FDA-approved J&J single-shot Covid vaccine

Food and Drug Administration officials endorsed Johnson & Johnson’s emergency Covid-19 vaccine, a crucial step in getting a third shot onto the U.S. market.

The employee report released on Wednesday is designed to brief the FDA’s Vaccines and Related Biological Products Advisory Panel, which will meet on Friday to review J & J’s application for emergency approval.

At a similar request from Pfizer and Moderna, the agency approved these companies’ vaccinations the day after the committee of external medical advisors endorsed approval for emergency use. The committee is expected to recommend J & J’s vaccine. The FDA does not need to follow the committee’s recommendation, but it often does.

FDA staff noted that the clinical trial results and safety data “are in accordance with the recommendations in the FDA guidelines on emergency approval of vaccines to prevent COVID-19.”

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, the FDA staff records 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.

As of February 5, there were seven Covid-19-related deaths in the placebo group and no Covid-19-related deaths in the vaccine group, according to the FDA.

According to the agency, no specific safety concerns were identified when analyzed by age, race and comorbidities. According to the report, there have been no reports of anaphylaxis, a serious and potentially life-threatening allergic reaction. The FDA said the most common side effects were headache and fatigue, followed by muscle pain, nausea, and fever.

The vaccine’s effectiveness was similar for age, race, and people with comorbidities, according to FDA staff. However, the effectiveness appeared to be less in people aged 60 and over who also had comorbidities such as diabetes or heart disease. The effectiveness rate was 42.3% about a month after the shot.

As of January 22, eight pregnancies had been reported, four of them in the vaccine group, to FDA staff. Among the participants in the vaccine group, two pregnancies are ongoing with currently unknown results, according to the report.

The news comes as the Biden government works to increase the supply of cans after states complained that demand for the shots was rapidly exceeding supply. Around 44.1 million out of around 331 million Americans have received at least their first two-dose dose of the Pfizer and Moderna vaccines, according to the Centers for Disease Control and Prevention. More than 19 million have already received their second shot.

If approved, J & J’s application would be the third Covid-19 vaccine to be approved in the U.S. after the emergency vaccines developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved on December 11th, and Moderna received approval a week later. J & J’s vaccine only requires one dose, which would make logistics easier for healthcare providers.

Such authorization is not the same as full approval, which can typically take 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. J&J is applying for permission to use it on anyone aged 18 and over.

J&J has signed a contract with the federal government to supply 100 million doses of its vaccine by the end of June. Jeff Zients, President Joe Biden’s Covid Tsar, told reporters last week that the company is unlikely to hold a “large inventory” of cans prior to launch in the US, as only a few million cans are manufactured.

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. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

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.

Lowe’s fourth quarter 2020 consequence (LOW) beats estimates

Shoppers wearing protective masks wait in line to pick up a store from Lowe’s Cos on Wednesday, May 20, 2020. To be entered in San Bruno, California, USA.

David Paul Morris | Bloomberg | Getty Images

Lowe’s announced on Wednesday that sales in the same store rose 28.1% in the fourth quarter as consumers spent more on home projects during the pandemic.

This is higher than the 22% growth forecast by analysts, according to StreetAccount. Despite the strong results, Lowe’s continues to believe sales could weaken as the pandemic eases.

Lowe’s shares rose 2.5% in premarket trading.

The company reported for the quarter ended Jan. 29, relative to Wall Street expectations, based on an analyst survey conducted by Refinitiv:

  • Earnings per share: $ 1.33 adjusted versus $ 1.21 expected
  • Revenue: $ 20.31 billion versus $ 19.48 billion expected

Lowe reported net income of $ 978 million, or $ 1.32 per share, for the fourth quarter compared to $ 509 million, or 66 cents per share, a year earlier.

Excluding items, the company earned $ 1.33 per share, beating the analysts polled by Refinitiv, which was forecasting $ 1.21 per share.

Net sales rose to $ 20.31 billion, beating analysts’ expectations of $ 19.48 billion.

Sales in its US stores were open for at least a year and online sales were up 28.6% for the quarter.

CEO Marvin Ellison said the company has seen high demand across the board. Sales increased 16% in all merchandising departments and more than 19% in all regions of the country. Online sales rose 121% in the quarter.

Lowe’s reiterated the prediction he made on an investor’s day in December. Chief Financial Officer David Denton had said home improvement product sales are likely to decline in 2021 as more people get Covid-19 vaccines and spend more time outside their homes.

He presented three scenarios for a robust, moderate or weak market. In a robust market, the retailer expects an adjusted base mix of 5% to 7% for home improvement demand in 2021. In a moderate and weak market, demand would likely decrease by 7% to 9% and 10% respectively.

Even in a weak market, Denton said, the retailer is ready to improve its operating margins. He said that since sales to do-it-yourself customers are moderate, they could gain a foothold with home professionals – a smaller segment of Lowe’s customer base, but one that is set to grow.

