Pharmaceutical firm Zydus Cadila received emergency use approval from the Drug Controller General of India (DCGI) - country's apex medicine regulator - on April 23 for the use of 'Virafin' in treating moderate COVID-19 cases.
Virafin, technically referred to as Pegylated Interferon alpha-2b, showed clinical and virological improvement in moderate COVID-19 cases, the company said.
Zydus has claimed that "91.15% of patients treated with PegIFN were RT-PCR negative by day 7", the report added.
A clinical trial for a COVID-19 vaccine variant is underway at Cincinnati Children's Hospital Medical, and researchers are seeking participants.
The trial is for a Moderna booster that is expected to guard against the B.1.135 COVID-19 variant, which was originally identified in South Africa. The B.1.351 variant and others can spread more easily, dodge some treatments and immunities or both, leaving them a threat even as more Americans get vaccinated.
"While it appears the variant is more easily passed from one person to another and the variant has a higher rate of infection, currently there is no evidence that this variant has any impact on disease severity," said Dr. Robert Frenck, director of the Cincinnati Children's Gamble Vaccine Research Center. "So, while more people may get mild illness, the variant does not seem to cause a higher percentage of infected people to be hospitalized or die from the virus."
The trial needs 30 to 50 adult participants who have not been infected with COVID-19 and have not received any COVID-19 vaccine. To enroll, fill out the screening form at https://bit.ly/32Jru3D for volunteers on the Cincinnati Children's site. Volunteers will be compensated up to $950 for their time.
Cincinnati Children's learned in March that its Gamble Vaccine Research Center would be one of four sites in the United States to host a trial for the variant-blocking booster.
The new formulation of the Moderna vaccine that volunteers will get could provide greater protection against COVID-19 than vaccines now available, Frenck said.
As of Friday, B.1.351 makes up 7% of U.S. COVID-19 cases for the last two weeks, Centers for Disease Control and Prevention data shows. In Ohio, the variant has made up 0.8% of the state's cases in the last four weeks; B.1.351 hasn't been detected in Kentucky so far.
"The South African variant remains quite unusual in Ohio," Frenck said. "While the variants are unusual, we are trying to get ahead of things and have information about combating the variants in case they become more of a problem."
That getting ahead is a new thing for the pandemic-related vaccines. "Over the past year, we have been playing 'catch up' against the virus," Frenck said. "This trial is a step to start getting ahead of the virus. In case infections caused by variant strains of COVID-19 become more common in the (United States), or if the current vaccines need to be modified to best prevent infection with the virus, this study is an important first step to know the best way to continue to combat the virus."
To learn more about vaccines, go to Cincinnati Children's Vaccine Resource Center, which the medical center created during the novel coronavirus pandemic.
A study for a third dose of the Pfizer vaccine is underway in Honolulu.
One volunteer of the two-year study said he is getting the booster shot for the safety of his family and those around him.
Gary Lahens proudly wore a bandage over his shoulder for the third time. He is participating in Pfizer’s booster shot study and says he has always had a desire to help his community.
“I want to help people, that’s why I was a cop before. So it stays with you as part of your blood,” Lahens said. “I feel if it works, it helps us open Hawaii, it helps a lot of people.”
He was among the first to get the two shots as part of the vaccine trials in September 2020. He continues to participate six months later.
“I did the study in the beginning because of my mom and my aunties they are all in their eighties,” Lahens said. “I think it was a good thing for me to do.”
Lahens was tested for COVID-19 as part of his third shot and samples of his blood will also be evaluated.
Pfizer says the study will assess the safety and immunity affects the shot may have against emerging variants.
Dr. Warren Sparks, who has been part of Kauai’s vaccination efforts, said he is curious to examine the findings from the latest studies.
“It’s been predicted that we might have a dramatic boost in antibodies after the third shot and we’re waiting to see on the many hundred fold level,” Dr. Sparks said. “And that might be a good thing, it might reduce the breakthrough cases to a true zero.”
