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Posts Tagged ‘vaccine

Science Policy Around the Web March 19th, 2020

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By Kellsye Fabian, MSc, PhD

Image from Pixabay

Trial of Coronavirus Vaccine Made by Moderna Begins in Seattle 

The National Institute of Allergy and Infectious Diseases (NIAID) announced that the first-in-human clinical trial of an experimental vaccine for COVID-19 began on March 16, 2020. The vaccine is composed of genetic material called mRNA that induces the creation of a stabilized form of the spike protein of the SARS-CoV-2 (also known as coronavirus and 2019-nCoV), which causes COVID-19. Once present in the body, this protein stimulates an immune response to SARS-CoV-2, hopefully resulting in the development of immunity to COVID-19. It was developed by Moderna Inc in collaboration with investigators from the Vaccine Research Center (VRC) at NIAID. The clinical trial is being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, which was chosen before the US had any known coronavirus cases and not because of the outbreak that erupted there. 

The main goal of this Phase I trial is to determine if the vaccine is safe. Three different doses of the vaccine will be tested on healthy adults, with 15 individuals in each group. So far, 4 participants were vaccinated on March 16 and 4 more were planned to be injected on March 17. There will be a pause to monitor the individuals before more people receive the vaccine. How well the participants tolerate the vaccine and whether the vaccine stimulates the immune system to make antibodies that can stop the SARS-CoV-2 from replicating will be assessed. After safety is established, later studies will be conducted to investigate its efficacy.

The Chinese authorities shared the genetic sequence of SARS-CoV-2 on January 11, 2020 and only two days afterwards, the VRC and Moderna finalized the sequence for the vaccine. The first clinical batch of the vaccine was completed on February 7. In February 24, after analytical analyses were performed, the batch was shipped to NIAID for use in clinical trial. On March 4, The Food and Drug Administration gave the go-ahead for the trial to begin. The rapid development of this vaccine was possible due to previous knowledge on related coronaviruses, SARS and MERS, that had caused other outbreaks. However, despite the accelerated progress and even if the vaccine is proven to be safe and effective, it will not be available to at least a year.

(Denise Grady, New York Times

Alcoholics Anonymous vs. Other Approaches: The Evidence Is Now In

A new report from the Cochrane Collaboration that reviewed 27 studies showed that Alcoholics Anonymous (AA) and similar Twelve-Step Facilitation (TSF) programs (AA/TSF) had increased rates and lengths of abstinence when compared with other common methods, such as motivational enhancement therapy (MET) and cognitive behavioral therapy (CBT). The data show that other treatments might result in about 15-25% of people who remain sober, compared to 22-37% of AA participants. AA/TSF also reduced drinking intensity, measured by drinks per day, at the same rate as methods provided by therapists or doctors who don’t rely on AA’s peer connection.

Rigorous studies of programs like AA are always confounded by the question: Do participants do better than nonparticipants because they are more motivated (i.e. self-select) or is it something inherent in the program? Even randomized trials can suffer from bias from self-selection if people assigned to AA don’t attend and if people assigned to the control group do. Despite the challenges, outstanding randomized trials studying AA have been conducted in recent years. 

One study found that subjects randomly assigned to therapist-directed AA/TSF resulted in more AA meetings attended, more active AA participation, and more abstinent days. Other studies also show that increased AA participation is associated with improved alcohol abstinence. Overall, the findings suggest that people already in treatment could get superior outcomes if they also participate in AA. 

In addition to increased abstinence, AA also has the benefit of lower cost. AA meetings are ubiquitous, frequent, and free. Furthermore, several studies found that participation in AA/TSF resulted in decreased psychiatric visits, outpatient visits and inpatient care, which leads to decreased health care cost. According the lead author of the Cochrane review, Dr. John F. Kelly of Harvard School of Medicine and Massachusetts General Hospital, “It’s the closest thing in public health we have to a free lunch.”

Alcohol use disorder and alcoholism are often overlooked public health priority despite the fact that in the US, alcohol causes approximately 88,000 deaths per year, accounts for the majority of all addiction treatment cases, and results in $250 billion in economic lost. The newly released review gives hope that a cost-effective and efficacious method to address this problem has been available for approximately 85 years – Alcoholic Anonymous. 

(Austin Frakt and Aaron E. Carroll, New York Times

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March 19, 2020 at 2:15 pm

Science Policy Around the Web October 25th, 2019

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By Andrew Wright BSc

Image by Arek Socha from Pixabay 

NIH and Gates Foundation lay out ambitious plan to bring gene-based treatments for HIV and sickle cell disease to Africa

Following the launch of an initiative to boost gene therapy treatments of sickle cell disease last month, the National Institutes of Health (NIH) and the Bill and Melinda Gates foundation have announced a joint funding agreement of at least $100 million over the next four years to expedite a cure for both sickle cell disease and HIV and make it available in Africa. 

