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Thursday, May 13, 2021

Over a Quarter of EU Adults Would Refuse COVID-19 Shot: Survey

 More than a quarter of adults in the European Union would be unlikely to take the COVID-19 vaccine when it was offered to them, a survey published on Thursday showed.

The results also suggested a strong link between vaccine hesitancy and the use of social media, particularly where social media is the main source of information, according to Eurofound which carried out the survey.

"Unfortunately, these findings reflect a failure to deliver persuasive and clear communication regarding the efficacy and safety of vaccines," said Daphne Ahrendt, Eurofound senior research manager.

Bulgarians were the most reluctant to get the vaccine, with 67% of adults saying they were unlikely or very unlikely to get it. In Ireland, only 10% of adults said they would not get the shot.

The survey found an east-west divide across Europe. Except for France and Austria, the intention to get vaccinated was above 60% in all Western member states - with Nordic and Mediterranean countries, Denmark and Ireland having even higher rates.

The rate of planned uptake in Eastern member states was much lower, ranging from 59% in Romania to 33% in Bulgaria.

The main influence on vaccine hesitancy was the time spent on social media and which medium was used, the survey said. The proportion rises to 40% among those who use social media as their primary source of news.

Among people who used traditional media including press, radio and television, only 18% of respondents were vaccine sceptics.

The survey also found that students, employed or retired people were less vaccine hesitant than average, while 39% of unemployed people or those with a long-term disease of disability were more hesitant.

The survey was conducted between February and March 2021, after a full year of living with COVID-19 restrictions across the bloc's 27 member states.

https://www.usnews.com/news/world/articles/2021-05-13/over-a-quarter-of-eu-adults-would-refuse-covid-19-shot-survey-says

U.S. Schools Unlikely to Mandate COVID-19 Vaccines Anytime Soon

 Pfizer and BioNTech's COVID-19 vaccine was authorized for use in children as young as 12 by the U.S. Food and Drug Administration this week - but do not expect schools to require shots for students anytime soon given public hesitation and political hurdles.

State governments for the most part can order a vaccine be required for a child to attend a K-12 public school, said Dorit Rubinstein Reiss, a University of California-Hastings law professor who researches school mandates and the legal issues around vaccines.

In all but a handful of states, a measure must pass the full legislature to be added to the mandatory vaccine list, Reiss said. No state government has mandated COVID-19 immunizations for schools, she added.

There is increased hesitancy over the shots because some of them rely on the newer mRNA technology and have been authorized on an emergency-use basis. Early studies also indicate children are far less susceptible to grave health complications from COVID-19, though they are not without risk and can transmit the disease.

Reiss said it is highly unlikely state legislatures will push through mandatory COVID-19 vaccinations for children this year.

"It takes political capital, and my bet is that legislators will not even try until they can do it for children aged 5 and up," she said. "They will not want to go through the process twice."

It is clear proponents of mandates could face opposition. Even before vaccinations were approved for younger adolescents, Republican lawmakers in dozens of statehouses filed bills seeking to block COVID-19 vaccination mandates, mostly arguing the vaccines are too new to force people to take against their will.

In Kansas, Republican state Senator Mark Steffen, an anesthesiologist, crafted a bill that would strip the state's department of health of its power to add a new shot to the existing list of required vaccines. The bill remains in committee.

"It's a vaccine that is experimental, a vaccine that is gene-manipulative," Steffen said during a March hearing on the bill. "Its long-term dangers won't be fully known for decades."

Researchers from Harvard, Northeastern, Northwestern and Rutgers universities, who are part of the COVID States Project, surveyed nearly 22,000 people nationwide in April and found that over a quarter of mothers were "extremely unlikely" to vaccinate their children.

Because of such reluctance, education leaders should not focus on mandating shots, said Randi Weingarten, president of the 1.7 million-member American Federation of Teachers (AFT)union.

"Right now it's about convincing people of their efficacy," she said of vaccines. "We have to build trust and confidence, particularly amongst our Black and brown parents who have borne the brunt of COVID."

