Category: Covid-19

The COVID-19 response illustrates steps officials should take to ensure the effectiveness of vaccine mandates.

The COVID-19 pandemic was the worst public health emergency of the last century. Despite aggressive attempts to contain the virus by social isolation, masking, and medical management, over 1.1 million Americans died between January 31, 2020, when the U.S. Department of Health and Human Services (HHS) declared COVID-19 a public health emergency, and March 11, 2023, when HHS declared the public health emergency over. Of those that perished, there was a particularly tremendous loss among the elderly, immunocompromised, and those in nursing homes.

In December 2020, the U.S. Food and Drug Administration issued emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines. Despite the widespread availability of the vaccines at no cost, their adoption varied considerably. For this reason, physicians and public health officials soon called for a COVID-19 vaccine mandate.

In August 2021, President Joseph R. Biden directed the Centers for Medicare and Medicaid Services (CMS) to require nursing homes to ensure their workers were fully vaccinated against COVID-19 as a condition of participating in the Medicare and Medicaid programs. The Social Security Act provides that facilities participating in Medicare must meet certain requirements and that the HHS Secretary may impose additional requirements deemed necessary to protect the health and safety of patients in hospitals, nursing homes, and other CMS-certified facilities.

HHSs emergency declarations authorized its component agencies, such as CMS, to issue new health and safety regulations. In addition, outside of public health emergencies, CMS has the authority to oversee healthcare delivery systems. CMS issued its vaccine mandate based on substantial evidence demonstrating that the prevalence of nursing home COVID-19 cases was related to low levels of vaccination among care staff. Furthermore, evidence that many nursing homes were not implementing standard infection control practices accelerated vaccine mandate drafting and execution.

The Administrative Procedure Act requires that agencies that wish to forgo notice-and-comment rulemaking during a public health emergency must demonstrate that undergoing notice-and-comment would be impracticable, unnecessary, or contrary to the public interest. The Biden Administration concluded on this basis that it could create an emergency regulation to require vaccines in nursing homes. Nevertheless, as CMS was developing its emergency regulation, nursing homes expressed concern that the mandate could trigger widespread staff shortages because workers would refuse to receive the vaccine. The industry feared that a staffing shortage could lead to worse health outcomes for residents.

While developing the vaccine mandate, the CMS Center for Clinical Standards and Quality convened several listening sessions from all corners of the healthcare industry. During this feedback period, several states issued their own vaccine mandates in both nursing homes and hospitals, and individual nursing home chains and hospital systems also proposed vaccine mandates. This patchwork approach further complicated efforts to limit the spread of COVID-19.

Hospitals and nursing homes were concerned that the variation between states rules could lead staff to move to different states to avoid a vaccine mandate. Several providers pushed for a national mandate. A marked increase in the proportion of nurses who sought employment through traveling services during the public health emergency validated this concern. Several national leaders suggested that a national mandate would be useful to manage interstate variability.

Because of these concerns, CMS and HHS began to explore the medical benefits of a national mandate for all healthcare facilities that receive Medicare funding. Data from the National Healthcare Safety Network demonstrated that COVID-19 rates among long-term care facilities were higher in facilities with lower vaccination coverage among staff. The agencies also explored the legal basis for a mandate. Critically, they determined that systems for documenting medical and religious exemptions to the vaccine mandate would be needed.

Ultimately, CMS issued its regulation in November 2021. Shortly thereafter, 14 states challenged the regulation and argued that CMS had exceeded its statutory authority under the Social Security Act. In January 2022, the U.S. Supreme Court, in a 54 decision, upheld the mandate, explaining that:

The Secretary of Health and Human Services determined that a COVID-19 vaccine mandate will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients. He accordingly concluded that a vaccine mandate is necessary to promote and protect patient health and safety in the face of the ongoing pandemic. The rule thus fits neatly within the language of the statute.

Importantly, the Court found that the HHS Secretary had examined sufficient evidence justifying the decision to (1) impose the vaccine mandate instead of a testing mandate; (2) require vaccination of employees with natural immunity from prior COVID-19 illness; and (3) depart from the agencys prior approach of merely encouraging vaccination.

After the Biden Administration declared the public health emergency over in March 2023, CMS ended its vaccine mandate in August. In the end, the mandate did not substantially disrupt the healthcare ecosystem, and staff resignations due to the mandate did not produce national adverse health outcomes.