The current medical intervention for sickle cell disease is a bone marrow transplant, a treatment that is limited by the availability of genetically compatible donors and can be risky for adult patients. This new partnership aims to build on funding towards more effective treatments that are less restricted and more cost effective. While genetic intervention is being used in a limited clinical setting, it is still necessary to destroy a patient’s stem-cells via chemotherapy before reintroducing the patient’s genetically modified ones. Using burgeoning gene-editing techniques such as CRISPR, researchers for this initiative hope to modify targeted genes with a process more similar to a blood transfusion using replication-deficient viruses or nanoparticles to carry the molecular tools to where they need to be. This should theoretically make treatments much less expensive and more available to regions that have limited medical infrastructure and a high incidence of sickle cell disease such as sub-Saharan Africa. 

Since there is also a high incidence of HIV in sub-Saharan Africa, this initiative also aims to tackle HIV in the region using similar techniques. The current standard for treating HIV is anti-retroviral therapy, which can allow patients to live a normal life, but also must be taken every day, is expensive ($429-$10,896 per month), and does not eliminate the disease. The drive behind genetic intervention strategies comes from serendipitous case-studies when two men were cured of HIV following stem cell transplants that intentionally had white-blood cells with a weakened protein to treat their blood cancers. The NIH-Gates funding initiative will focus on strategies to weaken these proteins (called CCR5 receptors) and to directly destroy HIV genetic material.

(Jon Cohen, Science)

Evidence links poliolike disease in children to a common type of virus

Since 2014 more than 570 children have experienced a condition known as acute flaccid myelitis (AFM) where some suddenly lost limb control, had trouble swallowing or breathing, or ended up paralyzed. These symptoms routinely followed symptoms of a common cold, like a runny nose or fever. Up until now, the route cause behind AFM was not well understood, but recent studies of patients’ spinal fluid suggest the culprit is enterovirus. Infections from enteroviruses are common and rarely cause severe symptoms (although they can cause respiratory illness in asthmatic populations). 

Previous studies into the cause of AFM had examined enterovirus but found no trace of it in the central nervous system, where it would need to be in order to lead to loss of motor control. In the most recent study conducted by the University of California San Francisco, researchers sampled for elevated levels of antibodies in the central nervous system rather than the virus itself. They found that 69% of AFM patients had elevated antibodies against enteroviruses. There are still questions as to why only some children experience AFM when infected by enterovirus when most only experience typical symptoms.

Unfortunately, enterovirus-AFM is currently untreatable beyond post-infection physical therapy, although the lead author of the study suggests that immunoglobin therapy may help reduce the worst symptoms. Ultimately, the only way to completely prevent enterovirus-AFM infections, referred to by some as ”the new polio“,  will be a vaccine.

(Kelly Servick, Science)

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October 25, 2019 at 3:39 pm

Science Policy Around the Web August 6th, 2019

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By Allison Dennis B.S.

Image by rawpixel from Pixabay 

Researchers weigh in on Trump’s $500 million plan to share childhood cancer data

Researchers are contemplating developing what they call The Childhood Cancer Data Initiative (CCDI). This approach comes in response to the 10-year $500 million research budget for childhood cancer proposed by President Donald Trump during his January State of the Union Address. Federal officials implementing the proposal have seized on an ongoing effort to transform “big data” into new medical discoveries by looking to expand the sharing of patients’ data to develop new approaches to treat childhood cancers. Currently, patient data can be found spread across state registries, tumor DNA databases, and clinical trial records, obscuring potential insights. 

A symposium held by the National Cancer Institute (NCI) in August 2019, gathered members of the research community to brainstorm the future of the CCDI. Experts made clear the need to first inventory what data already exists, including making efforts to digitally join the five largest existing pediatric cancer databases. Close attention and broad changes will be needed to unify the individual observations being made as children battling cancer make their way through the medical system. Yet despite these big ideas, it is not yet clear that Congress will follow through to appropriate the $50 million down payment needed to kick start CCDI. 

