- Massive studies have found that two leading
coronavirusvaccines are highly effective at preventing people from getting sick with COVID-19, the disease caused by the coronavirus.
- Top researchers are already pitching plans for additional studies, Business Insider has learned.
- This research aims to answer a critical question: Can these experimental shots also prevent transmission of the virus, particularly asymptomatic infections?
- Key barriers for these studies are getting funding and getting the vaccine developers
Pfizeror Modernaon board.
- Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center who’s leading the proposal, told Business Insider that these studies could start in January and produce results by May.
- The findings would inform our understanding of the benefits of the vaccines and help determine how long the public needs to keep wearing masks and socially distancing.
Leading vaccine researchers are hoping to launch an ambitious study as soon as possible to answer a crucial question about coronavirus vaccines: Can they stop the spread of the virus?
Two vaccines, from Pfizer and from Moderna, were highly effective at protecting people in late-stage studies from getting sick with COVID-19, the companies announced in November. But the trials don’t tell us whether the vaccines help block the virus from infecting people or stop it from jumping from person to person.
“We have no knowledge about whether it prevents you from actually acquiring the infection at all,” Dr. Larry Corey, an influential virologist at the Fred Hutchinson Cancer Research Center, told Business Insider.
He’s now crafting a study he hopes will deliver an answer.
Corey’s proposal is to sign up thousands of students on college campuses across the nation starting in January. These volunteers would receive two doses of an experimental vaccine, either Moderna’s or Pfizer’s, or placebo injections.
The students would then go about their lives as researchers test them for COVID-19 either every day or every other day and take routine blood draws.
In the first vaccine trials, volunteers got tested for the coronavirus only if they experienced symptoms. By testing everyone daily, the researchers will be able to spot asymptomatic infections and determine whether the vaccines can prevent those as well.
An answer matters a lot for controlling this pandemic.
New vaccine trials would tell us how long we need to keep wearing masks
While older people are at the greatest risk of getting seriously ill from this virus, most of the viral spread stems from younger people, who often don’t have symptoms. Asymptomatic carriers can unknowingly spread the virus to more vulnerable people, worsening the public-health crisis.
The information from new trials would also help determine how long people will have to wear masks and socially distance, even as vaccines are rolled out.
Corey recently pitched this trial idea to a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV. The group is a mix of top experts from government, academia, and the drug industry that has guided the most important US research on vaccines and therapeutics.
The proposal received “enthusiastic scientific support,” Corey said.
“We know if it reduces infectivity, the public-health benefit goes up spectacularly,” Corey said in a phone interview on Wednesday. “It is, we think, a very important thing to know and to know quickly.”
Supporters of the plan say the study could wrap up by May, neatly aligning with the length of the spring semester at most universities.
That timeline could also help dodge a thorny ethical question.
If an effective vaccine were widely available, it would be difficult to justify withholding it from some people to conduct an experiment. But young and healthy college kids won’t be a priority group to get the vaccine as long as supplies are limited. Public-health authorities don’t expect a COVID-19 shot to be widely available until late spring or early summer.
The trial is still a proposal, needing funding and an industry partner
The plans are not final and still need funding and buy-in from the drug industry.
Moderna and Pfizer did not respond to specific questions about this proposal. A Moderna representative, Ray Jordan, said the biotech had no data at the moment “that would be informative on asymptomatic transmission.”
Moderna’s chief medical officer, Tal Zaks, told Axios that while he believes it’s likely that his company’s vaccine does prevent transmission, there’s still no solid proof of that. And he cautioned that people shouldn’t change their behavior after being vaccinated. “When we start the deployment of this vaccine. we will not have sufficient concrete data to prove that this vaccine reduces transmission,” he said.
Pfizer didn’t respond to a request for comment.
The study would be expensive to run, but Corey said funding isn’t his top concern. The most critical hurdle is convincing Moderna or Pfizer to participate and provide vaccines.
Dr. Myron Cohen, a University of North Carolina virologist who supports the plan and is a member of ACTIV, said the study could raise questions about whether it’s the best use of a limited supply of vaccines.
“We’d be vaccinating subjects who aren’t of the highest risk,” Cohen said.
Finally, the study would need to enroll people at campuses that bring students back in person next semester. Corey estimated the trial would likely need to tally about 100 or 150 infections among volunteers to produce solid data.
That means if participants are too good at being careful and not getting exposed to the virus, it could take longer than anticipated to get results.
