Agenus Unit SaponiQx, Builds Adjuvant Platform, Collaborates with Ginkgo Bioworks

 Development of saponin molecules designed to provide high-efficacy and long-lasting protection for pandemic vaccines

 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections today announced the launch of SaponiQx, a subsidiary of Agenus, dedicated to driving innovation in novel adjuvant discovery and vaccine design, and its partnership with Ginkgo Bioworks, Inc. (“Ginkgo”), the leading horizontal platform for cell programming. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp. (Nasdaq: SRNG), is enabling customers across industries to improve products and manufacturing processes, and to increase efficiency and sustainability, by making biology easier to engineer.

SaponiQx is building an innovative adjuvant platform to deliver both sustainable manufacturing approaches and a secure supply of known adjuvants, as well as discover novel adjuvants and develop new, more effective vaccines utilizing optimized antigen-adjuvant pairings. Adjuvants are substances known to enhance the body’s immune response and are a key component of many existing vaccines. Ginkgo’s experience in metabolic engineering, enzymatic diversification, and process optimization can be applied to discover novel adjuvants and improve current manufacturing processes that can then be applied toward developing better-integrated vaccines.

https://finance.yahoo.com/news/agenus-subsidiary-saponiqx-builds-innovative-113000784.html

Estimates of COVID Cases, Deaths in Nursing Home Not Reported in Fed Data

 Karen Shen, PhD¹; Lacey Loomer, PhD, MSPH²; Hannah Abrams, MD³

doi:10.1001/jamanetworkopen.2021.22885

Key Points

Question  How many COVID-19 cases and deaths at nursing homes were missed in the federal National Healthcare Safety Network (NHSN) reporting system owing to the delayed start in required reporting?

Findings  In this cross-sectional study of 15 307 US nursing homes, approximately 44% of COVID-19 cases and 40% of COVID-19 deaths that occurred before the start of reporting were not reported in the first NHSN submission in sample states, suggesting there were more than 68 000 unreported cases and 16 000 unreported deaths nationally.

Meaning  These findings suggest that federal NHSN data understate total COVID-19 cases and deaths in nursing homes and that using these data without accounting for this issue may result in misleading conclusions about the determinants of nursing home outbreaks.

Abstract

Importance  Federal data underestimate the impact of COVID-19 on US nursing homes because federal reporting guidelines did not require facilities to report case and death data until the week ending May 24, 2020.

Objective  To assess the magnitude of unreported cases and deaths in the National Healthcare Safety Network (NHSN) and provide national estimates of cases and deaths adjusted for nonreporting.

Design, Setting, and Participants  This is a cross-sectional study comparing COVID-19 cases and deaths reported by US nursing homes to the NHSN with those reported to state departments of health in late May 2020. The sample includes nursing homes from 20 states, with 4598 facilities in 12 states that required facilities to report cases and 7401 facilities in 19 states that required facilities to report deaths. Estimates of nonreporting were extrapolated to infer the national (15 397 facilities) unreported cases and deaths in both May and December 2020. Data were analyzed from December 2020 to May 2021.

Exposures  Nursing home ownership (for-profit or not-for-profit), chain affiliation, size, Centers for Medicare & Medicaid Services star rating, and state.

Main Outcomes and Measures  The main outcome was the difference between the COVID-19 cases and deaths reported by each facility to their state department of health vs those reported to the NHSN.

Results  Among 15 415 US nursing homes, including 4599 with state case data and 7405 with state death data, a mean (SE) of 43.7% (1.4%) of COVID-19 cases and 40.0% (1.1%) of COVID-19 deaths prior to May 24 were not reported in the first NHSN submission in sample states, suggesting that 68 613 cases and 16 623 deaths were omitted nationwide, representing 11.6% of COVID-19 cases and 14.0% of COVID-19 deaths among nursing home residents in 2020.

Conclusions and Relevance  These findings suggest that federal NHSN data understated total cases and deaths in nursing homes. Failure to account for this issue may lead to misleading conclusions about the role of different facility characteristics and state or federal policies in explaining COVID outbreaks.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784031

USPS exempt from Biden vax mandate for 100M workers

 Neither rain, nor sleet … nor presidential proclamation.

President Biden on Thursday mandated COVID-19 vaccines for about 100 million US workers, but the more than 600,000 letter-carriers and administrative staff of the US Postal Service reportedly won’t have to get a shot.

A White House official confirmed the exemption to Washington Post postal reporter Jacob Bogage, adding that “we strongly encourage them to comply with these standards” anyhow.

