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Health

Moderna Vaccine Is Extremely Protecting and Prevents Extreme Covid, Knowledge Present

Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

WASHINGTON – Newly released data confirmed on Tuesday that Moderna’s coronavirus vaccine offers high levels of protection and sets the stage for this week’s emergency approval from federal regulators and beginning its spread across the country.

The Food and Drug Administration intends to approve use of the vaccine on Friday, said people familiar with the agency’s plans. The decision would give millions of Americans access to a second coronavirus vaccine as early as Monday.

The FDA review confirms Moderna’s earlier assessment that the vaccine had an efficacy rate of 94.1 percent in a study of 30,000 people. Side effects, including fever, headache, and fatigue, were uncomfortable but not dangerous, the agency found.

The success of Moderna’s vaccine has become all the more important to fighting the pandemic as other vaccine efforts have stalled. The hopeful news comes at a time with a record number of coronavirus cases overwhelming hospitals and an ever-increasing death toll that hit a bleak milestone of 300,000 on Monday.

The data release is the first step in a public review process that includes a one-day meeting on Thursday by an independent panel of experts. You will hear from Moderna, FDA scientists, and the public before they vote on whether to recommend approval. The panel is expected to vote yes and the FDA generally follows the experts’ recommendations.

Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already developed by Pfizer and BioNTech, the companies that only released the first emergency coronavirus vaccine last Friday . Healthcare workers received the first shots of the Pfizer BioNTech vaccine Monday with an efficacy rate of 95 percent.

The introduction of vaccines has been eagerly anticipated and is one of the most ambitious vaccination campaigns ever carried out in the United States.

Last summer, the federal government signed contracts with Moderna and Pfizer to dispense a total of 200 million cans in the first quarter of 2021. Since both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.

Last week the government announced that it had bought an additional 100 million doses of Moderna for the second quarter, bringing the number of Americans who can be vaccinated to 150 million. That leaves the question of how and when the 180 million or so other Americans will be covered.

Both vaccines are made available to the public free of charge.

Moderna’s vaccine has become a symbol of government scientists’ successes during the pandemic. After China released the genetic sequence of the new virus in early January, scientists from Moderna and the National Institutes of Health were able to focus on designing a vaccine in just two days. Unlike Pfizer, Moderna has a close relationship with Operation Warp Speed, the federal program that seeks to get a vaccine to market quickly. Nearly $ 2.5 billion federal funding helped Moderna buy raw materials, expand its factory, and increase its workforce by 50 percent.

Moderna’s success contrasts with two other high profile projects the US had hoped would increase vaccine supply: one from pharmaceutical companies Sanofi from France and GlaxoSmithKline from the UK and one from Anglo-Swedish drug maker AstraZeneca and the Oxford University.

AstraZeneca and Oxford used two different doses in clinical trials in the UK and Brazil. The effectiveness was 62 percent at one level and 90 percent at the other. These jumbled results have made it unclear when AstraZeneca will have enough data to obtain an emergency clearance.

Meanwhile, Sanofi and GlaxoSmithKline received disappointing results with their vaccine in early clinical trials. While it produced a promising immune response in volunteers under the age of 50, it did not do so in older people. The companies are now planning a series of new studies with a different version of the vaccine. Due to the delay, they are unlikely to provide vaccines before the end of 2021.

Moderna’s vaccine worked equally well in white volunteers and in color communities. There was also no significant difference between protecting men and women or between healthy volunteers and those at risk for severe Covid-19 who developed conditions such as obesity and diabetes. For people aged 65 and over, the study found an estimated effectiveness of 86.4 percent, which is below the overall estimate of 94.1 percent. However, the apparent difference was not statistically significant.

So far, FDA reviews have shown two possible differences between vaccines, but the results may reflect a lack of data more than real differences. The Pfizer BioNTech study showed that the vaccine began protecting against the coronavirus within about 10 days of the first dose. The experiment with the vaccine from Moderna, however, did not show such a noticeable effect after the first dose.

However, in the early days of the Moderna study, there were fewer cases of Covid-19 among study participants, making it more difficult to measure the differences between the vaccinated group and the placebo group. In either case, health officials have said that for both vaccines, two doses are essential for complete protection.

Updated

Dec. 15, 2020 at 9:31 am ET

A second difference concerns the ability to prevent serious diseases. Moderna presented more evidence that its vaccine can, according to the review. In his study, 30 volunteers developed severe cases of Covid. All of them belonged to the placebo group, with no cases among the vaccinated people.

