Amgen (NASDAQ:AMGN) today announced positive data from the HUYGENS Phase 3 study showing that Repatha® (evolocumab) in addition to optimized statin therapy, in comparison with optimized statin therapy alone, significantly improved features of plaque stability in patients with coronary artery disease (CAD). These data are being presented during an oral presentation at ESC Congress 2021, organized by the European Society of Cardiology, Aug. 27-30.
Friday, August 27, 2021
Supreme Court strikes down Biden administration's eviction moratorium
The United States Supreme Court has struck down President Biden’s eviction moratorium, ruling that it can only be extended via action from Congress.
"If a federally imposed eviction moratorium is to continue," the ruling said about the moratorium Biden imposed as a means of protecting renters negatively affected by the coronavirus, "Congress must specifically authorize it."
The three liberal justices on the court, Justices Sotomayor, Kagan, and Breyer, dissented from the ruling.
"The Biden administration is disappointed that the Supreme Court has blocked the most recent CDC eviction moratorium while confirmed cases of the delta variant are significant across the country," White House Press Secretary Jen Psaki said late Thursday. "As a result of this ruling, families will face the painful impact of evictions, and communities across the country will face greater risk of exposure to COVID-19. In light of the Supreme Court ruling and the continued risk of COVID-19 transmission, President Biden is once again calling on all entities that can prevent evictions - from cities and states to local courts, landlords, Cabinet agencies - to urgently act to prevent evictions."
It was the second loss for the administration this week at the hands of the high court’s conservative majority. On Tuesday, the court effectively allowed the reinstatement of a Trump-era policy forcing asylum seekers to wait in Mexico for their hearings. The new administration had tried to end the Remain in Mexico program, as it is informally known.
On evictions, President Joe Biden acknowledged the legal headwinds the new moratorium would likely encounter. But Biden said that even with doubts about what courts would do, it was worth a try because it would buy at least a few weeks of time for the distribution of more of the $46.5 billion in rental assistance Congress had approved.
The Treasury Department said Wednesday that the pace of distribution has increased and nearly a million households have been helped. But only about 11% of the money, just over $5 billion, has been distributed by state and local governments, the department said.
The administration at first allowed the earlier moratorium to lapse July 31, saying it had no legal authority to allow it to continue. But the CDC issued a new moratorium days later as pressure mounted from lawmakers and others to help vulnerable renters stay in their homes as the coronavirus’ delta variant surged. The moratorium had been scheduled to expire Oct. 3.
Landlords in Alabama and Georgia who challenged the earlier evictions ban quickly returned to court, where they received a sympathetic hearing. U.S. Judge Dabney Friedrich, an appointee of former President Donald Trump, said the new moratorium was beyond the CDC’s authority.
Most evictions for unpaid rent have been halted since the early days of the pandemic and there are now more than 15 million people living in households that owe as much as $20 billion in back rent, according to the Aspen Institute.
A majority of single-family rental homeowners have been impacted, according to a survey from the National Rental Home Council, and 50% say they have tenants who have missed rent during the pandemic.
Smaller landlords with fewer than four units, who often don’t have the financing of larger property owners, were hit especially hard, with as many as 58% having tenants behind on rent, according to the National Association of Realtors. More than half of back rent is owed to smaller landlords.
Landlords, big and small, are most angry about the moratoriums, which they consider illegal. Many believe some tenants could have paid rent, if not for the moratorium. The $47 billion in federal rental assistance that was supposed to make landlords whole has been slow to materialize. By July, only $3 billion of the first tranche of $25 billion had been distributed.
Thursday, August 26, 2021
Chinese pharma Kintor to commercialize Proxalutamide for COVID-19 treatment in Indonesia
Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics in China, has entered into a licensing agreement with PT Etana Biotechnologies Indonesia, on the commercialization of proxalutamide for the treatment of COVID-19 in Indonesia.
Pursuant to the Licensing Agreement, Kintor Pharma will receive from Etana upfront and milestone payments, in addition to the economic benefit relating to the sales from the launch of proxalutamide in Indonesia.
Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharma, commented, "We are excited to establish a strategic collaboration with Etana. Recently, the highly contagious Delta strain of COVID-19 variant has been reported in many countries around the world, including Indonesia."
