Cannabis use is linked to an increased risk of more serious COVID-19 outcomes, including hospitalization and intensive care unit (ICU) admissionsimilar to risks from tobacco useaccording to a study today in JAMA Network Open from researchers at the Washington University School of Medicine in St. Louis.
As cannabis use becomes legal in many states and is used for medical purposes, the drug has developed somewhat of a "health halo," with many Americans considering it healthier than tobacco or alcohol.
"What we found is that cannabis use is not harmless in the context of COVID-19. People who reported yes to current cannabis use, at any frequency, were more likely to require hospitalization and intensive care than those who did not use cannabis," said senior study author Li-Shiun Chen, MD, MPH, ScD, in a press release from Washington University School of Medicine.
The study, based on outcomes among 72,501 people seen for COVID-19 at centers in a major Midwestern healthcare system during the first 2 years of the pandemic, offers an important take on the risks associated with cannabis use, especially in comparison to tobacco use.
Among the study participants, 51,006 (70.4%) needed hospitalization, 4,725 (6.5%) required an ICU visit, and 2,717 (3.7%) died. The average age was 48.9 years, 59.7% were female and 40.3% male, 27.6% were Black, and 69.6% were White.
In total, 68.8% had at least one comorbidity that was identified as potentially affecting COVID-19 outcomes, including obesity, diabetes, and heart disease.
The authors found that, of the study participants, 13.4% currently smoked; 24.4% formerly smoked; and 9.7% reported current use of cannabis.
The authors calculated risks for hospitalization, ICU admission, and all-cause mortality. They found that cannabis use was significantly associated with increased risk of hospitalization (odds ratio [OR] 1.80; 95% confidence interval [CI], 1.68 to 1.93) and ICU admission (OR 1.27; 95% CI, 1.14 to 1.41) but not with all-cause mortality (OR 0.97; 95% CI, 0.82-1.14.)
Current tobacco smoking, as noted in previous studies, was associated with all three worse outcomes for COVID-19. Current tobacco smoking was significantly associated with increased risk of hospitalization (OR 1.72; 95% CI, 1.62 to 1.82), ICU admission (OR 1.22; 95% CI, 1.10 to 1.34), and all-cause mortality (OR 1.37, 95% CI, 1.20 to 1.57) after adjusting for other factors.
"Most of the evidence suggesting that cannabis is good for you comes from studies in cells or animals," Chen said. "The advantage of our study is that it is in people and uses real-world health-care data collected across multiple sites over an extended time period. All the outcomes were verified: hospitalization, ICU stay, death. Using this data set, we were able to confirm the well-established effects of smoking, which suggests that the data are reliable."
"Given the rising availability of cannabis, these findings also contribute to the existing limited research on potential effects of cannabis use on COVID-19 outcomes," the authors concluded. "Overall, this research calls for further investigation into the associations of tobacco and cannabis use with COVID-19 outcomes."
Given the rising availability of cannabis, these findings also contribute to the existing limited research on potential effects of cannabis use on COVID-19 outcomes
First author Nicholas Griffith, MD, a medical resident at Washington University, was a medical student at Washington University when he led the study. "People were asked a yes-or-no question: 'Have you used cannabis in the past year?' That gave us enough information to establish that if you use cannabis, your health-care journey will be different, but we can't know how much cannabis you have to use, or whether it makes a difference whether you smoke it or eat edibles.
"Those are questions we'd really like the answers to. I hope this study opens the door to more research on the health effects of cannabis."
Remember when the federal government accused social media companies of spreading misinformation about COVID-19? Well, according to a recent bombshell report from Reuters, top U.S. policy makers should have pointed their fingers at a giant mirror.
That's because the U.S. military, under both former President Donald Trump and President Joe Biden, deliberately spread misinformation on social media about the COVID-19 vaccines, in hopes of encouraging Filipinos to distrust the Chinese government. The disinformation campaignwhich involved hundreds of fake accounts on Xpromoted the idea that Sinovac, the COVID-19 vaccine created in China, was dangerous.
"COVID came from China and the VACCINE also came from China, don't trust China!" read one typical tweet.
Other tweets aimed at Asian Muslims incorrectly asserted that the vaccines contained pork and were contrary to religious dictates. One implied the Chinese vaccine contained rat poison. "What if their vaccines are dangerous?" wondered one Twitter user.