The findings could affect vaccination campaigns and better define the vaccine’s benefits
The study could advance the scientific community’s understanding of these vaccines in other ways, said Dr. Paul Offit, a vaccine researcher at the University of Pennsylvania. For instance, they could measure how much virus people discharge and whether the vaccines help reduce that amount.
The findings could also shape massive public-health programs, including awareness campaigns that encourage people to get vaccinated.
Information on how the vaccines affect the spread of the virus would help us figure out what proportion of the population needs to be vaccinated in order to halt the coronavirus’ spread, said Dr. Douglas Lowy, a principal deputy director at the National Cancer Institute and a member of the ACTIV working group.
A randomized trial is the best way to find the transmission answer, scientists say
The idea for an infectivity trial has been in the works since the spring, said Lowy, who helped develop the human papillomavirus vaccine. Lowy said he’d been talking with Corey about the idea since then, knowing that the initial studies would focus more on a vaccine’s impact on disease than on transmission.
Cohen, the UNC virologist, said that even if such a study winds up not happening, scientists would still be keen to understand a vaccine’s impact on viral spread.
Researchers would likely lean on surveillance data from the real-world rollout of the shots to see whether they can see an impact. That data might offer clues about protection, but not a definitive answer, Cohen said.
The next 2 weeks will tell if this is ‘really going to happen’
Cohen raised another question: Is it worth the effort to launch such an ambitious study, given that the vaccines are expected to be rolled out either way?
Cohen recalled a landmark research finding he made on HIV. Cohen spent 20 years trying to see whether HIV treatments stopped people from being contagious. Despite facing skepticism that such a study should — or could — be run, Cohen’s team carried on.
When the findings were published, “the world changed overnight,” he recalled. The researchers found that people were no longer contagious after being treated.
“When you provide people more information with more intensity and credibility, it has a pretty big effect,” he said.
Corey said there’s no good alternative to running a rigorous study to answer the transmission question. He advised against trying to extrapolate findings from other vaccines.
While the trial is still just a proposal, Cohen said it was far enough along to be seriously considered.
“We are way downstream on exploring it. It’s way past the ‘kinda laugh’ phase,” he said. “We have to decide in the next two weeks is this really going to happen.”
Charlotte’s Web’s CW Labs Announce New Scientific Collaboration Researching Hemp CBD Efficacy
Harvard Medical School’s Dr. Staci Gruber, Ph.D. is lead investigator BOULDER, Colo., Feb. 24, 2021 /PRNewswire/ – (TSX: CWEB) (OTCQX: CWBHF) Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the market leader in hemp CBD wellness products, today announced a long-term scientific collaboration between McLean Hospital, a Harvard Medical School affiliate, and the Company. […]
Harvard Medical School’s Dr. Staci Gruber, Ph.D. is lead investigator
BOULDER, Colo., Feb. 24, 2021 /PRNewswire/ – (TSX: CWEB) (OTCQX: CWBHF) Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the market leader in hemp CBD wellness products, today announced a long-term scientific collaboration between McLean Hospital, a Harvard Medical School affiliate, and the Company. Funding and product support are provided by the CW Labs division of Charlotte’s Web Inc.
Two distinct clinical trials will be overseen by lead researcher/investigator Dr. Staci A. Gruber, Ph. D, Associate Professor of Psychiatry at Harvard Medical School and Director of the MIND program at McLean Hospital in Belmont, Mass. These two studies will investigate the efficacy of a custom-formulated, hemp-derived high-CBD product. Clinical trial results are to be published in 2022. Dr. Gruber is also conducting a number of other studies, including a longitudinal observational study of Veterans who use a Charlotte’s Web product.
Dr. Gruber’s Marijuana Investigations for Neuroscientific Discovery (MIND) Program, established in 2014, is the first of its kind, and is dedicated to studying the long-term impact of cannabis and cannabinoids for medical and adult use which utilizes various clinical and cognitive tools as well as multimodal neuroimaging techniques.
We are honored to be working with Dr. Gruber, Harvard Medical School and McLean Hospital on these important clinical trials. Charlotte’s Web remains dedicated to supporting third-party research on hemp CBD investigated by some of the country’s top scientists.