In the Pfizer BioNTech study, the results were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too few to assess the vaccine’s ability to prevent serious diseases.

“The data available for these results did not allow firm conclusions,” said the FDA.

The documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only one day. Experts say people may need to take a day off after the shot.

During the Moderna trial, researchers also kept an eye out for volunteers who developed new disorders. In a multi-month study of 30,000 volunteers, it is normal for some to have conditions unrelated to the vaccine, health experts say. Comparing the rates between people receiving the vaccine and placebo, as well as general background rates, can help identify serious concerns and eliminate coincidences.

During the Moderna study, three vaccinated participants developed a form of temporary facial paralysis called Bell’s palsy, while one participant on the placebo experienced the same. Bell’s palsy, which can last weeks or longer, can be triggered by viral infections and other causes. Around 40,000 people develop the disease in the United States each year. Years of intensive research have found no evidence that any vaccine routinely recommended in the US causes Bell’s palsy.

In the review released Tuesday, the FDA said, “There is insufficient information currently available to establish a causal relationship with the vaccine.”

The Pfizer BioNTech study identified four cases in the vaccine group, including one in a person with a history of the disorder and none in the placebo group.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said in an interview with JAMA Monday that the cases of Bell’s palsy in the study were most likely not caused by the vaccine and that the apparent difference between the two groups of volunteers was only one reason Random question.

“Our working hypothesis is just that this is an imbalance in the background rates, as we’ve seen in other studies,” he said.

In its analysis of the Moderna vaccine released Tuesday, the FDA said it plans to recommend prosecuting Bell palsy cases when the vaccines are rolled out.

“We’re going to ask about this just to wrap up that question,” said Dr. Marks on Monday.

The FDA’s analysis did not reveal any serious allergic reactions to the Moderna vaccine. The same was true for the Pfizer-BioNTech clinical trial, but when vaccinations began in the UK outside of that study, two people with a history of serious allergies had a severe and potentially life-threatening reaction called anaphylaxis.

UK health officials have said people with a history of anaphylaxis should avoid the Pfizer BioNTech vaccine.

In the United States, the Centers for Disease Control and Prevention has stated that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

Moderna and Pfizer-BioNTech vaccines are similar in their ingredients, but not identical. Therefore, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA that is enclosed in a bladder made of a mixture of fats. The two companies use different fats.

Moderna has applied for approval to vaccinate people aged 18 and over, as in its study. The Pfizer BioNTech vaccine was approved for people aged 16 and over because the study included a number of younger volunteers. Both companies are conducting experiments with children aged 12 and over and plan to also study younger children.

Sharon LaFraniere contributed to the coverage.

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London to maneuver into prime tier of restrictions

London to move into top tier of restrictions

Commuters walk the Thames Path with a view of Tower Bridge in London, UK on Monday 14 December 2020.

Hollie Adams | Bloomberg via Getty Images

LONDON – London is being placed in England’s toughest coronavirus restrictions on Wednesday morning from midnight after a rapid surge in Covid-19 infection rates.

Health Secretary Matt Hancock confirmed the move on Monday when addressing lawmakers in the House of Commons. He said UK authorities had identified a new variant of the virus that could be linked to the faster spread of cases in the south-east of England.

“Initial analyzes indicate that this variant is growing faster than the existing variants,” said Hancock, adding that 1,000 cases of the new variant have been identified in England so far.

“There is currently no evidence that this variant is more likely to cause serious illness and, based on the latest clinical recommendations, it is highly unlikely that this mutation will not respond to a vaccine.”

Hancock said similar variants of the coronavirus had been identified in other countries in the past few months and that UK health officials had notified the World Health Organization. Public health experts would continue to analyze the newly identified variant of the virus in the UK, Hancock said.

Earlier this month the government put in place a three tier system of public health measures across England to contain the spread of the outbreak after a month-long lockdown.

At the time, millions of people across the country were placed in “Tier 3” but the UK capital was placed in the second highest level of restrictions.

A nationwide review of the tiered system was originally scheduled for December 16.

In addition to London, parts of Essex and Hertfordshire will move into “Tier 3” from 00:01 London time on Wednesday.

Health Secretary Matt Hancock arrives at the BBC Broadcasting House in London to appear on the Andrew Marr Show.