YEARNING FOR NORMALCY

Weingarten and others representing school leaders and staff noted wide agreement that vaccines are key to a more normal school experience.

In a sweeping policy speech given on Thursday in Washington, Weingarten said in-person learning, five days a week across the country must take place in the fall.

She said that ATF polling of parents shows that vaccines - along with social distancing, masking and testing - were mandatory to winning parents' confidence in sending kids back to school. Recent polling by the ATF and the NAACP shows 94% of parents would be comfortable with their children attending school in-person with those safety measures in place.

The Los Angeles Unified school district, the second-largest in the country with nearly 650,000 students, has been among the most proactive on vaccines for pupils. Fifteen vaccination clinics are located in L.A. schools.

Superintendent Austin Beutner said during a Monday news conference that he wants a vaccine available to every middle and high school student as soon as possible.

Some private schools are moving ahead with mandates. In Connecticut, students attending the 5th-12th grade St. Luke's school in New Canaan learned on Tuesday that they must take the COVID-19 vaccine to attend in the fall.

Mark Davis, the head of St. Luke's, said the mandate was made in conjunction with a health task force, largely composed of parents who are physicians.

Key to the policy was guidance from the U.S. Centers for Disease Control and Prevention that fully vaccinated people do not need to quarantine if exposed to the coronavirus. That means kids would almost certainly remain in the classroom full-time if they got the shot.

Most parents of the school's nearly 600 students overwhelmingly support the mandate, Davis said, adding that four or five families expressed concerns.

Davis said he understood COVID-19 has set off pitched debates, but pointed to the long history of mandated vaccines for diseases such as polio and whooping cough and the benefits of in-class learning for kids.

"It's such a shame that the issue of vaccines has become politicized," Davis said. "It's a critical step toward a much-needed return to the school experience that we all yearn for."

https://www.usnews.com/news/top-news/articles/2021-05-13/no-shot-us-schools-unlikely-to-mandate-covid-19-vaccines-anytime-soon

GoodRx reports mixed Q1

 GoodRx Holdings Inc - Ordinary Shares - Class A (GDRX) - Goodrx Releases First Quarter 2021 Financial Results.

Qtrly Earnings per Share - Diluted $0.00.
Qtrly Revenue $160.4 Million Versus $133.4 Million.
Q1 Earnings per Share View $0.07, Revenue View $160.6 Million -- Refinitiv Ibes Data (analyst estimates).
Sees Q2 2021 Revenue $172 Million to $176 Million.
Sees FY 2021 Revenue $740 Million to $760 Million.
Q2 Revenue View $172.4 Million -- Refinitiv Ibes Data (analyst estimates).
FY2021 Revenue View $748.4 Million -- Refinitiv Ibes Data (analyst estimates).

FDA Warns Cell Phone, Smart Watch Magnets Can Affect Medical Devices

 The US Food and Drug Administration (FDA) is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Today's warning comes on the heels of recent research reporting that high field strength magnets in newer smartphones may cause some implanted medical devices to switch to "magnet mode" and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

"The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact," it said. "The FDA also conducted its own testing on some products that use the high field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question."

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter-defibrillator and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

  • Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.

  • Do not carry consumer electronics in a pocket over the medical device.

  • Check your device using your home monitoring system, if you have one.

  • Talk to your healthcare provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

Biogen, Envisagenics to Collaborate on RNA Splicing Research

 

  • As part of the agreement, Biogen will leverage Envisagenics’ AI platform with the goal of better understanding Central Nervous System diseases

Biogen Inc. (Nasdaq: BIIB) and Envisagenics today announced a new collaboration to advance ribonucleic acid (RNA) splicing research within central nervous system (CNS) diseases. As part of the collaboration, Biogen will leverage Envisagenics’ proprietary artificial intelligence (AI)-driven RNA splicing platform, SpliceCore®, to define and understand the regulation of different RNA isoforms in CNS cell types.

