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First coronavirus vaccines roll out as officials share months-long timeline for immunization effort (nationthailand.com)

First coronavirus vaccines roll out as officials share months-long timeline for immunization effort

Health & BeautyDec 14. 2020

By The Washington Post · Paulina Firozi, Meryl Kornfield, Josh Dawsey

WASHINGTON – The first vials of the coronavirus vaccine were shipped Sunday, paving the way for inoculations to begin across the country this week.

https://www.washingtonpost.com/video/c/embed/23437ad3-0603-4558-b26f-0a89ae2641b9?ptvads=block&playthrough=false

Nearly 3 million doses of the Pfizer-BioNTech vaccine are expected to arrive at 145 facilities Monday, marking the beginning of a massive logistical effort to stop the rampant spread of the disease covid-19, which has so far killed more than 298,000 Americans. The vaccine against the virus it causes will arrive at nearly 500 additional sites Tuesday and Wednesday.

But even as state officials scrambled to distribute the first doses, they criticized the federal government for a lack of transparency and limited financial help, warning that both could hamper efforts to quickly vaccinate the most vulnerable populations, including health-care workers and the elderly.

As the vaccine doses made their way to hospitals Sunday, Centers for Disease Control and Prevention Director Robert Redfield gave the final nod, approving the decision to recommend Pfizer’s vaccine for people 16 and older.

Additionally, the governors of California, Washington, Oregon and Nevada announced Sunday that an independent review of the Pfizer vaccine found it safe for public use. They said the vaccine was on the way but did not give a specific estimate for when the first shots would be given.

As the vaccine arrived at a Louisville, Ky., hub for distribution across the East Coast on Sunday, Democratic Gov. Andy Beshear moved up his timeline, announcing that immunizations could begin as early as Monday. New Jersey Gov. Phil Murphy, a Democrat, said Sunday that the first vaccines are expected to be administered Tuesday at University Hospital in Newark.

Amid questions about when people can get their shots, a Sunday report said people in President Donald Trump’s White House circle were told to expect to be vaccinated shortly.

“Senior officials across all three branches of government will receive vaccinations pursuant to continuity of government protocols established in executive policy,” National Security Council spokesman John Ullyot said in a statement. The administration has not mentioned when Trump will get a dose. Since contracting the virus, Trump has repeated false claims that he is “immune,” though experts are not yet certain about how long immunity lasts.

Despite the rapid rollout of the Pfizer vaccine, it will be months before immunizations have any effect on the pandemic in the United States, where case numbers are surging. As of Saturday, more than 16 million people in the United States have tested positive, and an average of 2,415 people died of the virus every day for the past week, a pandemic record.

Officials stressed that a large proportion of the nation’s population – about 70% to 80% – will need to get the vaccine before herd immunity is achieved.

Moncef Slaoui, chief science adviser to the White House’s effort to develop a vaccine, said officials hope to “reach that point between the month of May and the month of June.”

“All in all, we hope to have immunized 100 million people, which would be the long-term-care-facility people, the elderly people with co-morbidities, the first-line workers, the health-care workers,” he said in an interview on “Fox News Sunday. “It’s about 120 million people – we would have immunized 100 million people by the first quarter of 2021 with two doses of vaccines.”

Health and Human Services Secretary Alex Azar detailed what could come in the weeks and months following the initial vaccine shipments. He said the plan is to have 20 million people vaccinated by the end of December, up to 50 million by the end of January and 100 million by the end of February. That includes plans for a second vaccine, developed by Moderna, which is expected to gain emergency authorization from the Food and Drug Administration soon.

The FDA gave emergency use authorization for Pfizer and BioNTech’s vaccine on Friday for people 16 and older, and Moderna’s vaccine is expected to be authorized following a review scheduled for this Thursday by the agency’s independent advisers.

“We’ll be getting more and more Pfizer product, and we’ve got 12 1/2 million Moderna product, assuming that we get approval at the end of this week on Moderna, that we’ll ship out very soon thereafter,” Azar said during an interview with CBS News’s “Face the Nation.”

He also was asked by host Margaret Brennan whether he believes President-elect Joe Biden’s team will be able to meet the goals, and Azar appeared to acknowledge that the incoming Biden administration will take over the process.

“If they carry forward with the plans that we’ve put in place, 100 million shots in arms by the end of February is very much in scope,” Azar said.

Officials hoping to bolster confidence in the vaccine worry that such a large immunization effort could be hindered by skepticism.Francis Collins, director of the National Institutes of Health, said the level of potential vaccine hesitancy in the nation is of “great concern for all of us.”

During an interview on NBC News’s “Meet the Press,” he urged viewers to “hit the reset button on whatever they think they knew about this vaccine that might cause them to be so skeptical.”

“The data is out there now. It’s been discussed in a public meeting, all the details of the safety and the efficacy for anybody who wants to look,” he said, adding: “I think all reasonable people, if they had the chance to sort of put the noise aside and disregard all those terrible conspiracy theories, would look at this and say, ‘I want this for my family. I want it for myself.’ People are dying right now. How could you possibly say? ‘Let’s wait and see’ if that might mean some terrible tragedy is going to befall?”

There’s also particular concern about addressing any vaccine hesitancy in communities of color, especially because they have been disproportionately affected by the pandemic.

NBC’s Chuck Todd asked Collins to respond to concerns from a health-care worker who said she hopes people who look like her and other Black doctors in the community also will help generate trust in the vaccines.

“She’s absolutely right. For somebody like me to say, ‘You should be signing up for this vaccine,’ OK, a White guy who works for the government. Sure, that isn’t necessarily going to be the voice that people need to hear if they’re skeptical,” Collins said. “We are working closely with health-care providers, especially those in communities of color, and trying to make sure that all of those messages are ready to go.”

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CDC advisory group recommends Pfizer vaccine for use (nationthailand.com)

CDC advisory group recommends Pfizer vaccine for use

Health & BeautyDec 13. 2020

By The Washington Post · Lena H. Sun, Isaac Stanley-Becker · NATIONAL, WORLD, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS 

WASHINGTON – A federal advisory panel voted overwhelmingly Saturday to recommend the nation’s first coronavirus vaccine for people 16 and older, paving the way for inoculations to begin as shipments of vaccine arrive at hospitals and state health departments Monday.