Mr. Nathan Tirtana, Co-founder and CEO of Etana, commented, "We hope the collaboration will help the governments to give a better treatment for COVID-19 patients in Indonesia as proxalutamide has demonstrated impressive clinical efficacy and safety in other countries clinical trials for the treatment of COVID-19 infection."
Largest real-world study of COVID-19 vaccine safety published
The Clalit Research Institute, in collaboration with researchers from Harvard University, analyzed one of the world's largest integrated health record databases to examine the safety of the Pfizer/BioNTech BNT162B2 vaccine against COVID-19. The study provides the largest peer-reviewed evaluation of the safety of a COVID-19 vaccine in a nationwide mass-vaccination setting. The study was conducted in Israel, an early global leader in COVID-19 vaccination rates.
Previous efforts to characterize vaccine safety have relied on voluntary active reporting by vaccinated individuals, which is known to be incomplete. The present study relies on the analysis of millions of anonymized electronic medical records, which are far more comprehensive.
Furthermore, in order to provide the necessary context for interpreting vaccine safety findings, this study is the first to examine a wide range of adverse events both among vaccinated individuals and among unvaccinated individuals who were infected with the coronavirus. Thus, two separate analyses were conducted:
- Vaccination Outcomes Analysis: 884,828 vaccinated individuals aged 16 and over were carefully matched with 884,828 unvaccinated individuals based on an extensive set of sociodemographic, geographic and health-related attributes. Individuals were assigned to each group dynamically based on their changing vaccination status (235,541 individuals moved from the unvaccinated cohort into the vaccinated cohort during the study). Rates of the 25 potential adverse events within three weeks following either vaccine dose were compared between the two groups. This analysis took place from December 20, 2020, the launch of Israel's national vaccination campaign, through May 24, 2021.
- Infection Outcomes Analysis: To provide context for the vaccine safety findings above, a separate analysis was conducted that estimated the rates of the same 25 potential adverse events among 173,106 unvaccinated individuals who were infected with the coronavirus, compared to 173,106 carefully matched controls who were not infected with the coronavirus. This analysis took place from March 1, 2020 (the beginning of the COVID-19 pandemic in Israel) through May 24, 2021.
The vaccine was found to be safe: Out of 25 potential side effects examined, 4 were found to have a strong association with the vaccine.
Myocarditis was found to be associated with the vaccine, but rarely—2.7 excess cases per 100,000 vaccinated individuals. (The myocarditis events observed after vaccination were concentrated in males between 20 and 34.) In contrast, coronavirus infection in unvaccinated individuals was associated with 11 excess cases of myocarditis per 100,000 infected individuals.
Other adverse events moderately associated with vaccination were swelling of the lymph nodes, a mild side effect that is part of a standard immune response to vaccination, with 78 excess cases per 100,000, appendicitis with 5 excess cases per 100,000 (potentially as a result of swelling of lymph nodes around the appendix), and herpes zoster with 16 excess cases per 100,000.
In contrast to the relatively small number of adverse effects associated with the vaccine, high rates of multiple serious adverse events were associated with coronavirus infection among unvaccinated patients, including: Cardiac arrhythmias (a 3.8-fold increase to an increase of 166 cases per 100,000 infected patients), kidney damage (14.8-fold increase; 125 excess cases per 100,000), pericarditis (5.4-fold increase; 11 excess cases per 100,000), pulmonary embolism (12.1-fold increase; 62 excess cases per 100,000), deep vein thrombosis (3.8-fold increase; 43 excess cases per 100,000), myocardial infarction (4.5-fold increase; 25 excess cases per 100,000), and stroke (2.1-fold increase; 14 excess cases per 100,000).
The research was conducted by Dr. Noam Barda, Dr. Noa Dagan, Yair Ben-Shlomo, Dr. Eldad Kepten, Dr. Jacob Waxman, Reut Ohana and Prof. Ran Balicer from the Clalit Research Institute, Dr. Doron Netzer of Clalit Health Services, as well as Prof. Miguel Hernán and Prof. Marc Lipsitch of the Harvard T.H. Chan School of Public Health, Prof. Isaac Kohane of the Department of Biomedical Informatics at Harvard Medical School, and Prof. Ben Reis of Boston Children's Hospital and Harvard Medical School.
This study focused on adverse events that may develop in the short to medium term after vaccination, and those with clinical significance. The study did not focus on common immediate symptoms such as redness and discomfort at the injection site or fever. Symptoms that occurred within 6 weeks of the vaccine (three weeks after each vaccine dose) were defined as an adverse event of the vaccine if they occurred more frequently among the vaccinated group compared to the control group.