Lahens will be monitored for side effects for a couple of months.
He said he only got a mild fever when he got his second dose. Lahens does not know if he got the higher or lesser dose of the booster shot at this point of the study.
Lahens said, “I am going to be waiting to see what occurs later tonight, you report it on an app, we report if you have any symptoms, fever, so forth.”
The Pfizer COVID-19 vaccine received emergency use authorization by the Food and Drug Administration for those who are 16 years old and above.
The risk of being exposed to Covid-19 indoors is as great at 60 feet as it is at 6 feet — even when wearing a mask, according to a new study by Massachusetts Institute of Technology researchers who challenge social distancing guidelines adopted across the world.
MIT professors Martin Z. Bazant, who teaches chemical engineering and applied mathematics, and John W.M. Bush, who teaches applied mathematics, developed a method of calculating exposure risk to Covid-19 in an indoor setting that factors in a variety of issues that could affect transmission, including the amount of time spent inside, air filtration and circulation, immunization, variant strains, mask use, and even respiratory activity such as breathing, eating, speaking or singing.
Bazant and Bush question long-held Covid-19 guidelines from the Centers for Disease Control and Prevention and the World Health Organization in a peer-reviewed study published earlier this week in Proceedings of the National Academy of Science of the United States of America.
“We argue there really isn’t much of a benefit to the 6-foot rule, especially when people are wearing masks,” Bazant said in an interview. “It really has no physical basis because the air a person is breathing while wearing a mask tends to rise and comes down elsewhere in the room so you’re more exposed to the average background than you are to a person at a distance.”
The important variable the CDC and the WHO have overlooked is the amount of time spent indoors, Bazant said. The longer someone is inside with an infected person, the greater the chance of transmission, he said.
Opening windows or installing new fans to keep the air moving could also be just as effective or more effective than spending large amounts of money on a new filtration system, he said.
Bazant also says that guidelines enforcing indoor occupancy caps are flawed. He said 20 people gathered inside for 1 minute is probably fine, but not over the course of several hours, he said.
“What our analysis continues to show is that many spaces that have been shut down in fact don’t need to be. Often times the space is large enough, the ventilation is good enough, the amount of time people spend together is such that those spaces can be safely operated even at full capacity and the scientific support for reduced capacity in those spaces is really not very good,” Bazant said. “I think if you run the numbers, even right now for many types of spaces you’d find that there is not a need for occupancy restrictions.”
Six-feet social distancing rules that inadvertently result in closed businesses and schools are “just not reasonable,” according to Bazant.
“This emphasis on distancing has been really misplaced from the very beginning. The CDC or WHO have never really provided justification for it, they’ve just said this is what you must do and the only justification I’m aware of, is based on studies of coughs and sneezes, where they look at the largest particles that might sediment onto the floor and even then it’s very approximate, you can certainly have longer or shorter range, large droplets,” Bazant said.
“The distancing isn’t helping you that much and it’s also giving you a false sense of security because you’re as safe at 6 feet as you are at 60 feet if you’re indoors. Everyone in that space is at roughly the same risk, actually,” he noted.
Pathogen-laced droplets travel through the air indoors when people talk, breathe or eat. It is now known that airborne transmission plays a huge role in the spread of Covid-19, compared with the earlier months of the pandemic where hand-washing was considered the leading recommendation to avoid transmission.
Those droplets from one’s warm exhalation mix with body heat and air currents in the area to rise and travel throughout the entire room, no matter how socially distanced a person is. People seem to be more exposed to that “background” air than they are by droplets from a distance, according to the study.
For example, if someone infected with Covid-19 is wearing a mask and singing loudly in an enclosed room, a person who is sitting at the other side of the room is not more protected than someone who is sitting just six feet away from the infected person. This is why time spent in the enclosed area is more important than how far you are from the infected person.