In its earnings report, Lowe’s said it spent more than $ 100 million in the fourth quarter and more than $ 900 million during the year on additional Covid-related compensation and benefits for employees. It said it spent nearly $ 1.3 billion on pandemic-related spending, including higher wages and business security measures during the fiscal year.

The company spent $ 3.4 billion on share buybacks and paid dividends of $ 452 million in the fourth quarter.

Rival Home Depot’s fourth quarter earnings also beat Wall Street’s expectations this week. The retailer reported strong demand for DIY project accessories, outdoor items like patio furniture and Christmas decorations as shoppers spend more time at home. However, there was no outlook for the year as it was uncertain how long the pandemic will last and what that means for consumer spending.

At the close of trading on Tuesday, Lowe’s shares were up nearly 35% last year. The company’s market value is $ 123.53 billion.

Read the full press release here.

Congress has a listening to on the Trump supporters’ rebellion within the Capitol

Former U.S. Capitol Police Chief Steven Sund testifies before a joint Senate hearing on Homeland Security, Government Affairs, and Senate Rules and Administration on February 23, 2021 in Capitol Hill, Washington, DC to discuss the April 6 attack on the Capitol Investigate January.

Andrew Harnik | AFP | Getty Images

The former head of the U.S. Capitol Police will tell Congress that he asked Senate and House NCOs on Jan. 4 to request the National Guard to attend a joint congressional session two days later for protection.

Both officials effectively denied this request from then-chief Steven Sund, which came from a group of supporters of then-President Donald Trump two days before the Capitol uprising on Jan. 6. This emerges from a copy of the testimony that Sund is expected to give a Senate hearing on Tuesday.

Sergeant at the time, Paul Irving, “stated that he was concerned about the” optics “of the National Guard’s presence and did not feel that the secret service supported it,” said Sund in his prepared testimony.

“He referred me to the Senate Sergeant at Arms [Michael Stenger] … to get his thoughts on the request, “wrote Sund.

“I then spoke to Mr. Stenger and asked the National Guard again. Instead of approving the deployment of the National Guard, Mr. Stenger suggested asking them how quickly we could get support if needed and lean forward if necessary . Ask for help January. “

Sund resigned in mid-January after the uprising that killed five people, including Capitol Police Officer Brian Sicknick, and for hours disrupted confirmation of Joe Biden’s electoral college win for the presidency.

Stenger does not directly address Sund’s claim in his own briefly prepared testimony, which does not discuss in detail the events that led to the uprising.

Senate Sergeant Michael Stenger walks the halls of the U.S. Capitol in front of the Senate Chamber during a pause in the impeachment proceedings of President Donald Trump on January 22, 2020 in Washington, DC.

Chip Somodevilla | Getty Images

Stenger resigned Jan. 7 after Senator Chuck Schumer, DN.Y., who is now majority leader, said he would be fired once the Democrats take majority control of the Senate.

But Irving says in his own prepared testimony that he and other Capitol security officials expected the scheduled January 6 and demonstration in Washington and the Capitol to be a “First Amendment” event.

“Intelligence reported that some groups were encouraging protesters to be armed, that violence was a possibility as it was in November and December, and that Congress would be the focus,” said Irving, who also resigned shortly after the uprising .

But he added, “Intelligence did not believe there would be a coordinated attack on the Capitol, nor was it considered in any of the inter-agency discussions I attended in the days leading up to the attack. “

Irving said he spoke with Sund and Stenger on Jan. 4 about an offer from the National Guard to include 125 unarmed troops in the security plan to provide transportation near the Capitol with the expectation that those troops would be Capitol police officers would be released in the Capitol. “

Irving also said: “Certain media reports have determined that the ‘optics’ determined my judgment about the use of these National Guard troops. That is categorically wrong.”

“‘Looks’ as portrayed in the media did not determine our security posture. Security has always been paramount in our January 6 security assessment,” said Irving.

“We discussed whether the Secret Service justified having troops in the Capitol, and our collective judgment at the time was no – the Secret Service did not justify it. The Secret Service justified the plan prepared by Chief Sund.”

House NCO Paul D. Irving, right, and Chief Administrative Officer of the House Phil Kiko say during the House Legislative Subcommittee hearing titled “House Officers FY2021 Budget” on Tuesday March 3rd 2020, in the Capitol.

Tom Williams | CQ Appeal, Inc. | Getty Images

Irving said in the course of his meeting with the other two security chiefs on January 4th, “We agreed that Chief Sund would ask the National Guard to have the 125 troops available as reserves.”

“If I had thought for a moment that the secret service required the presence of 125 unarmed National Guard troops for the transport service … I would not have hesitated to do whatever was necessary to ensure their presence,” said Irving.

“In addition, Chief Sund, Senate NCO at Arms Stenger, or one of the law enforcement officers involved in the planning, had concluded that the January 6th intelligence service requested the National Guard or some other resource (or that the security plan fell short in some way) I would not have hesitated to ensure the presence of the National Guard or make any other changes necessary to ensure the security of the Capitol. “

He added, “Our ultimate need for the National Guard was very different from that of unarmed transport troops.”