It was not immediately clear why postal workers — who serve every community in the United States, often with daily door-to-door deliveries and contact with millions of Americans — would be exempted from new mandates that apply to most federal workers and companies with 100 or more staff.

The White House did not immediately respond to The Post’s request for comment.

Biden described his justification for a package of vaccine mandates in stark terms. His rules would apply two-thirds of all American workers.

More than 600,000 US Postal Service employees won’t be forced to get the COVID-19 vaccine.

REUTERS

“We’ve been patient, but our patience is wearing thin, and your refusal has cost all of us,” Biden said in a speech. “This is not about freedom, or personal choice. It’s about protecting yourself and those around you.”

Biden on Thursday signed two executive orders: one requiring vaccination for most federal workers with limited medical and religious exemptions and another forcing federal contractors to also vaccinate their workforces.

President Joe Biden lashed out on unvaccinated Americans, claiming “Your refusal has cost us all.”

AP

The Labor Department will issue a rule forcing workers at all companies with 100 or more employees to get vaccinated or be tested weekly, Biden said. Fines of $14,000 per violation are expected.

Other new mandates impact teachers and health care workers. About 17 million employees of health care facilities that accept Medicare or Medicaid payments and 300,000 teachers in the Head Start programs for poor children also must now get vaccinated.

US Postal Service workers would be among the only federal employees to not be mandated to take the COVID-19 vaccine.

REUTERS

According to CDC data, 75.3 percent of US adults have had at least one coronavirus vaccine shot. But vaccination rates vary among states and the national infection rate is as high as it was in late January when few Americans were vaccinated.

Data indicate that young people, Republicans and members of some minority groups, including African-Americans and Hispanics, are less likely to be vaccinated.

Many postal workers are represented by the American Postal Workers Union, which is an affiliate of the AFL-CIO.

A different AFL-CIO union, the American Federation of Government Employees, gave a noncommittal statement on the new mandates — saying that “workers deserve a voice in their working conditions.”

“We expect to bargain over this change prior to implementation, and we urge everyone who is able to get vaccinated as soon as they can do so,” AFGE said.

https://nypost.com/2021/09/09/usps-exempt-from-biden-vax-mandate-for-100m-workers/

Despite 'Vax-Or-Test' Order, 1/3 Of NYC Workforce Has Not Been Jabbed

 Days away from having to comply with a health order that requires proof of vaccination or weekly coronavirus testing, more than a third of New York City's municipal workforce is still holding out on getting a vaccine shot.

As of Tuesday, only 65% of city workers, or approximately 239,000 people, have received at least one dose of the vaccine, according to data provided by the mayor's office. That rate is below the citywide coverage for adults—78% with at least one dose—but on par with the 66% for all ages. City officials said their workforce, which expands with the hiring of seasonal staffers, was roughly 367,000 people in mid-August.

But the vaccination rate among city workers has been slow to improve since the announcement of vax-or-test orders in late July. It stood at 58% three weeks ago. This slow pace could provide a stronger case for the city to move to a stricter vaccine mandate as the delta variant continues to surge, almost entirely among the unvaccinated.

"I think that city employees are trailing the rest of adults in the city by so much suggests that there is a lot of vaccine hesitancy in the city worker population," said Dr. Denis Nash, an epidemiology professor at the City University of New York. "I could be wrong, but don’t think that is it due to work-related barriers to getting vaccinated since the city has endeavored to remove barriers."

Mayor Bill de Blasio, who has urged the private sector to require vaccinations as a way of bringing workers back to the office, has repeatedly said he would be willing to consider such an option.

"We've been moving the mandates so far that we thought were absolutely essential, but we continue to look at that," he told reporters last week. "And, as I've said, we've been climbing the ladder."

Some experts predicted that more employers, including government entities, would issue full vaccine mandates after the U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine last month. De Blasio had also expressed confidence that vaccination rates would pick up as the deadline approached for his so-called "vax-or-test" mandate.

With that policy set to take full effect on Monday, it now appears that a large swath of city workers, from first responders to public housing employees, are willing to opt for weekly testing rather than getting vaccinated. The mayor has summoned all of its workers to resume their pre-pandemic in-person schedules beginning on the same day, and offices with too many unvaccinated employees could carry an increased potential for outbreaks.

"Telework will end, except in very limited circumstances," according to an email sent September 1st to employees and first obtained by The New York Times. The message noted that employees are entitled to "reasonable accommodations" for disability and medical conditions. The Times reported that the order applies to roughly 80,000 city office workers.

