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F.D.A. Panel Explores Challenges of Revamping Coronavirus Vaccines

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WASHINGTON — Researchers making an attempt to plan an up to date coronavirus vaccine to be used this fall must choose a formulation as early as June to fulfill that deadline, federal officers stated on Wednesday, regardless that some medical trials are simply now getting underway.

The evaluation got here throughout a daylong assembly of outdoor advisers to the Meals and Drug Administration, who convened to strategize about what the nation’s coronavirus vaccine coverage ought to appear to be transferring ahead. The session underscored how deeply the street forward is studded with uncertainties.

Among the many most simple questions debated: At what level would officers resolve that the present vaccines should not working properly sufficient? And if higher vaccines are deemed obligatory, when may medical trials present solutions about appropriate replacements?

The assembly captured a transition level for the Biden administration because it tries to style a vaccine technique for the remainder of this 12 months. Some federal well being officers are satisfied that the present vaccines must be retooled to supply higher safety than they do now. They hope to have a revised model by the autumn, once they concern the virus might resurge in pressure.

Doses of modified vaccine might price the federal authorities about $5 billion to $12 billion, one senior federal official stated. Congress has moved to slice the administration’s new Covid price range request roughly in half, which the official stated may not go away sufficient to cowl that price.

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On the similar time, vaccine producers and federal researchers are scrambling to determine what a revised vaccine ought to appear to be. A brand new examine by the Nationwide Institutes of Well being, for instance, is analyzing how Moderna’s vaccine works if revised to focus on three completely different variants, alone or together. However it solely simply started recruiting volunteers, with outcomes anticipated someday this summer time.

Robert Johnson, the director of an infectious illness division throughout the Division of Well being and Human Companies, instructed the panel that even as soon as regulators resolve upon a reconfigured vaccine, producers would want a number of months to supply doses.

“When you’re not in your method to that medical trial by the start of Might, it is vitally troublesome to have collectively throughout producers sufficient product to fulfill that demand” by fall, he stated. Dr. Peter Marks, who oversees vaccine regulation on the F.D.A., additionally described the timeframe as extremely compressed, saying regulators could have to choose a brand new vaccine formulation by Might or June in the event that they need to change from the present ones.

The trials underway are too small to offer efficacy information of the kind that led to the authorization of the present vaccines. However they might produce sufficient information for federal well being officers to find out whether or not a reconfigured vaccine will create a stronger or extra lasting immune response — a metric used to deduce efficacy.

Professional after knowledgeable on the assembly described how a lot guesswork is concerned in that effort. Nobody is aware of which variant of the virus will dominate within the fall, when federal officers contemplate a brand new surge extremely seemingly. There’s some likelihood that earlier than then, one other variant like Omicron will emerge and redraw the coronavirus image in an entirely surprising means. “Unlikely, nevertheless it’s there,” Dr. Marks stated of that risk.

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Trevor Bedford, a biostatistician on the Fred Hutchinson Most cancers Analysis Middle, stated the coronavirus had been mutating at a number of instances the speed of the flu virus, for which vaccines are redesigned yearly. Whereas that tempo could gradual, the virus’s plasticity signifies it “is prone to carry on evolving,” he stated.

How precisely it is going to do that’s anybody’s guess. “There’s no assure that each emergent variant goes to be the idea for the following variant,” warned Dr. Michael Nelson, an immunologist on the College of Virginia Medical Faculty.

In the meantime, federal officers and their exterior advisers proceed to grapple with what the edge is for figuring out that present vaccines should not doing a adequate job. Dr. Marks stated the committee’s consensus seemed to be that Covid vaccines ought to stop extreme illness, not essentially an infection or delicate illness.

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The query was particularly related as a result of simply final week, the F.D.A. approved a second booster for Individuals 50 and older, together with some others. However the C.D.C. director outright really helpful these pictures just for individuals 65 and older, and anybody 50 to 64 with severe underlying well being situations.

Some immunologists and vaccine consultants have stated the F.D.A. lacked the required information to authorize second boosters, whereas different well being officers have maintained that individuals ought to have the choice of one other shot.

Dr. James E.Okay. Hildreth, the president of Meharry Medical Faculty in Tennessee and a committee member, requested Dr. Marks why he didn’t solicit the panel’s recommendation earlier than deciding whether or not to authorize a second booster.

Dr. Marks stated the F.D.A. didn’t contemplate providing a second booster to be “a significant enlargement or a significant change.” Jerry Weir, one other senior company official, stated the F.D.A. anticipated to ask the advisory panel to overview any reconfiguration of the present vaccines earlier than transferring ahead with emergency authorization.

