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Who will make coronavirus vaccines for the developing world? India holds the key.

Health & BeautyNov 11. 2020

By The Washington Post · Joanna Slater · WORLD, HEALTH, ASIA-PACIFIC 
NEW DELHI – Adar Poonawalla is an Indian billionaire whose family-owned firm makes more vaccines a year than any other company on Earth. Ask him about the race for a coronavirus vaccine and he will offer some unvarnished opinions.

One prominent vaccine candidate is “a joke” that will not work for the developing world. Anyone who declares how long a vaccine will confer immunity is talking “nonsense.” The world’s entire population will not be immunized until 2024, he says, contrary to rosier predictions.

Poonawalla is equally frank about the gamble his company, Serum Institute of India, is making in the pandemic. He is putting $250 million of his family’s fortune into a bid to ramp up manufacturing capacity to 1 billion doses through 2021.

“I decided to go all out,” said Poonawalla, 39. Among the initial skeptics: his father, Cyrus, the company’s founder. “He said: ‘Look, it’s your money. If you want to blow it up, fine.’ “

It is a bet with global repercussions. In the quest for effective coronavirus vaccines, India is poised to play a critical role in supplying the developing world, which is starting the race with a distinct disadvantage.

Wealthy countries have already grabbed a major chunk of the available supply. The United States, the United Kingdom, Japan and Canada have struck deals large enough to vaccinate their entire populations. By contrast, a pooled global effort to distribute vaccines equitably to more than 150 countries – including dozens of low-income nations – has secured only 700 million doses.

Pfizer, which announced stellar early results for its vaccine candidate Monday, has not struck any deals to supply its product to developing countries, according to an analysis of publicly available data by Airfinity, a research firm in the United Kingdom. Pfizer’s vaccine must also be stored at ultra-cold temperatures, a major challenge in much of the world.

Rich nations are “all cutting in line and hoarding vaccine supply to immunize as many people as possible, even if this leaves other countries unable to immunize those at highest risk,” said Nicholas Lusiani, a senior adviser at Oxfam America, a nonprofit group devoted to fighting poverty.

Enter Indian vaccine makers, led by Serum Institute, the largest manufacturer in the world by volume. Well before the pandemic, India was a “vaccine powerhouse” specializing in affordable exports to low- and middle-income countries, said Andrea Taylor, an assistant director at the Duke Global Health Innovation Center.

Taylor said countries such as Brazil and China also have manufacturing capacity, but she singled out Indian vaccine makers because they moved so quickly to form tie-ups with global companies and increase their own production. India is “going to be the absolute star in the story,” she said.

Anthony Fauci, the top infectious-disease specialist in the United States, shared that sentiment during a panel earlier this year. India’s manufacturing capability is “going to be very, very important” as effective vaccines emerge, he said.

Four major pharmaceutical companies – AstraZeneca, Novavax, Johnson & Johnson and Sanofi – have reached agreements to produce at least 3 billion vaccine doses for low- and middle-income countries, Airfinity’s research shows. Serum Institute is set to manufacture more than two-thirds of those doses.

Some of the agreed-upon supply to low- and middle-income countries will come through the pooled initiative backed by the World Health Organization, known as the Covid-19 Vaccines Global Access Facility, or Covax. Covax includes higher- and lower-income countries, more than 150 in total. The United States declined to join.

Covax is being co-led by Gavi, a nonprofit vaccine alliance. In September, Gavi announced a partnership with the Bill and Melinda Gates Foundation to pay Serum Institute in advance for 200 million vaccine doses, at a cost of $3 each, to be distributed in developing countries, hopefully in early 2021. The $600 million infusion will help Serum ramp up production.

Gavi and the Gates Foundation “want to assure vaccine supply at an affordable price,” said Poonawalla, Serum’s chief executive. His aim, meanwhile, is to cover some of his costs. “At least my risk is taken away so I can sleep at night,” he said.

The partnership with Serum, given its size, is “crucial” to Gavi’s larger goal of ensuring that no country is left behind in the quest for vaccines, said Dominic Hein, who works on Gavi’s efforts to make vaccines more readily available in low-income countries.

Under the agreement, more than 60 countries – largely in Africa and Asia – would receive the vaccine developed by Oxford University and AstraZeneca or the vaccine under development by Novavax.

Serum Institute has struck deals to manufacture both vaccines, which are in Phase 3 trials. It has also inked deals to make two other vaccines, developed by the American biotechnology company Codagenix and Britain’s SpyBiotech, and is working on its own vaccine candidate that it hopes will enter trials late next year. While the Indian company has reached manufacturing agreements with American companies such as Novavax and Codagenix, it is not currently exporting its vaccines to the United States.

India has recorded the second-highest number of coronavirus cases in the world – more than 8.5 million. Those numbers mean India is a crucial market for future vaccines and an effective place to test them.

Advanced clinical trials of three vaccine candidates are underway in India: the AstraZeneca vaccine and vaccines developed by two Indian pharmaceutical companies, Zydus Cadila and Bharat Biotech. An Indian company is also starting clinical trials of Russia’s vaccine candidate, Sputnik V.

“Whether India makes a vaccine by itself or not, from a manufacturing standpoint, it’s going to be playing a very, very important role,” said Mahima Datla, managing director of Biological E., a 67-year-old vaccine producer based in the city of Hyderabad. Datla also sits on the board of Gavi.

India’s health minister recently predicted that the country would be in a position to start distributing a vaccine within the next six months. The government is working on a plan to immunize as many as 250 million people by July, he said.

Reaching that goal will require the manufacturing heft of Serum Institute. The company has diverted capacity from existing vaccines and started work on a new production facility to be completed next year at its headquarters in the western Indian city of Pune.

Poonawalla said the company has pledged to keep half of the vaccines it makes for use within India. It has already begun manufacturing the AstraZeneca vaccine, he said. About 20 million doses have been made, and he expects to have 10 times that amount ready in the next four months.