It is difficult to analyze the precise effects of the vaccine mandate because there were many states and local facilities that had already mandated the vaccine. Nonetheless, there are at least three important lessons public health officials can learn for the future from CMSs experience in imposing a COVID-19 vaccine mandate.

First, it will be important to address the non-uniform manner in which states and local healthcare facilities adopt a mandatory vaccination policy during any future pandemic. There should be a national vaccine for healthcare facilities as soon as a safe and effective vaccine is approved. Early adoption can ensure national uniformity, which can in turn help prevent localized staffing shortages. The federal government should also monitor and evaluate the impact of any such mandate and adjust the manner of implementation as needed.

Second, public health officials should proactively collect evidence to demonstrate the health and safety implications of unvaccinated staff in Medicare-certified facilities to justify the need to forgo notice and comment rulemaking. This evidence can also help justify a national vaccine mandate if challenged in the courts.

Finally, public health officials should develop and implement rigorous standards for determining who is exempt from the vaccine mandate by balancing civil rights with healthcare concerns. Rigorous standards will help ensure vaccines succeed in cutting community transmission.

The political debate around vaccination continues to this day but these three lessons can help public health officials prepare for future public health emergencies.

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Lessons Learned From COVID-19 - The Regulatory Review

As 10-year-old Aaditya Goswami holed up in his home during the COVID-19 pandemic, with an altered routine and decreased physical activity, he started gaining weight, soon turning obese. About a year ago, his father, Poorna, noticed that the boy, who before the pandemic enjoyed playing outdoors, was increasingly lethargic. He stayed glued to his screens and became irritable.

Poorna, a lawyer in the north Indian city of Mathura, consulted a pediatrician and realized that his son's changed behavior was due to his pandemic-induced obesity. Blood tests revealed that the child was prediabetic owing to his weight gain.

"He was 9 at the time, and we were very worried when we learned that he was at risk for developing diabetes," says Poorna, adding that the boy's ideal weight is 40 kilograms (88 pounds) but had increased to 57 kilograms (125 pounds) during the pandemic. "COVID made all the difference," Poorna says. "It changed the habits and lifestyles of kids. Go to the playground and check. There are no kids there anymore."

In the past few years,severalstudieshave established a link between the COVID-19 pandemic and the global surge in childhood obesity. A July 2023 studyinvolving two Indiana schools found a 9% increase in the prevalence of obesity among children, especially those ages 5 to 11, from 2019 to 2021. Similar observations were made in Australia,China,Sweden,Turkey, the United Kingdom, and other nations, which attributed the alarming rise in childhood obesity to several pandemic-related factors, including school closures, routine changes, sedentary lifestyles, excessive eating, irregular sleep, physical inactivity, and increased screen time among children.

Although the impact of the pandemic on childhood obesity is well established, little is known about the long-term consequences of this alarming rise

Although the impact of the pandemic on childhood obesity is well established, little is known about the long-term consequences of this alarming rise, which have now started manifesting as serious ailments among children in India. Vaishakhi Rustagi, a New Delhibased pediatric and adolescent endocrinologist, tells Think Global Health that before the COVID-19 pandemic, she hardly treated one case of type 2 diabetes resulting from obesity among children. After the pandemic, she says, the incidence has "increased dramatically," with at least 18 to 20 such cases in the last two years. Her patients include a 6-year-old girl, who weighs 80 kilograms (176 pounds), and a 12-year-old boy, who weighs more than 100 kilograms (220 pounds).

"Because there was muscle disuse for almost two years during the pandemic, kids are experiencing muscle wasting and bone problems now. Hence, they cannot do much physical activity, furtherincreasing the weight they gained during the pandemic," says Rustagi, "Now, in addition totheweight gain, they alsohave other ailments associated with obesity, such as type 2 diabetes, dyslipidemia, high cholesterol, and fatty liver."

Ahmed Sert, a pediatric specialist and one of the researchers behind a 2023 study in Turkey, which also concluded a direct relationship between the pandemic and childhood obesity, says that the condition has several long-term impacts on the physical as well as psychological health of children. Such children, he says, are at a higher risk of developing chronic diseases such as type 2 diabetes, cardiovascular diseases, asthma, hypertension, certain types of cancer, and orthopedic ailments such as arthritis and joint pain. Furthermore, childhood obesity can also lead to poor self-esteem, depression, and social isolation due to stigma and bullying.