Aaron Chown | PA Images via Getty Images

“I know this is difficult news and I know that it will disrupt plans and that it will be a severe blow to the companies affected,” said Hancock.

“But this measure is absolutely necessary, not only to keep people safe, but because we have seen that taking action early can help prevent more damaging and longer-lasting problems later,” he added.

What does tier 3 mean?

Under Tier 3 restrictions, people cannot mix indoors, in private gardens, or in most outdoor locations.

Shops, gyms, and personal care services such as hairdressers are allowed to stay open, but bars, pubs, and restaurants must be closed except for takeaway and delivery.

“I know these steps are difficult, but we mustn’t waver when we hit the final stretch. When we look back on this period of crisis we can all say we played our part,” said Hancock.

Last week, the UK became the first country to vaccinate people with a coronavirus treatment that has been fully tested.

Margaret Keenan, then 90, made history as the first person in the world to receive the Pfizer BioNTech vaccine outside of the experimental conditions.

It is now being given out to front-line health workers, nursing home workers and those over the age of 80 before it becomes more widespread among the UK population.

It is hoped that a safe and effective vaccine can help end the coronavirus pandemic.

To date, more than 72.3 million people worldwide have become infected with Covid-19, with 1.61 million deaths, according to Johns Hopkins University.

– CNBC’s Holly Ellyatt contributed to this report.

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Health

Fruit Flies Are Important to Science. So Are the Employees Who Hold Them Alive.

Fruit Flies Are Essential to Science. So Are the Workers Who Keep Them Alive.

The rooms of the Bloomington Drosophila Stock Center at Indiana University are lined with identical shelves from wall to wall. Each shelf is filled with uniform frames and each frame with indistinguishable glass bottles.

However, the tens of thousands of fruit fly species in the vials are each very different. Some have eyes that fluoresce pink. Some will jump if you throw a red light on them. Some have short bodies and iridescent curly wings and look “like little ballet flats,” said Carol Sylvester, who helps with grooming. Each strain is also a unique research tool, and it has taken decades to introduce the traits that make them useful. If left unattended, the flies will die in a few weeks and destroy entire scientific disciplines.

During the Covid-19 pandemic, workers from different industries held the world together and took great personal risk to care for sick patients, maintain supply chains, and feed people. However, other important professions are less well known. Dozens of employees come to work at the Stock Center every day to serve the flies that support scientific research.

For most casual watchers, fruit flies are tiny dots with wings that hang near old bananas. Over the past century, researchers have turned the insect – known in science as Drosophila melanogaster – into something of a genetic switchboard. Biologists regularly develop new “fly strains” in which certain genes are switched on or off.

Studying these light mutants can show how these genes work – including in humans, as we share more than half of our genes with Drosophila. For example, researchers discovered what is now known as the hippopotamus gene – which helps regulate organ size in both fruit flies and vertebrates – after flies with a defect in them became unusually large and wrinkled. Further work with the gene has shown that such defects can contribute to the uncontrolled cell growth that leads to cancer in humans.

Other work with the flies has shed light on diseases from Alzheimer’s to Zika, taught scientists about decision making and circadian rhythms, and helped researchers win six Nobel Prizes. Over a century of optimizing fruit flies and cataloging the results has made Drosophila the best characterized animal model we have.

It’s a big part of a humble mistake. “When I try to tell people what I’m doing, the first thing they usually say is, ‘Why should you keep fruit flies alive? I’m trying to kill her! “Said Ms. Sylvester, who has been a Bloomington warehouse keeper since 2014.

When a couple of hitchhikers come to her house from the grocery store and their children rape her, she added, “Mom, you brought your coworkers home from work.”

The Bloomington Drosophila Stock Center is the only facility of its kind in the United States and the largest in the world. It is currently home to over 77,000 different types of fruit flies, most of which are in high demand. In 2019, the center shipped 204,672 fly vials to 49 laboratories States and 54 countries, said Annette Parks, one of the center’s five lead investigators.

It’s “one of the jewels we have in the community,” said Pamela Geyer, a University of Iowa stem cell biologist who has been ordering flies from the storage center for 30 years.

Other model organisms can be frozen for long-term storage in certain life stages. Laboratory freezers around the world hold mouse embryos and E. coli cultures. But fruit flies cannot go on ice. Taking care of the creatures means turning them over regularly: they are transferred from an old vial to a clean vial that has been supplied with plenty of food. Under quarantine with other members of their species, the flies mate and lay eggs that hatch, pupate and reproduce and continue the cycle.