He is optimistic that in 2021, a new coronavirus vaccine will be licensed for public use every couple of months. “That’s the good news,” Poonawalla said. The less-good news is that it remains unclear which vaccine, if any, will offer long-term protection from the virus. “Nobody wants a vaccine that is only going to protect you for a few months,” he said.

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Trump officials promise fair distribution of new covid-19 antibody drug, but limited supply and logistical problems loom

Health & BeautyNov 11. 2020

By The Washington Post · William Wan · NATIONAL, POLITICS 
WASHINGTON – Trump administration officials Tuesday promised to fairly and swiftly distribute the first covid-19 treatment that helps to protect people with mild illness from developing severe symptoms. But the drug’s extremely limited supply and logistical difficulties in administering it could restrict how many people get access to it.

The Eli Lilly & Co. drug is similar to an experimental treatment President Donald Trump received when he was infected with the novel coronavirus. It is a laboratory-brewed antibody that imitates the immune system’s attack on the virus.

The federal government Monday granted emergency use authorization for the drug, seen as a powerful tool that could save people from developing the worst symptoms of covid-19 until a vaccine against the novel coronavirus is widely available.

The federal government has more than 80,000 doses ready for allocation and distribution this week, Health and Human Services Secretary Alex Azar said in a briefing Tuesday. The medication “has the potential to save thousands of lives and significantly reduce the disease’s burden on the health-care system,” he said.

The government has negotiated a contract to buy 300,000 doses through December, with an option to buy 650,000 more through June. But that comes as the nation records more than 100,000 new coronavirus cases each day.

Because of the limited supply, the number of doses each state receives will be determined by the number of confirmed cases and hospitalizations in a given week, federal officials said.

For example, this week, Vermont – with among the fewest cases – will receive only 20 doses. Meanwhile, South Dakota, where the virus is spreading uncontrollably, will get 820. Each week’s allocation will be made on a Wednesday.

By allocating the drug this way, officials hope to drive down hospitalizations because fewer patients will progress from mild symptoms to severe illness.

Federal officials said that before they order more medication for next year, they need to see whether hospitals have the staffing and capacity to give patients the drug, known as a monoclonal antibody.

The medication, bamlanivimab, must be delivered by intravenous infusion early in the illness. It is authorized for patients with mild or moderate cases of covid-19, the illness caused by the novel coronavirus, who also are at high risk of severe disease or hospitalization. Risk factors include being older than 65, having diabetes, obesity with different body mass index cutoffs depending on age, a suppressed immune system, and cardiovascular disease or high blood pressure in people over age 55.

But getting the drug to patients is a challenging proposition. It must be given over the course of an hour.

The Trump administration on Tuesday sent guidelines addressing those problems to hospitals and states. A government document on payment policy released last month mentions that providers could give the drugs in “temporary expansion sites, such as an erected tent, a retrofitted convention center, or the beneficiary’s home.”

“This is something we’ve never done before on this scale,” said Jeanne Marrazzo, the director of the infectious-diseases division at the University of Alabama at Birmingham. “You don’t just need the facilities, but the dedicated staffing to administer this drug. And a lot of hospitals are going to be trying to do this at a time when cases are shooting up and straining capacity in their system.”

Because of those challenges, some experts worry whether patients in poor and disadvantaged communities will receive equal access to the drug.

“In some populations, you have half the people who will meet that high-risk criteria, so who you give it to and how you make that decision isn’t clear,” said Helen Boucher, the chief of infectious diseases at Tufts Medical Center in Boston. “The worry is whether black and brown people get access who we know are being disproportionately affected by this disease.”

Because most people recover from covid-19 without serious symptoms, giving the drug to a general population would waste the limited supply. And the medication is not helpful to patients with severe symptoms. The FDA warned that the drug “may be associated with worse clinical outcomes” in people requiring high-flow oxygen or who are on ventilators.

“For this drug to be helpful, we have to identify and reach people quickly, and sadly, nine months into this pandemic, we have a large proportion of the country that still doesn’t have adequate testing capacity,” Boucher said.

Federal officials said they are basing distribution on a strategy similar to what is used for remdesivir, an antiviral drug administered to hospitalized patients. The Trump administration’s rollout of remdesivir was plagued by problems in its early phases. Doctors reported a confusing and unfair process, marred by incomplete medical information.

Some doses went to the wrong hospitals, to hospitals with no intensive care units and therefore having no eligible patients, and to facilities without the needed refrigeration for storage, meaning some doses were returned to the government

On Tuesday, Trump administration officials said they had learned from those mistakes.

“We’re building on lessons learned during remdesivir,” said John Redd, the chief medical officer in the office of the assistant secretary for preparedness and response at HHS. For example, allocation decisions could be made in five hours compared with a matter of days during the early days of remdesivir distribution.

Redd said the distribution of the antibody drug would be “fair, accessible, understandable and equitable.”

As with remdesivir, patients will receive the antibody drug free of charge, federal officials said, but their insurance could be charged for the administration of the medication.

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Pfizer coronavirus vaccine could be cleared by mid-December following release of data showing it is more than 90% effective

Health & BeautyNov 10. 2020A logo sits on a sign outside the headquarters of BioNTech in Mainz, Germany, on July 17, 2020. MUST CREDIT: Bloomberg photo by Alex Kraus 

By The Washington Post · Laurie McGinley, Lena H. Sun, Carolyn Y. Johnson · NATIONAL, HEALTH, HEALTH-NEWS 

The news Monday that Pfizer’s coronavirus vaccine is more than 90% effective sharply increased prospects that federal regulators will authorize the vaccine on an emergency basis as early as mid-December, and that the first shots will be administered before the end of the year or early next year.

The findings, announced by drug giant Pfizer and German biotechnology firm BioNTech, provided much-needed hope for a nation battered by surging virus cases, a stumbling economy and a bitterly fought presidential campaign. It augers well for other vaccines and could accelerate the timetable for reining in the pandemic, said scientists, who cautioned that any successful vaccine will still face obstacles, notably distribution to hundreds of millions of people.