As Reason's Matthew Petti points out, poorly conceived government-backed disinformation campaigns supposedly aimed at foreign adversaries are nothing new. But this one is especially hypocritical since opposition to vaccine misinformation has become one of the Biden administration's central philosophies.
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In January 2021, Biden was sworn in as president with a mandate to return the country to normalcy amid the death and destruction of the COVID-19 pandemic. By this time, the vaccines had become available to at-risk populations, and over the ensuing weeks and months, millions of Americans chose to become vaccinated.
But the Biden administration became unsatisfied with the pace of vaccination; government health advisers were particularly distraught about vaccine-hesitant Americans receiving bad information about COVID-19 from social media. In July 2021, Surgeon General Vivek Murthy released an advisory describing misinformation as an urgent crisis.
"In recent years, the rapidly changing information environment has made it easier for misinformation to spread at unprecedented speed and scale, especially on social media and online retail sites, as well as via search engines," wrote Murthy. "Misinformation tends to spread quickly on these platforms for several reasons."
Indeed, the traditional media soon became obsessed with the idea that people were insufficiently enthusiastic about vaccination and that social media was to blame. The Center for Countering Digital Hate, a British nonprofit, branded 12 vaccine-skeptical online accounts as the "Disinformation Dozen." In its write-up about the Disinformation Dozen, The New York Times lamented that one of the offenders, a Florida doctor named Joseph Mercola, had made "easily disprovable" claims on Facebook.
Mercola "declared coronavirus vaccines were 'a medical fraud' and said the injections did not prevent infections, provide immunity or stop transmission of the disease," complained the Times.
One sees the problem with stigmatizing any and all vaccine-related opinions that depart from the current orthodoxy. While some of these claims seemed "easily disprovable" in summer 2021, the scientific consensus subsequently conceded that vaccines do not fully prevent infection, provide immunity, or stop transmission. The vaccines lower the risk of serious illness and death, particularly for vulnerable people: the elderly, the obese, and the chronically sick. The miraculous powers initially attributed to them by government health adviserscoronavirus adviser Anthony Fauci described vaccinated Americans as "dead ends" for COVID-19have not withstood the test of time, unfortunately.
This is not to say that every crazy claim ever made about COVID-19 vaccines has been validated; some social media users have wrongly stated, for instance, that the vaccines caused a spike in deaths from heart conditions, even though researchers have found no evidence of this. Yet it remains the case that so many formerly controversial opinions relating to COVID-19 are no longer considered controversial at all: from the efficacy of cloth masks and social distancing (which Fauci now admits he essentially made up) to the possible laboratory origins of the disease.
Public commentators who inveigh against misinformation ought to have been more circumspect. Nevertheless, Biden himself joined the chorus of government officials railing against misinformation on social media. He accused Facebook and other platforms of "killing people" because they failed to police misinformation. This wasn't mere criticism; the White House communications director said the government was reviewing options to force the social media companies to take stronger actionspossibly by revoking their protection from some liability under Section 230, the federal law that makes the internet possible. Emails between social media moderators and federal bureaucrats suggest that the companies took these threats seriously: My March 2023 cover story for Reason argued that Facebook essentially outsourced coronavirus-related moderation to the Centers for Disease Control and Prevention.
It's true that the federal government shut down the military disinformation campaign to discredit Sinovac within the first several months of Biden's presidency. But given how stridently the Biden administration sought to shift the onus of responsibility for vaccine hesitancy to social media companies, it's really galling that its own hands were not exactly squeaky clean.
When he learned of the U.S. military's actions, Daniel Lucey, an infectious disease specialist at Dartmouth's Geisel School of Medicine, told Reuters: "I'm extremely dismayed, disappointed and disillusioned to hear that the U.S. government would do that."
Dismaying, indeed.
I'm joined by Amber Duke to discuss MSNBC's complaints about "cheap fake" videos, NBC's incoherence on the subject of bump stocks, and whether Rep. Cori Bush (DMo.) has magic powers.
"A Son for a Son," the first episode of House of the Dragon's second season, was quite good, though I had a few issues with it. (Spoilers to follow.)
As always, it's a delight to be back in Westeros. The world building is top notch and immersive; George R. R. Martin's vision truly comes to life. I appreciated small details, like the King's Landing soldiers bracing for conflict when they spot a dragon in the sky, only to breathe a sigh of relief when it's revealed the rider is on their side.