Masks work in general to prevent transmission by blocking larger droplets, therefore larger droplets aren’t making up the majority of Covid infections because most people are wearing masks. The majority of people who are transmitting Covid aren’t coughing and sneezing, they’re asymptomatic.
Masks also work to prevent indoor transmission by blocking direct plumes of air, best visualized by imagining someone exhaling smoke. Constant exposure to direct plumes of infectious air would result in a higher risk of transmission, though exposure to direct plumes of exhaled air doesn’t usually last long.
Even with masks on, as with smoking, those who are in the vicinity are heavily affected by the secondhand smoke that makes its way around the enclosed area and lingers. The same logic applies to infectious airborne droplets, according to the study. When indoors and masked, factors besides distance can be more important to consider to avoid transmission.
As for social distancing outdoors, Bazant says it makes almost no sense and that doing so with masks on is “kind of crazy.”
“If you look at the air flow outside, the infected air would be swept away and very unlikely to cause transmission. There are very few recorded instances of outdoor transmission.” he said. “Crowded spaces outdoor could be an issue, but if people are keeping a reasonable distance of like 3 feet outside, I feel pretty comfortable with that even without masks frankly.”
Bazant says this could possibly explain why there haven’t been spikes in transmission in states like Texas or Florida that have reopened businesses without capacity limits.
As for variant strains that are 60% more transmissible, increasing ventilation by 60%, reducing the amount of time spent inside or limiting the number of people indoors could offset that risk.
Bazant also said that a big question that is coming will be when masks can be removed, and that the study’s guidelines can help quantify the risks involved. He also noted that measuring carbon dioxide in a room can also help quantify how much infected air is present and hence risk of transmission.
“We need scientific information conveyed to the public in a way that is not just fearmongering but is actually based in analysis,” Bazant said. After three rounds of heavy peer review, he said it’s the most review he’s ever been through, and that now that it’s published he hopes it will influence policy.
While the Alzheimer's field waits for the FDA's decision on the investigational treatment aducanumab, drug developer Biogen has provided details and endpoints of EMBARK, the drug's ongoing phase IIIb redosing study.
Aducanumab, a monoclonal antibody that selectively binds to aggregated forms of amyloid beta, has raised considerable controversy in the wake of findings from two identical phase III studies, EMERGE and ENGAGE. The trials were terminated in March 2019 when a futility analysis determined aducanumab was unlikely to outperform placebo at completion. In October 2019, Biogen reversed its position, saying a review of previously unavailable data showed the drug actually reduced cognitive decline in EMERGE, but not in ENGAGE.
"Based on a larger dataset after the trials were terminated, it was determined that the assumptions in the futility analysis were not valid," said Carmen Castrillo-Viguera, MD, medical director of clinical development at Biogen, during a poster presentation at the American Academy of Neurology virtual meeting. "One of the studies, EMERGE, met the primary pre-specified and secondary endpoints. While the other study, ENGAGE, did not meet its primary endpoint, post-hoc analysis of data from a subset of patients exposed to high-dose aducanumab supported the findings in EMERGE."
The drug currently is up for FDA review. In November 2020, an FDA advisory committee voted overwhelmingly against the data presented about the Alzheimer's drug candidate, saying the positive results seen in one of the two trials could not be considered alone, but must be taken together with its twin, which was clearly negative.
In the advisory committee meeting, Biogen's senior vice president Samantha Budd Haeberlein, PhD, attempted to account for the differences between EMERGE and ENGAGE, suggesting that failure in one trial did not detract from the findings of the other.
Billy Dunn, MD, director of the office of neuroscience in the FDA's Center for Drug Evaluation and Research, agreed, echoing what was presented in the FDA's briefing documents and emphasizing the urgent need for Alzheimer's treatment.
EMBARK will study Alzheimer's patients who were actively enrolled in aducanumab trials when they were halted in March 2019, including participants in EMERGE, ENGAGE, the long-term extension of the phase Ib PRIME study, and the EVOLVE safety study. Participants will be titrated to receive 10-mg/kg aducanumab by intravenous infusion every 4 weeks. The study includes an approximately 8-week screening period, a 100-week treatment period, and an 18-week safety and follow-up visit after the last dose.