“It’s stunning,” said Eric Topol, director of the Scripps Research Translational Institute, one of several scientists who said they were heartened by the results, which far exceeded the Food and Drug Administration’s standard that a vaccine be more than 50% effective at protecting people compared with a placebo saline shot. “We could have a rollout in December.”

Even with the welcome development, experts warned that the longed-for return to normalcy will take many months or more, and that the path is certain to contain unexpected twists and turns. Even after a vaccine is approved, they said, people will need to wear masks and social distance for some time – in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading.

As if to underscore the difficult days ahead, the United States on Monday hit the latest grim milestone in the pandemic, surpassing 10 million confirmed cases of covid-19, the disease caused by the coronavirus, along with more than 238,000 deaths.

The unchecked spread of the virus threaten to make the coming weeks and months particularly dangerous for the nation, which still has little semblance of a coherent federal strategy to stem the tide of infections. And as yet another member of the Trump administration – Housing and Urban Development Secretary Ben Carson – tested positive for the virus, President-elect Joe Biden on Monday named his coronavirus task force, made up of scientists and physicians, vowing in a speech to “follow the science” when he takes office in January. But he warned that the nation still faces “a very dark winter.”

Still, the vaccine news buoyed scientists who have spent months battling a seemingly implacable foe.

“We will be giving vaccines to people very likely before the end of this year,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, predicted on CNN.

Scott Gottlieb, a former FDA commissioner in the Trump administration and member of Pfizer’s board, said if a vaccine were authorized by mid-to-late December, it would be available for the general public late in the second quarter or early in the third quarter of next year. In addition to Pfizer, Moderna, a biotech firm using a technology similar to Pfizer’s, might apply to the FDA for authorization in the next several weeks, company officials have said.

Fauci said in a separate interview with The Washington Post that although it was too soon to predict when the world would return to normal, “The more effective a vaccine is, the quicker you get to the point where you can get a degree of immunity in the general population, to allow you to get back to some sort of normalcy.” He predicted that a highly effective vaccine means “there will be more enthusiasm” among the public about receiving it.

Still, experts said, more information is needed on the Pfizer vaccine, including how long its protection lasts, how well it protects people in specific groups such as the elderly, and whether it causes side effects. Company officials said Monday it didn’t seem to cause serious safety problems.

In announcing the vaccine data, Pfizer and BioNTech said they plan to submit an application for emergency authorization to the FDA probably the third week of November, after receiving additional information on safety and the manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of the coronavirus, which Jansen said could take a few weeks. The additional data could influence the effectiveness of the vaccine.

The agency has said it will convene its outside advisory committee to consider each vaccine application; a meeting on the Pfizer vaccine could occur in early December, with the agency making a final decision days or weeks afterward.

If the vaccine is cleared by the FDA, an advisory panel to the Centers for Disease Control and Prevention – the Advisory Committee on Immunization Practices – is expected to hold a public meeting within 24 to 48 hours to vote on how the vaccine should be used and who should get the first shots. Its recommendations will go to the CDC director for approval. After that, federal officials have said, they plan to start shipping vaccine vials as soon as possible – probably within a day or two.

Pfizer has projected having 50 million doses – enough for 25 million people – by the end of the year, and 1.3 billion doses in 2021. On CNBC, Pfizer chief executive Albert Bourla said the company was examining ways to increase production.

“We are aware that the demand will be much higher than anything we can produce. We are also looking right now to see if there are other ways, thinking out of the box, that we can increase even further the manufacturing capacity,” Bourla said.

In talking about multiple vaccine candidates, officials with Operation Warp Speed, the government initiative designed to expedite development of vaccines and therapeutics, have repeatedly projected having 100 million doses available by the end of the year, and 600 million to 700 million doses by March or April. That does not ensure that all those vaccine candidates will be proven safe and effective. Along with Pfizer and Moderna, several other companies are working on coronavirus vaccines.

The challenges in distributing the Pfizer vaccine, which must be stored at ultracold temperatures of -70 degrees Celsius (-74 Fahrenheit) can’t be overstated.

“It’s a nontrivial thing to distribute tens of millions of doses, and it has to be given twice,” said John Moore, a virologist at Weill Cornell Medicine. “We won’t be going to motor-biker rallies in the foreseeable future.”

The CDC, which is coordinating the distribution with the Defense Department, has asked states to provide a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine with these ultracold requirements. The ultracold requirement and minimum orders of about 1,000 doses mean that most doctors’ offices will not have the ability to stock it. Hospitals and other institutions that have the necessary freezer storage are likely to be the first to administer the shots.

“It needs to be a perfectly choreographed dance, and we haven’t even started rehearsals yet,” said Soumi Saha, vice president of advocacy at Premier, a major group purchasing organization for hospitals.

Limited initial doses are likely to go first to health care workers, members of the advisory committee on immunization have said. Three additional groups are likely to be close behind: essential workers, people 65 and older, and individuals with underlying medical conditions that put them at higher risk of getting very sick with covid-19.

Close to 200 million people total are in those groups, according to immunization committee estimates.

The federal government will make recommendations on who should have priority to get the vaccine, and make allocations to the states. The final decision rests with states, which have been planning in earnest in recent weeks to get shots into arms.

Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times – most vaccines will require two shots – and to monitor for adverse events.

Beth Bell, a member of the immunization committee who also chairs the panel’s covid-19 vaccines work group, said she was hopeful Americans would start having more-normal lives next summer or fall. That assumes, she said, the nation has several effective vaccines by then and that the “virus doesn’t throw us any curveballs and, very importantly, that people have confidence in the vaccination program and are willing to be vaccinated.”