(Jocelyn Kaiser, Science)

 

‘Mosaic’ HIV vaccine to be tested in thousands of people across the world

The ‘mosaic” vaccine is the latest innovation in HIV prevention scheduled to start late-stage clinical trials in September. The experimental vaccine is designed to elicit an immune response to protect against more strains of HIV than any developed so far. The phase III trial (termed “Mosaico”) will be conducted in Europe and the Americas to follow its effectiveness at preventing the transmission of HIV in 3,800 participants, divided evenly into groups receiving four injections of vaccine or placebo. The innovative approach taken by researchers started with engineering a disabled common cold virus to carry pieces of DNA encoding synthetic copies of three HIV genes. The synthetic genes help the body to recognize several different global HIV strains. In addition to the DNA sequences, the vaccine is delivered with two synthetic proteins designed to match HIV strains common in Africa, the Americas, Europe, and Australasia.

Only four HIV vaccines have ever been tested for efficacy in humans. One which initially showed promise but whose efficacy waned over time resulted in a modest 31% difference in rates of infection between groups who received the vaccine compared with placebo. By combining DNA sequences and proteins reflecting a broad diversity of globally circulating HIV strains, the Mosaico team is hoping to give the body an immunological snapshot to prepare it to defend against any strain it might be exposed to. 

(Emiliano Rodriguez Mega, Nature)

 

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August 6, 2019 at 4:47 pm

Science Policy Around the Web – July 12th, 2019

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By Mohor Sengupta, Ph.D.

Source: Maxpixel

CDC made a synthetic Ebola virus to test treatments. It worked

During the 2014-2016 Ebola outbreak in Guinea, West Africa, infectious samples containing the virus were shared by local government with international scientific communities. Using these materials, Dr. Gary Kobinger and his team developed and tested the efficacy of a monoclonal antibody vaccine at the Canadian National Laboratory. The same vaccine, ZMapp, and other therapies are currently being deployed in the most recent Ebola outbreak, which is the second largest outbreak so far. Beginning in ] 2018 in the Democratic Republic of Congo (DRC), this outbreak is still on the roll. Unfortunately, the Centers of Disease Control and Prevention (CDC) did not have any viral samples this time, meaning they were unable to test the efficacy of ZMapp and other drugs against the recent viral strain. 

Scientists at the CDC, led by Dr. Laura McMullan, constructed an artificial virus from the sequence of the current strain shared by DRC’s National Biomedical Research Institute (INRB). The group used the sequence data to perform reverse genetics and generate the authentic Ebola virus that’s currently infecting scores of people in Ituri and North Kivu provinces of DRC. 

“It takes a lot of resources and a lot of money and a lot of energy to make a cloned virus by reverse genetics. And it would be so much easier if somebody had just sent the isolate”, Dr. Thomas Geisbert, who is not involved in the work, said. 

The CDC group established the efficacy of current treatments (a drug called Remdesivir and the vaccine ZMapp) on the viral strain by using their artificial virus for all the tests. Their work was published Tuesday in the journal Lancet.

For all four Ebola outbreaks that the DRC has seen, healthcare authorities have not shared viral specimens with foreign Ebola researchers. Instead, the whole genome sequence was provided every time. With the whole genome sequence data, the Lancet paper noted that there are at least two Ebola strains in DRC that have independently crossed into the human population.  

Reasons for not sharing viral samples by DRC are not known but it is a roadblock to rapid and efficient treatments in affected geographical regions. McMullan said that shipping of samples across such large distances is often a logistical issue and requires permission from several authorities and coordination of many people. 

 (Helen Branswell, STAT)

Plastic Has A Big Carbon Footprint — But That Isn’t The Whole Story

We are all too familiar with ghastly images of dead whales with plastic-filled stomachs. These images are compounded by pictures of how much waste is generated, such as a picture of a twenty-story high mound of plastic trash in a developing country that appeared in a recent news article. While there is worldwide concern about how to eliminate use of plastics, there is very little discussion about the environmental impact of the materials that will replace plastic. 

Plastic has a high carbon footprint. In a recent report the Center for International Environmental Law (CIEL) has broken down the individual steps of greenhouse gas production, from the beginning of plastic production until it ends up incinerated as a waste. Manufactured from oil and natural gas, plastic production adds to carbon footprint right from its cradle when gases and oils leak into the environment. Subsequently, delivery of raw materials to the production sites further add to the burden. Being among the most energy intensive materials to produce, plastic production takes a heavy toll on energy, water and electricity. Finally, when plastics are incinerated, greenhouse gases end up in the environment. 

But what about the materials that commonly substitute for plastic, such as paper, compostable plastic, canvas or glass? What is their carbon footprint in production stages? Research by several independent groups has revealed that these materials leave an even larger carbon footprint during their production. Data have shown that polyethylene plastic bags not only used lesser fuel and energy throughout production, they also emitted fewer global-warming gases and left lesser mass of solid wastes, when compared with paper bags and with compostable plastic bags. Being more durable than other materials, use of polyethylene bags are more energy friendly than use of paper bags. 

