 2019
Bill W. Massey, Ph.D. will be joining Vikor Scientific™ as Chief Scientific Officer to provide scientific leadership for Vikor’s molecular diagnostic and therapeutic management services, lead Vikor’s clinical research efforts related to their strategic alliances in the pharmaceutical and healthcare industries and continue to develop their model of personalized healthcare.
"I am very excited to be joining Vikor Scientific at this crucial point in their growth and evolution. They have an incredible vision to step beyond the traditional model for clinical laboratory services and to become the premier provider of therapeutic management services. This transition to becoming a partner with providers and healthcare organizations in the delivery of optimal, personalized care is paradigm changing and will set the standard for coordinated diagnostics and collaborative care," said Dr. Massey.
Dr. Massey is a world-renowned neuropharmacologist, pharmacogeneticist, life sciences professional, inventor and entrepreneur. Dr. Massey received his Ph.D. in Pharmacology at the University of Arkansas for Medical Sciences and subsequently an investigator at the Pritzker School of Medicine’s Drug Abuse Research Center at The University of Chicago. Dr. Massey holds long-standing adjunct faculty appointments at the University of Arkansas for Medical Sciences (Associate Professor, Dept. of Pharmacology and Interdisciplinary Toxicology) and the University of Mississippi Medical Center (Clinical Assistant Professor, Dept. of Psychiatry).
Dr. Massey has held leadership positions at Merck, Astra Merck, Quintiles, Scirex, Astra Zeneca, Scientific Commercialization, Litmus Molecular Design, SureGene, and GeneAlign. He has played a leadership role in placing 28 new drugs into human testing and 8 new drugs onto the market. Dr. Massey formerly held the Jack Martin, MD Research Professorship in Psychopharmacology at Vanderbilt University, where he conducted research into the genetics, biological basis and pharmacological treatment of schizophrenia and serious mental illness in collaboration with Dr. Herbert Y. Meltzer. Dr. Massey is currently a Visiting Scholar at the Feinberg School of Medicine’s Dept. of Psychiatry and Human Behavior at Northwestern University where he continues his research collaboration with Dr. Meltzer.
Dr. Massey has been a leader in the field of pharmacogenetics and personalized medicine for over two decades. Dr. Massey invented an easy-to-use combinatorial pharmacogenetic algorithm that makes clinical use of PGx practical for any physician and is currently patenting a direct-to-consumer product for weight loss.