If there are setbacks, “People need to be a little bit calm and to expect bumps in the road and not overreact to them,” said Bell, a global health professor at the University of Washington and former top CDC official overseeing infectious diseases. “I know we’re all sick of the pandemic . . . but we need to keep at it, go forward deliberatively and calmly.”

Peter Lurie, a top FDA official during the Obama administration, agreed much more information is needed about the Pfizer vaccine and that challenges in distributing it lie ahead. “But today is a brighter day,” he said. “And as the scientific and regulatory processes unfold, we will soon know how bright.”

The immunization committee has been holding special meetings to review data on the virus and the vaccines in development, including one last month. Members will review demographic data about the people receiving the vaccine, how different groups responded and side effects before making recommendations.

William Schaffner, an infectious-disease expert at the Vanderbilt University School of Medicine, said he hoped Thanksgiving 2021 would be far different from this year’s holiday.

“We will get back to something that is near normal, but it won’t be exactly the old normal,” he said. “This and the other vaccines won’t be a magic wand – they will be additional barriers to the transmission of the virus.”

Still, he and others said, the virus will become like the flu – it won’t go away, but humans will have learned to live with it.

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, noted that tens of thousands of people die of the flu every year, but it doesn’t end Americans’ activities.

“We live with that, I go to Eagles games,” he said. “I feel comfortable I’m not going to be one of those people who die of the flu. The question is – when will we feel that way about the coronavirus?”

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Pfizer’s coronavirus vaccine is more than 90% effective in first analysis, company reports

Health & BeautyNov 10. 2020

By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT
A front-runner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90% effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday.

https://www.washingtonpost.com/video/c/embed/3658ede2-f4cc-48ba-942e-17de469fe2d8?ptvads=block&playthrough=false

The early look at the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.

“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Hearing that at the interim analysis we are over 90% effective – it was almost stunning to hear.”

In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19, the illness caused by the coronavirus, in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy. The company’s shares soared more than 13% in premarket trading.The data is not yet published or peer-reviewed.

“The results are really quite good, I mean extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that the results might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, “which gives you hope we might even have two vaccines.”

Fauci said he had spoken with Pfizer chief executive Albert Bourla about the results, but had not yet reviewed the individual data.

The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier – and faster.

The race for a vaccine had become inextricably tied to election-year politics, and for months, outside experts had worried that Pfizer’s vaccine might be an “October surprise” pushed prematurely through the regulatory process. In the end, the data arrived nearly a week after the election, and shortly after the race was called for President-elect Joe Biden.

President Donald Trump, who had called Bourla to ask about the vaccine and previously accused regulators of a “political hit job” for slowing down a vaccine, celebrated the news. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Trump tweeted Monday morning.

The data committee noted no serious safety concerns. Jansen said the side-effect profile of the vaccine was similar to what was reported in an earlier study. That included pain at the injection site and fatigue, chills and fever – which occurred more frequently in younger trial participants than in adults over age 65.

Pfizer and BioNTech said they plan to submit an application for emergency authorization from the Food and Drug Administration after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of covid-19, which Jansen said could take a few weeks.

Vaccine development typically takes many years, even decades. But the coronavirus vaccines have been a rare success story in the response to the virus, able to move forward because of a flourishing of new vaccine technologies, a backbone of prior work on emerging pathogens and a mentality that rarely exists in the world of vaccine development – of governments and companies willing to devote nearly unlimited resources to make sure that a vaccine succeeds.

Outside experts said crucial details of the data need to be examined: How did the vaccine perform in high-risk populations, such as elderly people? Were the cases of disease mostly mild, or did the vaccine also prevent severe disease? Will the effectiveness hold up at this high level as the trial moves toward completion? How long will protection last? What do detailed safety data show?

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said the data look encouraging. The trial’s faster-than-expected progress to 94 cases, he said, was “the upside of having a virus that’s out of control.”

David Benkeser, a biostatistician at Emory University Rollins School of Public Health, said in an email that he was still digesting the news.

“It looks to be an incredibly promising result,” Benkeser wrote, noting that the two biggest questions are how long the effect lasts and how well the vaccine works to prevent severe cases of covid-19. “Both will still require more data to get a definitive answer, but for now, I think this is really good news.”

Regulators had set a far lower bar for the minimum performance of a vaccine, requiring it be at least 50% effective. The FDA has also set forth a requirement for five severe cases of the disease in the placebo group, but Jansen said that to preserve the integrity of the trial, Pfizer’s scientists remain blind to the details of the cases at this time.

The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech are working around-the-clock to scale up production, in hopes of having 50 million doses – enough for 25 million people to receive both shots – by the end of the year, and 1.3 billion doses in 2021.

The vaccine uses a new technology never before deployed in an approved medical product. Each injection contains lipid nanoparticles – fat bubbles – that surround a strip of genetic material called messenger RNA. The genetic material carries the blueprint for the distinctive spiky protein that studs the coronavirus surface. After being injected into a person’s arm, the fat capsule delivers its payload to the body’s cells, and the messenger RNA instructs those cells to build the spike protein, effectively teaching the immune system how to recognize and block the coronavirus.

Pfizer’s early signal is encouraging not just for messenger RNA, Fauci said, but as a proof of concept that vaccine candidates that present the spike protein – the approach being pursued by essentially all the major candidates – can succeed.

Pfizer, unlike its competitors, did not join Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing funding to companies and helping coordinate the trials. Instead, Pfizer plowed $2 billion of its own money into the project and then struck a $1.95 billion contract with the U.S. government to provide 100 million doses, contingent on the vaccine being effective.

Its trial initially had a more aggressive design than other late-stage studies in the United States, allowing earlier and more frequent peeks at the data. That raised concern from outside scientists that the company might seek authorization of its vaccine when there were only 32 cases among participants.

The FDA shared those concerns, according to Jansen, and urged the company to wait to do its first data look until there were more cases. Pfizer scientists were initially concerned it would take too long to reach that milestone, particularly as it appeared the pandemic might be coming under control in late summer, thus depriving the study of potentially infected participants. But Pfizer scientists amended their protocol to wait to look at the data until they reached 62 cases as the virus began to surge, and they completed that paperwork last week.