The advisory panel to the Centers for Disease Control and Prevention found the benefits of the vaccine from Pfizer and BioNTech, which has been shown to be 95% effective at preventing illness after two shots, far outweighed side effects, including sore arms, fatigue, headaches, muscle pain and chills that resolved within a few days. The action follows the Food and Drug Administration’s action late Friday authorizing the vaccine for emergency use for people 16 and older.

The vote was 11 in favor, with three members not voting because of conflicts of interest.

“I know we’re going to have very tough and sad times ahead because of the surge and a limited vaccine supply, but I am really hopeful that this is the beginning of the end of the coronavirus pandemic,” said Peter Szilagyi, a professor of pediatrics at the University of California at Los Angeles.

The panel’s recommendation is “a hugely important step,” said Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases.

Beth Bell, a global health expert at the University of Washington who chairs the panel’s coronavirus vaccine work group, referred to public concerns about the new vaccine and said she would get a shot when it is her turn and would recommend it for her family. Several members said they would do the same.

While Bell applauded the huge scientific achievement of developing a vaccine, she and others noted the stark imbalance between the $10 billion of taxpayer money used to fund vaccine development and the lack of funding – only “hundreds of millions” – for the enormously complicated and challenging distribution and vaccination effort rolling out across the country during the next year.

“The imbalance between that kind of money and funding provided for the vaccination program is really shocking and needs to be corrected,” Bell said. “We are not going to be able to protect Americans if we don’t have a way to deliver the vaccine to them.”

Jeffrey Duchin, a top health official for Seattle and King County, Wash., noted that the funding necessary for state and local health departments “has been put in the deep freeze with the vaccine,” referring to the vaccine’s ultracold storage and handling requirements.

Because the vaccine initially will be in extremely limited supply, the CDC recommended last week that about 21 million health-care workers and about 3 million residents of long-term care facilities be first to get the vaccine.

Health-care personnel are a priority because of their potential exposure to the virus and their critical role keeping the nation’s hospitals and clinics functioning. Residents and employees of long-term care facilities were prioritized because they account for nearly 40% of deaths from covid-19, the disease caused by the coronavirus.

The recommendations from the Advisory Committee on Immunization Practices were sent to CDC Director Robert Redfield, who is expected to approve them imminently. Once approved, they become the official CDC recommendation on immunization in the United States. Authorization from the FDA means the Pfizer vaccine is permitted to be administered, but an endorsement by the CDC immunization panel signals that the vaccine should be administered to the populations included in its guidance.

Recommendations from the group, an independent body of experts, have been the gold standard for evidence-based guidance on vaccine use in the United States for decades. Health-care providers rely on the group’s recommendations because of the committee’s reputation for rigor and attention to detail, said Jason L. Schwartz, a professor of health policy at the Yale School of Public Health. The committee has been planning for its recommendations for coronavirus vaccines since the spring.

The committee’s review of safety and efficacy data Friday and Saturday reached the same conclusions as the FDA and its advisory committee, including appropriateness of use in 16- and 17-year-olds. One member noted that teenagers can actively spread the virus to family members.

Committee members said pregnant women who are part of a group recommended to receive the shot may talk with their medical providers and choose to get vaccinated, even in the absence of data on the safety of coronavirus vaccines in pregnant women.

Many health-care personnel are women, and a significant percent are likely to become pregnant or to have recently had babies, noted physician Sandra Fryhofer, a liaison representative speaking on behalf of the American Medical Association.

Pregnant women have been excluded from coronavirus vaccine trials. A Pfizer official said Saturday the company plans to report to the FDA this month on a developmental and reproductive toxicity study in animals that could help elucidate any risks.

On Sunday, the CDC is expected to provide briefings for clinicians and provide additional detailed clinical considerations for health-care providers and patients on its website, including guidance on possible severe allergic reactions. Peter Marks, director of the FDA’s division that regulates vaccines, said Saturday that officials had looked carefully at such side effects and concluded that people should receive the vaccine unless they “have had a severe reaction to the vaccine or one of its components.”

Two health-care workers in Britain had severe anaphylactic reactions after getting the vaccine this week, according to authorities. Both had a history of serious allergic reactions and carry epinephrine auto-injectors, known as EpiPens, for such emergencies. A third health-care worker, with no history of allergies, developed a rapid heartbeat and skin reddening. The CDC is following up with British health officials on the cases and has convened experts in vaccine safety, immunology and allergy to investigate possible causes, officials said.

The weekend meeting was not devoted to deciding on allocation of finite vaccine supplies but whether to recommend its use.

But there was a preview of the jockeying certain to take place over who will gain preference following health-care workers and long-term care facility residents and staff, who constitute the first phase, known as phase 1a. Members of the advisory group heard from industry representatives and other advocates about why workers in certain sectors or particularly vulnerable people should have priority access.

John Allan III, vice president of regulatory affairs and international standards for the International Dairy Foods Association, warned that if food workers did not get immunized soon, “Our supply chains could eventually fall apart, creating widespread disruptions to our economy.”

Julie Russell, a representative of a school district in San Diego County, said teachers and other front-line education staff required attention because of “how many young lives each of them touch.”

And Charles Lee, president-elect of the American College of Correctional Physicians, said incarcerated people are of paramount concern because of the outbreaks that have torn through prisons.

There were also concerns about access in the first phase. A rural health advocate in Wisconsin said ultracold storage requirements and the batch size of the Pfizer vaccine, which is shipped in 975-dose allocations, threatens access beyond densely populated metropolitan areas.

Several members of the public warned about the pernicious effects of misinformation, asking the committee to develop a plan to combat false narratives about vaccination, particularly those targeting communities of color.