Genetic information encoded in the human chromosome is converted into RNA molecules which is then used as the template to make proteins. RNA splicing is the process that trims out extra information embedded in the intermediate RNA molecules, and this trimmed RNA is what is then used to produce functional proteins.

“Since Biogen’s earliest days, RNA splicing has been an integral part of our history and mission dating back to co-founder Phillip Sharp’s discovery of the process in 1977,” said Alfred Sandrock, Jr., M.D., Ph.D., head of research and development at Biogen. “By combining Envisagenics’ SpliceCore platform with our deep expertise in this scientific approach, we believe that Biogen will be able to advance our understanding of RNA splicing and potentially identify new drug targets for CNS diseases.”

https://finance.yahoo.com/news/biogen-envisagenics-announce-collaboration-advance-200600590.html

FDA unexpectedly grounds Rocket gene therapy for rare heart disease

 

  • The Food and Drug Administration has temporarily halted an early-stage trial of an experimental Rocket Pharmaceuticals gene therapy for a rare and deadly heart condition known as Danon disease.
  • The news came as somewhat of a surprise, as the agency didn't stop testing due to a new safety issue. Rather, the FDA asked Rocket to put "additional risk mitigation methods" into its clinical program, which executives on a conference call described as potential changes to enrollment criteria or drug regimens that would accompany treatment with the gene therapy.
  • The clinical hold is the latest in a string of regulatory setbacks for gene therapies due to safety or manufacturing concerns. It also marks the first bump in the road for Rocket's Danon program, a key driver of the biotech's recent stock surge. Rocket believes, however, that it can resolve the issue with no more than a three-month delay to study enrollment.
Over the past year, Rocket has grown to become one of gene therapy's most valuable independent companies, with a relatively broad pipeline of rare disease treatments and a market capitalization eclipsing more established companies like Bluebird Bio and UniQure.

Early data supporting its gene therapy for Danon — a deadly disease with no approved treatments for its underlying cause — are a large component of that rise. The disease is characterized by weakness of the heart and skeletal muscles, and leads to cognitive impairment, cardiomyopathy and often heart transplants. Males with the disease, on average, die at 19 years of age. Rocket estimates there are between 15,000 to 30,000 people with Danon in the U.S. and European Union.

Rocket's gene therapy is meant to restore cardiac function. Early testing has so far shown a decline in markers of heart failure among a small group of young adult patients.

It's unclear whether these effects will lead to improved function and health outcomes. No gene therapy has been proven to successfully treat a cardiovascular condition. Still, updated results Rocket disclosed from two patients treated with a low dose 18 months ago showed some promise, with evidence of "stabilization and even some modest improvements," where natural history would suggest these patients would decline further, said CEO Gaurav Shah, on a conference call.

Last year, Rocket did disclose one patient on a higher dose had an immune response that had to be treated with Alexion Pharmaceuticals' drug Soliris. That led Rocket to more closely monitor patients and increase safeguards, and there haven't been any new adverse events related to the therapy disclosed since. Rocket executives said that just as the company was preparing to treat a new cohort of pediatric patients last week, the agency halted dosing and asked for new risk mitigation measures to be put in place.

The requests fell into "two buckets," Shah said. One involves patient eligibility; Rocket needs to enroll patients who are younger and whose disease isn't as advanced. The other is to "further refine and enhance" the safety measures in its trial design. The company didn't provide specifics, though chief medical officer Jonathan Schwartz noted a more "rigorous, preemptive use" of drugs like Soliris "may be in the offing."

Rocket believes it can quickly resolve the situation. "This is not a [manufacturing] issue, it is also not a request for additional data that would otherwise result in a prolonged delay to the program," Shah said, predicting enrollment would only be delayed by a quarter.

Shares still fell by as much as 25% before trading down roughly 15% post-market close on Monday. It's "formally possible that the unpredictable and conservative FDA may translate to a longer-than-expected delay," wrote Stifel analyst Dae Gon Ha. Multiple gene therapy studies have been paused over the past year, and the agency is viewed as having taken a stricter approach in recent drug decisions.