“We have strains in our collection that have been continuously propagated this way since about 1909,” said Cale Whitworth, another senior investigator at the camp center, across generations and institutions. To keep the millions of Drosophila on their toes, the center employs 64 storekeepers plus a media preparer – think fly food cook – as well as a kitchen assistant and five dishwashers.

In the camp center, as everywhere, the first movements of the pandemic felt threatening. “I remember joking with people:” We are the people at the beginning of the dystopian novel, and we still don’t know what’s coming, “said Ms. Sylvester.

As the number of cases increased, Dr. Whitworth got a bag with a pillow and a toothbrush and imagined the worst. “I was in the ‘everyone is sick, last man on earth’ business,” he said. “How ‘How many flies can I fly in a period of 20 hours, sleep for four hours and keep turning the next day?'”

When Indiana University closed on March 15, the warehouse center remained open.

Kevin Gabbard, the fly food chef, made an emergency shop. Although they eat the same thing every day – a yeast puree made primarily from corn products – flies can be picky. Risking nothing, Mr Gabbard ordered two months of her favorite brands. “They think cornmeal is cornmeal,” he said. “But it’s not when it’s not right.”

The co-directors developed a more robust Hail Mary plan that would enable them, if necessary, to “keep most flies alive with just eight people,” said Dr. Whitworth. They also decided to stop all supplies and focus their energies on looking after flies.

On March 26th, the flies stopped leaving the building – and news of support came in almost immediately. “You are all amazing,” read an email. “The fly community is strong because of the phenomenal work you do.”

At around the same time, employees had a choice. They were considered essential workers and were allowed to come on campus. The university guaranteed them full pay even if they decided to stay home or an hour and a half to get in. (The center covers its costs through a combination of federal grants from the National Institutes of Health and its own income from sales of flies.)

The vast majority chose to keep working, said Dr. Whitworth – although suddenly the job was very different. The center is usually a very social place to work with birthday parties and group lunches. Working hours are usually flexible, a big selling point for employees, many of whom are parents, students, or have retired from full-time work.

Now people work in masks, often in separate rooms. Relocations in one of the buildings in the center were strictly planned to avoid overlap. “You can work alone for quite a while, maybe all day,” said Roxy Bertsch, who has been a warehouse keeper since 2018.

And for the first few weeks, the warehouse keepers – many of whom do additional duties like packing, shipping, and training – spent all of their time turning flies, which is monotonous and tough on the hands. “We just came in, fed flies and left,” said Ms. Bertsch.

But she kept going back. After her son may have been exposed to the coronavirus and she had to quarantine herself, she counted down the 14 days before she could return.

“There’s no way to keep me from work when I could be here,” she said.

Ms. Sylvester specializes in caring for flies whose mutations mean they will need additional DC. She also worked full time during the entire shutdown, borne by the care for her protégés. “Most of the time, I just love the flies and don’t want them to die,” she said. “I never thought I would love larvae so much.”

In mid-May, the center began shipping inventory again. Dr. Parks relayed another series of messages, many of which were now relieved.

“Feels like Christmas,” tweeted a laboratory at Aarhus University in Denmark with a photo of a box of vials.

A message in the spring from Tony Parkes, a biologist at Nipissing University in Ontario, had praised those “who do their job with few awards, but on which everyone counts as a basic backbone”.

When Dr. Parkes’ laboratory paused, he spent some of his unexpected downtime thinking about the storage center. It is a balance, he said, that enables even small laboratories to answer big questions “without using large resources”.

Plus, researchers can literally share their discoveries with one another. “You don’t need to have your own library to access all of this information,” he said, since the storage center is “there whenever you want.”

The people who keep the center going are also thinking about it. “It means a lot to know that you are part of it,” said Ms. Bertsch.

But it increases the pressure. “We all feel this great weight in making sure the storage center is there for everyone,” said Dr. Whitworth.

The pandemic continues, of course, and further obstacles loom. Although the fall semester has passed without incident, cases are increasing in the region, increasing the potential for another shutdown. Post delays at home and abroad have led the center to point out that their customers are turning to private freight forwarders – flies die if they’re on the road too long.

Although they are no longer paid extra, they all keep coming back to work. And even if things change, Dr. Whitworth ready. “I never unpacked my bag,” he said. “It’s still in the closet.”

