Tag: emergency

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Entertainment

Emergency Grants for New York Metropolis Artists With Disabilities

Emergency Grants for New York City Artists With Disabilities

The tulips are in bloom, Broadway is coming back and the pandemic slowdown in America seems to be in sight.

But for many artists who are still trying to recover from a year of lost or reduced income, normal is still a long way off.

Now a New York Foundation for the Arts program is accepting applications for $ 1,000 in cash for New York-based creators with disabilities who have struggled as a result of the pandemic. The Barbara and Carl Zydney Scholarship for Artists with Disabilities is open to literary, media, music, performing and visual artists aged 21 and over in each of the five boroughs.

The new program is named in memory of Barbara Zydney, who was born and raised in New York and teaches visually impaired children in the city’s public school system, and her husband Carl, a fellow patron of the arts.

“It brings together three things that were important to the Zydneys: their love for New York, their passion for the arts and Barbara’s commitment to working with people with disabilities,” said the announcement on the foundation’s website.

About one in five adults in New York is disabled, according to the New York State Health Department.

While there are no readily available statistics specifically tracking the impact of the pandemic on disabled artists, visual, performing and other artists had a disastrous year. Employment in the city’s arts, entertainment and recreation sectors fell 66 percent from December 2019 to December 2020, according to a February report by the New York State Comptroller’s Office. It was the biggest decline in the city’s economy.

Applications are accepted until Tuesday, June 15, 5 p.m. Qualified applicants will be selected by lottery and informed of the status of their application on July 24th.

A full list of guidelines can be found on the foundation’s website.

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Health

GlaxoSmithKline asks FDA for emergency authorization for antibody drug

GlaxoSmithKline asks FDA for emergency authorization for antibody drug

In this photo illustration, the UK multinational pharmaceutical company GlaxoSmithKline (GSK) logo is displayed on a smartphone with a computer model of the COVID-19 coronavirus in the background.

Budrul Chukrut | SOPA pictures | Getty Images

GlaxoSmithKline and Vir Biotechnology filed Friday with the Food and Drug Administration for emergency approval for their monoclonal antibody drug.

The companies apply for the permit for high risk individuals aged 12 and over.

The FDA filing is based on an interim analysis of a Phase 3 study evaluating the drug for the early treatment of Covid-19 in adults at high hospital risk. The drug reduced hospital admissions or death from Covid by 85% compared to a placebo. The test results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the study be discontinued because of the evidence of profound effectiveness for the registration,” the company said in a statement.

Companies began testing the antibody on early-stage Covid patients in August in hopes of preventing symptoms from getting worse. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already approved for use – by Regeneron and Eli Lilly – are not being used adequately.

GSK said the companies would also continue talks with the European Medicines Agency and other global regulators to make the drug available to Covid patients as soon as possible.

-Reuter contributed to this report.

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Politics

Cuomo to signal regulation stripping emergency his Covid powers

Cuomo to sign law stripping emergency his Covid powers

New York Governor Andrew Cuomo rejected calls to resign Sunday after new allegations of inappropriate workplace behavior were raised. However, he will sign a bill that removes his emergency powers to fight the Covid-19 pandemic as he faces growing political pressure from his own party.

The Democratic governor, who grappled with waves of criticism and called for his resignation over dueling crises in his government, also vowed that he would “not be distracted” in the fight against Covid.

“I am signing the State Emergency Powers Act today and I will implement it today,” Cuomo said on a conference call with reporters.

Cuomo said he would take this step with the “major change” that will allow Empire State restaurants outside of New York City to increase indoor dining capacity from 50% to 75%.

“The numbers have gone down. If the numbers have gone down, we’ll adjust the economic reopening valve,” said Cuomo.

The change will be implemented on March 19, according to the governor. But he warned: “If the numbers change, if something happens, if there is a downturn, then obviously we will adjust.”

Cuomo is under fire amid a growing number of allegations of sexual harassment or inappropriate workplace behavior, as well as an ongoing scandal over his government’s handling of care home deaths in Covid.

New York Senate majority leader Andrea Stewart-Cousins ​​on Sunday called for Cuomo’s resignation after two more women were added to the file to accuse the governor of inappropriate behavior.