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First coronavirus vaccine shipments set to arrive in states Monday (nationthailand.com)

First coronavirus vaccine shipments set to arrive in states Monday

Health & BeautyDec 13. 2020Pharmacy Director Ahmed El Kority opens a new ultra freezer that will be used to store COVID-19 vaccines at the Riverside Shore Memorial Hospital in Onancock, Va. MUST CREDIT: photo for The Washington Post by Parker Michels-Boyce. 

By  The Washington Post · Frances Stead Sellers, Ariana Eunjung Cha, , Lena H. Sun, Isaac Stanley-Becker · NATIONAL, HEALTH, HEALTH-NEWS 

WASHINGTON – Hospitals that have spent months seeking a silver bullet against a virus that has killed more than 295,000 people in the United States will begin receiving shipments of the first coronavirus vaccine on Monday, U.S. officials said, comparing the start of distribution this weekend to the Allied invasion of Normandy in June 1944.

Saturday, said the four-star Army general overseeing vaccine rollout, was “D-Day,” following the Food and Drug Administration’s Friday-night clearance for emergency use of the two-dose regimen developed by Pfizer and the German company BioNTech.

“D-Day was a pivotal turning point in World War II; it was the beginning of the end,” said the general, Gustave Perna, who is chief operating officer of Operation Warp Speed, the public-private partnership speeding the development of vaccines and therapeutics. “D-Day was the beginning of the end, and that’s where we are today.”

The initial distribution of 2.9 million doses, a sliver of what was initially anticipated and intended only for health care workers and residents and staff of long-term care facilities, will arrive at hospitals battling climbing case counts and mounting deaths. Immunization in its early phases will not curtail intensifying outbreaks, experts cautioned, underscoring the need for continued public-health precautions.

But the vaccine’s clearance on Friday night from the FDA, followed by backing on Saturday from a Centers for Disease Control and Prevention advisory group, set into motion one of one of the most complicated logistical missions in U.S. history, marking a new phase of the pandemic. The vaccine, which must be stored at ultracold temperatures, is being sent nationwide by plane and guarded truck.

“It’s a hugely important step,” Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said Saturday as the CDC’s Advisory Committee on Immunization Practices recommended the nation’s first coronavirus vaccine for people 16 and older. 

Members of the committee stressed that the vaccine, while developed in record time, had moved transparently through all required regulatory channels. They also expressed alarm about the lack of resources available to state and local authorities to carry out vaccination, in contrast to the billions in taxpayer dollars devoted to quickening the vaccine’s rollout.

As experts gave final sign-off, boxes were being packed and loaded with the vaccine, Perna said. The cargo would begin moving Sunday morning from Pfizer’s manufacturing facility in Kalamazoo, Mich., to FedEx and UPS hubs nationwide, he said.

Vaccine, he predicted, would arrive at 145 sites, mostly large hospital systems, on Monday, with another 425 sites receiving supply on Tuesday. The final 66 of the 636 locations poised to receive doses in the first round of Pfizer shipments would receive their supply on Wednesday, Perna said.

The general made clear that earlier-than-anticipated clearance from federal regulators, which took place late Friday instead of Saturday after pressure from the White House, did not alter the timetable for the distribution or actual administration of the shots. Delivery, he said, must occur when “professionals are available to receive it, and then eventually administer it,” making Monday the anticipated target.

Top FDA officials took steps on Saturday to assure the public that the vaccine was safe, that its clearance was not driven by politics and that health care sites would be equipped in the event of a rare allergic reaction observed among two British health care workers with a history of severe reactions. 

Stephen Hahn, the FDA commissioner, told reporters he would get the vaccine as soon as he was eligible for it, denying, as he did on Friday, that his job had been threatened over the timing of the vaccine’s approval. Asked about the possibility of allergic reactions, Peter Marks, director of the agency’s division that regulates vaccines, said officials had examined possible side effects and concluded that people should be vaccinated unless they have had a severe reaction to one of the vaccine’s components.

The initial shipments include only the first shot in a two-dose regimen for some of the nation’s most at-risk people, with another 2.9 million doses set for distribution 21 days later. According to CDC recommendations, the nation’s 21 million health care workers and three million residents of long-term care facilities should receive the vaccine first. With a second vaccine from Moderna expected to gain approval from the FDA soon, as many as 40 million doses could be delivered by the end of the year – enough to vaccinate the CDC’s first priority group. Additional vaccines are in late-stage trials.

Health care workers, who have been prioritized because of their exposure to the virus and critical role in sustaining the nation’s strained health care system, will begin receiving the shots within days. Each hospital system is moving on a slightly different timetable, depending on resources and staffing needs, with many saying vaccination would not begin until Wednesday. Some medical centers were independently reviewing the vaccine data to double-check the FDA’s decision.

Inoculation at long-term care facilities could begin by the end of the week, Perna said. Separate kits with needles and alcohol wipes are being shipped so as to sync up with vaccine batches at each site, underscoring the complex choreography of the operation.

Perna tempered his confidence with an acknowledgment of the challenges involved in a mass vaccination campaign against a rampaging virus, with limited supplies initially available for a country of 330 million people eager to return to normal. 

“We know that the road ahead of us will be tough,” Perna said.

The vaccines will arrive at hospitals overwhelmed with covid patients. As of Saturday, more than 108,000 were hospitalized nationwide, according to Washington Post data.

These facilities have spent months grappling with the ethical and logistical challenges of distributing the vaccine. At some institutions, intensive care unit staff members will receive priority; others are including those who work in housekeeping or with cancer patients or newborns. Hospitals wrestled with whether to include those working with covid-19 patients in full protective gear ahead of masked staff members interacting with people who may be asymptomatic carriers.

At many health care institutions, surveys are quietly being sent out, lotteries launched and invitations issued to one of the most highly anticipated events of 2020: the opportunity to get in line for a shot. At the same time, institutions are seeking to address unease about a brand-new vaccine.

On Thursday, Temple Health in Philadelphia emailed 3,000 invitations to employees deemed at “high risk” of infection. Within minutes, janitorial staff and anesthesiologists began signing up. And within 24 hours, each of the 252 slots at the main campus’s vaccination site was taken.