“We saw that huge upswing, we realized that maybe we should listen and come back to the suggestion of the FDA to have more cases,” Jansen said. “It just shows you the enormous uptick right now of the pandemic, that certainly it took us by surprise – how quickly it really went.”

Once the independent data committee met Sunday, there were 94 cases in the trial – meaning the study is more than halfway done.

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White House hit with fresh outbreak of coronavirus cases

Health & BeautyNov 08. 2020White House Chief of Staff Mark Meadows greets supporters during a Nov. 1 rally in Michigan. MUST CREDIT: Washington Post photo by Jabin Botsford 

By The Washington Post · Anne Gearan, Josh Dawsey · NATIONAL, HEALTH, WHITEHOUSE, HEALTH-NEWS 
WASHINGTON – The White House has been hit with a fresh wave of coronavirus infections, an administration official said Saturday, with Chief of Staff Mark Meadows and five other Trump aides having received positive test results in the period around Election Day.

Meadows, who tested positive Wednesday, at first told others not to disclose his condition. But after his diagnosis became public late Friday, the official confirmed that a broader outbreak threatens to create a new crisis in the West Wing just as Meadows and other top aides are trying to help President Donald Trump navigate a bitter loss at the polls to Democrat Joe Biden.

The official, who spoke on the condition of anonymity because they were not authorized to discuss the matter on the record, declined to name the affected aides or provide information about their conditions. In addition to the six White House staffers, a Trump campaign official said campaign adviser Nick Trainer has also tested positive.

The outbreak comes as coronavirus cases are spiking across the nation: Saturday brought more than 134,000 new cases – setting a record for the fourth day in a row – and deaths and hospitalizations are also on the rise. Biden may have won the presidency by relentlessly attacking Trump’s decision to downplay the severity of the virus and disregard basic advice from public health experts for combating a pandemic that so far has killed more than 237,000 Americans.

Meadows, for instance, has rarely worn a mask in public, has ridiculed Democratic governors for locking down bars, restaurants and other businesses. and has fought with federal science advisers about the administration’s response to the pandemic. 

The influence of health professionals such as Anthony Fauci, the nation’s top infectious-disease specialist, has steadily waned under Meadows’s management. And Meadows has supported Trump’s strategy of pressing to reopen schools and send people back to work, arguing last month on CNN’s “State of the Union” that “we’re not going to control the pandemic.”

A majority of Americans have disapproved of the president’s handling of the coronavirus almost from the start. As Election Day neared with the outbreak raging, some older voters, politically moderate women and other constituencies, blamed Trump for doing too little to blunt it.

Declared the winner on Saturday, Biden has promised that, as president, he will listen to public health experts and try to bring the pandemic under control. Trump has not conceded the election, however, and his campaign issued a statement Saturday accusing Biden of “falsely posing” as the victor. 

The White House outbreak is at least the third wave of infections to strike White House employees and residents. The first erupted in the days after a Sept. 26 Rose Garden ceremony honoring Trump’s most recent appointee to the U.S. Supreme Court, Justice Amy Coney Barrett, which Fauci called a “superspreader event.” 

Trump, first lady Melania Trump and their son Barron Trump all tested positive, and Trump was briefly hospitalized. Senior adviser Hope Hicks and White House press secretary Kayleigh McEnany also were infected.

Two weeks later, at least five aides or advisers to Vice President Mike Pence tested positive, including Pence Chief of Staff Marc Short. 

Despite the repeated infections, Trump, Meadows and their allies have continued to flout public health guidelines, holding large indoor gatherings where few people wear masks or follow advice for social distancing. On election night, for instance, Trump hosted an event at the White House billed as a victory party where people mingled close together and few wore masks.

“The contrast is really disheartening between what we’re seeing at the White House and what we know to be critical to controlling the virus. As a scientist – and a parent – it’s particularly exasperating,” said Ben Sommers, a doctor who teaches at the Harvard T.H. Chan School of Public Health.

“Kids are wearing masks for soccer outside and for hours a day in schools, and millions of children gave up trick-or-treating this year to avoid large crowds. Meanwhile, key White House leaders can’t bring themselves to follow those same guidelines,” Sommers said.

It is not clear when or how Meadows became infected. But it often takes several days after exposure to the virus before an infection can be detected through testing. Though Meadows tested positive on Wednesday, his diagnosis did not become widely known until late Friday, when it was first reported by Bloomberg News.

Many White House staffers are angry with Meadows for not disclosing his infection sooner, according to the administration official who confirmed the new infections. The official said top White House officials and Cabinet officers who had close contact with Meadows in the days around Election Day had been kept in the dark. 

Meadows had traveled with Trump for whirlwind election rallies in several states during the week before his diagnosis. The stops included Wisconsin and Michigan, states where coronavirus cases are spiking. 

Last Sunday, Meadows was photographed greeting supporters lined up along a barricade at a Trump rally in Opa-Locka, Fla. Meadows was a yard or so away from the crowd. Neither he nor many in the tightly packed group of supporters wore masks.

On Election Day, Meadows visited the campaign office with Trump, where he was photographed standing close to campaign and White House staffers. Later, he watched election returns with Trump in the family’s residence quarters and the Map Room. And in the wee hours after midnight, he was at the White House as Trump addressed supporters during an election night party in the East Room. 

The event included a buffet where people could load their own plates with chicken wings and sliders, according to one person who attended. “It was basically like a large cocktail party,” the attendee said. 

Those milling about included Cabinet officials, allies and donors. Meadows was in and out of the room but walked in with the Trump family just before the president spoke. He meandered toward the back of the room, speaking to a handful of reporters and standing amid the throng, the attendee said. 