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New Jersey Gov. Phil Murphy optimistic on rollout

New Jersey Gov. Phil Murphy optimistic on rollout

Democratic Governor Phil Murphy was optimistic about the launch of a Covid-19 vaccine in New Jersey on Monday, but urged state residents to continue to follow public health protocols as hospital admissions increase.

“We’re still in the thick of it,” Murphy said on CNBC’s “Squawk Box”. The vaccine distribution “is really good news, but I think the next six or eight weeks will be very difficult in New Jersey and our country.”

“There’s a lot of fatigue, a lot of private diffusion, lots of holidays, cold weather – all of this is conspiratorial. In the near future, I’d just … ask people to do the right things and keep their watch,” Murphy added.

The governor’s comments came when the first Americans were vaccinated against Covid-19 outside of clinical trials. The Food and Drug Administration issued an emergency clearance for the vaccine from Pfizer and BioNTech on Friday, which kicked off the complex logistics network that allowed health care workers in several states to take their first admissions on Monday morning.

In New Jersey, the first vaccinations for hospital staff will be given Tuesday morning at Newark University Hospital, according to Murphy. The state will initially receive 76,000 doses, which is enough for 38,000 people to get vaccinated as it requires two shots. From there, Murphy said the state will receive “an increased allotment” of Pfizer BioNTech doses each week “until it plateaus” earlier this year.

Murphy also noted that Moderna’s Covid-19 vaccine could soon be approved. The FDA meeting was held later that week to review the emergency approval application. In this case, New Jersey expects “another string of shipments over time,” Murphy said.

The rollout of a coronavirus vaccine in New Jersey and across the country is at a critical juncture. The 7-day average of daily new infections in the US is at a record high of 213,748, according to a CNBC analysis of data compiled by Johns Hopkins University. The 7-day average of Covid-19 deaths per day is 2,403, according to CNBC analysis, which is also an all-time high during the pandemic. That’s 9% more than a week ago.

Hospital stays are increasing in 24 states, including New Jersey and Washington, DC, according to a CNBC analysis of data from the COVID Tracking Project run by journalists at The Atlantic.

Murphy said he understand Americans are tired of pandemic restrictions and said, “I know it stinks. Who doesn’t get tired, including yours?” However, he urged people to hold small holiday gatherings among individuals “in your bladder” in December, continue to wear face masks, and maintain social distance.

“It’s basic principles to rely on. New Jersians were exceptional. We just need one more kick, especially if we get through the holiday season,” Murphy said.

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Did You Get the Coronavirus Vaccine, or Are You Planning To?

Did You Get the Coronavirus Vaccine, or Are You Planning To?

With the approval of the Food and Drug Administration, Pfizer is shipping doses of its coronavirus vaccine to hospitals across the country this week.

Health care workers have already started taking the pictures and most nursing home residents will have them next week. Other priority groups – likely a combination of key workers, people aged 65 and over, and people at high risk for disease – are expected to gain access sometime in January.

The New York Times reporters writing about the vaccine would like to hear – or try – your experience with the vaccine. We also want to know if receiving a vaccine changes your daily behavior or your attitudes about going out in public and interacting with others.

We will not publish any part of your submission without contacting you first.

Required fields are marked with an asterisk.

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Not all seniors will get Covid vaccine rapidly. Most should wait

Not all seniors will get Covid vaccine quickly. Most will have to wait

Ergin Yalcin | E + | Getty Images

For the nation’s oldest seeking protection from Covid, the waiting game has begun.

Shipments of 2.9 million doses of the first U.S.-approved coronavirus vaccine began on Sunday and resulted in hundreds of locations across the country. Because initial supply is limited – the total US population is around 330 million – the Centers for Disease Control and Prevention recommend that priority be given to healthcare workers and residents of long-term care facilities during this first phase.

In other words, without the elderly in these facilities – including nursing homes and the like – the 65-year-old and the elderly may need to be patient.

“Seniors might start vaccinating in the first quarter, but it really will depend on how quickly the supply increases,” said Jennifer Kates, senior vice president and director of global health and HIV policy for the Kaiser Family Foundation.

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The Food and Drug Administration on Friday approved Pfizer and BioNTech’s coronavirus vaccine for emergency use in people aged 16 and over. One from Moderna could also get similar approval from the FDA in the coming days.

“If the Moderna vaccine gets approved this week, it will help because there will be more coverage,” Kates said.

