China approves human testing for coronavirus vaccine grown in insect cells

China has approved human testing for a potential coronavirus vaccine cultivated within insect cells, local government in the southwestern city of Chengdu said on Saturday.

China is in a global race to develop cost-effective vaccines to curb the COVID-19 pandemic.

Using insect cells to grow proteins for the coronavirus vaccine – a first in China – could speed up large-scale production, the city government of Chengdu said in a notice on social media WeChat.

The vaccine, developed by West China Hospital of Sichuan University in Chengdu, has received approval from the National Medical Products Administration to enter a clinical trial, the notice said.

When tested on monkeys, the vaccine was shown to prevent SARS-CoV-2 infections with no obvious side-effects, the notice added.

Chinese scientists are already leading work on at least eight other potential coronavirus vaccines that have entered different stages of clinical trials.

Foreign players, including Germany’s BioNTech (BNTX.O) and Inovio Pharma (INO.O) in the United States, have also cooperated with local firms to test their experimental vaccines in China.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china/china-approves-human-testing-for-coronavirus-vaccine-grown-in-insect-cells-idUSKBN25I0G6

How big gatherings spread COVID-19: German scientists stage concert experiment

Around 1,500 volunteers equipped with face masks, hand disinfectant and tracking gadgets attended an indoor concert in Germany on Saturday as part of a study to simulate how the novel coronavirus spreads in large gatherings.

As part of the so-called Restart19 study, researchers from the University Medical Center in Halle want to find out how cultural and sporting events can safely take place without posing a risk to the population.

Volunteers were handed protective facemasks of the type typically used in hospitals and bottles of flurorescent hand sanitizer at the concert of German singer-songwriter Tim Bendzko in an indoor arena in Leipzig.

“I am extremely satisfied with the discipline displayed by the participants,” Stefan Moritz, the head of the study, told a news conference after the concert. “I was surprised how disciplined everyone was in wearing masks.”

He said results of the study, which is being financed by the states of Saxony and Saxony-Anhalt, were expected in 4-6 weeks.

The participants were also given contact tracers to help track the distance between concertgoers and to identify in which parts of the arena, such as entrance halls and grandstands, people might crowd too closely together.

Researchers asked participants to regularly disinfect their hands using the fluorescent sanitiser so scientists can identify – with the help of ultra-violet light – which surfaces are touched frequently and pose a risk for spreading the virus.

Sporting events such as Liverpool’s Champions League soccer match against Atletico Madrid and the Cheltenham Festival, a horseracing event, in Britain in March have been blamed for playing a role in spreading COVID-19.

Most events with big crowds have been put on hold.

A decision to grant approval for a concert of German singer Sarah Connor with 13,000 attendees on Sept. 4 in Duesseldorf has faced sharp criticism by virologists and local politicians.

https://www.reuters.com/article/us-health-coronavirus-test-concert/how-big-gatherings-spread-covid-19-german-scientists-stage-concert-experiment-idUSKBN25I0IR

Nasal vaccine against COVID-19 prevents infection in mice

Scientists at Washington University School of Medicine in St. Louis have developed a vaccine that targets the SARS-CoV-2 virus, can be given in one dose via the nose and is effective in preventing infection in mice susceptible to the novel coronavirus. The investigators next plan to test the vaccine in nonhuman primates and humans to see if it is safe and effective in preventing COVID-19 infection.

The study is available online in the journal Cell.

Unlike other COVID-19 vaccines in development, this one is delivered via the nose, often the initial site of infection. In the new study, the researchers found that the nasal delivery route created a strong immune response throughout the body, but it was particularly effective in the nose and respiratory tract, preventing the infection from taking hold in the body.

“We were happily surprised to see a strong immune response in the cells of the inner lining of the nose and upper airway — and a profound protection from infection with this virus,” said senior author Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine and a professor of molecular microbiology, and of pathology and immunology. “These mice were well protected from disease. And in some of the mice, we saw evidence of sterilizing immunity, where there is no sign of infection whatsoever after the mouse is challenged with the virus.”