Later Wednesday, Meadows worked from campaign headquarters, but did not notify campaign staff that he had tested positive, officials said. Instead, he told only the president and Jared Kushner, officials said. 

Meadows did not respond to calls seeking information about his diagnosis, symptoms and whereabouts. He was not seen at the White House on Saturday, as huge crowds gathered outside the gates to celebrate Biden’s victory. 

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Frozen shoulder – a painful and enigmatic ailment

Health & BeautyNov 08. 2020

By The Washington Post
Jill U. Adams

The pain sneaked up on me – my shoulder hurt though I didn’t remember doing anything to injure it. I would reach behind my back to rearrange a throw pillow and feel a painful twinge in my shoulder.

I had to turn my whole body around to plump that pillow.

Over time, my pain-free arm movement became more limited and my repertoire of workarounds increased. I switched arms to back the car out of the driveway.

I did my best to rest the shoulder and let it recover. But then I’d do something and be met with a jolt of pain that brought tears to my eyes. Eventually, I went to the doctor.

My doctor sent me to a physical therapist, who diagnosed me within minutes. I couldn’t raise my arm over my head and she couldn’t either. It’s the classic test for frozen shoulder. (If I’d had a rotator cuff injury, which is more common, she’d have been able to move my arm all the way.)

Frozen shoulder is painful, aggravating and inscrutable. Sometimes it occurs after a shoulder injury, but more often, “It just happens,” says Todd Schmidt, an orthopedic surgeon in Atlanta.

An inflammatory process causes the ligaments that hold the shoulder together to contract and tighten up. “It’s like a shrink wrap around the joint,” Schmidt says.

The condition affects women more often than men, and tends to occur between the ages of 40 and 60. People with diabetes, hypothyroidism or lipid disorders have elevated odds of getting frozen shoulder. These characteristics hint at some hormonal contribution, but precisely what triggers frozen shoulder is unknown. It can happen to someone who’s physically active and it can happen to someone who is sedentary.

Here’s another curiosity: The shoulder freezes, and then it thaws. That’s the natural course of the condition, even without treatment. “It might take two years,” Schmidt says. “But it will resolve on its own.”

Still, treatment helps. Physical therapy and corticosteroid injection into the shoulder are typical first-line treatments for frozen shoulder.

My physical therapy sessions began with 10 minutes of transcutaneous electrical nerve stimulation, or TENS, and a very warm heating pad. Next, the therapist would stretch me, moving my arm to the point of resistance repeatedly. After that, I’d head out to the gym for a customized series of stretches and exercises with various pieces of equipment.

Being stretched by another person was painful – there’s no other way to say it. But by the end of the hour-long session, I always felt better – I gained more range of movement and more confidence. Some of that confidence came from an unexpected place: Learning that inadvertently triggering pain with an unwise reach was not reinjuring myself, it was not going to set me back.

My physical therapist also advised me how to stretch at home, and she measured my progress.

“Physical therapy is all about function – increasing mobility and managing pain,” says Brian Eckenrode, associate professor of physical therapy at Arcadia University near Philadelphia. In addition to monitoring your progress, therapists alter stretches and exercises as needed and they can help you find a more comfortable position for sleep. “They can fine-tune everything.”

The evidence for physical therapy alone tends to be scientifically wanting in that studies often don’t have a placebo group. And because physical therapy sessions are multidimensional and customized, it’s hard to pinpoint precisely what is most helpful.

In the clinic, Eckenrode says, success is measured by “reduced pain, improved function, increased motion and satisfied patients.”

Steroid injections into the shoulder joint may improve both pain and mobility. A 2014 review of studies found more improvement when steroid injections were combined with physical therapy compared with physical therapy alone.

Although, Eckenrode points out, the improvements were measured over the course of weeks. “It’s not clear that it improves long-term outcomes,” he says.

A 2020 review of studies reported that steroid injection may be more effective as the shoulder is in the freezing stage, while physical therapy manipulation may be more effective once the joint is frozen.

If you don’t see progress after three to six months of physical therapy and steroid injections, the orthopedic surgeon can offer more invasive treatments, Schmidt says. One puts the patient under general anesthesia while the doctor forces the arm beyond the frozen position. Another option is arthroscopic surgery to cut through the tightened joint capsule. Both of these treatments would typically be followed with more physical therapy.

How do you know what doctor to see first? A general practitioner, a physical therapist or an orthopedic surgeon?

“If you have a good relationship with your primary care provider, that’s a good place to start,” says Schmidt, the orthopedic surgeon. “But we’re here when needed.”

A final note. Most people recover from frozen shoulder, although recovery may not be complete. A 2013 paper highlighted several studies in which researchers could measure less-than-full arm mobility while at the same time noting that subjects were satisfied with their recovery. That means, my left arm’s range of movement may never match my right arm’s, but if I can do everything I could do before, I’ll be happy.

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Covid-19 cases exceed 100,000 a day for the first time, even as the nation is split on the pandemic vs. the economy

Health & BeautyNov 05. 2020

By The Washington Post · Lenny Bernstein, Joel Achenbach, Frances Stead Sellers, William Wan · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
The coronavirus pandemic reached a dire milestone Wednesday when the number of new U.S. infections topped 100,000 a day for the first time, continuing a resurgence that showed no sign of slowing.

The pandemic is roaring across the Midwest and Plains states. Seven states set records for hospitalizations for covid-19, the disease caused by the virus. And Connecticut, Iowa, Maine, Michigan, Minnesota, Nebraska and North Dakota saw jumps of more than 45 percent in their seven-day rolling average of new infections, considered the best measure of the spread of the virus.

The record 104,004 cases was reached a day after the deeply divided nation went to the polls to choose between President Donald Trump and Democratic nominee Joe Biden, an election widely seen as a choice between fully reopening the economy and aggressively quelling the outbreak.

Just as they split almost down the middle on the two candidates, voters broke into almost equal camps on how to address the pandemic that has killed more than 233,000 people and infected nearly 9.5 million people in the United States.