The final sequence of the episode, the infamous murder of a young child, was certainly gripping and terrible, but it lacked a certain amount of plausibility. Where on earth were the guards? It was very, very hard to believe that two not-especially-competent assassins could break into the Red Keep, bumble around, and commit the murdereven if the captain of the Kingsguard, Ser Criston Cole, was, er, busy at the time.
As Covid continues to settle into everyday life, health experts are noticing it has certain patterns, and a few other changes from the first few years the virus struck.
Summer Covid is a thing. This is not what health officials expected from the virus. Sure, there's the common winter cold and flu season. Many expected Covid to align with that timing and join the other respiratory viruses, but it seems the pattern Covid has settled into is to spike during winter, and then again in summer, just as you get ready to go on vacation.
"For the first two years, I said, 'Oh ya know, this is just an anomaly.' But now as we head in to year three of this, it's clear that we are having summer Covid," Dr. Helen Chu with the University of Washington Medicine told Seattle Now.
RELATED: Covid isolation reduced to 24 hours in Washington state
"We are heading into a summer surge," she added. "If you remember from the last couple of years, there is a large winter surge, and then there is often a smaller, but still significant, surge in mid- to late-summer. So, we're heading into that now."
Officials began noticing Covid cases were on the rise in early June. Viral levels in wastewater, both nationally and in Washington state, were getting higher and higher. The CDC currently states the national level of Covid is "low," based on viral testing of wastewater. Chu reported that the viral levels are highest in the Northeast, Florida, and California, "but we're not far behind." As of early June, Washington state was trending slightly higher than the national average.
Chu said visits to emergency rooms for Covid have also been increasing in Washington. Covid hospitalizations are not up, but she noted those numbers usually lag behind the the other surges.
"As we head into summer travel season, you don't want to ruin your vacation. So, remember doing the things we did in the past wearing a mask in crowded spaces, testing yourself if you're symptomatic if you are gathering with loved ones, especially those who are more vulnerable," she said.
Looking at Washington's Covid dashboard, the surge in Covid cases heading into summer 2024 is not nearly as severe as the spikes during the pandemic era. Still, Chus said it's worth noting for those who are more vulnerable immunocompromised people and older adults. Chu stressed that such groups should keep up-to-date on their Covid booster shots. While the Covid booster vaccine expected in the fall is designed for the current strain causing the spike in cases (JN1), vulnerable groups should be boosted as soon as possible.
RELATED: Why Anthony Fauci approaches every trip to the White House as if it's his last
Summer surges are just one aspect of Covid that health experts are beginning to notice, though Chu expects that it will continue to evolve.
There are some changes to the illness in 2024 that stray from previous seasons.
"One thing that is a little bit different than we've seen over the last few years, is that the number of people reporting loss of sense of taste or smell is decreasing," Chu said. "Also, the proportions of people developing long Covid after their infections is going down."
"It tells us that we are not at a steady state with this virus yet," she added. "Right now, we're still learning how to interact with it, how our immune systems are responding to it, and whether or not the population as a whole just doesn't have long-lasting immunity that gets us through until the next season. So, we're seeing these little surges that are happening every summer. It may take much longer to get to a state where we see Covid turn into a normal seasonal respiratory virus like flu or RSV."
KUOW's Dyer Oxley contributed to this article.
There is a new set of COVID-19 strains circulating in the U.S. in time for a possible summer surge.
The FLiRT strains are subvariants of Omicron, and they now account for more than 50% of COVID cases in the U.S. up from less than 5% in March.
Some experts have suggested that the new variants could cause a summer surge in COVID cases. However, the Centers for Disease Control and Prevention also reports that COVID viral activity in wastewater is low.
Dr. Catherine Troisi, a professor at the School of Public Health at UT Health Houston, said these new subvariants are spreading better than previous iterations of the virus.
The COVID virus changes very quickly, she said. And these variants are just the latest ones. They appear to be more infectious. Either theyre spreading better or they are evading our immune system better. But luckily, theres no indication that they cause more serious disease.
Troisi said the folks most at risk for serious illness from this variant are the same groups who have always faced a higher risk from COVID the elderly and people with underlying conditions.
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She said its not unreasonable to think there could be a surge of cases this summer.