"Childhood obesity is a global issue and its effects are not limited to specific regions," emails Sert, who specializes in pediatric allergy and immunology. He adds that only the rates of childhood obesity and its consequences may vary across regions "depending on factors such as socioeconomic status, access to health care, cultural norms, and dietary habits."

Think Global Health spoke with five doctors across India, all of whom report an alarming increase in pandemic-induced childhood obesity and its related comorbidities. Shiv Kumawat, a pediatrician in the north Indian city of Jaipur, says that following the pandemic, at least 1 in every 4 of his patients are now either overweight or obeseas opposed to 1 in about 20 children before the pandemic. Most of these overweight and obese children are now reporting obesity-associated complications, including constipation, sleep apnea, breathing difficulties, asthma, allergy rhinitis, and dermatitis.

"At least 15 to 20% of these overweight and obese kids are already asthmatic," says Kumawat, "Although I havent seen many cases of type 2 diabetes and heart diseases yet, all these kids are at the risk of developing such diseases."

Children watch online lectures on mobile phones inside a digital mobile education library, amid the spread of COVID-19, in Mumbai, India, on October 16, 2020. REUTERS/Francis Mascarenhas

Similar trends have also been reported in the eastern Indian city of Kolkata, where, according to pediatrician Parichaya Bera, such cases have "more than doubled" in the recent past. Bera cites the case of a 13-year-old boy who became obese during the pandemic and now weighs around 85 kilograms (187 pounds). A few months ago, the boy's family approached the doctor after the adolescent developed an intestine infection. Bera, suspecting high sugar levels, had the boy undergo some tests, which revealed that he was diabetic.

"Type 2 diabetes is usually seen in adults over 35 years of age, but after the surge in childhood obesity during the pandemic, we are getting such cases much earlier now," says Bera.

Alok Sardesai, a Mumbai-based pediatric endocrinologist, has also noticed a substantial increase in complications such as type 2 diabetes resulting from pandemic-induced obesity among children. Diving into the cultural influences of weight gain, Sardesai says that childhood obesity thrives in India because families do not recognize it as a disease. He attributes this to India's history of child malnutrition, which, he says, lingered until two decades ago and made weight gain desirable. The same thought, he adds, persists today, and to ensure healthier children, the outlook toward obesity needs to change.

"People fail to distinguish normal weight gain with abnormal weight gain, and it is still appreciated when the child starts getting overweight and obese," says Sardesai.

A study published in the UK in January 2024 found "steep increases" in overweight and obesity prevalence among children during the pandemic in England. One of its researchers, Keith Godfrey, a professor of epidemiology and human development at the University of Southampton, tells Think Global Health that the economic impact of this rise in the UK would result in more than 8.7 billion British pounds in additional national health care as well as broadened economic and social costs. This, he says, is "hugely concerning" because health-care systems are ill equipped to handle the consequent burden of pandemic-induced childhood obesity.

"Mitigating the long-term effects of obesity in children likely requires a 'whole-systems' approach that addresses obesity at multiple levels simultaneously, including individual, family, community, environmental, and policy levels," Godfrey said in an email interview.

Health-care systems are ill equipped to handle the consequent burden of pandemic-induced childhood obesity

Rustagi, the pediatric and adolescent endocrinologist from Delhi, says that althoughthe long-term impacts of childhoodobesityhave already started manifesting among children in India, perpetrating enduring complications, most parents continue to remain unconcerned with their children's weight gain and are irregular with their follow-ups. She cites the case of a teenage girl who attempted suicide due to obesity-related depression but did not continue with her medical treatment, adding that in India, awareness among families is the key to mitigating the long-term impacts of childhood obesity.

"Everyone talks about obesity in adults, but these children, who are our future, are going to become a real load on the country after a few years," says Rustagi.

The problem, however, goes beyond childhood obesity, says Smrithi Bhagirathi, a pediatrician in the south Indian city of Bengaluru, who reports a 30% increase in the incidence of childhood obesity since the pandemic. She says that the pandemic has led to a fall in the general health of children, both physical and emotionaland that the "general trend is towards unhealthier physical and developmental health among kids." The doctor, however, is optimistic about the future.

"Children are easily adaptable," she says, "So anything which has caused havoc can be reversed by improving their diet and encouraging them to play."

The same is also true in the case of 10-year-old Aaditya, who, with regular exercise and dietary modifications, has lost five of his 17 excess kilograms, bringing him closer to his ideal weight and a healthier future. "Slowly, he's getting better," says his father.