To develop the vaccine, the researchers inserted the virus’ spike protein, which coronavirus uses to invade cells, inside another virus – called an adenovirus – that causes the common cold. But the scientists tweaked the adenovirus, rendering it unable to cause illness. The harmless adenovirus carries the spike protein into the nose, enabling the body to mount an immune defense against the SARS-CoV-2 virus without becoming sick. In another innovation beyond nasal delivery, the new vaccine incorporates two mutations into the spike protein that stabilize it in a specific shape that is most conducive to forming antibodies against it.

“Adenoviruses are the basis for many investigational vaccines for COVID-19 and other infectious diseases, such as Ebola virus and tuberculosis, and they have good safety and efficacy records, but not much research has been done with nasal delivery of these vaccines,” said co-senior author David T. Curiel, MD, PhD, the Distinguished Professor of Radiation Oncology. “All of the other adenovirus vaccines in development for COVID-19 are delivered by injection into the arm or thigh muscle. The nose is a novel route, so our results are surprising and promising. It’s also important that a single dose produced such a robust immune response. Vaccines that require two doses for full protection are less effective because some people, for various reasons, never receive the second dose.”

Although there is an influenza vaccine called FluMist that is delivered through the nose, it uses a weakened form of the live influenza virus and can’t be administered to certain groups, including those whose immune systems are compromised by illnesses such as cancer, HIV and diabetes. In contrast, the new COVID-19 intranasal vaccine in this study does not use a live virus capable of replication, presumably making it safer.

The researchers compared this vaccine administered to the mice in two ways — in the nose and through intramuscular injection. While the injection induced an immune response that prevented pneumonia, it did not prevent infection in the nose and lungs. Such a vaccine might reduce the severity of COVID-19, but it would not totally block infection or prevent infected individuals from spreading the virus. In contrast, the nasal delivery route prevented infection in both the upper and lower respiratory tract — the nose and lungs — suggesting that vaccinated individuals would not spread the virus or develop infections elsewhere in the body.

The researchers said the study is promising but cautioned that the vaccine so far has only been studied in mice.

“We will soon begin a study to test this intranasal vaccine in nonhuman primates with a plan to move into human clinical trials as quickly as we can,” Diamond said. “We’re optimistic, but this needs to continue going through the proper evaluation pipelines. In these mouse models, the vaccine is highly protective. We’re looking forward to beginning the next round of studies and ultimately testing it in people to see if we can induce the type of protective immunity that we think not only will prevent infection but also curb pandemic transmission of this virus.”

This work was supported by the National Institutes of Health (NIH), grant and contract numbers 75N93019C00062, R01 AI127828, R01 AI130591, R01 AI149644, R35 HL145242, HHSN272201400018C, HHSN272201200026C, F32 AI138392 and T32 AI007163; the Defense Advanced Research Project Agency, grant number HR001117S0019; a Helen Hay Whitney Foundation postdoctoral fellowship; and the Pulmonary Morphology Core at Washington University School of Medicine.

Diamond is a consultant for Inbios, Vir Biotechnology, NGM Biopharmaceuticals, and on the scientific advisory board of Moderna. The Diamond laboratory has received unrelated funding support from Moderna, Vir Biotechnology, and Emergent BioSolutions. Diamond, Curiel, Ahmed Hassan and Igor Dmitriev have filed a disclosure with Washington University for possible development of ChAd-SARS-CoV-2. Michael Holtzman is a member of the DSMB for AstroZeneca and founder of NuPeak Therapeutics. The Baric laboratory has received unrelated funding support from Takeda, Pfizer and Eli Lily.

Hassan AO, et al. A single-dose intranasal ChAd vaccine protects upper and lower respiratory tracts against SARS-CoV-2. Cell. Aug. 19, 2020.

Nasal vaccine against COVID-19 prevents infection in mice

Schools Have No Good Options for Reopening

Even as schools have already begun reopening across the United States, debate is still intensifying over whether students should be physically present in classrooms. Children are widely thought to be at relatively low risk of developing severe COVID-19, but a new report from the American Academy of Pediatrics (AAP) indicates that cumulative cases doubled in roughly the past month: between July 9 and August 13, the number increased from about 200,000 to over 406,000. Physically reopening schools might accelerate the increase—potentially raising the number of children with severe symptoms and spurring spread among the community at large.