“Every day there is a different report that stands out from the government business,” said Stewart-Cousins.

“We have allegations of sexual harassment, a toxic work environment, the loss of credibility related to the Covid-19 nursing home data and questions about the construction of a major infrastructure project.”

“New York is still in the midst of this pandemic and still facing the social, health and economic repercussions,” she said. “We have to govern without daily distraction. For the good of the state, Governor Cuomo must resign.”

Carl Heastie, the Democratic spokesman for the New York State Assembly, said in a statement Sunday that he “agrees with Stewart cousins” on the governor’s ability to continue running this state.

“The allegations about the governor that have been reported over the past few weeks have been deeply troubling and have no place in government, at work or anywhere else,” said Heastie.

“We face many challenges and I think it is time for the governor to give serious thought to whether he can effectively meet the needs of the people of New York.”

But Cuomo was defiant earlier on Sunday when he was riddled with questions about several women’s allegations, including two more who came up on Saturday.

“There are some lawmakers suggesting that I step down on allegations,” Cuomo said. Some members of Cuomo’s own party, including Senator Alessandra Biaggi, have asked him to resign.

“I was elected by the people of this state, I was not elected by politicians. I will not resign on charges,” he said.

“The premise of resigning on allegations is indeed anti-democratic,” added Cuomo. He urged people to let New York Attorney General Letitia James conduct her independent investigation into harassment claims before drawing any conclusions.

“Let the attorney general do her job. She’s very good, she’s very competent. And that’s going to be a due process and then we’ll have the facts,” he said.

“There is no way I can step down,” added Cuomo. “But I won’t let that distract me either … We have a lot to do.”

When asked about Biaggi in particular, Cuomo replied: “I have a flash of news for you: There is politics in politics.”

“I have political differences with people,” said Cuomo, also with some Democrats and Biaggi. “But they don’t override the will of the people. They don’t override elections. They cannot hear an allegation and decide on the allegation,” he said.

– CNBC’s Dan Mangan contributed to this report.

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Health

FDA approves J&J’s single-shot Covid vaccine for emergency use

FDA approves J&J's single-shot Covid vaccine for emergency use

The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use. This gives the US a third tool to fight the pandemic as highly contagious variants are gaining a foothold across the country.

With the FDA’s approval for the emergency on Saturday, the federal government’s plan begins to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna vaccines, patients with the single dose of J&J do not need to take a second dose and can be stored at refrigerator temperature for months.

J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

Initially, doses would be limited, J&J said. The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. US officials say they are working with the company to increase supply as soon as possible.

In the past few weeks, US health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to decrease the effectiveness of vaccines both in market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the declines in Covid-19 cases reported in the US since early January could flatten as the variants spread.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. However, FDA documents show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The Pfizer vaccine was found to be 95% effective against Covid-19, while the Moderna vaccine was around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved J & J’s vaccine for people 18 years of age and older. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no indication of benefit” in coronavirus patients.

The FDA was expected to approve J & J’s emergency vaccine.

The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Panel on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

No specific safety concerns were identified with J & J’s vaccine. Headache, fatigue, and muscle aches were some of the most common side effects among people who received the vaccination, according to an FDA report released Wednesday. There have also been reports of nausea, fever and injection site pain, the report said.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The company has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

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FDA panel unanimously recommends emergency use

FDA panel unanimously recommends emergency use

A key advisory body to the Food and Drug Administration unanimously endorsed Johnson & Johnson’s emergency single-shot coronavirus vaccine on Friday. This is a critical step that paves the way for a third preventive treatment to be distributed in the US next week.

The non-binding decision, made 22-0 by the FDA’s Advisory Committee on Vaccines and Related Biological Products, comes because the Biden government is working to increase the supply of vaccine doses and get Americans vaccinated as soon as possible. US health officials are increasingly concerned about new emerging variants of the virus, particularly South African strain B.1.351, which has been shown to reduce the effectiveness of vaccines on the market and under development.

The head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned earlier on Friday that the decreases in Covid-19 cases reported in the US since early January could flatten as the variants continue to spread.

“In the past few weeks, cases and hospital admissions in the US have decreased since early January, and deaths have decreased over the past week,” Walensky said during a press conference at the White House. “However, the latest data suggests that these declines may stall and possibly weaken if a number is still very high.”