High demand assuaged Chief Medical Officer Tony S. Reed’s fears that vaccine hesitancy would keep people away, wasting precious vaccine. Among the first takers, who will likely start receiving shots Wednesday, will be people working on covid-19 floors and in the emergency room. The goal is simple, Reed said: “To do the most good for the most people.”

In Philadelphia, all of the city’s hospitals will be receiving vaccine, either directly from the federal distributor or from the city health department’s ultracold storage, said James Garrow, a spokesman for the health department.

On Thursday, a package needed to administer the Pfizer vaccine suddenly showed up at the University of Pittsburgh Medical Center’s Presbyterian hospital, including vaccination record cards, masks, visors, information sheets, syringes and the diluent that needs to be mixed with every dose before it is injected.

The multi-facility Cleveland Clinic has set up a “refrigeration farm” with rows of gleaming white freezers capable of keeping the vaccine at Antarctic temperatures. The atrium at the UF Health Jacksonville hospital in Florida is being turned into a vaccination site. And other hospitals are preparing to receive the ancillary supplies needed for the finicky Pfizer vaccine.

But much depends on the supply of vaccine.

Dora Anne Mills, who is overseeing the vaccine rollout for MaineHealth, which operates 10 hospitals, said the entire system may get around 970 doses in this first round – covering a fraction of the 17,000 patient-facing employees the system aims to vaccinate as soon as possible.

“We are all facing the same dilemma: How do we stabilize the hospital systems at a time when we have so many doctors and nurses out because of covid exposure?” she said. The hospital has been holding Zoom sessions to explain the vaccine to staff and convince them of its safety.

At Salt Lake City-based Intermountain Healthcare, a 23-hospital system that serves Utah, Idaho and Nevada, officials have asked staff to sign up around their shifts in case they have mild to moderate side effects in the days after they get the vaccine.

In Minnesota, which has reported one of the nation’s highest per capita rates of infection, state health officials have meticulously planned for months the rollout of the vaccine. The Minnesota Department of Health designated 25 main distribution hubs around the state that will deliver the vaccine to 118 smaller facilities, including in rural areas.

Still, Gov. Tim Walz acknowledged lingering concerns, including access to dry ice, which the Democratic governor said could pit the state and health-care industry against Upper Midwest cheese and dairy producers that use dry ice to ship cheese curds.

In Florida, Gov. Ron DeSantis (R) said this week he expects the state to receive 180,000 doses of the vaccine in its first release. Of those, 100,000 doses will go to five hospitals that can store the shots, DeSantis said. The rest of the doses, he said, will go to nursing homes and long-term care facilities.

John Couris, president and chief executive of Tampa General Hospital, acknowledged challenges in convincing staff to be immunized. He noted, “If we say you must take the vaccine, if you don’t, what are we going to do? Terminate them?”

At the UF Health Jacksonville hospital, the atrium offers space to spend 15 minutes monitoring those who are vaccinated. The space is large enough to accommodate 500 to 1,000 people a day, said Leon Haley Jr., chief executive of UF Health Jacksonville and Dean of the University of Florida’s College of Medicine. Haley said he will be videotaped getting one of the first doses to boost confidence for others.

Riverside Health System, based in Newport News, Va., will receive 2,925 doses for five hospitals. It expects to start vaccinating personnel at the highest risk for covid-19 exposure Wednesday, including doctors, nurses and housekeeping staff, said Cindy Williams, Riverside’s chief pharmacy officer.

“There are so many moving pieces,” Williams said. The system is used to administering flu shots, but must change its clinic layout for the coronavirus vaccine to allow for social distancing and recipients to be monitored for 30 minutes post-jab.

Riverside Health System, based in Newport News, Va., will recpehilaive 2,925 doses for five hospitals. It expects to start vaccinating personnel at the highest risk for covid-19 exposure Wednesday, including doctors, nurses and housekeeping staff, said Cindy Williams, Riverside’s chief pharmacy officer.storage to an ultracold freezer or three minutes for transfer between low temperatures and thawing. The vaccine must remain in frozen storage for at least two hours if it is put back in an ultracold freezer after room temperature exposure.

The health system had previously surveyed employees before news about the efficacy of the Pfizer-BioNTech and Moderna vaccines. It found about a third of respondents were willing to get a shot. A more recent survey this week found that about 60% were interested in getting the vaccine, Williams said.

Lauren Sauer, director of operations at the Johns Hopkins Office of Critical Event Preparedness and Response, which has hospitals in the District of Columbia, Florida and Maryland, said she is concerned about the emotional burdens being placed on already exhausted health-care workers as they are turned into role models.

“We are asking them to take a brand-new vaccine and then in addition to be advocates for patients, friends, family members,” Sauer said.

“That is a lot to ask during a pandemic.”

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FDA authorizes the first coronavirus vaccine, a rare moment of hope in the deadly pandemic (nationthailand.com)

FDA authorizes the first coronavirus vaccine, a rare moment of hope in the deadly pandemic

Health & BeautyDec 12. 2020

By The Washington Post · Laurie McGinley, Carolyn Y. Johnson

WASHINGTON – The Food and Drug Administration on Friday gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy.

The historic authorization of the vaccine from Pfizer and BioNTech, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.

The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened.

Meadows’s threat followed months of efforts by FDA scientists to try to ward off President Donald Trump’s importuning on the vaccine and keep the review process apolitical and transparent in hopes of boosting public confidence in the shots. The FDA already had planned to clear the vaccine Saturday morning, and accelerating the authorization to Friday night was not expected to change the delivery timeline of the first shots.

The nation set a record for covid-19 deaths Thursday for the second day in a row, surpassing 3,300. The death tally for Friday was 2,950, only slightly lower, bringing the U.S. death toll to nearly 295,000.

Federal officials have said distribution of the first 2.9 million doses of the highly effective vaccine would begin within 24 hours of an authorization. Meanwhile, an advisory committee for the Centers for Disease Control and Prevention, which has recommended that health-care workers and nursing home residents be the first recipients, was expected to bless the vaccine on Saturday, paving the way for inoculations to begin early next week.