Whether children attend classrooms or learn remotely at home, each option carries a risk of harm to students, their families and the adults who work with them. The novel coronavirus that causes COVID-19 can spread through the enclosed halls and classrooms of a school building; but prolonged reliance on virtual learning alone may disrupt a child’s educational and social development, and can have serious longer-term economic repercussions. In an attempt to minimize damage, individual schools are implementing a variety of different plans, and are prepared to change course if local conditions shift.

The Public Health Risk

Existing evidence suggests that children—though definitely not immune to COVID-19—are in some ways less vulnerable than adults. A June study in Nature Medicine found that people younger than 20 are half as likely as older adults to contract the disease. The AAP report that indicated increasing cases among children also found this population represents just 9.1 percent of all U.S. COVID-19 cases—and that severe cases of coronavirus are rare among children, resulting in fewer hospitalizations and deaths. “Fortunately, COVID in children, in the vast majority of cases, is a very mild, self-limited illness. Many children are often even asymptomatic,” says Danielle Dooley, a pediatrician and spokesperson for the AAP.

Although the risk is lower, it is not nonexistent. The AAP report, which includes data from 44 states, notes that a small percentage of this age group—between 0.2 and 8.8 percent of child COVID-19 cases—did require hospitalization. The same report indicates that 19 of the states reported no deaths among children, and the highest rate of pediatric deaths was 0.6 percent of cases. But if the total number of infections in this age group rises, the number that develop a severe case would likely increase as well.

Children also might pass the coronavirus to adults, who tend to have much more severe symptoms. Teachers, janitors, bus drivers and others must all spend significant amounts of time with students in enclosed spaces, where they are at a relatively high risk of contracting COVID-19 from children (as well as each other). Before students even entered public school buildings in Gwinnett County, Ga., 260 employees who attended planning meetings either tested positive for COVID-19 or had had contact with someone else who had. In Santa Clara, Calif., 40 school officials took part in an indoor meeting; days later, one of the officials received a positive COVID-19 test—and as a result of their exposure, the other attendees had to go into quarantine. Many school employees fear that returning to the classroom will put their lives, and those of their loved ones, at very real risk.

“The issue we need to worry about is whether or not [children are] vectors,” says Helen Jenkins, an infectious disease epidemiologist at Boston University School of Public Health. The science on how much children transmit the coronavirus is not settled. Some data suggest, Jenkins says, that “those infected are half as likely as adults to transmit to others.” Dooley notes that “We also are seeing increasing data that [children] don’t tend to be spreaders, so they’re not necessarily passing it to other children or other adults in their household or their community—from the data that we have so far.” But other data indicate children older than 10 can act as vectors. A study in Emerging Infectious Diseases, published online in July, analyzed contact-tracing reports for nearly 6,000 coronavirus patients in South Korea, and found those aged 10 to 19 spread the virus as much as adults did.

[More information on the ongoing question of how children spread the coronavirus.]

Even if transmission rates and serious cases are very low, students physically attending school could carry at least some infections home to family members—who could face far worse health threats and spread the virus more effectively among the general population. This may have contributed to a second wave of coronavirus cases in Israel; in May the country’s numbers were encouragingly low, so schools reopened with few restrictions. But then the number of infections in children quickly spiked, followed by those among older Israelis. In other countries, schools safely reopened by being more cautious and implementing a variety of restrictions—mandating masks, limiting student interaction, or slowly ramping up their plans to begin reopening with only younger children present or for only one day a week.

The Developmental Risk

There are enormous advantages to having kids in classrooms. “Schools play a really central role in children’s lives, and it’s just not possible to deliver all of the services and benefits of schools when you are in a remote learning situation,” Dooley says. She explains that schools often provide food—more than 30 million children rely on them for nutritious meals—as well as recreation and physical and mental health care. Beyond this, “being around your peers, being around a community of supportive adults—that’s really critical for a child’s development,” she points out. “They need that contact with their peers in order to grow.”