"The EMBARK redosing study was really designed to assess two fundamental questions," Castrillo-Viguera said. "One is, what are the long-term safety and efficacy of aducanumab dosing with the highest dose tested in the phase III trials? And two, what are the changes in the clinical and biomarker measures during the treatment gap?"
Endpoints include number of adverse events and serious adverse events, adverse events leading to treatment discontinuation or study withdrawal, number of participants with amyloid-related imaging abnormalities (including edema, hemorrhage, or superficial siderosis), and number of participants with anti-aducanumab antibodies.
The study currently is enrolling and "is expected to be one of the largest clinical trials in Alzheimer's disease, with an estimated enrollment of 1,800 patients," Castrillo-Viguera said. As of March 9, a total of 1,361 people have enrolled.
The FDA is scheduled to decide aducanumab's fate by June 7 amid ongoing debate among experts, including those who agree with the agency's advisory committee members and those, like the Alzheimer's Association, who think aducanumab should be approved and accompanied by a phase IV post-marketing surveillance study. If approved, aducanumab will be the first disease-modifying drug for Alzheimer's disease.
Disclosures
This study is sponsored by Biogen. Authors are employees of Biogen.
Primary Source
American Academy of Neurology
Mobile crisis teams and peer support services can help to serve those struggling with a mental health crisis and connect them to care, but can they replace police?
As calls for defunding the police increase, the question has become even more timely and was front and center at a hearing on Thursday of the Subcommittee on Criminal Justice and Counterterrorism for the Senate Judiciary Committee, which focused on policing and behavioral health.
Among both the subcommittee members and the other witnesses, there appeared to be broad support for improving police training in deescalation tactics and for engaging mobile crisis teams and other types of support. Some witnesses, however, questioned the ability of mobile teams to safely address and quickly respond to high-risk situations.
"The purpose of the hearing is to talk about changes we need to make when it comes to how we as an overall society are going to respond to people dealing with mental health crisis," said Subcommittee Chair Cory Booker (D-N.J.).
Police officers have become de facto social workers, mental health counselors, and medical experts, as they are often called on to respond to individuals in the throes of a mental health crisis, but most police have neither the training nor the skills to address these problems, Booker said.
As a result, situations can escalate quickly, he said, noting that people with untreated mental illness are 16 times more likely to be killed during a police encounter compared with the general public.
One of the hearing's witnesses, Keris Jän Myrick, MBA, MS, co-director of the Mental Health Strategic Impact Initiative and a board member of the executive committee for the National Association of Peer Supporters, has been diagnosed with schizophrenia.
Her first close-up encounter with police happened in her 30s in Los Angeles, she related. She was in emotional distress and feeling paranoid. She was expecting an ambulance or fire truck with paramedics, but instead, to her embarrassment, the police arrived at her apartment, announced loudly that they were doing a welfare check, deemed Myrick a danger to herself, and took her to a police station, where she was handcuffed to a chair. She was terrified.
This was the first time she had ever experienced a heightened sense of distress and the need for mental health support, she said. "What I didn't need was the police response, and being treated like a criminal."
Scarred by that experience, Myrick said, she was reluctant to ask for help to deal with mental health problems in the future, when she needed them most.
Mobile Crisis Response Teams
Ebony Morgan, RN, program coordinator for Crisis Assistance Helping Out On The Streets (CAHOOTS), a mobile crisis response team, described how the response to a mental health crisis can be dramatically different from what Myrick experienced.
CAHOOTS staff operate in unarmed pairs of a crisis worker and a medical professional and respond to calls taken by police dispatchers. Using police radios the teams coordinate with the police departments and community partners to determine which calls are appropriate for their staff, and then meet community members where they are. This frees up local police to respond to the kinds of calls they are trained to address.