We can look historically and say that in the last four years, weve seen surges in the summer for various reasons. So, you know, its not unlikely well see that this year, she said. Although a lot of people, probably about 97% of the country, has some sort of immunity. So even if you get sick, were hoping not to see those hospitalizations and deaths [go up].
Other than that, its hard to tell because we dont have testing results like we did earlier in the pandemic. So we can look at hospitalizations theyre up a little bit in the country. We can look at deaths theyre not up. And the same is true in Texas as well.
Troisi said people can mask to protect others if they have symptoms or are worried about exposure in a public place. There is also an updated booster shot that hit the market in fall 2023 that can help increase protection.
Back in the fall of 2023, there was a recommendation that everybody get an updated booster. Uptake was not very good, she said. And then in February, another recommendation was that if you were over the age of 65 or had underlying conditions because, again, youre at higher risk of more severe outcomes if you get infected that you get a second booster. Uptake was even worse on that second booster.
Now for the fall theres going to be your recommendation that everybody get a booster. And we probably wont even call it a booster. Well just call it the 2024-2025 vaccine. And the FDA and CDC have made the recommendation that the vaccine be tweaked to include this new variant or one of the children of that variant, to increase immunity.
Engin_Akyurt / pixabay.com
COLLEGE PARK, Md. When it comes to protecting others from respiratory viruses, the type of mask you wear matters. A new study has found that N95 respirators are significantly more effective than cloth masks, surgical masks, and KN95 respirators at reducing the amount of viral particles exhaled by people infected with COVID-19.
The study, conducted by researchers at the University of Maryland, is the first controlled human study to directly compare the efficacy of different mask types as source control blocking respiratory viruses exhaled by infected individuals. Using a special bioaerosol collector, the researchers measured the amount of SARS-CoV-2 RNA in breath samples from 44 COVID-positive volunteers, with and without masks.
The results published in The Lancet were striking. On average, wearing an N95 respirator reduced the viral particles exhaled into the air by a whopping 98% compared to no mask. In comparison, cloth masks blocked 87% of the virus, loose-fitting surgical masks blocked 74%, and KN95s blocked only 71% on average.
Despite the variability in individual results, the overall trend was clear N95s outperformed all other mask types by a significant margin when it came to containing exhaled virus. The researchers calculated that an N95 is capable of reducing transmission risk by a factor of 20, compared to not wearing a mask at all.
Our findings support strong recommendations that face masks should be worn in areas with high risk of transmission, says study lead Dr. Donald Milton in a media release. N95 respirators could become the standard of care for source control in healthcare settings. They should be worn by healthcare workers to protect their vulnerable patients, as well as themselves.
To assess the efficacy of masks as source control, volunteers provided two 30-minute breath samples back-to-back first while wearing a mask, then without a mask. This allowed each person to serve as their own control for comparison.
Importantly, the researchers intentionally did not provide any training on proper mask usage to the volunteers. They wanted to mimic real-world conditions as closely as possible. The only instructions given were to pinch the nose wire if present and how to position the straps on the N95s.
Aerosol samples were collected in two size ranges: fine particles under five microns in diameter that can remain airborne for extended periods and larger coarse particles over five microns that settle more quickly. The amount of SARS-CoV-2 RNA in each sample was then precisely measured using PCR testing.
After controlling for factors like age, sex, coughing frequency, and which COVID variant the person was infected with, N95 respirators remained the clear winner. On average, N95s reduced fine aerosol viral particles by 99% and coarse aerosol viral particles by 94%.
Cloth masks came in second place, reducing fine and coarse particles by 92% and 74% respectively. Surgical masks ranked third with 81% reduction in fine and 54% reduction in coarse viral aerosols. KN95s surprisingly performed the worst, with 79% fine and 48% coarse aerosol reduction.
The researchers quantified the relative source control performance of the different masks by comparing outward leak fractions. Leak fraction represents the proportion of virus that escapes through and around a mask during exhalation. A lower leak fraction equates to better source control.
N95s showed leak fractions 94% lower than KN95s on average. Compared to surgical masks, N95s reduced leak fractions by 93%. Even against well-fitting cloth masks, N95s still demonstrated an 87% reduction in leak fraction, a statistically significant improvement.
Duckbill N95 masks should be the standard of care in high-risk situations, such as nursing homes and health care settings, says first author Dr. Jianyu Lai. Now, when the next outbreak of a severe respiratory virus occurs, we know exactly how to help control the spread, with this simple and inexpensive solution.