The results of this study validate and complement the previously reported findings of the Pfizer/BioNTech Phase-III randomized clinical trial, which, with 21,720 vaccinated individuals, could not precisely and comprehensively assess vaccine safety. The present study's large size allows a more detailed assessment of the vaccine's safety across a wider range of adverse events.
"The extensive nationwide rollout of Israel's COVID-19 vaccination campaign provided the Clalit Research Institute with a unique opportunity to assess, through its rich and comprehensive digital datasets, the safety of the vaccine in a real-world setting, without needing to rely on individual-driven active reporting of side-effects" said Prof. Ran Balicer, senior author of the study, Director of the Clalit Research Institute and Chief Innovation Officer for Clalit. "These results show convincingly that this mRNA vaccine is very safe and that the alternative of 'natural' morbidity caused by the coronavirus puts a person at significant, higher and much more common risk of serious adverse events. These data should facilitate informed individual risk-benefit decision-making, and, in our view, make a strong argument in favor of opting-in to get vaccinated, especially in countries where the virus is currently widespread," added Prof. Balicer, who also serves as Chairman of Israel's National Expert Advisory Team on COVID-19 response.
"This study sheds light for the first time on the significant side effects of the coronavirus vaccine. Since this is a more comprehensive analysis based on electronic medical records, these are more reliable assessments than those published to date which have relied on voluntary active reporting systems," explains Doron Netzer, Chief Medical Officer of Clalit's Community Health Division.
Prof. Ben Reis, Director of the Predictive Medicine Group at the Boston Children's Hospital Computational Health Informatics Program and Harvard Medical School, said, "To date, one of the main drivers of vaccine hesitancy has been a lack of information regarding potential side effects of the vaccine. This careful epidemiological study provides reliable information on vaccine safety, which we hope will be helpful to those who have not yet decided about vaccination." He continued, "Those who have hesitated until now to get vaccinated due to concerns about very rare side effects—such as myocarditis—should be aware that the risks for this very same side effect are actually higher among unvaccinated infected individuals."
Prof. Miguel Hernán, Director of the CAUSALab and Professor at the Harvard T.H. Chan School of Public Health, said, "This research is a perfect example of how randomized trials and observational healthcare databases complement each other. The original trial of the Pfizer/BioNTech vaccine provided evidence of its safety, but the estimates were too imprecise given the small sample size. This analysis of Clalit's high-quality database emulates the design of the original trial, uses its findings as a benchmark, and expands upon them to confirm the vaccine's safety on a wide range of adverse events. This combination of evidence from randomized trials and observational studies is a model for efficient medical research, something which is especially important in COVID times."
Prof. Marc Lipsitch, Director of the Center for Communicable Disease Dynamics and Professor at the Harvard T.H. Chan School of Public Health, said, "In all studies of vaccine safety, a major challenge is to ensure that those we are comparing to identify the vaccine's side effects are similar in the other characteristics that may predict whether they will experience these side effects. This is especially hard in the context of a rapidly growing, age-targeted vaccine campaign. Clalit's extraordinary database made it possible to design a study that addressed these challenges in a way that provides tremendous confidence in the inferences that come out of the study."
The research was funded in part by the newly announced Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute. "The strengthening of the scientific collaboration between Harvard and Clalit made possible by the Berkowitz Living Laboratory Collaboration is already bearing fruit and giving us a foretaste of the value of healthcare systems instrumented for research," said Prof. Isaac Kohane, Chair of the Department of Biomedical Informatics at Harvard Medical School and co-Director of the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration along with Professor Balicer. "Israel offers a unique environment in which to study the vaccine and its effects, and this study is an excellent example of what can be accomplished through such close scientific collaborations."
More information: Noam Barda et al, Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting, New England Journal of Medicine (2021). DOI: 10.1056/NEJMoa2110475
Differences in COVID antibody responses become evident
Hope for a future without fear of COVID-19 comes down to circulating antibodies and memory B cells. Unlike circulating antibodies, which peak soon after vaccination or infection only to fade a few months later, memory B cells can stick around to prevent severe disease for decades. And they evolve over time, learning to produce successively more potent "memory antibodies" that are better at neutralizing the virus and more capable of adapting to variants.