Students play during recess at a school, in Ahmedabad, India, on February 25, 2022. REUTERS/Amit Dave

Puja Changoiwala is an award-winning journalist and author based in Mumbai.

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How COVID Increased Childhood Obesity in India - Think Global Health

COVID-19 breakthrough infections in vaccinated individuals may offer an unexpected benefit: heightened immunity against future SARS-CoV-2 infections.

Research from La Jolla Institute for Immunology (LJI) reveals that those who experience breakthrough infections develop a more robust immune response, particularly through improved T cell recognition and targeting of the virus.

The LJI scientists analyzed blood samples from vaccinated volunteers who had breakthrough infections.

The team discovered that these individuals developed T cells capable of recognizing multiple parts of the SARS-CoV-2 virus, including its variants like Omicron and Delta. This enhanced ability is referred to as an immunity wall.

The virus evolves, but, importantly, so does the immune system. T cells do not sit idle. Instead, they learn to recognize the parts of the virus that mutate, explained Professor Alessandro Sette, who co-led the study.

Vaccination against SARS-CoV-2 provides significant protection against severe disease. LJI studies show that this protection is long-lasting and effective against new viral variants.

The researchers focused on how breakthrough infections impact T and B cells by tracking a group of vaccinated volunteers who later contracted COVID-19.

With this study volunteer cohort, we were in a unique position to see how the immune system looked before and after a breakthrough infection, noted Professor Alba Grifoni.

Breakthrough infections prompted T cells to expand their repertoires, meaning they could recognize multiple features of SARS-CoV-2. This broadening was due to the combination of vaccination and infection.

Vaccines taught T cells to recognize the spike protein, while infections helped them recognize additional viral proteins. As a result, T cells could target SARS-CoV-2 even if it mutated.

Breakthrough infections also stimulated B cells to produce diverse antibodies targeting common epitopes between the vaccine and the infecting variant. These new antibodies were effective against both the vaccines antigens and the viral variants.

New B cell responses that are only specific to the infecting variant, but not the vaccine, are very rare, said study co-author Parham Ramezani-Rad.

Another significant finding was the location of immune cell development. COVID-19 vaccines are typically administered in the upper arm, while SARS-CoV-2 infects the upper respiratory tract. This discrepancy can delay the immune response. A breakthrough infection can add an extra layer of protection by initiating immune cells closer to the infection site.

The experts identified markers of previous SARS-CoV-2 infection in about 30% of volunteers who never showed symptoms, suggesting they had asymptomatic infections.

Our study suggests most people who never thought they got a breakthrough infection actually did, explained Professor Grifoni. The majority of the population appears to be affected by a combination of vaccination and one or more breakthrough infections.

The research also dispels concerns about T cell exhaustion from repeated vaccinations and infections. Instead, breakthrough infections prompted T cells to produce more cytokines, enhancing their infection-fighting capabilities.

After the breakthrough infection, the same cells produce multiple types of cytokines, making them more efficacious, noted Professor Grifoni. Not only are our T cells not exhausted, but they are actually improving their capabilities.

However, the immunity wall has its limits. Following an asymptomatic breakthrough infection, T cell abilities were found to plateau with subsequent symptomatic infections, although B cells continued producing neutralizing antibodies.

Despite the benefits of breakthrough infections, the researchers emphasize the importance of following current CDC guidelines for booster vaccines. SARS-CoV-2 continues to evolve, and COVID-19 can still cause serious illness, especially in immunocompromised individuals.

This research provides crucial insights for developing new vaccines against future SARS-CoV-2 variants and other potential pandemic viruses. Researchers are keen to explore how future variants or new vaccine designs might further enhance the immune response.

Studies of local B cell responses in the upper airway where the infection occurs will also be informative on how B cells responses are induced, particularly after breakthrough infection, said Ramezani-Rad.

The ultimate goal is to train T cells to recognize multiple types of coronaviruses simultaneously, potentially leading to a pan-coronavirus vaccine. This breakthrough study marks a significant step in understanding how to protect against viral infections and future pandemics.

Were very interested to see if this phenomenon could be exploited in general to prepare against other potential pandemic threats, said Sette. This is a step in a journey to help us protect against viral infections and potential pandemics.

The study is published in the journal Cell Reports Medicine.