The vaccine achievement creates a paradigm for vaccine development, proving that fast and flexible technologies paired with a single-minded focus by pharmaceutical companies and government can accomplish in 11 months what typically takes years. And it marks a rare triumph for the Trump administration, which in many other areas – such as ensuring adequate testing supplies and providing consistent guidance on whether to wear masks – has failed to produce a coherent and sustained response to the crisis.

“It’s an all-capital-letters, followed by several exclamation points,” accomplishment, said Howard Markel, a medical historian at the University of Michigan who predicted that the scientists who were responsible will be lionized for ending the pandemic.

Daniel Carpenter, a political scientist at Harvard University, said it was unprecedented to go from the discovery of a disease to the development of a vaccine in 11 months. The shortest timeline previously was for the mumps vaccine, which took four years. Most vaccines are produced for ailments that have been around for a long time, after years of research often marked by failures and disappointments. In the case of AIDS, there still is no vaccine, nearly four decades after HIV was identified.

Pfizer and its Germany-based partner, BioNTech, harnessed a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a clinical trial with tens of thousands of participants. The vaccine has already been approved in Britain, Canada, Saudia Arabia and Bahrain.

Meanwhile, the FDA, working closely with the companies, conducted an accelerated review that compressed into three weeks the typical months-long scrutiny of safety, effectiveness and data on manufacturing quality.

Operation Warp Speed, the administration’s effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer-BioNTech’s being the first to cross the finish line. Unlike the other companies, Pfizer and BioNTech did not take government money for research and development, but they did receive a $1.95 billion contract for 100 million doses, about 25 million of which will be delivered this year.

“To get there has required a host of innovations. . . . Any one of those would have been cause for considerable amazement,” said Francis Collins, director of the National Institutes of Health. “But when you put them together, it’s a path so revolutionary it would be hard to imagine somebody contemplating it five years ago.”

But while the vaccine enterprise has been impressive, its credibility has been repeatedly threatened by Trump, who for months pressured the FDA to authorize a vaccine before Election Day and, when that did not happen, bitterly accused the agency and Pfizer of deliberately orchestrating delays to harm his reelection prospects. On Friday, he continued his criticism on Twitter, calling the agency “a big, old, slow turtle,” adding, “Get the dam vaccines out NOW.”

The White House maneuvers seemed designed to ensure Trump gets credit just as the vaccine crosses the finish line. But experts said his behavior risked undermining public confidence – not because it would force a vaccine through prematurely but because it could create the appearance that politics, not science, drove the decision.

“There was no plausible way the FDA would not authorize this vaccine . . . but this makes it appear [their decision] is politically motivated,” said Dorit Reiss, a professor of law who writes about vaccine policy at the University of California Hastings College of the Law. “Making it appear there was political pressure will undermine trust.”

Hahn, in a statement Friday, dismissed reports that his job was threatened. “This is an untrue representation of the phone call with the Chief of Staff,” he said. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

The White House said in an email that “we don’t comment on private conversations, but the Chief regularly requests updates on progress toward a vaccine.”

The political machinations are in sharp contrast to the impressive scientific achievement of producing a vaccine in record time. The Pfizer-BioNTech product, and the one right on its heels, from biotechnology company Moderna, use a snippet of genetic material encapsulated in a fat bubble to instruct cells to build the spiky proteins that dot the coronavirus. These shots will be the first time the genetic technology has been used in people outside clinical trials.

The government’s big bet on the promising method, which allowed for much faster vaccine development, was controversial but is paying off: Moderna’s shot is expected to be authorized shortly after a review by the FDA’s outside advisers scheduled for Thursday. The biotech companies behind the vaccines, Moderna and BioNTech, have never made a commercial product but ballooned into pharmaceutical heavyweights, with Moderna valued at $60 billion and BioNTech at $30 billion.

“I feel focused, and I feel also that this is a huge task,” said Ugur Sahin, chief executive of BioNTech.

While a potential lifesaver for those who receive it, the new coronavirus vaccine is not likely to have a dramatic impact on the immediate course of the pandemic. The supply of vaccines will initially fall far short of the 300 million doses some officials had hoped for last spring, when Operation Warp Speed was created.

In addition, formidable challenges lay ahead involving the massive scale-up of manufacturing and a complicated distribution plan overseen by cash-strapped states. On scientific questions, experts still do not know how long the vaccine’s protection lasts.

While the CDC’s Advisory Committee on Immunization Practices has recommended that health-care workers and nursing home residents be first in line for the vaccine, states ultimately will have the final say on which groups get priority. Much of the general population – including younger people who do not have underlying health conditions or jobs that put them at risk – are unlikely to be offered the vaccine before late spring or early summer. And if a significant proportion of Americans spurn the shot, efforts to banish the coronavirus or turn it into a low-level threat could be made much more difficult.

Still, the unquestionably good news on the Pfizer shot arrives as other vaccines also have moved forward: AstraZeneca and the University of Oxford published results in a peer-reviewed journal, China’s Sinopharm announced positive results, and Russia has reported promising data on a vaccine. But even multiple successful vaccines may not prove enough to reach all the world’s people.

“The entire world is seeing the light at the end of the tunnel, but for most of the world, they are still in a very, very long tunnel, and that’s the problem,” said Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, a nonprofit group that funds vaccine development. “The reason we’ve developed the vaccine is to end the pandemic, and you don’t end the pandemic until you . . . protect the most vulnerable people, who are globally distributed.”

The FDA’s action came the day after an agency advisory committee found that the benefits of the Pfizer vaccine exceeded the known risks and recommended that an emergency use authorization be granted for people 16 and older. The agency directed Pfizer to keep a close eye on possible allergic reactions after British health authorities reported two recipients had severe allergic responses after being vaccinated Tuesday.

FDA emergency authorizations are temporary approvals used to accelerate the availability of medical products during a public health emergency. They require less data than regular approvals and can be issued based on a lower standard. In the case of a vaccine, however, the FDA has said it would use rigorous criteria because millions of healthy people are expected to receive it.