Sharon Alroy-Preis, the director of public well being companies for Israel’s Well being Ministry, instructed the panel that administering a second booster for these 60 and older earlier this 12 months saved lives. The Israeli presentation appeared to again up the F.D.A.’s choice.

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However European Union regulators concluded on Wednesday that it was “too early” to manage second booster pictures to the final inhabitants, however affordable to supply them to individuals 80 and older.

Dr. Amanda Cohn, a senior C.D.C. official, stated her company’s information confirmed that present vaccines are greater than 80 p.c efficient in stopping hospitalization in Individuals with out immune deficiencies — together with older individuals and people with continual medical situations. She recommended that Covid therapies after an infection could also be simpler than further pictures of vaccine in defending Individuals in opposition to extreme illness.

Dr. Christopher Murray, a professor on the College of Washington whose institute has modeled the pandemic’s tendencies, predicted that antiviral therapies just like the capsules lately developed by Pfizer will minimize mortality charges even when a brand new variant as infectious as Omicron and as lethal as Delta emerges.

Dr. John Beigel, a medical analysis director on the N.I.H., described his company’s analysis evaluating how properly Moderna’s present vaccine works in opposition to modified variations aimed on the identified variants, each alone and together.

Within the first stage, researchers are hoping to quickly enroll 600 volunteers who’ve already been vaccinated and acquired a booster. Some will probably be given the present vaccine. Others will get experimental vaccines focused to the Omicron variant alone in addition to three different variations: Omicron plus the Beta variant, the Delta variant and the prototype virus that emerged first within the pandemic.

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In an interview on Tuesday, Dr. Beigel stated the present vaccines should still develop into the very best. He stated he hoped outcomes from his trials could also be prepared by midsummer, though some federal officers are hoping for earlier.

Deciding on the following step, he instructed the panel, “goes to be difficult.”

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Life after death: Take a glimpse into the world of cryonics

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Life after death: Take a glimpse into the world of cryonics

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Since the age of 13, Joseph Kowalsky has harbored a fascination with life after death, pondering ways to extend his existence indefinitely. 

Today, Kowalsky, now 59, is among some 2,000 individuals who have signed up with the Cryonics Institute in Clinton Township, Michigan, betting on a future where death is not the end.

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Chilling prospect of immortality

Cryonics, the process at the heart of Kowalsky’s hopes, involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them. 

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Shortly after a person dies, organizations like the Cryonics Institute use a heart-lung resuscitator, circulate a medical-grade antifreeze in the blood and suspend the body in aluminum pods filled with liquid nitrogen. 

Dennis Kowalski, current president of the Cryonics Institute (and no relation to Joseph Kowalsky), told Fox News that over 250 individuals are currently in “suspension” at the Michigan facility.

Cryonics involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them.  (Cryonics Institute)

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Could defying death be affordable?

The Cryonics Institute is just one player in a burgeoning industry. 

Alcor, the world’s oldest cryonics company, which is based in Scottsdale, Arizona, boasts a state-of-the-art facility where more than 200 individuals are preserved. 

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For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000. 

Alcor CEO James Arrowood dispels the notion that cryonics is solely for the wealthy, highlighting that many clients use life insurance policies to cover costs. 

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Cryonics Institute

Over 250 individuals are currently in “suspension” at the Michigan facility, the president of the Cryonics Institute told Fox News. (Cryonics Institute)

“About 80% of people who sign up are middle-class,” Arrowood told Fox News.

He pointed out that the clientele includes notable figures such as baseball legend Ted Williams, whose head and body were cryopreserved separately.

Skeptics cast doubt

Critics dismiss cryonics as speculative and unproven, labeling it an “iceberg scheme” lacking scientific backing. 

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“It’s a sad case of people being beguiled by a very understandable dream of resurrection,” Clive Coen of King’s College London told Fox News.

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The neuroscience professor raised concerns over the damage inflicted during the preservation and revival process, warning that “there will be billions of mini-strokes in every millimeter of brain tissue” due to the inability of antifreeze to traverse the brain’s complex landscape.

Hope springs eternal for death defiers

There is currently no scientific evidence or successful case of a human being revived from a cryonically preserved state. 

Cryonics Institute

For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000.  (Cryonics Institute)

Despite the skepticism, Joseph Kowalsky, who formerly worked with the Cryonics Institute, remains undeterred. 

“Worst-case scenario, I’m still dead … And the upside? It could be a potentially life-saving medical technique,” he said.