Tim Orr, President of Charlotte’s Web’s CW Labs divison
For More Information About the MIND Program: https://www.drstacigruber.com/
About the MIND Program:
In 2014 Dr. Staci Gruber launched the Marijuana Investigations for Neuroscientific Discovery (MIND) program at Mclean Hospital, a Harvard Medical School affiliate. The MIND program is the first program of its kind designed to clarify the specific effects of medical cannabis use and is designed to support a wide range of study designs that generate ecologically valid, empirically sound data to close the gap between policy and science. MIND utilizes valid, robust research models and supports numerous projects designed to address the impact of medical cannabis on important variables such as cognition, brain structure and function, mood, conventional medication use, quality of life, pain, sleep, and other health-related measures. Through observational longitudinal investigations, survey studies, and clinical trials of custom-formulated cannabinoid products, MIND aims to examine the unique and synergistic effects of cannabis and its constituents to determine the efficacy of cannabinoids for specific conditions and diseases and to clarify the overall impact of cannabinoid-based treatments on physical and mental health. MIND is poised to improve patients’ overall wellbeing by striving to harness the therapeutic potential while minimizing harms of cannabinoid-based treatment.
About Charlotte’s Web and its CW Labs Division
Charlotte’s Web Labs (“CW Labs”) is the research and development division of Charlotte’s Web, advancing science around hemp-derived phytocannabinoids, terpenes and flavonoid compounds. CW Labs is headquartered at the Hauptmann Woodward Research Institute on the campus of the University at Buffalo’s Jacobs School of Medicine and The Center for Integrated Global Biomedical Sciences, and is part of the State University of New York (SUNY) network of 64 national and international research and medical institutions.
About Charlotte’s Web Holdings, Inc.
Charlotte’s Web Holdings, Inc., a Certified B Corporation headquartered in Boulder, Colorado, is the market leader in the production and distribution of innovative hemp-derived cannabidiol (“CBD”) wellness products under a family of brands which includes Charlotte’s Web™, CBD Medic™, CBD Clinic™, and Harmony Hemp. The Company’s premium quality products start with proprietary hemp genetics that are 100-percent American farm grown and manufactured into whole-plant hemp extracts containing a full spectrum of naturally occurring phytocannabinoids including CBD, CBC, CBG, terpenes, flavonoids and other beneficial hemp compounds. Charlotte’s Web product categories include CBD oil tinctures (liquid products), CBD gummies (sleep, stress, inflammation recovery), CBD capsules,CBD topical creams and lotions, as well as CBD pet products for dogs. Charlotte’s Web is the number one CBD brand in the USA and distributed through more than 22,000 retail locations, select distributors and online through the Company’s website at www.CharlottesWeb.com.
Charlotte’s Web was founded by the Stanley Brothers with a mission to unleash the healing powers of botanicals through compassion and science, benefiting the planet and all who live upon it. Charlotte’s Web is a socially and environmentally conscious company and is committed to using business as a force for good and a catalyst for innovation. The Company weighs sound business decisions with consideration for how its efforts affect employees, customers, the environment, and diverse communities. The rate the Company pays for agricultural products reflects a fair and sustainable rate driving higher quality yield, encouraging regenerative farming practices, and supporting U.S. farming communities. Management believes that its socially oriented and environmentally responsible actions have a positive impact on its customers, suppliers, employees, and stakeholders. Charlotte’s Web donates a portion of its pre-tax earnings to charitable organizations.
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Is cbd oil worth it’s price or should I stick to flower?
Tldr- bud or bottle?
So, I have been smoking high quality outdoor/greenhouse CBD/CBG from Beleafer. Now, my problem is, I dont really feel effects anymore, like, I use my cbd flower to mix with normal high potency weed and it works great, I feel less paranoia, thats all well, but as I say, if I smoke cbd alone its really like im doing something for nothing, this could be because I only get ounces from Beleafer as they last me months, but I probably have a tolerance with each strain by the time I finish it.
My issue is this. I need relief badly(psychological and physical issues), and when I used a high quality cbd oil, it helped, at low 5% dosage, but it was a pretty penny.
When I look at the cbd I want to get now its 129€ for 40% or I can get 2x 20% for the same price. They are 10ml bottles.
HOWEVER, I can get an ounce of indoor cbd for a similar slightly less price, only issue is shipping times, AND – IS SHIPPING OF CBD FLOWER STILL POSSIBLE OR TOTALLY STOPPED? This is probably my only issue now thinking about it.
I digress, basically I can get good strong cbd to smoke for months, or I can get a bottle of oil that could last a month depending if it works and if I stick to dosages instead of just start doing drops all day.
I enjoy cbd and it does work, I just dont know if I have a high tolerance now and it means I have to only fork out on high potency stuff.
Oh, the point of this post is that with smoking cbd, I cant say I feel any health benefits like pain relief etc, however when I used oil I think it definitely helped in more ways than just one (relaxed after a bong)
What would you do in this case? Bud or bottle?
Oh im in France so this makes it difficult with certain brands that dont ship intl.
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