Vaccination produces greater amounts of circulating antibodies than natural infection. But a new study suggests that not all memory B cells are created equal. While vaccination gives rise to memory B cells that evolve over a few weeks, natural infection births memory B cells that continue to evolve over several months, producing highly potent antibodies adept at eliminating even viral variants.
The findings highlight an advantage bestowed by natural infection rather than vaccination, but the authors caution that the benefits of stronger memory B cells do not outweigh the risk of disability and death from COVID-19.
"While a natural infection may induce maturation of antibodies with broader activity than a vaccine does, a natural infection can also kill you," says Michel C. Nussenzweig, the Zanvil A. Cohn and Ralph M. Steinman professor and head of Rockefeller's Laboratory of Molecular Immunology. "A vaccine won't do that, and in fact, protects against the risk of serious illness or death from infection."
Your body on COVID-19
When any virus enters the body, immune cells immediately churn out hordes of circulating antibodies. Foot soldiers of the immune system, these antibodies burn bright but decay at variable rates depending on the vaccine or infection—they may protect us for months or years but then dwindle in number, allowing possible reinfection.
The immune system has a backup plan: An elite cadre of memory B cells that outlive circulating antibodies to produce so-called memory antibodies that provide long-term protection. Studies suggest that memory B cells for smallpox last at least 60 years after vaccination; those for Spanish flu, nearly a century. And while memory B cells don't necessarily block reinfection, they can prevent severe disease.
Recent studies have suggested that within five months of receiving a vaccine or recovering from a natural infection, some of us no longer retain sufficient circulating antibodies to keep the novel coronavirus at bay, but our memory B cells stand vigilant. Until now, however, scientists did not know whether the vaccines could be expected to provide the sort of robust memory B cell response seen after natural infection.
The convalescent advantage
Nussenzweig and colleagues resolved to tease out any differences in memory B cell evolution by comparing blood samples from convalescent COVID-19 patients to those from mRNA-vaccinated individuals who had never suffered natural infection.
Vaccination and natural infection elicited similar number of memory B cells. Memory B cells rapidly evolved between the first and second dose of the Pfizer and Moderna vaccines, producing increasingly potent memory antibodies. But after two months, progress stalled. The memory B cells were present in large numbers and expressed potent antibodies, but were not getting any stronger. Although some of these antibodies that can neutralize delta and other variants there was no overall improvement in breadth.
With convalescent patients, on the other hand, memory B cells continued to evolve and improve up to one year after infection. More potent and more broadly neutralizing memory antibodies were coming out with every memory B cell update.
To boost or not to boost
There are several potential reasons that memory B cells produced by natural infection might be expected to outperform those produced by mRNA vaccines, the researchers say.
It is possible that the body responds differently to viruses that enter through the respiratory tract than those that are injected into our upper arms. Or perhaps an intact virus goads the immune system in a way that the lone spike protein represented by the vaccines simply cannot. Then again, maybe it's that the virus persists in the naturally infected for weeks, giving the body more time to mount a robust response. The vaccine, on the other hand, is flushed out of the body mere days after triggering the desired immune response.
Regardless of the cause, the implications are clear. We can expect memory B cells to undergo limited volleys of evolution in response to mRNA vaccines, a finding that may have significant implications for the design and rollout of booster shots. A booster with the currently available mRNA vaccine would be expected to engage memory cells to produce circulating antibodies that are strongly protective against the original virus and somewhat less so against the variants, Nussenzweig says.
"When to administer the booster depends on the object of boosting," he says. "If the goal is to prevent infection, then boosting will need to be done after 6 to 18 months depending on the immune status of the individual. If the goal is to prevent serious disease, boosting may not be necessary for years."
Explore further
More information: Alice Cho et al, Antibody Evolution after SARS-CoV-2 mRNA Vaccination, (2021). DOI: 10.1101/2021.07.29.454333
Rotating presence at school, work may limit COVID spread
The best way to keep COVID cases out of businesses and schools while maintaining some in-person presence is to create two rotating groups, a French study showed Thursday.
Several research institutions including the CNRS and the University of Paris mapped real-world contact networks using data from a high school, a primary school and a business in France.
They then used the networks to simulate the spread of coronavirus from a single case, testing what method of partial teleworking would most efficiently mitigate an outbreak.