Of course, all that is on top of the most important service schools provide: education. “Education is a really important determinant of health and lifelong health outcomes,” Dooley says. Students who try to take classes virtually require the equipment and internet connections to do so. Special education students need extra attention that they cannot always receive via videoconference. Younger children require adult engagement, often from a stay-at-home parent or a hired tutor, in order to complete their work. Many students, particularly those from lower-income households, lack these options and are falling behind in their studies as a result. Wealthy families can buy supplies, provide high-speed internet and hire private tutors, allowing their children to avoid such setbacks. Also, the wealth gap between white and minority families means this imbalance in school outcomes may increase the achievement gap between white and minority students, according to reports from the Center for American Progress research institute and the consulting firm McKinsey & Company.

Many parents and communities also have to rely on school systems for basic child care during working hours. And since online learning itself often requires at least some adult help, even parents who are able to work from home can find themselves in the extremely stressful position of having what amounts to two full-time jobs: paid work, and unpaid child care and teaching. The situation is often described in terms such as “crushing.” This can cause economic problems as well as mental health ones. If schools do not reopen, some parents (many of them mothers) may be forced to leave the workforce—and then be unable to return. On an individual level, families will lose income; on a society-wide level, this could severely damage the economy.

To avoid this, institutions including the AAP, the U.S. Centers for Disease Control and Prevention, educators’ organizations and the National Academies of Sciences, Engineering, and Medicine have advocated for in-person schooling—if it can be done safely. This means establishing effective and rigorously enforced rules and protocols that will allow students to physically attend school while minimizing risks to their health and that of their communities.

How to Reopen Schools

There can be no universal, one-size-fits-all rules for reopening physical campuses safely. Community transmission rates vary greatly from region to region, and month to month. Different districts face widely disparate financial realities. Even within the same school system, younger and older students differ in their ability to learn virtually—and in their likelihood of spreading the novel coronavirus. “We have to be prepared and flexible for an ever-changing school year,” Dooley says. “Protocols and procedures put in place at the beginning of the school year may need to change as the level of disease may increase in a community.”

Many of the measures for keeping school attendees safe are the same as the ones meant to help protect the general population: covering faces, regularly washing or sanitizing hands throughout the day, limiting students to small social “bubbles” (also called “pods” or “cohorts”), improving ventilation in classrooms, and even teaching outdoors when possible. Keeping children and adults at a distance from each other would also help, but this can be difficult because it requires space that is often simply unavailable. Some contend this problem can be addressed by staggering schedules so each student attends classes in person fewer days a week (studying online from home the rest of the time), reducing the number of people in a building at a given time. “Another thing we can do is regular testing,” Jenkins says. “Children are more likely to be asymptomatic,” so rapid testing would allow schools to identify and isolate people with COVID-19 to protect other students and teachers.

Several of these measures—improving ventilation, having some children attend classes virtually, and providing fast and regular tests—will be inconvenient and require additional funding, potentially from the federal government. Perhaps because of this difficulty (as well as political pressure from some who insist that enforcing pandemic precautions is unnecessary or overly intrusive), many schools have pushed to physically reopen without the requisite precautions. Last month Florida and Iowa announced that schools must provide in-person instruction, despite the fact that COVID-19 cases were rising in both states. In Georgia, photos of mostly maskless high school students crowding a hallway spread on social media; after nine people tested positive for COVID-19, the school had to institute online-only learning while the building was closed for cleaning. Without safety measures—or with sudden spikes in community spread—other schools may reopen only to quickly close campuses as well.

“One of the best things we can do to keep [schools] safe is to keep local community transmission low,” Jenkins says. To do so, she recommends that authorities take strong action to control the virus—even when that means closing businesses such as gyms and bars. “It’s very tempting to want to reopen as many industries making money as possible, because there’s big pressure to get the economy going,” she says. “But it’s unlikely we can have everything. I hope [governors are] thinking of priorities, and I’d hope schools would come near the top of that.”

https://www.scientificamerican.com/article/schools-have-no-good-options-for-reopening-during-covid-19/

Coronavirus hasn’t devastated the homeless as many feared

When the coronavirus emerged in the U.S. this year, public health officials and advocates for the homeless feared the virus would rip through shelters and tent encampments, ravaging vulnerable people who often have chronic health issues.