According to a CDC advisory committee, demand is expected to outstrip supply in the first few months of the vaccination program. Although the vaccine will be phased out and administered to prioritize the most vulnerable populations, it is not certain how long it will take to cover each of these audiences.

According to a new Kaiser study, 19.7 million adults work in the healthcare sector, of which 15.5 million have direct patient contact. Around 2 million people live between nursing homes and assisted living facilities.

Introducing the Pfizer vaccine is a complex federal and state undertaking. Not only does the vaccine need to be stored at subzero temperatures and handled according to strict protocols, but it also requires two doses three weeks apart.

While Medicare – which insures a large proportion of the 65-year-olds and the elderly – recently changed its rules to fully cover a fast-moving vaccine, individual states are tasked with actually distributing the doses and identifying priority populations to be vaccinated. All states generally follow federal recommendations for their initial audiences, Kates said, adding that some have an expanded list of priorities.

What [the advisory committee] In reflection it has been said that they are very likely to recommend that key workers come next, then seniors and those with existing medical conditions.

Jennifer Kates

Senior Vice President at the Kaiser Family Foundation

It is uncertain which groups the CDC will recommend for prioritization after the first round of reporting or whether an earlier target of 20 million people vaccinated by the end of the year will be achieved. However, the Agency’s Advisory Committee on Immunization Practices last month suggested that the next priority population should be people 65 and over, critical workers, and those with underlying medical conditions who are at higher risk for Covid complications.

“What [the advisory committee] has said on reflection that they are very likely to recommend that key workers come next, and then seniors and those with existing medical conditions, “Kates said.

If these three populations focused on health care workers and residents of long-term care facilities, an estimated 87 million vital workers, more than 53 million people aged 65 and over, and 100 million would be targeted with high-risk medical conditions, Kaiser finds in new research.

Availability also depends on how many doses each state is receiving, which is currently based on each state’s adult population. However, there aren’t the same proportions of audiences across all states – for example, some have more health care workers while others have more nursing home residents, Kates said.

“It’s possible that some of the initial assignments might not match,” Kates said.

According to the latest data from Johns Hopkins University, the pandemic has killed at least 299,191 people in the United States, with the number of cases over 16.25 million. These numbers account for around 19% of the 1.6 million Covid deaths worldwide and 23% of the 72.3 million cases worldwide.

CDC data shows that of approximately 262,000 Covid deaths as of December 9, more than 209,000 people were 65 years of age or older. Overall, residents of long-term care facilities have caused about 40% of deaths in the United States from Covid to date, according to the CDC.

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Listening to Aids Might Use Some Assist

Hearing Aids Could Use Some Help

But Dr. Lin said, “Most of what you see out there – ’50 dollar wonder device! ‘ – is complete rubbish. People can’t tell who to trust. “

However, once the state requirements for over-the-counter hearing aids are established, manufacturers of high-quality PSAPs can apply for approval. “All other PSAPs will fall by the wayside,” said Dr. Lin. If their labels say they’re not FDA approved, “Nobody is going to buy them, and they shouldn’t.”

In the face of a huge and underserved market, consumer electronics companies (allegedly Apple and Samsung) as well as startups stand ready. “There’s a lot of venture capital into hearing technology once the barriers come down,” said Dr. Rathi.

Bose acted early and received FDA approval in 2018 for its Hearphone, which the buyer could set with a smartphone app. But without the new rule, government restrictions would have prevented national sales so Bose wouldn’t market them.

However, the company is working on a new over the counter product. “We are cautiously optimistic that 2021 will be the year,” said Brian Maguire, director of the Bose Hear Group.

Once the FDA takes action and companies and retailers ramp up, expect new products and advertisements to appear in stores and online. “We’re going to have some Wild West time,” said Ms. Kelley. “People will be confused. You will need a lot of information. “

From this point onwards, audiologists will no longer act as exclusive gatekeepers for hearing aids. But they can still provide important services: testing, education and advice, adapting devices – even if customers bought them elsewhere.

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Pfizer negotiating with U.S. to supply a further 100 million doses, CEO says

Pfizer negotiating with U.S. to provide an additional 100 million doses, CEO says

Vials in cartons containing the Pfizer-BioNTech Covid-19 vaccine are being prepared for shipment on December 13, 2020 at Pfizer Global Supply’s Kalamazoo manufacturing facility in Kalamazoo, Michigan.