If CAHOOTS employees arrive at a scene and determine that they need law enforcement's support, they can contact them over their radios.
These mobile crisis teams can also link clients to community resources such as walk-in crisis centers, permanent supportive housing, or sobering and "detox" centers. But communities must, in turn, identify these needs and invest in such programs.
"No employee has ever lost their life or been seriously injured on the job despite never carrying a weapon, and no clients have died as a result of us showing up to help," Morgan said.
Policing issues hit close to home: Morgan's father Charles died during an encounter with police when he was 25 and she was 5.
Peer Support Services
Witnesses also highlighted the benefits of engaging peer support specialists, individuals with lived experience of a mental or behavioral health problem, when responding to crises.
Certified peer support specialists, those with special training, can be particularly helpful in the midst of a crisis in helping to identify the needs of an individual in crisis and to "slow things down," Myrick said.
Peers can be part of a mobile crisis response team and should also be incorporated into the response to calls to 988 -- the three-digit suicide prevention hotline, expected to launch in 2022.
Myrick also pointed to peer "respites," safe spaces where a person with a behavioral health problem can go after a crisis, as an alternative to hospitalization.
In addition, she said, as part of a more long-term solution, peers can help others develop Wellness Recovery Action Plans as well as a strategy for responding to potential future crises, known as psychiatric advanced directives.
She said that there is evidence that when peers engage others who are in crisis, by sharing their own stories of recovery, those struggling with a mental health problem are more willing to participate and adhere to treatment and hospitalizations; homelessness also drops, Myrick noted.
Safety Issues, Timeliness
Terri O'Connor, a former 911 dispatcher from Philadelphia, whose husband, Sgt. James O'Connor, was killed in the line of duty in 2020, said she didn't think it was realistic to expect a mobile response team to arrive quickly to a scene.
"I don't know how long it would take to get a mental health worker to show up to a situation. I feel like the police are always going to be the first one to respond," she said.
Rafael Mangual, JD, senior fellow and deputy director of legal policy at the Manhattan Institute in New York City, said mobile response teams are not necessarily built to replace police but the model could be helpful when complementary to a police response.
Mangual cited data from a study conducted in Philadelphia showing that in 20% of police calls, the nature of a call does not appear to be "predictable." In other words, calls made regarding situations that are initially viewed to be public health-related may later be deemed criminal activity.
"While reform is a worthy pursuit," the government's first duty is to provide for the public's safety, he said.
The Demand for Services
Morgan disagreed with the notion that mobile response teams were not sufficient on their own to respond to most mental health crises.
According to the latest CAHOOTS call data from 2019, she said, staff responded to about 17% of calls to police or about 17,700 calls. Of those, staff requested police backup for 1.5% of calls or 311 times, and of those 311 calls, only 5% of them were seen as situations where there was an "imminent threat."
Another witness, Major Martin Bartness, commander for the Education & Training Section of the Baltimore Police Department, praised the co-responder model, but said there are glaring capacity issues.
Response teams in Baltimore consist of a licensed clinical social worker and a trained crisis intervention team officer, he explained. They're accessible 7 days a week, but only 8 hours a day, and are responsible for the entire city.
Such teams do respond quickly to calls but, he said, "in order to do that to scale, there has to be more funding."
https://www.medpagetoday.com/psychiatry/generalpsychiatry/92264
When police respond to a person gripped by a mental health or drug crisis, the encounter can have tragic results. Now a government insurance program will help communities set up an alternative: mobile teams with mental health practitioners trained in de-escalating such potentially volatile situations.
The effort to reinvent policing after the death of George Floyd in police custody is getting an assist through Medicaid, the federal-state health insurance program for low-income people and the largest payer for mental health treatment. President Joe Biden’s recent coronavirus relief bill calls for an estimated $1 billion over 10 years for states that set up mobile crisis teams, currently locally operated in a handful of places.