They scrambled to move people into hotel rooms, thinned out crowded shelters and moved tents into designated spots at sanctioned outdoor camps.

While shelters saw some large COVID-19 outbreaks, the virus so far doesn’t appear to have brought devastation to the homeless population as many feared. However, researchers and advocates say much is unknown about how the pandemic is affecting the estimated half-million people without housing in the U.S.

In a country that’s surpassed 5 million identified cases and 169,000 deaths, researchers don’t know why there appear to be so few outbreaks among the homeless.

“I am shocked, I guess I can say, because it’s a very vulnerable population. I don’t know what we’re going to see in an aftermath,” said Dr. Deborah Borne, who oversees health policy for COVID-19 homeless response at San Francisco’s public health department. “That’s why it’s called a novel virus, because we don’t know.”

More than 200 of an estimated 8,000 homeless people in San Francisco have tested positive for the virus, and half came from an outbreak at a homeless shelter in April. One homeless person is among the city’s 69 deaths.

In other places with large homeless populations, the numbers are similarly low. In King County, which includes Seattle, more than 400 of an estimated 12,000 homeless residents have been diagnosed. In Los Angeles County, more than 1,200 of an estimated 66,000 homeless people have been diagnosed.

It’s slightly higher in Maricopa County, which includes Phoenix, where nearly 500 of an estimated 7,400 homeless people have tested positive, including nine who died.

Health experts say the numbers don’t indicate how widespread the disease is or how it might play out long term. It’s unknown how many people have died of conditions indirectly related to the virus. While the coronavirus may dissipate more easily outdoors than indoors, living outside has its own risks.

With public libraries and other places closed, homeless people say they’re short on food and water, restrooms and cash. In San Francisco, 50 homeless people died over an eight-week period in April and May — twice the usual rate, said Dr. Barry Zevin, medical director of the public health department’s street medicine program.

But because New York’s shelters have more children than the general population, when deaths are adjusted for age, the mortality rate for homeless people is 67% higher than for the overall population, said Giselle Routhier, policy director for the Coalition for the Homeless.

“That’s extraordinarily high, in our opinion,” she said.

While advocates push for private hotel rooms for homeless people, a massive 1,200-person shelter at San Diego’s convention center is showing it’s possible to keep the case count low by strictly adhering to 6-foot (2-meter) spacing, frequent cleaning and mask-wearing.

“We have a team of firefighters that walk the floors to put the cots back where they’re supposed to be,” said fire Deputy Chief Chris Heiser, who is incident commander for the shelter.

He estimates about 3,000 people have come through. And of more than 6,000 COVID-19 tests administered, 18 so far have been positive. San Diego County has reported more than 200 positive cases and no deaths among its nearly 8,000 homeless people.

Richard Scott, who is in his mid-50s, moved to the convention center about three months ago after his roommate, who is medically fragile, told him that he could either stay home and not work or leave. Since then, Scott has slept on a cot alongside about 500 men in a cavernous room with high ceilings and a big floor.

Sometimes there’s a theft or disruptive person, but overall Scott calls it a safe place to stay.

“We wash our hands 20 times a day — well some of us — and we get our temperatures checked every day, and they’ve been real strict about that, too,” Scott said. “I’m so happy being here; it’s a blessing.”

Virginia McShane, 63, sleeps in a separate part of the center. She arrived in April after she could no longer afford a $25-a-night hostel.

“We’ve got a back entrance and a front entrance, and that keeps the air circulating pretty good, so I think that’s why all of us haven’t come down with the coronavirus,” she said.

The rates at which homeless people have tested positive for COVID-19 are all over the place, says Barbara DiPietro, senior policy director for the National Health Care for the Homeless Council, which is working with the Centers for Disease Control and Prevention to study the issue.

Surveillance testing of more than 10,000 people at shelters and encampments nationwide has resulted in a rate just over 8%. But DiPietro says over 200 testing events of homeless residents in five cities showed rates ranging from 0 to 66%.

“So this is a wildly variant, moving target depending on who and how and when you test,” she said.
https://www.charlotteobserver.com/news/article245000245.html#storylink=cpy