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COVID-19 breakthrough infections build an 'immunity wall' - Earth.com

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Researchers have unveiled critical insights into how our genetic makeup influences the body's response to COVID-19 vaccines. The study, published in Nature Communications, may open new paths to personalized vaccination strategies.

The study, led by Junqing Xie, Postdoctoral Researcher in Pharmacoepidemiology and Pharmacogenetics at NDORMS, examined the genetic variations in the human leukocyte antigen (HLA) genes and their impact on the antibody responses induced by the COVID-19 vaccination.

HLA genes play a crucial role in the immune system's ability to recognize and respond to foreign substances, including viruses, and have been shown to be effective in response to other vaccines such as hepatitis B, measles, and influenza.

The researchers analyzed data from over 368,000 participants who had received a COVID-19 vaccination, with a subset of 194,371 individuals having their antibody levels measured. The study confirmed findings from previous studies that certain genetic variations, specifically in the HLA-DQB1*06 gene, are associated with improved antibody responses to COVID-19 vaccines.

However, the team found that while the DQB1*06 variant enhances antibody production, it does not support the claim that this alone can significantly reduce COVID-19 risk in the general population. This indicates that antibody levels alone do not tell the full story when it comes to vaccine effectiveness.

"Our findings highlight the complex interplay between genetics, antibody responses, and real-world protection against COVID-19," explained Junqing. "It's not as simple as just boosting antibodieswe need to consider the extent and broader immune mechanisms at play."

The researchers discovered and validated six additional HLA alleles that independently influence antibody responses. Importantly, they also found that the combined effect of these HLA variations can impact the risk of breakthrough COVID-19 infections.

The team also used those genetic variations to randomize COVID-19 vaccine-induced antibodies (a novel statistical method) and estimated that antibody positivity offers approximately 20% protection against infection and 50% protection against severe illness. This underscores the importance of other immune factors, such as T-cells, in providing comprehensive defense against the virus.

"This is a significant advancement in our understanding of the genetic factors that shape the body's response to COVID-19 vaccines," said Daniel Prieto Alhambra, the corresponding author for the study. "By uncovering these novel genetic associations, we are one step closer to developing personalized vaccination strategies that can optimize protection for individuals."

More information: Junqing Xie et al, Relationship between HLA genetic variations, COVID-19 vaccine antibody response, and risk of breakthrough outcomes, Nature Communications (2024). DOI: 10.1038/s41467-024-48339-5

Journal information: Nature Communications

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Cracking the genetic code for COVID-19 vaccine effectiveness - Medical Xpress

Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.

The good news is that in the early spring of 2024, COVID-19 cases were down, with far fewer infections and hospitalizations than were seen in the previous winter. But SARS-CoV-2, the coronavirus that causes COVID, is still mutating. In April, a group of new virus strains known as the FLiRT variants (based on the technical names of their two mutations) emerged.

The FLiRT strains are subvariants of Omicron. One of them, KP.2, accounted for 28.2% of COVID infections in the United States by the third week of May, making it the dominant coronavirus variant in the country; another, KP.1.1, made up 7.1% of cases.

Some experts have suggested that the new variants could cause a summer surge in COVID cases. But the Centers for Disease Control and Prevention (CDC) also reports that COVID viral activity in wastewater (water containing waste from residential, commercial, and industrial processes) in the U.S. has been dropping since January and is currently minimal.

Viruses mutate all the time, so Im not surprised to see a new coronavirus variant taking over, says Yale Medicine infectious diseases specialist Scott Roberts, MD. If anything, he says the new mutations are confirmation that the SARS-CoV-2 virus remains a bit of a wild card, where its always difficult to predict what it will do next. And Im guessing it will continue to mutate.

Perhaps the biggest question, Dr. Roberts says, is whether the newly mutated virus will continue to evolve before the winter, when infections and hospitalizations usually rise, and whether the FLiRT strains will be included as a component of a fall COVID vaccine.

Below, Dr. Roberts answers three questions about the FLiRT variants.

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3 Things to Know About FLiRT, the New Coronavirus Strains - Yale Medicine

In 2020, Zhang was appointed leader of Shanghais clinical expert team for Covid-19, becoming a household name and central figure in the countrys fight against the virus.

He has published hundreds of papers in the field of public health and infectious diseases. But now he is embarking on a new initiative to address the intersection between two growing threats: climate change and infectious diseases.

Research examining this relationship will become a growing focus globally, he said.

As the planets climate changes, including the expansion of the tropics, the way pathogens evolve and mutate is also changing.