Not all city employees can avoid vaccination by getting tested. Department of Education staffers, including teachers and custodians, are required to get at least one dose by September 27th. And under a health order directed by former Governor Andrew Cuomo, all statewide health care workers, including hospital and nursing home staffers, must also be vaccinated by the same date.

The slow pace of municipal vaccinations comes as the mayor has trumpeted the success of the city's broader vaccination effort, which has included cash incentives and mandates for indoor activities like dining, gym workouts and concerts. After falling below 8,300 new recipients a day in early July, fresh demand climbed to roughly 17,000 people a month later. It has now dropped slightly again, hovering around 14,000 new takers every day.

A spokesman for the mayor's office noted that the city's data on municipal employee vaccinations does not include workers who were vaccinated outside the city, meaning that the numbers were a "conservative" estimate.

The breakdown of vaccination rates by a list of 47 city agencies showed a wide range, from the highest level—92% for the Conflicts of Interest Board—to the lowest—44% for the city's Sanitation Department. A worrisome trend was the coverage among the city's first responders, who tend to have frequent contact with the public: 57% of fire department employees have received one dose, while the rate for emergency management workers is 54%. Lower still was the vaccine rate within New York City Police Department. The agency's roughly 52,000 civilian and uniformed members had an uptake of 53%.

At the New York City Housing Authority, the vaccination rate was 46% among its roughly 12,000 workers. The Department of Corrections, whose workforce consists of around 11,000 uniformed and civilian officers, had a similarly abysmal inoculation rate, that of 45%.

"The more than two-fold variability from the lowest to the highest agency in terms of [the] first dose of vaccine coverage suggests that this is not an effective citywide policy," said Nash from CUNY.

He added that he was surprised vaccination in the city's healthcare workers—78% for Department of Health staffers and 77% for city hospital workers—was not higher given their ease of access to shots and the nature of their work. By comparison, the Department of Education, whose 143,000 employees are also required to be immunized, has a 72% vaccination rate. (Unlike other city agencies, the vaccination rate for educators was determined by a self-reporting portal the DOE is using.)

Mark Levine, a Manhattan City Councilmember who chairs the health committee, speculated that non-clinical staff members may be delaying the shot, but he also pointed out that even nurses have expressed hesitance over getting vaccinated.

"They are not too different from the broader city workforce," Levine said. "It’s part of the broader challenge of people being fed misinformation and having an understandable fear based on the history of racism in the medical field."

But the vax-or-test rule has also been opposed by some unions, many of which argued the mayor should have consulted them first. “While we encourage everyone to get vaccinated and support measures to ensure our members’ health and wellbeing, weekly testing is clearly subject to mandatory bargaining,” said Henry Garrido, president of the union DC37, which represents cafeteria workers and school aides, in a statement back in July.

"This is politically challenging," Levine said. He said he would support a full mandate now for city workers, with a carveout for medical and religious exemptions.

Vaccinations, he argued, are "most critical for public workers with contact with members of the public."

https://gothamist.com/news/despite-vax-or-test-order-one-third-nyc-workforce-has-not-been-vaccinated

Job postings with COVID-19 vaccine requirements doubled in August: Indeed

 Job postings that require applicants to be vaccinated against COVID-19 skyrocketed in August amid a sharp increase in coronavirus cases, according to data released Thursday by hiring website Indeed.

In the seven days ending Aug. 30, the share of job postings on Indeed that required COVID-19 vaccinations rose 119 percent from the same period in July. Job postings that mentioned a general vaccination requirement, but not COVID-19 specifically, rose by 242 percent over the same period.

The sharp increase in vaccination requirements came as the delta variant drove a staggering rise in COVID-19 cases and wiped out job growth in crucial sectors last month.

The U.S. added just 235,00 jobs in August amid the delta surge, dropping sharply from the nearly 1.1 million gained in July and falling well short of the 750,000 gain expected by economists.

While vaccine-dependent job openings made up less than 1 percent of all ads on Indeed, “employers are undoubtedly wondering how they can keep their business’s recovery on track,” wrote AnnElizabeth Konkel, an economist at the Indeed Hiring Lab.

“Vaccine requirements are a way to keep staff and customers safer and business operations running,” she continued, noting that some employers have asked applicants to upload proof of vaccination or have offered vaccine-related bonuses.

