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The results of two back-to-back randomized double-blind placebo controlled trials has shown that a 100-year-old vaccine originally developed to prevent tuberculosis helps protect people with type 1 diabetes from COVID-19 and other infectious diseases. The research by investigators at the Massachusetts General Hospital (MGH) found that the Bacillus Calmette-Gurin (BCG) vaccine provided continuous protection against all the viral variants for almost the entire COVID-19 pandemic.
The results of the 18-month trial are published today in iScience. The Phase III trial was conducted later in the pandemic when the Omicron variant was circulating in the population. An earlier Phase II trial was conducted earlier in the pandemic, and those results were published in the journal Cell Reports Medicine.
Individuals with type 1 diabetes are highly susceptible to infectious diseases and had worse outcomes when they were infected with the SARS-CoV-2 virus, said senior author Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at MGH. Published data from other investigators show mRNA COVID-19 vaccines are not very effective in this group of vulnerable patients. But weve shown that BCG can protect type 1 diabetics from COVID-19 and other infectious diseases.
Testing for the efficacy of the BCG vaccine against infection by the SARS-CoV-2 virus was conducted by a number of different research organizations around the world with mixed results. In these trials the TB vaccine was given as a single booster shot to people who were already BCG-vaccinated. Data from these trials expanded the clinical trial database that has shown vaccinating newborns with the vaccine provides a base for fighting all infectious diseases with protection potentially spanning decades.
But in these early trials, five randomized studies showed efficacy, while another seven showed no patient benefit.
Undeterred by these results, the team at MGH took a markedly different approach to employing the BCG vaccine. First, instead of trial participants receiving a single booster dose, these Phase II and Phase III trials received five or six doses. We know that in people who are nave to BCG vaccine, the off-target effects can take at least two years to achieve full protection, said Faustman. Giving multiple doses of the vaccine may speed up that process.
Other differences in the trial design included using a more potent strain of the BCG vaccine than was used in previous trials. Lastly, participants in these two trials were followed for three years, as opposed to weeks or months of previous trials.
Faustman believes the positive results of the US-based clinical trials are potentially the result of the use of BCG vaccines in newborns in other countriesa practice that has not been taken in the U.S.as well as the trials including people with previous exposure to TB. He noted that these factors may have obscured any benefit from a BCG booster.
In total, the MGH trial enrolled 141 people with type 1 diabetes split roughly two-to-one in the treatment arm and placebo group respectively. The treatment group received five or six doses of BCG, while the placebo group received a sham vaccine.
During the Phase II trial from January 2020 to April 2021 when the SARS-CoV-2 virus was less transmissible but more lethal, the BCG vaccine was 92% effective, or comparable to the effectiveness of the Pfizer and Moderna vaccines. Over the 34 months of U.S. COVID-19 pandemic, the TB vaccine showed efficacy of 54.3%, with the researchers showing participants had lower rates of not only COVID-19 infections, but also other viral, bacterial and fungal infections.
This finding has significant implications not just in fighting COVID-19, but a range of other viral infections. With protection that potentially lasts decades, the BCG vaccine could be more effective than yearly flu vaccines which confer effective protection for only a few months.
The BCG vaccine offers the prospect of near-lifelong protection against every variant of COVID-19, the flu, respiratory syncytial virus, and other infectious diseases, Faustman noted.
A Centers for Disease Control and Prevention program that provides uninsured adults access to free COVID-19 vaccines is set to expire.
The CDC said its Bridge Access Program will end in August.
The program also offers free vaccines to those with insurance plans that do not fully cover the cost of the shots.
While many health insurance, Medicare and Medicaid plans cover COVID-19 vaccines, there are still 25 million to 30 million adults either without insurance or whose insurance only provides partial coverage.
The program expanded access for millions to get their shots at no cost. Those eligible must be living in the U.S. and be 18 or older.
Officials with the Biden administration are seeking a permanent solution to free COVID-19 shots for those without access through the Vaccines for Adults program proposed in the fiscal year 2023 and 2024 presidential budgets.
People looking to see if their COVID-19 shots are covered by insurance should contact their health insurance provider or search their coverage plan on their providers website.
Scripps News has reached out to the CDC for more information.
The National Advisory Committee on Immunization says the mpox vaccine can be given at the same time as an mRNA COVID-19 vaccine, reversing its previous recommendation to wait at least four weeks due to safety concerns.
It said Friday that data is now available to show there is no increased risk of myocarditis or anaphylaxis for people who are given Imvamune, the vaccine for mpox, when they are also vaccinated against COVID-19.
The recommendation also says that Imvamune can be given at the same time as any other live or non-live vaccines.
The committee recommended the mpox vaccine two years ago after outbreaks in several countries, mostly among men who have sex with men as well as sex workers.
The first case in this country was reported to the Public Health Agency of Canada in May 2022, and the committee says there were 1,541 cases up to the end of last year.
Ontario had 737 cases, Quebec reported 531 cases and British Columbia had 213, the committee said.
Symptoms of the disease include a rash, fever, body aches, back pain and swollen lymph glands that appear within seven to 21 days after exposure.
Two doses of Imvamune are given at least 28 days apart to protect against the disease or as soon as possible after exposure to the virus to prevent illness or severe outcomes.
Those considered at highest risk of mpox include men who have sex with men and meet at least one of these criteria: they have more than one partner, are in a relationship where at least one of the partners has other sexual partners or they have had a confirmed sexually transmitted infection in the last year.
The committee says sex workers, regardless of gender or sexual orientation, are also at risk of infection, as are people who have had sexual contact in sex venues or work or volunteer there.
It says that while cases of mpox have declined significantly since the fall of 2022, the disease remains an important public health concern.
A spokeswoman with Toronto Public Health says the city has had 36 lab-confirmed cases so far this year compared to 27 cases for all of last year.
Toronto Public Health says the mpox vaccine will be offered by appointment at Metro Hall on June 1 and June 8 as part of Pride month awareness efforts that will also involve community organizations.
This report by The Canadian Press was first published May 24, 2024.
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
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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
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.
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.
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.
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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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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