The study does have some limitations to keep in mind when interpreting the results. The study population consisted mostly of young adults with mild symptoms, so the findings may not directly translate to older or sicker individuals.
Most of the surgical masks and KN95s tested were limited to a single brand, so performance may vary for other products. The cloth masks were an assortment of types and fits brought in by participants. Neck gaiters, bandanas, and double masking were not evaluated.
Also, the unmasked viral levels were often higher for the KN95 and N95 groups compared to cloth and surgical masks. This is because more of those respirator samples were collected during the Delta and Omicron waves, when viral shedding tended to be higher, while more of the cloth and surgical mask data came from earlier variants. The researchers controlled for this potential confounding factor in their analysis.
This study provides real-world evidence that N95 respirators are the gold standard when it comes to reducing the spread of viral respiratory particles, even without special fit testing or training. Wearing an N95 properly can make a dramatic difference in blocking the virus from being exhaled into shared air spaces.
As the COVID pandemic persists and new viral threats inevitably emerge, these findings have important implications for infection control policies and public health guidance. While any mask is better than no mask, N95s should be the first choice in high-risk settings like hospitals, nursing homes, and crowded indoor environments when virus transmission is prevalent.
Improved respiratory protection policies are needed that are graded appropriately to the level of risk. These new insights on source control efficacy will help inform those policies and highlight the critical role of masks and respirators as part of a multi-layered strategy to reduce airborne transmission of dangerous pathogens now and in the future.
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Researchers infected 36 people with the virus that causes COVID-19 to understand why some people seem to evade the virus. The answer was in their immune system.
New research has looked at why some people do not get sick from COVID-19 by deliberately infecting a small number of healthy individuals under highly controlled settings.
Researchers administered the virus to 36 healthy adult volunteers without a previous history of COVID-19 through the nose.
They looked at the study participants cells from their noses and blood and published their findings in the journal Nature.
Then, they used a technology called single-cell sequencing to look at the genetic information (DNA and RNA) of individual cells.
This was an incredibly unique opportunity to see what immune responses look like when encountering a new pathogen in adults with no prior history of COVID-19, in a setting where factors such as time of infection and comorbidities could be controlled, Dr Rik Lindeboom, co-first author of the study from the Netherlands Cancer Institute, said in a statement.
Individuals who quickly eliminated the virus did not display a typical widespread immune response. Instead, they showed subtle immune responses.
High levels of activity of a gene called HLA-DQA2 before exposure could have helped these participants to prevent a prolonged infection, the researchers said.
Conversely, six individuals who developed a prolonged infection had a rapid immune response in their blood but a slower one in their nose, which allowed the virus to establish itself there.
These findings shed new light on the crucial early events that either allow the virus to take hold or rapidly clear it before symptoms develop, said Dr Marko Nikoli, another of the studys authors from University College London.
Researchers also found common patterns in activated T cell receptors (TCRs), the protein at the surface of T cells which are designed to recognise specific antigens.
When a TCR binds to a pathogen presented by an infected or abnormal cell, it triggers the T cell to become activated.
Then, T cells can directly kill infected cells, activating other immune cells and helping with long-term immunity by remembering the pathogen.
This study provided insights into how immune cells communicate and could help in developing targeted T-cell therapies for not only COVID-19 but other diseases as well.
We now have a much greater understanding of the full range of immune responses, which could provide a basis for developing potential treatments and vaccines that mimic these natural protective responses, Nikoli said.
This study is part of the Human Cell Atlas, an international collaborative group launched in 2016 aiming to map all human cells.
Sanofi - Aventis Groupe
Sanofi and Biovac spearhead polio vaccine manufacturing capabilities in Africa
Paris, June 20, 2024. Sanofi and Biovac, a Cape Town, South Africa-based biopharmaceutical company, announce today their local manufacturing partnership to produce inactivated polio vaccines (IPV) in Africa. This agreement is designed to enable regional manufacturing of polio vaccines to serve the potential needs of over 40 African countries. This partnership with Sanofi makes Biovac the first African producer of IPV on and for the African continent and supports the Africa Centers for Disease Control and Preventions ambition to have 60 percent of local vaccines produced in Africa by 2040.