Research done on behalf of the American Chemistry Council has shown that replacing plastic would eventually do more harm to the environment than their use. Finally, consumer habits count. If people don’t reuse plastics, then its advantages over paper cease to exist. Of course, the problem of permanent waste and global health consequences are issues that cannot be overlooked. The solution might lie in using plastics more wisely and re-using them as much as possible. 

(Christopher Joyce, NPR

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July 12, 2019 at 3:18 pm

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Science Policy Around the Web – February 5, 2019

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By: Neetu Gulati, Ph.D.

Source: Pixabay

Macedonia name change paves way for science cooperation with Greece

Greece and the Republic of Macedonia have been at odds for decades over the name of the latter country. After the dissolution of Yugoslavia in the early 1990s, the nation known colloquially as Macedonia was founded. However, because a region in northern Greece shares a name with the republic, Greece has disputed the country’s name, and tried to bar its entry to international organizations such as NATO and the UN. The Prespa Agreement, ratified by the Republic of Macedonia on January 11, 2019 and Greece on January 25, 2019, is set to relieve tensions by changing the disputed country name to ‘The Republic of North Macedonia,’ and the short name of ‘North Macedonia.’

The Prespa Agreement not only ends the political stand-off between the two nations, but also opens the door for strategic partnerships in many ventures, including science. While some people opposed the Agreement, scientists in both nations welcomed the change, commenting that political tensions and bureaucratic procedures will hopefully no longer hinder collaboration. “Science is done by people, and many people were affected by the mutually negative spirit among the two countries that prevailed in the past years,” commented Ioanna Chouvarda, a Greek scientist.

Many are hopeful that the name change will positively impact scientific and diplomatic ties between the two nations. A spokesperson for the Republic of Macedonia’s science ministry commented that they hope the agreement will lead to more formal scientific and technological cooperation between the two nations. Greek Alternate Minister for Research & Innovation Costas Fotakis commented, “scientific diplomacy is an effective tool that can strengthen the relations between Greece and North Macedonia, as well as the Western Balkans in general. This agreement is very timely, especially considering that several research themes are of mutual interest in both countries.” 

(Julianna Photopoulos, Nature)

The modern tragedy of fake cancer cures

The news media can sometimes sensationalize and overclaim the results of scientific advances. This is especially dangerous when results have yet to be vetted by the peer-review process, as was the case when the Dan Aridor, chairman of a small biotechnology company in Israel claimed, “we believe we will offer in a year’s time a complete cure for cancer.” The story, published by the Jerusalem Post, made bold and likely unattainable claims that the new technology would have no side-effects, be less expensive than current therapies, and be “effective from day one.” However, the new treatment has so far only been tested in a single study in mice. Furthermore, it has not yet been published and therefore has not been scrutinized or validated by other scientists in the field of cancer research. 

The claims made by Aridor may just his optimism and faith in his product, but if taken at face value they are completely unbelievable. For one thing, the original article points out that the company has not yet started clinical trials, which would take years to complete, negating the hope of a cure within a year’s time. But even those clinical trials are not likely to succeed. The odds that a cancer therapy will successfully pass clinical trials is 3-5%, according to data from MIT and the Biotechnology Industry Organization. However, even the hurdle of getting from animal studies to clinical trials is not to be overlooked, which can easily take over five years.

Cancer therapies are still worth the investment of time and money. Successful drugs like Keytruda have made a large impact on those suffering from the cancer. However, therapies do not perform the same in every patient, and ‘cancer’ is not just one disease. Often, proper dosing of cancer therapies involves a balance between the effectiveness of the treatment and the harm of the side effects. Thus, it is unlikely that a single treatment will cure all cancers without a hitch, as boldly claimed by Aridor. It is much more realistic that some treatments will work for particular types of cancers more effectively than others, with limited side effects. Speaking more conservatively about the new treatment, the CEO of the company, Ilan Morad, commented that while the company believes their therapy will cure cancer, “we still have a long way to go.”

(Matthew Herper, STAT)

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February 5, 2019 at 12:22 pm

Science Policy Around the Web – February 1, 2019

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By: Caroline Duncombe, B.S.

Source: Pixabay

How old emails hold new clues to Coca-Cola and CDC’s controversial relationship

The mission of the Centers for Diseases Control and Prevention (CDC) is to protect America from health, safety, and security threat. Yet, private emails obtained through the Freedom of Information Act reveal that a Coca-Cola Company’s influence over the federal agency refutes such a mission. Email correspondences between top CDC officials and Coca-Cola employees exposed how the soda giant tried to push the World Health Organization (WHO) to emphasize exercise over diet as the solution to the obesity epidemic via CDC’s influencing power.