They looked at scenarios in which an entire population would alternate its presence daily or weekly, as well as scenarios in which populations would be divided into two groups rotating daily or weekly.
For all three settings, two groups rotating weekly work best to slow transmission of an infection, the study published in the journal PLOS Computational Biology concluded.
The second most effective method is to have two groups rotate daily, it found.
Alternating the presence of a whole population of students or workers on a weekly or daily basis, however, was found to be least effective for social cohesion.
Researchers used information on real-world interactions between individuals and simulated the spread of coronavirus using known information about the virus's behaviour.
They accounted for the fact that COVID can be contagious before symptoms appear and included random "super-spreader" events in their models.
In a baseline scenario—a primary school with normal attendance—there was a 27 percent chance that a positive case will lead to an outbreak, which is defined as one person infecting at least five others.
But that likelihood falls to just 12 percent if the population is divided into groups that rotate weekly. The risk is only slightly higher for groups that rotate daily, 12.3 percent.
The weekly rotation model is also the most efficient at delaying an outbreak and at limiting the overall number of infections.
But these strategies only work if the amount of virus circulating in the local population remains limited.
If the average number of persons infected by a single case is more than 1.7, "then none of these strategies, except for the full-time telecommuting, suffices to prevent the onset of an outbreak", the study says.
But if the virus is spreading at a rate of 1.4 new cases for each infected person, "all four of these strategies are satisfactory and manage to curb the epidemic", the study shows.
An in-person return to school is planned for all students in France next week.
A system of weekly rotating groups applied to some middle- and high-schools across the country could return if cases start to rise again, officials have said.
Explore further
More information: Simon Mauras et al, Mitigating COVID-19 outbreaks in workplaces and schools by hybrid telecommuting, PLOS Computational Biology (2021). DOI: 10.1371/journal.pcbi.1009264
Anti-parasite drug used on Arkansas jail's inmates for COVID
Inmates at a northwest Arkansas jail have been prescribed ivermectin to combat COVID-19, despite warnings from federal health officials that the antiparasitic drug should not be used to treat the coronavirus.
Washington County's sheriff confirmed Tuesday night that the jail's health provider had been prescribing the drug. Sheriff Tim Helder didn't say how many inmates at the 710-bed facility had been given ivermectin and defended the health provider the jail uses that has been prescribing the medication.
“Whatever a doctor prescribes, that is not in my bailiwick," Helder told members of the Washington County quorum court, the county's governing body. Helder did not immediately respond to a call from The Associated Press, and a spokesperson for the sheriff's office referred questions to Karas Correctional Health, the jail's health provider.
It's not clear what information inmates who were prescribed the drug have been given about it, including warnings that it isn't approved to treat COVID.
The U.S. Food and Drug Administration has approved ivermectin in both people and animals for some parasitic worms and for head lice and skin conditions. The FDA has not approved its use in treating or preventing COVID-19 in humans.
“Using any treatment for COVID-19 that’s not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm," the FDA said in a warning about the drug.
Health officials in Arkansas and Mississippi this week warned people to not take the veterinary formulation of the drug after seeing an uptick in calls to their poison control centers. The drug has been touted by some Republican lawmakers in Arkansas as a potential treatment for COVID.
Eva Madison, a member of the quorum court, called the use of the drug on inmates “disturbing,” noting that they're not in a position to seek a second opinion from physicians about its use.
“Are we allowing him to effectively experiment on our detainees at our jail with no oversight?" Madison said.
Karas Correctional did not immediately return a message left Wednesday morning. Helder said Karas informed him of the drug's use in July, the Northwest Arkansas Democrat-Gazette reported.
Helder said Tuesday night that the jail has had zero inmate deaths from the coronavirus, and jail officials said inmates have also been offered the Johnson & Johnson vaccine.
The American Civil Liberties Union of Arkansas criticized the drug being prescribed to inmates, citing the FDA's warnings about the drug. The group said it was seeking additional records about the drug's use from the sheriff's office and from the health provider.
“They need to stop this practice immediately," ACLU of Arkansas Executive Director Holly Dickson said.
None of the jail's inmates administered ivermectin were state prisoners being held by the facility, the state Department of Corrections said. The department and its medical services provider are not providing ivermectin to any of its inmates, spokeswoman Cindy Murphy said.
https://abcnews.go.com/US/wireStory/anti-parasite-drug-arkansas-jails-inmates-covid-79645515
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