Scaling-up vaccinations could help mitigate the effects of the highly contagious variants, Adam MacNeil, epidemiologist at the CDC, said during a presentation the Friday before the vote. He added that the US “isn’t getting close” to herd immunity, but vaccination may help “bring us closer to closing the herd immunity gap”.

The FDA advisory panel plays a key role in approving flu and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does. At a similar request from Pfizer and Moderna, the FDA approved these companies’ vaccinations the day after the committee endorsed approval for emergency use. If J&J follows the pattern, a third vaccine could be approved on Saturday.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

Initially the doses would be limited. The U.S. plans to ship 3 to 4 million doses of J & J’s vaccine to states, pharmacies and community health centers next week pending FDA approval, President Joe Biden’s Covid czar Jeff Zients told reporters on Wednesday . The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to deliver 100 million doses of its vaccine by the end of June.

Federal and state health officials have been eagerly awaiting approval of J & J’s vaccine. Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J&J only requires one dose, which makes logistics easier for healthcare providers. J & J’s vaccine, unlike the other two vaccines, which must be stored at subzero temperatures, can also be stored at refrigerator temperatures for months.

J & J’s single-dose vaccine “is easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

An EUA means that the FDA allows some people to receive the vaccine while the agency continues to analyze data. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The company is asking the FDA to approve use of the vaccine in people 18 years and older.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. However, FDA staff records indicate that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

FDA officials on Wednesday approved J & J’s vaccine and stated in documents that the clinical trial results and safety data “are in line with recommendations in the FDA’s guidelines on approving the emergency use of vaccines to prevent COVID-19 “.

The FDA report found no specific safety concerns for the vaccine when analyzed by age, race, and comorbidity. Headache, fatigue, and muscle pain were some of the most common side effects in people who received the vaccination, the report said. There have also been reports of nausea, fever, and pain at the injection site.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The FDA report says there have been some cases of Bell’s palsy, a condition in which half of your face falls off but was “balanced” with the number in the general population. The FDA previously announced that the condition would be monitored in vaccine recipients after flagging it as a potential problem with Pfizer’s shots, and noted that this isn’t necessarily a side effect, but it is worth looking out for.

CNBC’s Hannah Miao contributed to this report.

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Business

Tiger Woods crashes automotive, golf star recovering after emergency surgical procedure

Tiger Woods crashes car, golf star recovering after emergency surgery

A luxury SUV driven by Tiger Woods crashed and rolled over in Southern California on Tuesday morning. The golf superstar was seriously injured, the authorities and his agent said.

According to a statement posted on his Twitter account, Woods is “awake, reacting and recovering in his hospital room” after an emergency operation.

Dr. Anish Mahajan, chief medical officer and interim CEO of Harbor-UCLA Medical Center, said Woods sustained “significant orthopedic injuries” to his right lower leg.

A rod was introduced to stabilize his tibia and femoral bones, while a “combination of screws and pins” was used to stabilize injuries to the bones of his foot and ankle, the statement said on Woods’ Twitter account.

Woods, who was the only person in the Genesis GV80 SUV, was trapped in the wreckage that occurred after hitting a mean mean on the road and then crashed into a paintbrush just before 7:12 a.m. PT. A neighbor of the crash scene named 911.

Los Angeles County Sheriff Alex Villanueva said Woods was “traveling at a relatively higher speed than normal”.

Woods was freed from the vehicle by firefighters and then taken to Harbor UCLA, a major trauma center.

Villanueva said at a press conference that MPs responding to the scene saw “no sign of impairment” on Woods.

Since there was no sign of impairment, Villaneuva said, “There was no effort to draw blood in the hospital.”

Woods was conscious and able to communicate with MPs.

“I spoke to him. I asked his name. He told me his name was Tiger and that was when I recognized him straight away,” deputy Carlos Gonzalez told reporters.

“It is very lucky that Mr. Woods got out alive,” said Gonzalez.

The scene of the accident on the border between Rolling Hills Estates and Rancho Palos Verdes is known to the police due to the frequency of the accidents and the tendency of drivers to exceed the speed limit.