Morry Gash | AFP | Getty Images

Albert Bourla, CEO of Pfizer, said the company is negotiating with the federal government to provide an additional 100 million Covid-19 vaccine doses next year, as Americans will receive some of the first shots on Monday.

Pfizer and the US are working out timing details, Bourla said Monday morning in an interview with CNBC’s “Squawk Box”. The company could provide many of these cans in the third quarter of 2021, but the U.S. government is pushing for them in the second quarter, he said.

“We are working very cooperatively to find a solution and allocate that 100 million [doses] in the second quarter if possible or in many of them, “Bourla said, adding the company has not yet signed an agreement with the US.

The comment came after the Food and Drug Administration approved Pfizer and BioNTech’s emergency coronavirus vaccine late Friday. The vaccine has been approved for people aged 16 and over.

The first doses of a Pfizer vaccine with BioNTech were shipped to the US over the weekend. Trucks carrying boxes of vaccine doses left Pfizer’s Kalamazoo, Michigan manufacturing facility on Sunday and should arrive on Monday, according to Pfizer. The company said 189 boxes for a total of 184,275 cans will be shipped to locations in all 50 states and 4 boxes will be shipped to US territories. The vaccine consists of two doses, with the doses given three weeks apart.

Initial doses of the Pfizer vaccine will be limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The vaccine is expected to be distributed in phases where the most critical U.S. workers and vulnerable people receive it first. The CDC has given states an outline recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.

General Gustave Perna, who oversees logistics for Operation Warp Speed, said Wednesday the government would distribute 2.9 million doses of the vaccine within 24 hours of FDA approval, followed by another 2 , 9 million doses 21 days later for patients to get their second shot. Pfizer’s vaccine takes two doses three weeks apart.

Pfizer has already signed a contract with the U.S. government to supply 100 million doses of the vaccine under the Trump administration’s Operation Warp Speed ​​vaccine program, enough to vaccinate 50 million people. Under the agreement, the Americans will receive the vaccine for free.

The previous Monday, Pfizer board member Dr. Scott Gottlieb told CNBC that the US government turned down an offer to receive additional doses of the Pfizer vaccine in November.

The vaccine couldn’t come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even grimmer records. The director of the Centers for Disease Control and Prevention, Dr. Robert Redfield, warned earlier this month that the next few months of the pandemic would be “some of the most difficult in the history of this country’s public health.”

President Donald Trump previously said he would invoke the Defense Production Act if necessary to ensure Americans can get a vaccine.

Bourla said Monday it was “very positive,” he said. “I hope they will do that very soon as we are facing critical delivery restrictions on some components in particular. But I think they will, so it won’t be a problem.”

– CNBC’s Spencer Kimball contributed to this report.

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Enhancing Your Stability to Stop Falls

Improving Your Balance to Prevent Falls

The 70-year-old Locker explained, “Posture retraining exercises use the body’s own weight to move the postural muscles to balance the body.” The exercises are isometric; There is no movement. Rather, the postural muscles are tensed and the tension is maintained for as long as possible, building strength in both the muscles and bones.

While I am usually very skeptical of such advice from a non-specialist with no degree in physiotherapy, kinesiology, rehabilitation medicine, or exercise training, one paragraph in Mr. Locker’s book convinced me:

“Walking on a flat surface is not stressful,” at least not as Mr. Locker defines it, because it does not train postural muscles. “The knee tends to lock when the foot hits the ground, and the foot doesn’t stay on the ground for more than a moment. Hence, walking, while wonderful and healthy, does not improve balance. Walking a rocky Adirondack trail with both legs constantly bent for balance is stressful. “

I immediately referred to this description. I spent most of last summer in the lower Catskills, hiking my dog ​​over rocks and roots on uneven trails for an hour or more every other morning. In the first two weeks of July, I felt very insecure and fell twice. But with every trip I got safer and by the end of summer my balance and stability had improved noticeably. Even when I was jostled by a dog on a rocky surface, I easily remained stable and upright.

While many people are unable to train their postural muscles by hiking in the woods, Mr. Locker describes exercises that people can safely perform at home using their own bodies as equipment. No gym or equipment is needed, not even an exercise band. Basically, the feet learn to be more firmly attached to the ground as the body weight moves within a support base.