Many 911 calls are due to a person experiencing a mental health or substance abuse crisis. Sometimes, like with Daniel Prude in Rochester, New York, the consequences are shocking. The 41-year-old Black man died after police placed a spit hood over his head and held him to the pavement for about two minutes on a cold night in 2020 until he stopped breathing. He had run naked from his brother’s house after being released from a hospital following a mental health arrest. A grand jury voted down charges against the officers.
Dispatching teams of paramedics and behavioral health practitioners would take mental health crisis calls out of the hands of uniformed and armed officers, whose mere arrival may ratchet up tensions. In Eugene, Oregon, such a strategy has been in place more than 30 years, with solid backing from police.
The concept “fits nicely with what we are trying to do around police reform,” Eugene Police Chief Chris Skinner said. The logic works “like a simple math problem,” he adds.
“If I can rely on a mechanism that matches the right response to the need, it means I don’t have to put my officers in these circumstances,” Skinner explained. “By sending the right resources I can make the assumption that there are going to be fewer times when officers are in situations that can turn violent. It actually de-conflicts, reducing the need for use of force.”
Eugene is a medium-size city about 100 miles (160 kilometers) south of Portland, known for its educational institutions. The program there is called Crisis Assistance Helping Out On The Streets, or CAHOOTS, and is run by the White Bird Clinic. CAHOOTS is part of the local 911 emergency response system but operates independently of the police, although there’s coordination. Crisis teams are not sent on calls involving violent situations.
“We don’t look like law enforcement,” White Bird veteran Tim Black said. “We drive a big white cargo van. Our responders wear a T-shirt or a hoodie with a logo. We don’t have handcuffs or pepper spray, and the way we start to interact sends a message that we are not the police and this is going to be a far safer and voluntary interaction.”
CAHOOTS teams handled 24,000 calls in the local area in 2019, and Black said the vast majority would have otherwise fallen to police. Many involve homeless people. The teams work to resolve the situation that prompted the call and to connect the person involved to ongoing help and support.
At least 14 cities around the country are interested in versions of that model, said Simone Brody, executive director of What Works Cities, a New York-based nonprofit that tries to promote change through effective use of data.
“It’s really exciting to see the federal government support this model,” Brody said. “I am hopeful that three years from now we will have multiple models and ideally some data that shows this has actually saved people’s lives.” Portland, Oregon, launched its own crisis teams in February and the program has already expanded to serve more areas of the community.
About 1,000 people a year are shot dead by police, according to an analysis by the Treatment Advocacy Center, which examined several publicly available estimates. Severe mental illness is a factor in at least 25% of such shootings, it estimated. The center advocates for improved mental health care.
Mobile crisis teams found their way into the COVID-19 relief bill through the efforts of Oregon Democratic Sen. Ron Wyden, who chairs the Finance Committee, which oversees Medicaid.
“Too often law enforcement is asked to respond to situations that they are not trained to handle,” Wyden said. “On the streets in challenging times, too often the result is violence, even fatal violence, particularly for Black Americans.”
Wyden’s legislation includes $15 million in planning grants to help states get going. The Congressional Budget Office estimates the program could take a couple of years to fully implement. The $1 billion will be available to states for five years, beginning next April. Wyden said it’s a “down payment” on what he hopes will become a permanent part of Medicaid.
The idea may be well-timed, said Medicaid expert MaryBeth Musumeci, of the nonpartisan Kaiser Family Foundation. The coronavirus pandemic has worsened society’s pervasive mental health and substance abuse problems. At the same time, protests over police shootings of Black people have created an appetite for anything that could break the cycle.
“All of those things coming together are putting increased focus on the need for further developing effective behavioral health treatment models,” Musumeci said.
In Rhode Island, nurse turned malpractice lawyer Laura Harrington is helping coordinate a grassroots campaign to incorporate crisis teams into the state’s 911 system. She said she’s been surprised at the level of interest.
“I don’t want to get into blaming,” Harrington said. “We could blame social services. We could blame people who don’t take their medications. We could blame the police. I want to move forward and solve problems.”