“It’s clear we’re heading into a period where we’re going to see increasing hospitalization and deaths in the U.S. And it worries me how little we’re doing about it,” said Tom Frieden, director of the Centers for Disease Control and Prevention during the Obama administration. “We know by now how fast this virus can move. You have to get ahead of it.”

After more than nine months of restrictions, some state leaders are hesitant to risk further pandemic fatigue, Frieden said.

But if case counts continue rising at the current rate and strong action isn’t taken, viral transmission may soon reach a point in some areas where nothing will stop the virus except another shutdown, he said.

“The numbers keep going up, and we’re only getting closer and closer to Thanksgiving and Christmas,” when some families are expected to congregate indoors and risk spreading the virus further, said Eleanor Murray, an assistant professor of epidemiology at Boston University. “For so many reasons, the next few weeks are going to be bad for us and good for covid.”

With Trump and his aides fighting to hold on to the White House, the federal response to the pandemic, which already leaves major responsibilities to the states, may be even more fractured, Murray said.

“Something that deeply worries me is either way this election goes, Trump will still be in charge the next few weeks, when cases are higher than they’ve ever been,” she said. “And he’s made clear there will be no top-down, coordinated action coming from the federal government.”

Despite months of surveys that clearly indicated strong voter disapproval of the president’s response to the pandemic could weigh heavily against his reelection effort, more voters chose the economy as the primary issue in casting their ballots, exit polling showed.

Even if Biden captures the White House, the results appear to signal that, for many people, covid-19 disease is not as daunting as the prospect of being unable to pay their bills or send their children to school.

“I got news for you, pal. Covid-19 is over. It’s done,” said Nick Arnone, owner of HLSM, a software company for the power sports industry, in Plains, Pa. “We have therapeutics, so deaths are way down; we are very close to a vaccine. We’ve got to ride it out now.

“But if we don’t have a strong economy, there is no way we can do anything. Trump is correct. Without a good economy, there is no way to dig our way out of this.”

About 35% of voters said the economy was the most important issue for them, while about 17% cited the pandemic and roughly 2 in 10 were motivated most by racial inequality.

At the same time, however, just over half the voters said it is more important to contain the virus, even if that hurts the economy, while slightly more than 4 in 10 said rebuilding the economy is most critical, even if that impairs work to quell the virus.

Those more concerned with the virus broke heavily for Biden. But they were matched by the proportion of Trump voters who supported his persistent call for a return to normalcy and a revived economy.

In El Paso, Texas, where the pandemic is surging, James Clark said he voted for Biden because of the uncontrolled outbreak.

“Covid was the main reason . . . and the things he was saying specifically about it,” Clark said. “I mean there were some things Trump was doing well, too, but overall it was covid.”

Some analysts were surprised and concerned that voters appeared to view the decision before them as a choice between the virus and their livelihoods, rather than as intertwined problems that could be solved together.

“That was shocking to me, that Trump could convince so many people it was a choice between the economy and pandemic,” said Eric Topol, a cardiologist and head of the Scripps Research Translational Institute in San Diego. “I’m amazed the extent he pulled that off, because it’s so obviously a false dichotomy. There’s no way for the economy to thrive unless we get control of the pandemic.”

On the campaign trail, Biden warned voters of a “dark winter” and invoked empty chairs in homes where families grieved the death of a loved one. He suggested he would follow science and tighten restrictions in places where that was necessary.

Trump repeatedly declared that the country was “rounding the turn” on the pandemic and said a vaccine was almost ready to be distributed. “You know what we want? We want normal,” Trump said this past weekend in Butler, Pa.

The two political messages were consistent with the viewpoints of each candidate’s base, said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center at the University of Pennsylvania.

Biden has much more support among urban voters and people of color who, until recently, have been hit harder by the pandemic. Trump’s base is more White and rural, constituencies that have been slammed by the virus only in recent weeks, as the number of infections soared in the Upper Midwest and Plains states, she said.

“Who’s more likely to know someone’s who’s died? People who are already more likely to be Democrats than Republicans,” Jamieson said. “The lived experience of the two constituencies, the base vote for each side, is different.”

In Florida, which Trump carried more easily than expected, Biden’s emphasis on the pandemic hampered grass-roots campaigning, said Susan MacManus, an emerita professor of political science at the University of South Florida. With Biden emphasizing social distancing, the Democratic campaign there followed his lead.

“The Republicans never let their foot off the pedal in terms of continuing to register [voters] and going door to door, all through the covid,” she said. “The Democrats, once covid hit, they made a conscious effort, not going door to door.”

Rep. Donna Shalala, D-Fla., who appeared to be headed to losing her seat to television newscaster Maria Elvira Salazar, a Republican, in Miami, campaigned heavily on Trump’s response to the virus.

Stefan Baral, a physician and epidemiologist at Johns Hopkins School of Public Health, Wednesday faulted Democrats’ pandemic messaging, saying Biden did not adequately express empathy for the economic hardships caused by the pandemic-related shutdowns.

“This is a terrible virus. But empathy for all the folks who have lost their jobs and lost their opportunities and kids who are out of school – I just never felt that message of empathy come across at all,” Baral said.

When some people heard Biden talk about the dark winter ahead, they thought, “The first thing he’s going to do is close my business,” Baral said.

Voters also had to make up their minds amid a torrent of misinformation and purposeful distortion about the pandemic, said Matthew Seeger, a risk communication expert at Wayne State University, who helped the CDC develop its past communications plans.

“The messaging around the pandemic has been deliberately confused and strategically manipulated to downplay its significance,” Seeger said. “You combine that with the fact that this is a slow-moving crisis with risk fatigue starting to settle in, and you can see why public perception is what it is.”

In Chandler, Ariz., a suburb southeast of Phoenix last week, Al Fandick said he considers the pandemic wildly overblown and masks largely pointless. Fandick, 53, who runs a transport company, said he found it absurd that he was required to don a mask to enter a restaurant but could remove the face covering once he sat down.