            Within the 295 pages of communications from 86 emails was a request by former Coca-Cola senior vice president Alex Malaspina that WHO “should not only consider sugary foods as the only cause of obesity but consider also the lifestyle changes that have been occurring throughout the universe.” Other uncovered emails revealed that the former CDC director of Division for Heart and Disease, Barbara Bowman, gave advice to a Coca-Cola executive on potential contacts that have influence over WHO’s regional office and then director-general Dr. Margaret Chan.

            Though Coca-Cola enacted a policy in 2015 to disclose on its website its funding portfolio for scientific research and partnerships. There is little to no federal oversight over sugar and beverage industries. This is a startling fact when considering the extent of the obesity epidemic in America and the significant role that sugary drinks play in augmenting such an epidemic. After the revelation of the relationship between Coca-Cola and the CDC, discussions have increased on restricting direct contact between federal agencies and soda giants. 

(Jacqueline Howard, CNN)

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February 1, 2019 at 4:24 pm

Science Policy Around the Web – January 28, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

A Drug That Eases Miscarriages Is Difficult For Women To Get

The CDC estimates that each year in the U.S. alone, over 1 million women suffer miscarriages during the first trimester of pregnancy.  When a woman finds out that her pregnancy is not viable, she is usually given three options: wait for the miscarriage to occur on its own, take medicine to induce the miscarriage, or undergo a surgical procedure (known as a D&C) to remove the contents of the uterus.  For women who want to avoid a surgical procedure but do not want to wait for the miscarriage to occur on its own, the medically induced miscarriage is a favored option. 

Misoprostol is the medication currently prescribed in the U.S. to induce miscarriage.  Although this medication works for many, a single dose of the medicine is ineffective for about 30% of women.  When the medicine is ineffective, women end up either returning to their doctor for another dose or moving forward with surgery.  However, a recent studyin the New England Journal of Medicine found that combining the currently used medication, misoprostol, with mifepristone is more effective than misoprostol alone in inducing miscarriage.  The study followed 300 women experiencing first trimester pregnancy lose and found the combination of misoprostol and mifepristone increased the chance of successfully inducing miscarriage to 90%, a 14% increase over misoprostol alone. 

Although this new study may provide hope for women suffering an early pregnancy loss and wishing to avoid surgical intervention, most doctors in the U.S. are unable to prescribe mifepristone due to current FDA regulations.  Mifepristone was approved by the FDA in 2000 but is currently regulated under what is known as a Risk Evaluation and Mitigation Strategy (REMS).  The REMS designation means that the FDA can restrict how and where the medication is distributed.  For mifepristone, the REMS restriction prohibits its availability in commercial pharmacies; the drug can only be distributed from clinics or hospitals designated as mifepristone suppliers.  

As mifepristone is commonly used for abortions, some argue that the REMS designation for the drug is driven by political motives rather than due to concerns about drug safety.  Currently, medical societies including The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association are trying to overturn the FDA REMS classification of mifepristone.  

(Mara Gordon and Sarah McCammon, NPR)

Ebola Vaccine Supplies Are Expected to Last

The Democratic Republic of Congo (DRC) is currently facing a devasting Ebola outbreak and recently reported 689 confirmed and probable infections and 422 deaths. However, the World Health Organization (WHO) recently announced that they expect to have adequate supplies of an experimental Ebola vaccine to stop the outbreak. 

The experimental vaccine, known as V920, is made by Merck and was first shown to be highly effective in a clinical trial during the West African Ebola crisis of 2014-2016. In the current outbreak, Dr. Peter Salama, WHO’s deputy director-general of emergency preparedness and response, has reported that the vaccine is “highly, highly efficacious”, showing a efficacy rate well above 90%.  

After the West African Ebola crisis of 2014-2016, Merck made an agreement with the WHO and with Gavi, the Vaccine Alliance to maintain a stockpile of 300,000 doses of the vaccine at all times while they worked to get the vaccine licensed. As most Ebola epidemics have been controlled after less than 100 cases, the 300,000-dose stockpile seemed more than sufficient. However, tens of thousands of doses of the vaccine have already been used with the recent outbreak in the DRC, raising concerns that the supply would be depleted.  

Merck’s team lead for the Ebola vaccine project, Beth-Ann Coller, confirmed that in addition to the 100,000 doses of the vaccine that the company has already sent to the WHO, they still have about 300,00 doses on hand. However, due to the uncertainly of around the outbreak, Coller said the company is also exploring options to expand the stockpile further. 

(Helen Branswell, STAT)

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January 29, 2019 at 3:18 pm