The front end of the SUV was destroyed. Woods likely survived the single car accident because the interior of the SUV was left intact, an official said. The Genesis has 10 airbags.

Woods was wearing a seat belt during the crash, officials said.

They also said there were no skid marks on the scene and “no signs of braking”.

LA County Sheriff’s officers are investigating an accident involving golfer Tiger Woods on Hawthorne Blvd. in Rancho Palos Verdes, February 23, 2021.

Wally Skalij | Los Angeles Times | Getty Images

Woods, 45, was at Rolling Hills Resort last week after hosting the Genesis Invitational tournament. He shot under a contract with Golf Digest and the Discovery Channel.

His agent, Mark Steinberg, said in a statement, “Tiger Woods was in a car accident in California this morning in which he sustained multiple leg injuries.”

“He is currently in surgery and we thank you for your privacy and assistance,” Steinberg said.

Last month Woods announced that he had “recently” had a fifth microdisectomy on his back to remove a pressurized disc fragment that caused him pain during the PNC championship in Orlando, Florida in December, the last competition prepared.

He played in this tournament with his 11 year old son Charlie. The duo came in seventh.

“I’m looking forward to starting training and focusing on getting back on tour,” Woods said in a January statement.

Tiger Woods watches from the 18th hole during the final round of the Genesis Invitational golf tournament at the Riviera Country Club in Pacific Palisades, California on February 21, 2021.

Brian Rothmüller | Icon Sportswire | Getty Images

The resident of Jupiter, Florida has won 82 PGA titles, most of which were related to Sam Snead. He has won 15 major championships, including five Masters tournaments.

PGA Commissioner Jay Monahan said in a statement: “”We were made aware of the Tiger Woods car accident today. We are waiting for more information when he comes out of the operation. “

“On behalf of the PGA TOUR and our players, Tiger is in our prayers and will have our full support when he recovers,” said Monahan.

Sportswear giant Nike, which sponsors Woods, said in a statement: “We follow the news all around Tiger and our thoughts and hearts are with him and his family at this time.”

Woods Equipment and Club Sponsor TaylorMade Gold said: “We are shocked at the news of Tiger Woods’ accident this morning and send our thoughts and prayers to him, his family and his team as they assist him through his operation recovery . “

Wood’s stellar career was shaken in November 2009 when he crashed an SUV into a fire hydrant one morning outside his then home in Windermere, Florida.

Woods was knocked unconscious for more than five minutes in that accident, and his then-wife, Elin Nordegren, reportedly used a golf club to smash a window in the vehicle and pull it out.

After this mysterious crash, Woods is said to have had numerous extramarital affairs. Soon after, he entered a Mississippi clinic for treatment.

In May 2017, Woods was accused of driving under the Florida influence after police discovered him sleeping in a damaged car. He later apologized and issued a statement to several reporters saying that he assumed full responsibility for the arrest, which he attributed to “an unexpected reaction” to a mixture of prescribed drugs.

“I want the public to know it’s not alcohol,” Woods said at the time.

“I would like to wholeheartedly apologize to my family, friends and fans. I also expect more from myself,” said Woods. “I will do everything in my power to make sure this never happens again.”

A month after this arrest, Woods entered a clinic for treatment for problems with prescription pain medication and a sleep disorder.

Steinberg said at the time that Woods used pain medication to get up and move around while he was recovering from four back surgeries.

Senior golfer Justin Thomas choked on Tuesday speaking about Woods at a press conference.

“I have a stomach problem. It hurts to see that one of my closest friends is in an accident and I just hope he’s okay,” Thomas told reporters. “I’m just worried about his children. I’m sure they are fighting.”

Woods was spotted on social media on a golf course with former Miami Heat basketball star Dwyane Wade on Monday.

Actor David Spade also tweeted a photo of himself with Woods on the course on Monday.

On Sunday, during an interview with CBS Sports, Woods was asked if he would play at the Georgia Masters tournament in August.

“God I hope so,” said Woods.

“I have to get there first. Much of it is based on my surgeons, my doctors and my therapists, and getting it right because this is the only back I have, so I don’t have much wiggle room here.”

– CNBC’s Jessica Golden, Amanda Macias and Christine Wang contributed to this report.