But both Dae Gon Ha and SVB Leerink analyst Mani Foroohar expect little disruption for Rocket going forward. Foroohar, for instance, believes safety concerns should be mitigated as Rocket treats younger patients with a lower dose.

https://www.biopharmadive.com/news/rocket-fda-clinical-hold-danon-gene-therapy/599941/

Implanted Sensor Translates Brain Signals Into Text

 

An example of text characters translated from brain signals by an implanted sensor
Image Credit: BrainGate

A man paralyzed from the neck down used an implanted sensor that processed his brain signals to create text, achieving a typing speed rivaling that of his able-bodied peers.

The intracortical brain-computer interface (BCI) decoded his attempted handwriting movements from neural activity and translated them to text in real time at a rate of 90 characters per minute, more than double the previous record for typing with a BCI, reported Francis Willett, PhD, of Howard Hughes Medical Institute at Stanford University, and co-authors in Nature.

The 65-year-old man, referred to as T5 in the paper, had a spinal cord injury in 2007 that immobilized his limbs. Nine years later, as part of the BrainGate2 clinical trial, researchers placed two BCI chips, each the size of baby aspirin, in the part of his motor cortex that governs hand movement.

As the man imagined writing, a machine-learning algorithm used signals from individual neurons in his brain to recognize patterns he produced with each letter, allowing him to communicate as quickly as someone his age typing on a smartphone.

"We've learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements," Willett said in a statement.

Complicated intended movements that involve changing speeds and curved trajectories -- like handwriting -- can be interpreted more easily by artificial intelligence algorithms than simpler motions like straight lines, Willett noted. "Alphabetical letters are different from one another, so they're easier to tell apart," he said.

Commercially available assistive typing devices rely predominantly on being able to make eye movements or deliver voice commands, observed Pavithra Rajeswaran, MEng, and Amy Orsborn, PhD, both of the University of Washington in Seattle, in an accompanying commentary.

Eye-tracking keyboards can let people with paralysis type at around 47.5 characters per minute but have limitations: it's hard to reread an email to compose your reply while you're typing with your eyes, they noted.

So far, BCIs for typing have not been able to compete with simpler assistive technologies. But the approach in this study "leapfrogs far beyond past devices, in terms of both performance and functionality," Rajeswaran and Orsborn wrote.

At first, T5 concentrated on writing imaginary letters on lined paper with an imaginary pen. Then he was given groups of sentences and instructed to make a mental effort to write each one; later, he was asked to give answers to open-ended questions. A deep-learning model called a recurrent neural network learned the neural activity patterns he produced with each character.

Over time, the algorithm showed better ability to differentiate his neural firing patterns. Eventually, it was able to decipher the correct letter 94.1% of the time. An offline autocorrect function boosted that accuracy to over 99%.

This work could one day benefit people who've lost the use of their upper limbs or the ability to speak due to spinal cord injuries, strokes, or amyotrophic lateral sclerosis (ALS), the researchers said. At this point, however, it's a proof of concept that a high-performance handwriting BCI is possible: it is not a clinically viable system.

The approach still needs to demonstrate similar results in other people, allow text to be edited, and show it will perform well as neural activity patterns change, Willett and co-authors noted. The intracortical technology used in the study also needs to show longevity, safety, and efficacy before it can be used clinically.


Disclosures

The study was supported by the National Institute of Neurological Disorders and Stroke, NIH BRAIN Initiative, National Institute on Deafness and Other Communication Disorders, Howard Hughes Medical Institute, the U.S. Department of Veterans Affairs, L. and P. Garlick, S. and B. Reeves, the Simons Foundation, and the Wu Tsai Neurosciences Institute.

Researchers reported relationships with Neuralink, Paradromics, Synchron, Enspire DBS, Facebook Reality Labs, MIND-X, Inscopix, and Heal. Several authors are inventors on a patent application that covers the neural decoding approach in this work.