“In tai chi,” noted Locker, “we don’t move to achieve balance. First we balance, then we move. “Balance is not subject to conscious control, but it can be improved with use and decreased with non-use, he explained. “The key to balance and stability in humans is the ability to create a downward force that goes beyond body weight. Thus, neither a statue nor a surfer who is stiff as a statue can stay upright on a surfboard. “

A Sample Lesson: You’ve probably heard advice on improving balance by standing on one leg while brushing your teeth. A far better plan is to flex the knee and ankle of the leg you are standing on to activate the postural muscles. At the same time, the pelvic muscles remain relaxed. If extra assistance is needed, use the fingertips of one hand on the sink or wall. Note, however, that the goal is to stand without support and only use the wall as a counterbalance.

Another simple exercise is to stand straight with your hamstrings and glutes relaxed, and then bend your knees and ankles as if you were sitting in a high chair. Keep your spine straight and your pelvis relaxed. Hold this position for as long as possible, gradually increasing the time as your postural muscles get stronger, up to 15 minutes.

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Health

Recipes for Chocolate Truffles – The New York Occasions

Recipes for Chocolate Truffles - The New York Times

Slightly uneven little balls dusted with cocoa to simulate the bottom of a freshly dug mushroom – the black tuber melanosporum – define a chocolate truffle in its most basic form. Inside there is a firm but velvety center, a confection called ganache. Truffles are never cheap, but before taking the credit card out, consider the homemade variety. They couldn’t be easier to manufacture and don’t require special equipment. Under supervision, an 8-year-old can sculpt and dive truffles for a nice afternoon activity.

In addition to the classic version with a cocoa coating, chocolate truffles are often wrapped in a chocolate shell, which is sometimes decorated with nuts, frosting, and even gold leaf. Their taste can also be varied depending on whether you go for dark, milky, or white chocolate, adding ingredients like raspberry puree, nuts and coffee, or spirits like port, brandy and even champagne. Size also plays a role. Chocolate truffles should be just one bite and no more than an inch in diameter – three-quarters of an inch is ideal.

Time: 4 hours including chilling

Yield: approx. 40

6 ounces high quality semi-sweet or bittersweet chocolate, 70 percent cocoa

½ cup of heavy cream

3 tablespoons of ruby ​​port or grape juice

½ cup of unsweetened cocoa using the Dutch method

1. Cut the chocolate into small pieces, place in a small, heavy saucepan and add the cream. Place on low heat, stirring occasionally, until the chocolate has melted. Remove from heat, stir in port wine or juice; put in a bowl. Cover and refrigerate until mixture is firm, about 2 hours.

2. Spread a sheet of waxed paper or parchment paper on a baking sheet. Have a bowl of ice water ready. Use a spoon or spoon or melon baller to scoop up mounds of mixture about 3/4 inch in diameter. Roll lightly between the palms of your hands to form beautiful balls and place them on the paper. Occasionally moisten the spoon and your hands with ice water to keep the chocolate from sticking. Chill until firm, about 2 hours or overnight.

3. Spread the cocoa on a chilled plate. Take the truffles out of the refrigerator, roll them each in cocoa and place them back on the baking sheet. Cool to firm. Truffles can be frozen for up to a week.

Time: 6 hours including chilling

Yield: approx. 40

6 ounces high quality semi-sweet or bittersweet chocolate, 70 percent cocoa

½ cup of heavy cream

3 tablespoons of prosecco

½ pound high quality white chocolate to coat

1. Break the dark chocolate into small pieces, transfer them to a small, heavy saucepan and add the cream. Place on low heat, stirring occasionally, until the chocolate has melted. Remove from heat, stir in the prosecco and place in a bowl. Cover and refrigerate until mixture is firm, about 2 hours.

2. Spread a sheet of waxed paper or parchment paper on a baking sheet. Have a bowl of ice water ready. Use a spoon or spoon, or a melon baller, to scoop up mounds about 3/4 of an inch in diameter. Roll lightly between your palms to make beautiful balls and put them on paper. Occasionally moisten the spoon and your hands with ice water to keep the chocolate from sticking. Chill until firm, about 2 hours or overnight.

3. Break white chocolate into pieces and melt on top of a double boiler or place in a microwave-safe bowl and microwave at 50 percent power for 1 minute, stirring every 15 seconds. Let the chocolate cool to about 90 degrees at room temperature and stir it from time to time. Drop chilled truffles one at a time into melted chocolate and quickly lift them out with a small fork or professional wire dip loop to allow excess water to drain off. Place on a baking sheet and store in the refrigerator for about 2 hours.