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Business

2.5 Million Girls Left the Work Power Through the Pandemic. Harris Sees a ‘Nationwide Emergency.’

2.5 Million Women Left the Work Force During the Pandemic. Harris Sees a ‘National Emergency.’

Childcare remains an issue for working mothers, and it was a main topic of Thursday’s round table. Nearly 400,000 childcare jobs have been lost since the pandemic began, Ms. Harris said. The shutdowns of small businesses and the loss of millions of jobs have created the “perfect storm” for women, especially black entrepreneurs, she added. “The longer we wait to act,” she said, “the harder it will be to get these millions of women back into work.”

Updated

Apr. 18, 2021, 5:19 p.m. ET

The government’s aid proposal would provide around $ 130 billion to help reopen K-12 schools, a key element of childcare. But how and when to do this – and how to explain decision-making to Americans – has proven to be a stumbling block for the president and his advisors.

President Biden has promised to reopen as many schools as possible in the first 100 days of his term in office. This promise has been challenged by teachers’ unions seeking security measures before schools reopen. On Thursday, Ms. Harris kept her comments on the schools limited, saying the plan would “provide funding to help schools reopen safely”. Ms. Harris said in an appearance on the “Today” show Wednesday that “teachers should be a priority” to get vaccinations.

Several representatives of women’s advocacy groups took part in the call with Ms. Harris, including Fatima Goss Graves, President of the National Center for Women’s Rights. She said that the vice president did not “go into” detail “about reopening schools, but that the group emphasized other issues, including the importance of direct payments to families in difficulty.

“People barely hold it together right now,” said Ms. Goss Graves. “I was pleased to hear that she understood this investment and spoke with urgency.”

As the pandemic drags on, the statistics for women are indeed grim.

A report released last year by researchers at the University of Arkansas and the University of Southern California’s Center for Economic and Social Research found that women’s employment began to decline almost immediately after the onset of the coronavirus last spring. Since then, researchers have found that women took on a heavier burden than men in looking after children.

Women without a university degree and women with skin color are disproportionately affected. Another report released by the Brookings Institution in the fall showed that nearly half of all working women have low-paying jobs. These jobs are more likely to be filled by black or Latin American women, and they are in sectors like food and travel that are the least likely to return to normal soon.

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Health

J&J requests FDA emergency use authorization

J&J requests FDA emergency use authorization

Artur Widak | NurPhoto | Getty Images

Johnson & Johnson filed with the Food and Drug Administration for emergency approval to use its coronavirus vaccine after data was released last week showing that protection against the virus was about 66% effective.

If the application is approved by J&J, this will be the third Covid-19 vaccine approved for emergency use in the US, after vaccines developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna’s vaccine was approved a week later.

US officials and Wall Street analysts are eagerly awaiting J & J’s vaccine approval, which could come as early as this month. President Joe Biden is trying to speed up the pace of vaccination in the US, and experts say his government will need a range of drugs and vaccines to beat the virus that killed more than 450,000 Americans in the past year.

Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J & J’s vaccine only requires one dose, making logistics easier for healthcare providers.

J&J said on Jan. 29 that its vaccine was 66% overall effective against Covid-19. However, the vaccine appeared to be less effective against other variants. The level of protection was only 57% in South Africa, where a new, highly contagious strain called B.1.351 is spreading rapidly. South Carolina officials discovered the first known US case of this strain last month.

Infectious disease experts suggest that J & J’s numbers cannot be used as a direct comparison with Pfizer and Moderna vaccines, which were found to be 95% and 94% effective, respectively. That’s because J & J’s vaccine is a single dose, and the company’s study came about when there were more infections and new, more contagious variants.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the key finding from the J&J data was that the vaccine was 85% effective at preventing major diseases.

“The most important thing, which is more important than preventing someone from getting a pain and a sore throat, is preventing people from getting serious illnesses,” said the director of the National Institute of Allergies and Infectious Diseases, speaking to reporters on Jan. January. 29. “This will alleviate so much stress and human suffering and death in this epidemic.”

The FDA has announced that it will approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces people’s risk of influenza by 40% to 60% compared to people who are not vaccinated, according to the Centers for Disease Control and Prevention.