Vaccination requirements increased at the sharpest rate for openings for personal and home health aides, medical technicians, therapists, and community and social service positions — all of which involve substantial in-person interaction. But requirements also increased sharply in other fields with greater capacities for teleworking

Several major companies have also announced vaccine requirements and penalties for unvaccinated employees since the delta surge began, though others have held off over concerns it could make it even harder to fill a record number of job openings. 

President Biden is also set to announce a COVID-19 vaccination requirement for all federal employees and contractors during a speech Thursday, removing the option of being tested regularly instead of getting vaccinated.

Konkel said a small but growing proportion of job-seekers were looking for jobs that specifically did not require COVID-19 vaccinations, predominantly in health care, one of the first industries to impose vaccine mandates. 

Nearly 60 percent of searches for jobs without vaccine requirements came from the search term “no vaccine required nursing,” she added, an alarming sign as nursing homes struggle to hire and retain workers willing to get the shot.

“Time will tell how much further this trend goes,” she wrote.

https://thehill.com/policy/finance/571510-job-postings-with-covid-19-vaccine-requirements-doubled-in-august

NC: Nearly half of state's middle and high school Covid-19 clusters tied to sports

 Forty-five percent of all Covid-19 clusters in North Carolina's middle and high schools since July have been among sports teams, according to the North Carolina Department of Health and Human Services (NCDHHS).

The state's department of health said it was seeing a "sharp increase" in clusters among sports teams.

"Clusters among school sports teams accounted for 45% of all clusters in North Carolina middle and high schools, despite most school sports activities not beginning until August as schools began the fall semester," North Carolina's health department said in a news release.

The health department reported 42 athletics-related clusters and defines a cluster as a minimum of 5 cases.

Between July 1 and September 2, there were 340 cases in those 42 athletics-related clusters in North Carolina public, charter and private middle and high schools, according to the NCDHHS.

"To protect students' privacy, no other identifying information, including county or school, will be released," it said.

The NCDHHS said the numbers underscored an urgent need for vaccination among school children as soon as possible. Children 17 and under were 31% of the state's new Covid-19 cases, the highest since the pandemic began, the health department said.

"We need everyone, including our student athletes and their coaches, to increase layers of prevention to fight this more contagious Delta variant: Don't wait to vaccinate and urge others to do the same," NCDHHS Chief Medical Officer and State Health Director Dr. Elizabeth Cuervo Tilson. "Tested, safe and effective COVID-19 vaccines are the best tool for preventing the spread of COVID-19. Student athletes who are fully vaccinated do not need to quarantine after a close contact with someone with COVID-19."

North Carolina's health department recommends face masks be worn in indoor settings, as well as recommending sports programs "practice social distancing when possible, disinfect equipment frequently and avoid sharing water bottles."

"Teams should also consider working out, including weight training, in groups or pods to limit exposure should someone become sick," according to the NCDHHS. "Sports in which participants have frequent and prolonged contact, such as basketball, football, cheerleading, wrestling and others, are higher risk."

Both the US Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP) have advised that sports can play a role in the spread of Covid-19 among students, especially those who are unvaccinated.

The CDC recommends children limit youth sport participation and follow specific guidelines when engaging in those types of activities. The agency listed nearly a dozen different recommendations, including minimizing the time spent indoors and reducing the amount of time players spend in close contact with each other.

Last month, a number of sports and medical associations said they believe all athletes who can get can be vaccinated against Covid-19 should, as soon as possible, and urged medical providers to talk about the vaccine at all sports physicals. In addition to the AAP, other organizations included in the statement include the American College of Sports Medicine, the National Federation of State High School Associations and the US Olympic and Paralympic Committee, among others.

"We, the undersigned organizations, believe all athletes who do not have contraindications should be vaccinated against COVID-19 as soon as they are eligible," said a news release from the AAP.

https://www.cnn.com/2021/09/09/us/north-carolina-covid-school-sports/index.html

L.A. Unified school board approves COVID vaccine mandate for students 12 and older

 Los Angeles school board members approved a plan Thursday to require all students 12 and older at the nation’s second-largest school district to be fully vaccinated against COVID-19 to attend classes in person.

Under the proposal adopted with a 7-0 vote by the L.A. Unified School District Board of Education, all students who are at least 12 years old will have to get their first vaccine dose no later than Nov. 21, and their second dose no later than Dec. 19. 

If the vaccine-eligible students are part of in-person extracurricular programs like sports, they would have to get their first vaccine dose even earlier — by no later than Oct. 3.

