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Vaccines against COVID-19, the seasonal flu and RSV are our best chance of preventing a winter surge

Newly approved and updated vaccines are the best tools available to combat COVID-19, the flu and RSV, as infections and hospitalizations tick upward and…

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The CDC recommends getting your updated COVID-19 shot and your seasonal flu shot as soon as possible. AngelaMacario/iStock via Getty Images

As cold and flu season ramps up, health care experts are once again on high alert for the possibility of a tripledemic, or a surge brought on by the respiratory viruses that cause COVID-19, the flu and respiratory syncytial virus, or RSV. The good news is that this year, health officials have more tools at their disposal to combat them.

Americans ages 6 months and older are eligible to receive the newest COVID-19 vaccine and the annual flu vaccine. In addition, this year the Food and Drug Administration approved the first vaccine against RSV for use in late pregnancy and adults 60 years of age and older.

RSV, COVID-19 and the flu are all contagious respiratory illnesses that have similar symptoms, making it difficult to distinguish between the three viral infections without a lab test. Testing is the only way to know which virus is causing your symptoms. In fact, researchers are working to create one test that can detect COVID-19, RSV and the flu.

As a nursing professor with experience in public health promotion, I am often asked about the differences between these respiratory viruses. This year, I am fielding many questions about the timing of getting the new COVID-19 and RSV vaccines along with the flu shot, and whether they can be given together.

What to know about the symptoms

Symptoms of COVID-19, RSV and the flu can range from mild – or even no noticeable symptoms at all – to severe. Flu symptoms typically come on suddenly, while RSV and COVID-19 often start out mild but can become severe over time. In addition, while a flu infection does not typically affect one’s ability to taste or smell, the loss of taste or smell can be a common COVID-19 symptom.

All three infections can cause fevers and fatigue, while chills and body aches are more common with COVID-19 and the flu. More severe symptoms of these infections include difficulty breathing and subsequent infections like pneumonia.

Health care experts are emphasizing the importance of getting a lab test to accurately identify the source of your infection.

Timing the shots

With the new RSV vaccine and updated COVID-19 vaccine now available and flu season just around the corner, a natural question is whether there is an optimal schedule for the three shots.

The answer to that question is, if you are eligible, to get these vaccines as soon as possible. It is important to consider that it takes approximately two weeks after vaccination for your body to develop antibodies from both the COVID-19 vaccines and the flu vaccine.

The Centers for Disease Control and Prevention recommends that anyone who is either unvaccinated or has previously received a COVID-19 vaccine before Sept. 12, 2023, to get the updated vaccine. This means now is the time to get the updated COVID-19 vaccine that targets a previously dominant variant of the omicron family.

The original COVID-19 vaccines and booster series have dramatically reduced the number of COVID-19 infections, hospitalizations and death rates from the virus.

While everyone 6 months of age and older is advised to receive both the COVID-19 and flu vaccines, certain populations have a higher risk for severe infection, such as pregnant women, and should be extra vigilant about getting vaccinated.

In addition, among those vaccinated against COVID-19, symptoms during an infection tend to be milder. However, due in part to the quickly evolving nature of the virus, it has become clear that immune protection from COVID-19 vaccination or infection diminishes over time. While studies show that the primary COVID-19 series maintains efficacy against severe disease and death six months after vaccination, protection after vaccination decreases over time. Viruses, such as those that cause COVID-19 and influenza, also continuously mutate and evolve.

The fact that COVID-19 vaccine immunity decreases over time and that viruses evolve are exactly why updated vaccines are so critical. Without a large uptake of updated vaccines in the population, COVID-19 infection rates could surge again.

Timing is also important with the flu vaccine. Flu cases typically begin to rise in October and peak between December and February, but can last through May. Ideally, people should get vaccinated before flu begins to spread, making the month of October the ideal flu vaccination time.

But if you miss that deadline, it is absolutely better to get vaccinated later in the season than not at all. Flu, COVID-19 and RSV vaccines are available at your health care provider’s office, your local health department and most retail pharmacies, although access to the newly updated COVID-19 vaccine is still limited in some areas of the country.