J&J has announced that it will ship the vaccine at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are between negative 112 and negative 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.

The Department of Health and Human Services announced in August that it had signed a contract with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the opportunity to order another 200 million cans, according to the announcement.

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Operating low on oxygen, emergency employees in Los Angeles County are advised to manage the minimal vital.

Running low on oxygen, emergency workers in Los Angeles County are told to administer the minimum necessary.

California’s daily coronavirus case numbers remain about four times what it was during the state’s summer flood, and officials predict the aftermath of a December wave related to holiday gatherings will worsen over the winter.

After new infections – fueled by Thanksgiving trips and gatherings, then Christmas festivities – led to a surge the state hadn’t seen before, the trend in its new cases flattened somewhat in the early days of 2021.

But there are more than twice as many Covid-19 patients in California hospitals as there were a month ago, and many intensive care units in the state are overcrowded. It has also been found that at least six people in the state are infected with the new, more transmissible variant of the virus first identified in the UK.

The state is also facing a lack of oxygen for patients and has deployed the U.S. Army Corps of Engineers and the California Emergency Medical Services Authority to help with the delivery and refilling of oxygen tanks.

As a sign of how bad the shortage is, Marianne Gausche-Hill, the medical director of the Los Angeles County EMS agency, issued guidelines on Sunday for emergency responders to administer the “minimum amount of oxygen” required keep the patient’s oxygen saturation at a level or just over 90 percent. (Levels in their low 90s or below are an issue for people with Covid-19.)

In the brutal logic of the pandemic, more cases inevitably lead to more suffering and death. As of Monday evening, 4,258 people had died with Covid-19 in the past two weeks, compared to 3,043 in the two weeks prior.

Updated

Jan. 5, 2021, 6:31 p.m. ET

“This is a deadly disease, this is a deadly pandemic,” Governor Gavin Newsom told reporters on Monday. “It remains deadlier today than at any point in the history of the pandemic.”

Some progress has been made. For example, California’s daily average of 38,086 cases per day for the past week is an 11 percent decrease from the average for two weeks earlier. And although hospital stays in Covid-19 have increased 18 percent to 20,618 in the past two weeks, that means a slight flattening of the curve, according to Governor Newsom.

But the state’s last major Covid-19 surge in the summer only caused about 10,000 infections on the worst days. And in Los Angeles County, the recent crisis has made the healthcare system so thin that patients arriving at a hospital were recently ordered to wait in an outdoor tent.

Los Angeles Mayor Eric Garcetti said Sunday that the county’s recent spike infected a new person every six seconds and that many transmissions were in private settings.

“It’s a message for all of America: We may not all have the same density as LA, but what is happening in LA can and will come to many churches in America,” he said.

The state’s worst outbreak is centered in southern California and the San Joaquin Valley, where intensive care units are zero percent. Officials are now working to recruit additional nurses to handle the flood of patients. Governor Newsom said 90 patients were being held in “alternative care locations” outside of hospitals to ease the burden.

More vaccinations would help ease the burden on California, but Governor Newsom said vaccinations were only just increasing after some early challenges. So far, the state has only administered about 35 percent of the coronavirus vaccine doses received.

“That’s not good enough,” he said. “We recognize that.”

In the meantime, says Dr. Mark Ghaly, the secretary of state for health and human services, Californians should be extra careful when meeting with people outside of their household as the virus is so widespread.

“The same activities that you did a month ago today are much riskier today than from a Covid transmission perspective,” he said.

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Moderna Covid vaccine FDA accepted for emergency use

Moderna Covid vaccine FDA approved for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.

With the FDA’s approval for the emergency on Friday, the federal government’s plan to distribute approximately 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the country next week will be approved.

“We’ll probably see gunshots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. is planning to ship 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the first product to be approved by the FDA.

“With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day,” said FDA Commissioner Dr. Stephen Hahn said in a statement.

US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending that health workers and nursing homes be prioritized. However, states may distribute the vaccine at their own discretion.

States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid’s vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved Moderna’s vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn’t work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

Prior to the vote, some committee members stressed their approval of Moderna’s vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.

During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency is looking into the problem.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

The FDA said while this isn’t necessarily a side effect, it does recommend monitoring people who receive Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.