Thomas Triomphe Executive Vice President, Vaccines, Sanofi For 40 years, Sanofi has supplied billions of polio vaccine doses globally, supporting the world getting close to polio eradication. But with the COVID-19 pandemic, many routine pediatric vaccination programs were halted or disrupted. Catching up will be key to preventing a rise in cases in many countries worldwide and this Sanofi partnership with Biovac is a step in that direction. Establishing this manufacturing partnership now, ahead of time, is key to enabling Biovacs manufacturing capabilities for future international tenders.
Dr Morena Makhoana Chief Executive Officer, Biovac We are very proud of this partnership with Sanofi, which will empower Biovac as an African manufacturer to champion polio eradication on and for the continent by bringing manufacturing of IPV doses closer to people needs.
Sanofi has been a critical partner of the Global Polio Eradication Initiative since 1988 and has supplied the world and UNICEF with more than 1.5 billion doses of IPV through GAVI, the Vaccine Alliance, which aims to vaccinate the populations of more than 70 of the poorest countries on the planet with the aim to eradicate polio.
Sanofi will continue to produce the bulk of IPV and Biovac, who will hold the marketing authorization, will be responsible for late-stage formulation, filling, packaging, and delivery of millions of IPV doses to UNICEF for GAVI countries in Africa.
Biovac is a leading biotechnology company and a Centre of Excellence, rooted in Africa, specializing in the development and manufacture of vaccines and other biologicals for Africa and beyond. In collaboration with the South African government, Biovac was established in 2003 to revive local human vaccine development and manufacturing capability in Southern Africa.
Polio is a highly contagious disease which mainly affects children under five years of age, who suffer the highest burden of temporary or permanent paralysis and death. Polio is an incurable infection that can only be prevented through immunization. Infected individuals shed the polio virus in the environment through fecal matter, or through the droplets from a sneeze or cough of an infected person, for several weeks. Almost 90 percent of infected people have no symptoms or very mild symptoms that usually remain undetected. In others, initial symptoms include fever, fatigue, headache, vomiting, aching muscles, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis.
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Over the last 30 years, under the Global Polio Eradication Initiative (GPEI), 2.5 billion children have been immunized against polio resulting in a 99 percent reduction in the number of cases worldwide. At the end of 2023, polio was endemic in only two countries (Afghanistan and Pakistan). As a result of the global effort to eradicate the disease, almost 20 million people have been saved from paralysis.
About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media Relations Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com
Investor Relations Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com Aliz Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com Arnaud Delpine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com Thibaud Chtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Attachment
The Commonwealth Healthcare Corp. has been notified of an Important Drug Warning notice by Pfizer, the manufacturer for Pfizer-BioNTech/Comirnaty mRNA COVID-19 vaccines, relating to a shipping error that affected certain COVID-19 vaccine products sent to the CNMI, Guam, Palau, Micronesia, and Alaskan cities.
The error is due to a vaccine temperature excursion meaning vaccines reached temperatures outside of the recommended range during shipment. Temperature excursions can affect the potency and effectiveness of vaccines.
Out of abundance of caution, the vaccine manufacturer, U.S. Centers for Disease Control and Prevention, and U.S. Food & Drug Administration is recommending revaccination for individuals who received vaccinations from the affected inventory.
Approximately 260 doses of the impacted vaccines were administered in the CNMI this year. The CHCC will be contacting identified community members who may need revaccination to inform them about the situation and schedule them should they choose to do so. Patients can expect to be vaccinated at the CHCC Immunization Clinic, Rota Health Center, and Tinian Health Center at no cost.
The CHCC wants to assure community members that their health and safety continues to be their priority. Vaccines continue to be one of public healths critical preventative measures against diseases and outbreaks. Ensuring proper storage, handling, and timely delivery of vaccines is a constant challenge, however, steps are in place for our team to monitor and manage vaccine shipments.
For more information about CHCC programs, follow @cnmichcc on Facebook, Instagram, and Twitter; visit https://www.chcc.health; or call the CHCC Immunization Program at (670) 236-8745. (PR)
Pakistan's polio eradication campaign is in disarray afterthe South Asian country of 240 million peoplereported the year'sfifth case of the highly infectious virus.It isanother blowto the country's efforts to eradicate the debilitating disease.
Four polio cases were reported inthe southwestern Balochistan province bordering Afghanistan, while a fifth case is the latest to bereported from the southern Sindh province, raising concerns about the feasibility of eradicating polio in the near future.