Pharmacy shelves stocked with various products and a sign on a counter advertising that flu shots are available there.
Many pharmacies are offering walk-up seasonal flu and COVID-19 shots. Cecilie_Arcurs/E+ via Getty Images

A difficult respiratory virus season ahead

While infections and hospitalizations from COVID-19 declined dramatically in 2023, experts are remaining vigilant against the possibility of new, more-infectious variants causing another fall and winter surge. Adults 65 and older continue to be the highest-risk group for severe infection.

Flu seasons are inherently difficult to predict. Since the emergence of the COVID-19 pandemic, flu cases have been lower than prior to the pandemic. However, the 2022-2023 flu season still caused over 300,000 hospitalizations and up to 98,000 flu-releated deaths, making vaccination an important prevention tool.

To further compound this, flu vaccine rates have been lower during the pandemic, suggesting that Americans may be out of the habit of getting their annual flu shot.

Shots can be given together

Many are also wondering whether they can or should get the updated COVID-19 booster, the new RSV vaccine and the flu shot at the same time. The good news is, the CDC clearly indicates that it is safe for both adults and children who are eligible for the updated COVID-19 vaccine to get this vaccine simultaneously with the annual flu shot.

A 2022 study found that common vaccine side effects, such as pain at the injection site, occurred at slightly higher rates when someone received the flu vaccine and a COVID-19 vaccine at the same time, as opposed to receiving only a COVID-19 booster. However, those reactions, including fatigue and headache, were mild and resolved within a day or two. In addition, a recent study found that the immune response was the same when both vaccines were given together compared to when given separately.

Since the RSV vaccine is new, there is no data yet on receiving all three vaccines at the same time. Instead, those at the highest risk of RSV infection should get this vaccine as soon as they are able.

Community matters too

Getting the COVID-19, RSV and flu vaccines isn’t just about your own health – it’s about family and community health too. Communities with higher vaccination rates have fewer opportunities to spread the virus.

Keep in mind that many people cannot be vaccinated, because they have weakened immune systems or are undergoing treatments. They depend on those around them for protection. While one person may experience mild symptoms if they contract RSV, COVID-19 or the flu, they could spread the virus to others who could become severely ill.

Because it’s impossible to predict how people will react if they get sick, getting the flu and COVID-19 vaccines – and the RSV vaccine if you are eligible – is the best prevention strategy.

This is an updated version of an article that was originally published on Sept. 22, 2022.

Libby Richards has received funding from the National Institutes of Health and the American Nurses Foundation.

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide…

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide Black Lives Matter riots in the summer of 2020, some elite colleges and universities shredded testing requirements for admission. Several years later, the test-optional admission has yet to produce the promising results for racial and class-based equity that many woke academic institutions wished.

The failure of test-optional admission policies has forced Dartmouth College to reinstate standardized test scores for admission starting next year. This should never have been eliminated, as merit will always prevail. 

"Nearly four years later, having studied the role of testing in our admissions process as well as its value as a predictor of student success at Dartmouth, we are removing the extended pause and reactivating the standardized testing requirement for undergraduate admission, effective with the Class of 2029," Dartmouth wrote in a press release Monday morning. 

"For Dartmouth, the evidence supporting our reactivation of a required testing policy is clear. Our bottom line is simple: we believe a standardized testing requirement will improve—not detract from—our ability to bring the most promising and diverse students to our campus," the elite college said. 

Who would've thought eliminating standardized tests for admission because a fringe minority said they were instruments of racism and a biased system was ever a good idea? 

Also, it doesn't take a rocket scientist to figure this out. More from Dartmouth, who commissioned the research: 

They also found that test scores represent an especially valuable tool to identify high-achieving applicants from low and middle-income backgrounds; who are first-generation college-bound; as well as students from urban and rural backgrounds.

All the colleges and universities that quickly adopted test-optional admissions in 2020 experienced a surge in applications. Perhaps the push for test-optional was under the guise of woke equality but was nothing more than protecting the bottom line for these institutions. 

A glimpse of sanity returns to woke schools: Admit qualified kids. Next up is corporate America and all tiers of the US government. 

Tyler Durden Mon, 02/05/2024 - 17:20

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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