A study published in the peer-reviewed Journal of Geophysical Research: Atmospheres in 2020 found that ocean surface warming in subtropical regions was expanding the width of the tropics.

02:27

Mosquito scientist leading fight against the worst dengue outbreak ever in Bangladesh

Mosquito scientist leading fight against the worst dengue outbreak ever in Bangladesh

It has been expanding from near the south the more tropical areas towards the north, and now it has also begun to expand to the Yangtze River Basin. So we can now also detect dengue fever in the Yangtze River Basin, Zhang said.

The World Health Organization (WHO) has said that in future decades climate change will affect the spread of vector-borne diseases like malaria due to changes in global temperature and precipitation patterns.

There is a hypothesis that the Covid-19 pandemic spread to humans from bats, whose habitats are also expanding.

So the work we are doing now is actually for the next pandemic.

But countries will need more data if they are to work together to create global disease management agreements and strategies to respond quickly to another global pathogen.

As director of the Shanghai Sci-Tech Inno Centre, Zhang signed a memorandum of understanding with the University of Hong Kong (HKU) to work towards that goal at the annual Pujiang Innovation Forum in Hong Kong in late April.

As part of the project, experts in climate change, public health, infectious disease control and public policy will be brought together for research at HKUs Centre on Contemporary China and the World (CCCW).

Resident and non-resident experts will pursue original research, establish regular monitoring systems and provide public policy discourse platforms, according to the CCCW.

Using this platform, infectious disease experts and microbiologists can work with environmental experts and climate experts to conduct in-depth research on climate change and infectious diseases together, Zhang said.

While Zhang and other experts from the mainland will begin their work alongside experts in Hong Kong, preparing for the next pandemic will need to be a group effort for researchers around the world.

It will require science from different angles and levels to provide as much evidence as possible for policy experts and governments to use when devising disease management strategies.

As part of the work with the CCCW, an information-sharing platform will be created so that we scientists have some systems that we can use to communicate, Zhang said.

The work scientists are doing today will be guided by the research that has been done in the past few years since the coronavirus pandemic.

Beyond preparing to manage the spread of future pathogens, scientists are also concerned with how climate change will affect treatments for infected patients.

Antimicrobial resistance when bacteria, parasites, viruses and fungi develop resistance to drugs meant to kill them is another growing challenge.

Zhang said that in 2019, 1.27 million people died directly as a result of antibiotic resistance around the world.

An issue that scientists all over the world agree on is that by 2050, annually, 10 million people will die of drug resistance, Zhang said. That is equal to the number of people who currently die of cancer each year.

In the past, research on drug resistance was separated into clinicians studying how to treat it and pharmacologists trying to make new antibiotics.

But we have now discovered that the emergence of drug resistance is faster than the emergence of antibiotics, Zhang said.

02:50

World Health Organization announces Covid-19 is no longer a global health emergency

World Health Organization announces Covid-19 is no longer a global health emergency

While research on how climate change and drug resistance may be linked was currently lacking, expanding on this field should be an important part of pandemic preparedness, he said.

One of the strategies that has been proposed is One Health, an initiative that the WHO describes as an integrated global approach mobilising different sectors of society to work together on issues like managing global health threats.

This includes researchers, doctors, government officials, world organisations and global communities.

Although the world officially came out of Covid-19 lockdowns last year, Zhang said that how the virus mutates and evolved is still of great concern.

We will also observe how coronavirus spreads from the natural reservoir to human society, he said. This is due to the expanding habitable areas for its vectors.

It will have important implications for the future.

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China's top Covid expert is already preparing for the next pandemic. Here's why - South China Morning Post

As commuter buses and trains ran nearly empty at the height of the Covid-19 pandemic, the federal government stepped in with $69.5 billion in relief funds.

It was about five times the federal support for transit approved for 2019, and it is credited with rescuing public transit and saving more than 50,000 jobs in the United States.

It was really a lifeline for the industry for Congress to step up and provide those resources, said Paul Skoutelas, president and chief executive of the American Public Transportation Association. But, he added, Those dollars have essentially run out.

With ridership still lagging and the prospects for mass transit again uncertain, the health of large transportation agencies around the country could hinge, in large part, on how much aid and in what form the federal government can supply.

The stakes are high, said Lindiwe Rennert, a senior research associate at the Urban Institute. Were really talking service or no service. For some agencies, it is at that point.

Transportation agencies around the country are already feeling the pressure.