The first 2.9 million shots are expected to be shipped to more than 600 sites – mostly large health-care systems – from Pfizer’s freezer farm in Kalamazoo, Mich., in special coolers packed with 50 pounds of dry ice. The vaccines must be kept at sub-Antarctic temperatures, by refreshing the coolers or by storing doses in an ultra-low-temperature freezer.

The government is holding back another 2.9 million doses for the second shot, to be administered 21 days later, and reserving 500,000 doses in case some are lost or spoiled. Officials say it will take time for nursing homes to coordinate with the pharmacy chains responsible for administering shots at those sites. CVS Health plans to administer the first shots of the Pfizer-BioNTech vaccine in nursing homes Dec. 21, according to spokesman T.J. Crawford.

Government officials project that Moderna and Pfizer will be able to deliver 40 million doses of vaccine this year, enough for 20 million people to receive the full regimen. The pace of vaccination is projected to increase in the first months of next year as manufacturing capacity increases and as other vaccines potentially come online. Data on the effectiveness of a one-shot vaccine from Johnson & Johnson is expected in early January.

But long-term questions about the supply remain. The United States has secured only 300 million shots – enough for 150 million people – from Pfizer-BioNTech and Moderna and needs hundreds of millions of additional doses to cover the populace. The country has secured additional doses from other vaccine makers, but it is still uncertain whether those vaccines will be successful.

FDA scientists, in their review of the Pfizer data, confirmed the vaccine was safe and highly effective at preventing illness after two shots spaced three weeks apart. They identified a promising signal that the vaccine appeared to provide a level of protection even after a single shot, meaning that vaccinations could begin to have an impact sooner than many had expected.

In its effort to clear the first coronavirus vaccine, the FDA has faced daunting technical and political challenges.

For months, the agency has tried to balance pressures to expedite the vaccine with the need to keep standards high, to reassure the public that a vaccine produced in record time would be safe and effective.

Adding to the sensitivity was the agency’s effort to bolster its own credibility. Its image was tarnished when earlier in the year it authorized hydroxychloroquine, a malaria medicine that Trump repeatedly touted as a covid-19 treatment, then revoked that authorization when subsequent data showed it could be harmful.

In August, Hahn overstated the benefits of another treatment, convalescent plasma, during a briefing with Trump. Stung by criticism from the scientific community, Hahn apologized and began speaking out about the importance of agency career scientists’ making independent decisions.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, which oversees vaccines, said during a recent American Medical Association webinar that the FDA helped expedite the clinical trial process by eliminating “dead spaces” that typically occur between phases of investigation by vaccine makers.

To ensure that companies understood the FDA’s expectations, the agency took the unusual step of issuing guidelines in June that specified any vaccine should be at least 50 percent effective compared with a placebo, or saltwater shot. A few months later, after it became clear the agency would employ an emergency use authorization to clear the vaccine, the FDA spelled out detailed standards and called for the manufacturers to produce two months of safety data on half of the trial participants.

That safety requirement meant any vaccine would be delayed until after Election Day, infuriating Trump, who tweeted angrily about the FDA and Pfizer. White House ire intensified when Britain authorized the vaccine first, on Dec. 2.

On the AMA webinar, Marks acknowledged that the agency had paid a price for its careful scrutiny. “Unfortunately, there is a cost to being this careful. Another regulatory agency made the vaccine available before we did,” he said. “That’s because we are really taking care to make sure when people get this vaccine, we will have really vetted it for safety.”

Harvard’s Carpenter said being careful will pay off in the long run with greater acceptance of the vaccine, boosting public health. “You need to think about the confidence effects,” he said.

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FDA poised to authorize first coronavirus vaccine in the U.S., a rare moment of hope (nationthailand.com)

FDA poised to authorize first coronavirus vaccine in the U.S., a rare moment of hope

Health & BeautyDec 12. 2020

By The Washington Post · Laurie McGinley, Carolyn Y. Johnson, William Wan

WASHINGTON – The Food and Drug Administration was poised Friday evening to authorize the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy.

The vaccine’s clearance was moved up by about 12 hours after the White House pressured the agency Friday to complete its work by day’s end. White House Chief of Staff Mark Meadows on Friday told FDA Commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not authorize the vaccine by the end of the day, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened.

Meadows’s threat followed months of efforts by FDA scientists to keep the review process apolitical and transparent in hopes of boosting public confidence in the shots. The FDA already had planned to clear the vaccine Saturday morning, and accelerating the authorization to Friday night was not expected to change the timeline for the first shots.

The last-minute injection of chaos and pressure into the approval process comes at a crucial inflection point, with record-setting daily death tolls projected to worsen this winter, even as federal, state and local officials prepare an unprecedented mass vaccination effort.

The nation set a record for covid-19 deaths on Thursday, the second day in a row with more than 3,300 reported. The death tally for Friday was 2,950, only slightly lower, while more than 237,000 new infections were reported.

While a potential lifesaver for those who receive it, the vaccine is not likely to have a dramatic impact on the immediate course of the pandemic. The initial supply of vaccines will fall far short of the 300 million doses some officials had hoped for last spring, when Operation Warp Speed was created. On Friday, federal officials announced they would purchase an additional 100 million doses of Moderna’s soon-to-be approved vaccine, bringing the expected supply of the two leading vaccines to 300 million, probably by midyear.

Still, many saw the imminent arrival of even a limited supply as a source of hopeamid forecasts of a deadly winter.The two-shot vaccine, which has been shown to be 95 percent effective in randomized trials involving tens of thousands of people, has already been cleared by Britain, Canada, Bahrain and Saudi Arabia.

The vaccine from Pfizer and German firm BioNTech was expeceted to be authorized just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists. Its clearance would set in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States.

Federal officials have said distribution of the first 2.9 million doses would begin within 24 hours of the agency’s announcement. An advisory panel for the Centers for Disease Control and Prevention has recommended that health-care workers and nursing home residents be the first recipients, and is expected to give its final blessing to the vaccine this weekend, paving the way for inoculations to begin early next week.