"The cases this year are a striking reminder that no child anywhere would be totally safe from the crippling disease until Pakistan succeeded in eradicating polio completely," said Malik Mukhtar Bharath, the Prime MinisterShehbaz Sharif's coordinator on national health services.
According to the World Health Organization, polio, which isfound typically in children under the age of 5 and canlead to paralysis or even death, remains endemic in two countries Afghanistan and Pakistan.
Last year six casesof the virus were detected in Pakistan. According to the Global Polio Eradication Initiative (GPEI), Pakistan was tantalizingly close to the elimination of polio after just onecase was reported in 2021.
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Experts believe that the cases emerging in Pakistan are due to various factors.
"Pakistan and Afghanistan continue to operate in a highly complex and challenging environment,"Dr Hamid Jafari, director of polio eradication at the WHO Eastern Mediterranean Region, told DW.
"Primary drivers of risks include large population movements, insecurity compromising access and quality of vaccination in key infected areas,combined with communities with significant vaccine hesitancy and persistently low routine immunization coverage in polio-critical geographies."
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"All five cases reported this year in Pakistan are linked to the two YB3A related genetic clusters following extensive cross-border transmission from Afghanistan.These cases have been reported from Chaman, Dera Bugti, Kila Abdullah, Shikarpur and Quetta,"added Jafari.
The polio workforceisfrequently targeted in Pakistan where Islamist militants and hardliner clerics blamedgovernment vaccination drives as a foreign agenda to sterilize Muslim children and a cover for Western spies.
"The current widespread detections are especially concerning as we have just now entered the high transmission season.The virus has been reestablished in our historic reservoirs. From there it is spreading. We can expect more spread over this high transmission season,"Natalia Molodecky, who worked with GPEI in Pakistan's polio emergency operations center in Islamabad, told DW.
"The main factorattributed to large unpredictable movements of populations resulting in virus detection in areas that had been polio-free for years.The large unusual population movements were in part related to the repatriation of Afghan migrants,"underlined Jafari.
However the five cases reported are not clustered and are reported from five different districts of two provinces.
"Natural disasters including torrential rains, heat waves, and flooding create a snowball effect where internal displacement results in low vaccine uptake while poor sewage allows entry of polio virus in the water reservoirs. Lack of clean drinking water forces people to drink unhygienic water, increasing the risks,"Dr Fareeha Irfan, a public health physician and expert in policy working with the Punjab healthcare commission, told DW.
Experts warned that there could be a spike in polio cases ahead and the risks of the virus resurging in high-risk areas is real.
"The persistent detection of poliovirus in environmental samples and sporadic cases will delay the interruption of transmission beyond the timeline of end 2024, and will likely get pushed to the next low season in the first half of 2025,"asserted Jafari.
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Molodecky agrees."As poliocontinues to move out of the core reservoirs during this high transmission season, we may see an increased case burden outside of these historic reservoir areas," the health expert said.
Despite a remarkable progress in the global effort to eradicate the cripplingvirus, both Pakistan and Afghanistan continueto combatsporadic outbreaks, particularly in remote regions with disrupted access to healthcare services.
"The programin Pakistan hasreached a high level of sophistication and possesses the resilience, capabilities, resourcesand support needed to finish the job," affirmedJafari.
Diversion of resources, human and infrastructural, to matters deemed more important have been responsible in the past for an uptick in polio cases.
"Vaccine hesitancy always underscores a suboptimal uptake of vaccines in Pakistan, and while the trend was limited to a less educated strata of the society, now even educated families are reluctant to get their children vaccinated, especially with oral vaccines,"said Dr Irfan.
Experts suggest that urgent and diligent work to end polio must continue throughout this yearto carefully identify and remap migrants and all unvaccinated children.
"We must ensure these missed children are vaccinated to stem outbreaks and ensure historic reservoirs,the major population hubs that were free of polio for more than two years, stop the virus as soon as possible,"suggested Jafari.
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The pattern of virusdetections strongly suggests that populations living in bordering districts are contributing to the persistence and spread of the virus.
"When we are talking about sources versus sinks of virusthe source of virus is typically our historic reservoirsso tackling things at the source is critical for sustained success. We know how to clear poliofrom these areas and have done it before,"underlined Molodecky.
"Greater coordination and collaboration of efforts along border areasof Afghanistan and Pakistan,known as 'virus corridors,' is essential in the coming months,"stressed Jafari.
Edited by: John Silk
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