The three transit operators serving the Chicago region are anticipating a deficit of more than $700 million by 2026, and riders could face service reductions of 40 percent or more without additional funding, according to the Chicago Metropolitan Agency for Planning.

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Federal Spending Rescued Mass Transit During Covid. What Happens Now? - The New York Times

Cue Health, the once high-flying San Diego biotech supplying rapid COVID-19 test kits to the NBA and Google, is laying off all employees and shutting down on Friday.

Cues closure comes a week after the U.S. Food and Drug Administration warned consumers to throw away its COVID-19 test kits because they could give false results. The San Diego firm said on Thursday it stopped selling the COVID-19 tests, its only fully FDA-approved commercial product.

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The company notified employees on Monday that its entire workforce will be laid off effective Friday, according to Cues Worker Adjustment and Retraining Notification Act (WARN) paperwork filed with the state of California.

Earlier this month, Cue laid off half of its workforce, or 230 employees, to cut costs and refocus its pipeline of products.

The latest WARN notice informed the state that Cue is accelerating the end date for these employees from July to Friday. Employees will receive their final paycheck this week, which includes compensation and benefits they would have received through July.

After the last round of layoffs, Cue, which has eight locations across the county in Sorrento Valley and Vista, had about 250 employees left. Now, those remaining 250 workers are also getting laid off this week.

Due to the fluid nature of this situation and based on the information available at this time, the Board of Directors of Cue Health has determined that the affected employees employment will conclude effective May 24, 2024, Cue Healths chief human resource officer, Allison Blackwell wrote in the notice. Similarly, the Company is concurrently informing all remaining US employees that their jobs are affected, and, as such, every remaining U.S. employee who has not yet received a WARN Notice, including Company leadership, is receiving a WARN notification today.

Cue Health has been skirting the edge of a financial cliff since the demand and government funding for COVID-19 tests dropped off over the past year.

Early in the pandemic, Cue inked major partnerships to supply rapid COVID-19 tests for the NBA and big companies, like Google. The biotech grew its headcount from 99 employees in January 2020 to 1,515 full-time employees at the end of 2022.

The company, which was founded in 2010, soared into the public market with a $200 million IPO in 2021, fueled by its first commercial product, the COVID-19 test. Its market cap swelled to $2.3 billion.

In hindsight, the companys rapid rise was enabled by the once-in-a-generation circumstances of the pandemic allowing for fast-track approval of its product. Additionally, record levels of private investment in 2021 and early contracts to provide testing for the Department of Defense, the NBA, Google, NASA, Netflix and more fueled Cues ascent.

Its sleek, high-tech kit delivered results in 15 minutes straight to a smartphone and was one of the first to get fast-track approval from the FDA during the pandemic. Then, the company notched the notable achievement of securing the first, full FDA approval for an at-home COVID-19 test last June.

In 2021, SEC filings show that Cue recorded $86 million in profit but in 2022 and 2023, the company lost $194 million and $373 million respectively.

Even after layoffs, Cue struggled. In its March filing with the Securities and Exchange Commission, Cue wrote that its near-term revenue will almost exclusively depend on sales of our COVID-19 test until we can obtain regulatory clearance or other appropriate authorization for, and commercialize additional tests.

Cue tried to expand its diagnostic services into at-home tests for sexual health, heart health and metabolic tests where samples are sent to a lab and the results go straight to the users phone. Cue also enabled its smartphone app to connect users to telehealth services.

In recent months, Cue tried to get fast-track approval for other test products, including its tests for flu and RSV. But those clearances didnt materialize.

The companys only commercial diagnostic tests on the market at the time were its COVID-19 and mpox, previously known as monkeypox, tests.

With its losses mounting and no new revenue streams in sight, Cue warned in its March filing to the SEC that These factors, underscored by the inherent uncertainty of obtaining timely regulatory approvals, when considered in the aggregate, raise substantial doubt about our ability to continue as a going concern.

Jay Lichter, managing partner of local life science investment firm Avalon Bioventures, said that while hes not intimately familiar with Cue Healths business, he said it is not surprising that a biotech company would fall hard and fast relying on a single product. While Cue Healths test was hit by regulatory issues from the FDA, Lichter said any number of things could kill a company.

Youre very much at risk with a single product, Lichter said. It could be that you have a supply chain issue ... It could be you have the disease go away and the market is gone. So you have a lot of things that could go wrong.