Ahead of the vote, board members spoke in favor of the plan. Board member Nick Melvoin said he supports the mandate because it will help keep students and teachers in the classroom for in-person learning.

“We want to do everything possible to make sure that L.A. Unified doesn’t end up on the long list of school districts that have had to re-close and go back to distance learning after welcoming students back this fall,” he said.

Melvoin added that public schools have long required immunization against other illnesses like polio, measles, mumps and rubella, “and consequently most parents don’t have to worry about their kids contracting those illnesses and their kids may not have ever heard of them.”

Board member Jackie Goldberg said she grew up as polio was “ravaging Los Angeles.”

“And you know what stopped it? Vaccinating every single student in the entire state, in the entire country, and eventually in a lot of the world,” she said.

One board member, Scott Schmerelson, recused himself from the vote and discussion because he holds stock in Pfizer. But all others favored the move.

Several parents spoke in opposition to the mandate during the public comment section of Thursday’s afternoon’s special board meeting. One who identified herself as chair of a parents committee, questioned why the board doesn’t focus on other health issues threatening children, like proper nutrition to help prevent diabetes and high blood pressure.

But state Sen. Richard Pan, who is a pediatrician and parent, called in to voice his support of the move.

“Our students are vulnerable to COVID-19 and mandating vaccines is a positive step to make sure more communities are protected and ensuring our schools are safe,” he said. “Because vaccines are safe and they work, they’re effective.”

Pan noted that even for those who are too young for a vaccine, having more older students vaccinated will help protect them from infection.

Board member Mónica García said she expected pushback to the decision, calling it “tough on multiple fronts,” but was confident it was the right one.

“It is easy to wait for someone to tell us what to do,” she said. “L.A. Unified is leading because we must. Our communities cannot wait.”

Dr. Smita Malhotra, L.A. Unified’s medical director, said recent studies from the U.S. Centers for Disease Control and Prevention show infection rates are 10 times higher for unvaccinated adolescents than those who are fully vaccinated, and that increasing rates of pediatric hospitalization nationwide are due to how contagious the delta variant is.

“At this time in history, we are being called to move away from our individualism and make decisions for the greater sake of humanity are specifically for the sake of our children,” she said. “Schools are known to be foundations and pillars of our society. And so it makes sense that we play a part in mitigating the public health crisis we are faced with today.”

Malhotra noted that the CDC has also found the vaccine’s benefits outweigh possible risks to those age 12 and up.

“Vaccination directly impacts the health and well-being of children,” she said. “It doesn’t just protect those who are vaccinated. It protects the communities around them.”

Students at L.A. Unified are already required to undergo weekly coronavirus testing — regardless of vaccination status.

And the district has been requiring all teachers and staff to be fully vaccinated against COVID-19 as a condition of continued employment.

Still, thousands of students have tested positive for coronavirus and many more have had to quarantine.

Thursday’s vote comes amid concerns that L.A. County’s quarantine requirements for students, which are stricter than the state’s, are causing too many student absences.

During just the first week of school at LAUSD, 6,500 students missed one or more days due to the coronavirus.

Throughout August, L.A. County reported multiple outbreaks at school campuses since students returned for in-person learning, according to public health officials.

From Aug. 15 to Aug. 29, a total of 5,207 student cases and 729 staff cases were reported countywide, with a vast majority of the cases at L.A. Unified campuses, officials said last week.

The LAUSD vaccine mandate proposal says that the delta variant coronavirus surge and current transmission levels in the region, including among school age children, have “proven to be disruptive to full-time, in-person instruction and student learning.”

“Adoption of the Resolution will result in the safest school environments possible and minimize disruption to full-time, in-person instruction brought about by the COVID-19 pandemic,” the resolution reads.

The vaccines are free, with mobile clinics set up to dispense them at every LAUSD middle school and high school campus, officials said.

Eligible students would be asked to upload proof of vaccination on LAUSD’s Daily Pass program before Jan. 10 next year in order to be permitted in school facilities, according to the proposal.

The vaccine requirement would also apply to charter school students on co-located LAUSD school campuses who are eligible to receive the COVID-19 vaccine.

The mandate would exclude students with qualified and approved exemptions under LAUSD’s existing immunization policies.

As the state goes through yet another coronavirus surge, school officials throughout California have been mulling added safety measures to keep the virus from spreading on campuses.

Culver City Unified was the first in the region to implement a vaccine mandate for eligible students. 

https://ktla.com/news/local-news/l-a-school-board-to-vote-on-whether-to-mandate-covid-vaccinations-for-students-12-and-older/