“Having a face mask on while I walk into that restaurant, but then I can take that face mask off, that’s like having a peeing section in a pool,” Fandick said.

Aside from trips to visit people in the hospital, he never wore a mask until Maricopa County began mandating it for public spaces, a policy he vehemently opposes, he said.

“Don’t need the hassle,” he said.

On the other side of the gulf are those who see the accelerating pandemic and a possibly very deadly period ahead.

“It is demoralizing to feel like: Here we are in November. A third surge is not just underway, but has already surpassed past surges. And people still don’t understand what’s happening and what’s at stake,” Murray, of Boston University, said.

“We are in the middle of an emergency. We have cases higher than they have ever been since this pandemic started, and yet you will have people paying less attention than ever to covid,” Murray said. “We as a country are not in a place right now where it’s safe to do that.”

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Denmark finds covid strain that might hamper vaccine effort

Health & BeautyNov 05. 2020Prime Minister Mette Frederiksen 

By Syndication Washington Post, Bloomberg · Morten Buttler · WORLD, EUROPE 
Denmark says it’s found a new strain of covid-19 that might hamper efforts to develop a vaccine, after an outbreak in the country’s mink population triggered a mutation of the virus.

Prime Minister Mette Frederiksen told reporters that, because of developments in Denmark, there is now “a risk that the effect of a future vaccine will be weakened or, in a worst case scenario, be undermined,” during a virtual press briefing on Wednesday.

Her government has passed on the information to the World Health Organization, and now plans to cull Denmark’s entire mink population. According to Kopenhagen Fur, an auction house owned by Denmark’s mink breeders, some 16 million animals are raised each year.

As the new coronavirus has spread from person to person, it has changed thousands of times. The vast majority of these changes are incremental, without what’s known as a functionally significant mutation, though there’s been previous debate over research showing that it may have evolved to become more contagious.

The mutation of the virus that’s now been identified in Denmark “can have serious negative consequences for the global handling of the pandemic,” Frederiksen said. There are 12 known cases in which humans have contracted the new form of the virus from mink, she said.

Denmark has already culled thousands of mink in recent months due to outbreaks of the virus. According to Wednesday’s briefing, cases of Covid-19 were found in 217 out of 1,139 Danish mink farms.

Speaking at the same briefing, Kare Molbak, Denmark’s top epidemiologist, said that in a “worst-case scenario, the pandemic will restart, this time in Denmark.” He said the WHO would have to make the final call on whether the mutation found in Danish mink farms warrants a new classification.

The Danish prime minister and other government members and health officials who participated in Wednesday’s briefing spoke via TV screens, after an outbreak of Covid in the parliament forced Frederiksen and more than half her cabinet to self-isolate.

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CureVac covid vaccine shows immune response in early trial

Health & BeautyNov 02. 2020

By Syndication Washington Post, Bloomberg · Suzi Ring · NATIONAL, BUSINESS, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
A coronavirus vaccine under development from CureVac NV showed a good immune response in early trials, validating the biotech company’s 20 years of research into messenger RNA’s ability to train the body’s defenses.

The vaccine’s strongest dose produced an immune response comparable to that found in recovered patients in an early-stage test on more than 250 volunteers, the German company said in a statement Monday. Chief Executive Officer Franz-Werner Haas said advanced clinical trials are on track to start by year-end. CureVac shares rose as much as 5% in Frankfurt trading.

CureVac was thrust into the spotlight earlier this year amid reports that the U.S. government had tried to buy it or persuade it to move its research work there. The company has spent two decades investigating the potential of messenger RNA, in which a vaccine or drug teaches the body’s cells to identify and create its own substances to ward off disease.

Before the pandemic, CureVac studied mRNA therapies and vaccines for diseases such as cancer and rabies. If the covid-19 shot is successful, it will be the company’s first product.

Two other front-runner vaccine developers are also betting on mRNA — Pfizer Inc. and its German partner BioNTech SE, and the U.S. biotech Moderna Inc. Given that no such vaccine has ever been approved, Haas said a win for rivals can only be good for CureVac too.

This technology is “not only for the covid-19,” Haas said in a telephone interview. “In five years it’s for the Covid-25, or whatever it is.” The approach, he said, could “revolutionize the entire prophylactic vaccine field.”

Haas said the company held lengthy discussions in January to decide whether to repurpose its research, using some of it to develop a coronavirus jab.

“It was certainly a big stretch for a company like ours,” Haas said. We decided “not to do it would not be an option.”

The phase 1 trial data showed a strong induction of binding and neutralizing antibodies as well as the first signs that T cells — a type of white blood cell that helps destroy infection — had been activated, CureVac said. The full test results will be published in more detail after peer review in the coming weeks.

The trial included as many as 10 people who had previously tested positive for the coronavirus. CureVac has started some middle-stage trials in Peru and Panama in September with adults over 60.

Haas reiterated the company’s denial that the U.S. tried to buy the company. “There was no formal or informal or oral or written offer,” he said. “At least not that I know.”

In June, the German government agreed to acquire a 23% stake in the company $350 million (300 million euros) and CureVac listed in the U.S. in August.

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Make-up brand NYX to close all stores in Thailand from November 30

Health & BeautyNov 02. 2020

By The Nation

Global professional make-up brand NYX will cease operations in Thailand from November 30.

The company posted the message on its Facebook page on Monday regarding the closure of its stores.

The brand expressed its gratitude to its fans who have “always given love and inspiration” to the brand.

NYX Professional Makeup is a famous make-up brand from LA, USA founded in 1999, which is known as a make-up artist.

The NYX brand launched in Thailand in 2016, with a large opening in the heart of Siam Square One as Asia’s first and only flagship store that brought the concept of “Digitised Destination of Beauty Junkie” to enable girls to have fun with buying products and get a fiesta make-up experience through VR technology.