Lichter added that his firm stopped investing in diagnostic companies years ago to focus on biotechs developing therapeutics to treat cancer and other diseases. While diagnostics such as test makers play a vital role in health care, he said a successful test solution often turns a smaller return than a successful therapy.

Diagnostic products are almost as difficult, time-consuming and expensive to develop as therapeutic products, but the value is one-tenth of the therapeutic, Lichter said.

In this business, whether its therapeutics or diagnostics or whatever, theres so many ways for things to go wrong, he said. And then you make all the right decisions and still things can go against you. Sometimes its just bad luck, as opposed to bad management. Sometimes its bad management. I couldnt say with Cue if it was bad luck or bad management, but in the end, you know when youre a single product company you have to protect that business.

Lichter noted that all of the government grants that went to COVID-19-related companies like Cue, appeared as revenue and blew up these businesses. But in fact, those subsidies go away then the market goes away and the whole thing is like a double collapse.

The demand (for COVID-19 products) is way down and you can just look at Pfizer revenue and you can see that as well, Lichter said. COVID is just not that big of a problem its still around, but youre not getting half the population testing twice a week like you did three years ago.

In some ways, its a bit of a perfect storm, but also somewhat predictable. When the government is throwing billions of dollars a year at COVID anything and you know, everybody gets money. Then that money starts to dry up and its only the really special companies that survive.

At Cue Health, as demand for COVID-19 tests continued to decline and funding sources dried up, the company conducted multiple rounds of layoffs over the past 12 months.

Then, the latest blow came via the FDAs warning letter on May 9, which urged company leaders to stop selling its COVID-19 test.

An FDA inspection of Cue Health facilities late last year found that the company had modified its COVID-19 tests in a way that reduced its reliability to detect the virus. The warning letter says Cue changed its product without telling the FDA and as a result, the tests arent as accurate as they should be to meet previously approved safety standards.

All of this comes after Cues board stepped in to reshape its leadership and expenses in the face of declining market value and investor pressure.

In March, Cues longtime CEO and co-founder, Ayub Khattak, stepped down. He was replaced by Cue co-founder Clint Sever. Additionally, last month, Cue Chief Financial Officer Aasim Javed resigned.

Amid the leadership shakeup, Cues board also initiated a strategic review of its options, including the potential sale of the company.

However, the attempts to change the trajectory of Cues fate were unsuccessful.

Cue Health did not immediately respond to the Union-Tribunes request for comment.

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San Diego COVID-19 test maker Cue Health once worth $2.3B lays off entire company and shuts down - The San Diego Union-Tribune

MINNEAPOLIS (FOX 9) - Two Minneapolis business consultants are facing charges for allegedly defrauding COVID-19 aid programs out of more than $1 million.

Tezzaree El-Amin Champion and Marcus Alexander Hamilton, both 27, are accused of submitting fake invoices and applications for relief funds through their firm, Futuristic Management Group LLC. They allegedly scammed multiple federal, state, local, and private pandemic relief programs.

The pair reportedly used their contracts with Hennepin County's "Elevate Business" program to bill for work that wasnt done or was already paid for by clients. They also submitted false applications for the Paycheck Protection Program (PPP) and Economic Injury Disaster Loans (EIDL) on behalf of their clients, pocketing some of the funds themselves.

Authorities also accuse Champion of intimidating clients, sometimes displaying a firearm in the process.

During a search of Champions home in April 2023, authorities found $126,000 in cash and a firearm. Because Champion has a prior felony conviction, he is prohibited from possessing firearms or ammunition.

Champion and Hamilton face multiple counts of mail fraud, wire fraud, and theft of government money. Champion is also charged with possessing a firearm as a felon.

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Two Minneapolis men accused of $1M fraud of COVID-19 program - FOX 9 Minneapolis-St. Paul

During the Covid-19 pandemic, vaccines were the main line of defense. Startlingly effective shots quickly helped immunize a large portion of the population at least initially, and in high-income countries.

Antiviral treatments were not as impactful. Remdesivir requires transfusions, which made it difficult to access; Paxlovid is easier to obtain, but has more unpleasant side effects, and carries the risk of rebound. Molnupiravir is taken orally, but is less effective than the other options.

Yet the need for effective antivirals remains even with strong vaccines, to protect people who are unvaccinated, immunocompromised, or otherwise unable to build an antibody response to a vaccine.

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Next-generation antiviral effective against coronaviruses in mice - STAT - STAT