The record-breaking time frame of the vaccine’s development creates a new paradigm, proving that fast and flexible technologies paired with a single-minded focus by pharmaceutical companies and government can accomplish in 11 months what typically takes years. It also marks a rare triumph for the Trump administration, which in many other areas – such as ensuring adequate testing supplies and providing consistent guidance on masks – has failed to produce a coherent and sustained response to the crisis.

“It’s an all-capital-letters, followed by several exclamation points” accomplishment, said Howard Markel, a medical historian at the University of Michigan who predicted that the scientists who were responsible will be lionized for ending the pandemic.

Pfizer and its Germany-based partner, BioNTech, harnessed a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a large clinical trial.

Harvard political scientist Daniel Carpenter said it was unprecedented to go from the discovery of a disease to the development of a vaccine in 11 months. The shortest timeline previously was for the mumps vaccine, which took four years. Most vaccines are produced for ailments that have been around for a long time, after years of research often marked by failures and disappointments. In the case of AIDS, there still is no vaccine, nearly four decades after HIV was identified.

Meanwhile, the FDA, working closely with the companies, conducted an accelerated review that compressed into three weeks the typical months-long scrutiny of safety, effectiveness and data on manufacturing quality.

Operation Warp Speed, the administration’s effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer-BioNTech’s being the first to cross the finish line. Unlike the other companies, Pfizer and BioNTech did not take government money for research and development, but they did receive a $1.95 billion contract for 100 million doses, about 25 million of which will be delivered this year.

“To get there has required a host of innovations. . . . Any one of those would have been cause for considerable amazement,” said Francis S. Collins, director of the National Institutes of Health. “But when you put them together, it’s a path so revolutionary it would be hard to imagine somebody contemplating it five years ago.”

But while the vaccine enterprise has been impressive, its credibility has been repeatedly threatened by the president, who for months pressured the FDA to authorize a vaccine before Election Day and, when that did not happen, bitterly accused the agency and Pfizer of orchestrating delays to harm his reelection prospects. On Friday, he continued his criticism on Twitter, calling the agency “a big, old, slow turtle,” adding, “Get the dam vaccines out NOW.”

Experts said the president’s behavior risks undermining public confidence – not because it would force a vaccine through prematurely, but because it creates the appearance that politics, not science, drove the decisions.

“There was no plausible way the FDA would not authorize this vaccine . . . but this makes it appear [their decision] is politically motivated,” said Dorit Reiss, a professor of law at the University of California Hastings College of the Law who writes about vaccine policy. “Making it appear there was political pressure will undermine trust.”

The FDA has repeatedly said its scientists would review the vaccine and come to their own independent judgments, and on Friday, Hahn denied the White House brought pressure to speed the authorization.

“This is an untrue representation of the phone call with the Chief of Staff,” Hahn said in a statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

A White House official declined to comment on the latest pressure, saying, “We don’t comment on private conversations, but the Chief regularly requests updates on progress toward a vaccine.”

The political machinations are in sharp contrast to the scientific achievement in producing a vaccine in record time. Pfizer-BioNTech’s product, and another vaccine right on its heels from biotechnology company Moderna, both use a snippet of genetic material encapsulated in a fat bubble to instruct cells to build the spiky proteins that dot the coronavirus. These shots will be the first time the genetic technology has been used in people outside clinical trials.

The government’s big bet on the promising method, which allowed for much faster vaccine development, was controversial but is paying off: Moderna’s shot is expected to be authorized shortly after a review by the FDA’s outside advisers scheduled for Thursday.

Formidable challenges lay ahead involving the massive scale-up of manufacturing and a complicated distribution plan headed by cash-strapped states. On scientific questions, experts still do not know how long the vaccine’s protection lasts.

While the CDC has recommended who should get the shots first, starting with health-care workers and nursing home residents, states ultimately will have the final say on which groups get priority.

Much of the general population – including younger people who do not have underlying health conditions or jobs that put them at risk – is unlikely to be offered the vaccine before late spring or early summer. And if a significant proportion of Americans spurn the shot, efforts to banish the coronavirus or turn it into a low-level threat could be made much more difficult.

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Pfizer vaccine allergic reactions probed by FDA before clearance (nationthailand.com)

Pfizer vaccine allergic reactions probed by FDA before clearance

Health & BeautyDec 12. 2020Alex Azar, secretary of Health and Human Services, during a news conference at the White House in Washington on Aug. 23, 2020. MUST CREDIT: Bloomberg photo by Stefani Reynolds. 

By Syndication Washington Post, Bloomberg · Anna Edney

The Food and Drug Administration is scrutinizing recent reports of allergic reactions to Pfizer Inc.’s covid-19 vaccine as it readies an emergency-use authorization — a step that could come as soon as this weekend, according to top U.S. health officials.

One of the last things the FDA does before clearing a product for public use is make sure the instructions for doctors and patients on the label include up-to-date information about who should use it and how.

In the past several days, there have been reports of serious allergic reactions to the vaccine in the U.K. After starting immunizations Tuesday, the U.K.’s National Health Service said people with a significant history of allergies shouldn’t receive the shot.

The FDA is seeking more information on the reactions from the U.K. drug regulator, Marion Gruber, director of the Office of Vaccines Research and Review, told a committee of agency advisers Thursday. The panel voted 17-4, with one abstention, that the benefits of Pfizer’s vaccine for people over the age of 16 outweighed any risks.

“That’s something we’re working with Pfizer right now on is the appropriate language for the doctors, is if you have a pre-existing serious allergic reaction to anything in these vaccines or medical allergies, you should exercise caution in getting these vaccines initially,” Health and Human Services Secretary Alex Azar said Friday in an interview with Fox Business News.

Still, any final hurdles are expected to be cleared in relatively short order. The FDA is working toward a rapid authorization of the shot, and has “notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the agency said in a statement Friday.

A formal go-ahead from the FDA would set in motion a nationwide distribution effort, starting with 2.9 million doses being made available to states. Azar told ABC that Americans may start getting shots as soon as Monday. He tweeted that Pfizer has already been advised that the authorization was coming.