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As science and ethics continue to grapple with the implications of cryonics, individuals like Kowalsky illustrate a deep-seated hope for defying mortality, one frozen body at a time.

Andres del Aguila and Griff Jenkins contributed to this report.

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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Most of the 38 million people living with diabetes in the U.S. use daily injections or insulin pumps to keep glucose at safe levels — but new research suggests that a third option could be just as effective.

In a study led by Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, an inhaled form of insulin — similar to an asthma inhaler — worked just as well as injections or pumps to control type 1 diabetes.

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The research was presented last week at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, Florida.

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The clinical trial tested a product called Afrezza, an inhaled insulin made by MannKind Corporation in California. 

Afrezza, the only inhaled insulin on the market, has been available since getting FDA approval in June 2014.

An inhaled form of insulin worked just as well as injections or pumps to control type 1 diabetes in a recent study. (iStock/MannKind)

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Benefits of a third option

“In those with type 1 diabetes, insulin is required for survival,” Hirsch told Fox News Digital in an interview. 

“With continuous glucose sensing, glucose control has been dramatically improved — but not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” he said.

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With pumps, people must wear the device, which can lead to skin problems

They also have to purchase extra accessories.

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Blood glucose levels can also drop with exercise, Hirsch warned, which can be problematic. 

Afrezza inhaler

Afrezza, an inhaled insulin pictured here, is made by MannKind Corporation in California.  (MannKind)

“Injections overall can be more convenient for some, but they don’t do as well as pump patients,” he said.

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, Hirsch noted.

“Patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice.”

During the 17-week study, researchers evaluated the results of 141 adults who were assigned to either use the Afrezza inhaler or continue with traditional methods of injection or pump delivery.

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At the 17-week mark, all participants switched to the inhaler for another 13 weeks.

Dr. Irl B. Hirsch

Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, led the new study. (MannKind)

All groups were assessed with continuous glucose monitoring at the start of the study, at 17 weeks and again at 30 weeks.

Among the inhaled insulin group, 30% of participants reached their target glucose levels (less than 7% blood sugar) compared to 17% of the people using injections and pumps.

There was no difference in hypoglycemia (low blood sugar) between the groups.

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“In general, there was no difference in our primary endpoint, HbA1c, a reflection of average blood sugar,” Hirsch said. 

“But that alone is misleading — many patients did better with their glucose control, while others did worse.”

Afrezza inhaler

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, a doctor said. (MannKind)

“The point is, inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

The people who saw the best results inhaled insulin between meals and at bedtime, Hirsch added.

                             

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At the end of the study, more than half of the participants said they would opt to stay on the inhaled insulin therapy.

“The biggest takeaway is that patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice,” he recommended.

‘Adds value’

The American Diabetes Association acknowledged the promise of the study findings in an email to Fox News Digital.

“We look forward to our Scientific Sessions every year to see data like the INHALE-3 study’s findings, which have the potential to expand diabetes care,” Raveendhara Bannuru, M.D., PhD, the ADA’s vice president of medical affairs and quality improvement outcomes in Boston, Massachusetts, told Fox News Digital via email.

diabetes CGM

“With continuous glucose sensing, glucose control has been dramatically improved,” a doctor told Fox News Digital. (iStock)

“We are hopeful for the continuous development of alternative insulin delivery methods that could offer options for people living with diabetes,” the group also said in the statement.

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“The INHALE-3 trial demonstrated that inhaled insulin, combined with insulin degludec, effectively reduces A1c levels without increasing hypoglycemia or weight gain in people with type 1 diabetes. This adds value to the options in insulin therapy.”

Potential risks and limitations

While more people met their glycemic targets with Afrezza, some subjects saw worse readings when switching from usual methods to inhaled insulin — “potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime,” the researchers wrote.

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“We didn’t see any concerns,” Hirsch said when asked about side effects. 

“As expected, a few people coughed immediately when dosing their insulin, but no major concerns were seen and everyone continued on their inhaled insulin.”

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Insulin injection

“Not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” a doctor said. (iStock)

The most common side effects noted in the study were hypoglycemia, cough and throat pain or irritation. 

Afrezza has been linked to a risk of acute bronchospasm in patients with chronic lung disease, such as asthma or COPD, according to the manufacturer.

“Inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

Before starting Afrezza, patients should see a doctor for a physical examination and testing to measure lung function.

Patients who smoke or who recently quit smoking should not take the inhaled medication.

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Fox News Digital reached out to MannKind requesting additional comment.

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