President Donald Trump and his administration have placed tremendous political pressure on the FDA to clear the vaccine, which Canada has also approved. As of Friday, the pandemic had killed more than 292,000 Americans, and confirmed cases topped 15.6 million. A new surge of cases in the aftermath of the Thanksgiving holiday has strained hospital capacity nationwide.

Trump in a Friday tweet called the FDA “a big, old, slow turtle,” and demanded Stephen Hahn, the agency’s commissioner, “get the dam vaccines out NOW.”

Pfizer declined to comment. The shares fell as much as 2.5% as of 11:06 a.m. in New York. American depositary receipts of BioNTech, Pfizer’s partner in developing the shot, lost as much as 3.4%.

Thursday’s FDA advisory panel discussion touched on incidents of Bell’s palsy, a temporary facial paralysis that was experienced by four people who received Pfizer’s vaccine in clinical trials. No one in the placebo group reported the condition.

FDA staff said the number of Bell’s palsy cases was consistent with the rate of the condition in the general population, and there was no reason to believe it was related to the vaccine, but some advisers were skeptical.

The FDA has asked Pfizer to conduct surveillance for Bell’s palsy cases in vaccine users in the general public. The agency may want to flag the issue on the vaccine’s label, in light of the advisory panel’s discussion.

“At this point it’s really a matter of working out some of the final details — dotting the i’s, crossing the t’s, getting the fact sheet for the doctors,” Azar told Fox.

The panel also considered whether there was enough data to support the vaccine’s use in 16 and 17 year olds, leaving some members uncomfortable with voting in its favor. However, others said data from older trial participants could be extrapolated to younger people.

Clinical-trial data has shown that Pfizer’s vaccine is 95% effective in preventing symptomatic Covid-19. It isn’t yet known whether the vaccine can prevent transmission of the disease. Pfizer has said it plans to file with the FDA for a full approval for the shot in April.

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Military-grade camera shows risks of airborne coronavirus spread (nationthailand.com)

Military-grade camera shows risks of airborne coronavirus spread

Health & BeautyDec 12. 2020

By The Washington Post · Dalton Bennett, Sarah Cahlan

As winter approaches, the United States is grappling with a jaw-dropping surge in the number of novel coronavirus infections. More than 288,000 Americans have been killed by a virus that public health officials now say can be spread through airborne transmission.

https://www.washingtonpost.com/video/c/embed/5be9a5bf-0177-4f7b-832c-85d1cf82b4f3?ptvads=block&playthrough=false

The virus spreads most commonly through close contact, scientists say. But under certain conditions, people farther than six feet apart can become infected by exposure to tiny droplets and particles exhaled by an infected person, the Centers for Disease Control and Prevention said in October. Those droplets and particles can linger in the air for minutes to hours.

To visually illustrate the risk of airborne transmission in real time, The Washington Post used a military-grade infrared camera capable of detecting exhaled breath. Numerous experts – epidemiologists, virologists and engineers – supported the notion of using exhalation as a conservative proxy to show potential transmission risk in various settings.

“The images are very, very telling,” said Rajat Mittal, a professor of mechanical engineering in Johns Hopkins University’s medical and engineering schools and an expert on virus transmission. “Getting two people and actually visualizing what’s happening between them, that’s very invaluable.”

The highly sensitive camera system detects variations in infrared radiation that are not visible to the naked eye. The technology is more typically used in military and industrial settings, such as detecting methane gas leaks in pipelines. In 2013, it was deployed by law enforcement during the 20-hour manhunt for the Boston Marathon bombers.

But fitted with a filter that specifically targets the infrared signature of carbon dioxide, the camera can be used to map in real time the partial path of the nearly invisible particles we exhale.

According to experts, the footage underrepresents the potential risk of exposure from airborne particles. Those particles may spread farther or linger longer than the visible exhalation plume, which dissipates quickly to a level of concentration the camera can no longer detect.

Environmental factors such as airflow in a space, wind and sunlight can reduce the chances of spread, as can such behavioral factors as mask-wearing and social distancing. The risk of exposure increases when people are not wearing masks and are close together in an enclosed space or in an area with poor ventilation.

Many of those circumstances will become more common as Americans increasingly spend time indoors in the coming months.

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Pollution in Bangkok hits harmful levels on Friday (nationthailand.com)

Pollution in Bangkok hits harmful levels on Friday

Health & BeautyDec 11. 2020

By The Nation

Air pollution in Bangkok hit dangerous levels on Friday morning with PM2.5 readings coming in at 30 to 70 micrograms per cubic metre (μg/m3), the Pollution Control Department’s Air Quality and Noise Management Bureau reported.

Thailand’s standard for safe levels of PM2.5 (particles less than 2.5 micrometres in diameter) is 50 μg/m3, though the World Health Organisation sets it at 25 μg/m3.

People in areas where PM2.5 pollution is bad have been advised to stay indoors and monitor their health.

The PM2.5 situation can be followed via the Air4Thai.com website or smartphone app, or via bangkokairquality.com, the bureau said.

As of 10am, PM2.5 was at dangerous levels in Din Daeng, Prakhanong, Dusit, Pom Prab (Sattru Phai), Samphanthawong, Pathum Wan, Bang Rak, Sathorn, Yannawa, Bang Na, Don Muang, Sai Mai, Bang Kapi, Prawet, Khlong San, Bangkok Yai, Bangkok Noi, Taling Chan, Thawee Watthana, Phasi Charoen, Nong Khaem, Bang Bon, Thung Khru, Phra Nakhon, Bang Sue, Laksi, Bang Khen, Chom Thong, Bang Khae, Bang Khunthien, Bueng Kum and Thung Khru.

Meanwhile, PM2.5 levels in other regions of Thailand were as follows:

North: 14 to 49 μg/m3.

Northeast: 17 to 86 μg/m3, with pollution in Nong Khai’s Muang district highest.

Central and West: 15 to 55 μg/m3, with pollution in Suphan Buri’s Muang district highest.

East: 21 to 44 μg/m3.

South: 6 to 35 μg/m3.