Irving also said that Sund gave a briefing on Jan. 5 in which the then chief of police “stressed that” hands on deck “were and described the assets of the law enforcement and contingent National Guard that would be on call.”

“Like Chief Sund, based on the intelligence and extensive use of law enforcement resources, I mistakenly believed we were prepared,” Irving said.

“As we now know, the security plan for the unprecedented attack on January 6th was not sufficient.”

Barack Obama says he as soon as broke a classmate’s nostril for calling him a racial fraud

We all know that our eternal President Barack Obama showed a lot of grace and poise during his tenure, but recently he admitted that he used to have his paws on a classmate for calling him by his name.

During a recent episode of Bruce Springsteen’s “Renegades” podcast, Obama revealed that he once broke a classmate’s class after his then-boyfriend referred to him as “c ** n” during a locker room fight, The Hill reports.

“Look, when I was in school I had a boyfriend. We played basketball together, ”Obama told Springsteen during a major conversation about the race. “And once we argued and he called me ac ** n.”

Obama continued, “First of all, there are no problems in Hawaii, are there? It’s one of those things that he might not even know what it was. He knew, “I can hurt you if I say this.”

Obama said he remembered “slamming” his friend in the face and breaking his nose.

“Well done,” Springsteen replied to Obama’s story.

Apparently this blow also brought a lesson.

“I explained to him – I said, ‘Never call me that,” Obama said.

It is believed that this was the first time Obama told this story publicly.

He recalls telling his classmate, “I may be poor. I can be ignorant. I can be mean I can be ugly. I may not like myself. I can be unhappy. But do you know what I am not? I’m not you.”

He went on to say that this type of rhetoric is then institutionalized and used to justify dehumanizing someone or worse, killing them.

We imagine Obama heard far worse things from racists when he was the leader of the free world, but he definitely got his flowers to keep himself professional.

That doesn’t mean he won’t stop advocating social justice. He has spoken repeatedly about the continuing effects of racism on American society, even while in office.

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Investor Rakesh Jhunjhunwala on India’s electrical car market

Indian billionaire Rakesh Jhunjhunwala counts on automaker Tata Motors as one of the winners in India’s growing electric vehicle market.

“I think the biggest and best electric car player in India will be Tata Motors,” Jhunjhunwala told CNBC’s Street Signs Asia on Tuesday.

“I’m a major shareholder in Tata Motors. I play the EV story through Tata Motors,” said the investor.

He explained that the judging will ultimately not determine who will win the electric vehicle race. Instead, according to Jhunjhunwala, large companies with manufacturing and investment capabilities, sales channels, manufacturing experience, and the ability to design good cars will ultimately have the edge.

“I think it will be the Mercedes, the Volkswagen and the Tata Motors that will be the real winners in the electric race,” he said, adding that another factor that is required for success in India is ability Adapting the cars is for Indian road conditions – for example, the ability to drive these cars on flooded roads.

India is also a cost-conscious market where EV use is likely to be dependent on government incentives, the investor said. Infrastructures such as charging stations still have to be expanded in order to achieve broad acceptance. But, Jhunjhunwala said, India is “ready like any developing country, but I think the pace of readiness will increase like anything else.”

Both Tata Motors and competitor Mahindra & Mahindra already sell electric vehicles. American electric vehicle giant Tesla is reportedly preparing to open an electric car manufacturing facility in southern India.

The signage for Tata Motors was displayed at the company’s headquarters in Mumbai, India on January 27, 2018.

Dhiraj Singh | Bloomberg | Getty Images

Diversified financial services firm Motilal Oswal told CNBC earlier this month that the excitement in India’s electric vehicle market is coming from ancillary areas like battery manufacturing.

Among automakers, Maruti prefers Suzuki – India’s largest automaker – for its strong distribution network, though Maruti isn’t quite as optimistic about electric vehicles itself.

India is trying to both reduce its reliance on oil and improve its air quality. That should trigger a boost in electric vehicles.

Reuters reported last year that India has potential plans to offer $ 4.6 billion in incentives to companies setting up advanced battery-making facilities as part of its efforts to encourage the use of electric vehicles. The country previously approved a program to subsidize sales of electric and hybrid vehicles.

In this month’s annual budget for fiscal year beginning April 1, India announced a voluntary vehicle scrapping policy to remove old vehicles that contribute to the country’s poor air quality.

The IATA app can restart worldwide flights with out quarantine

People wait for passengers in one of the international arrivals lounges at London Heathrow Airport in west London on February 14, 2021

JUSTIN TALLIS | AFP | Getty Images

A new app to be released within a few weeks could represent the first step towards resuming quarantine-free international travel.

With the travel app of the International Air Travel Association (IATA), governments and airlines can digitally collect, access and share information about the status of the Covid-19 test and the vaccination of individual passengers.

The industry association, which includes 290 airlines, said the tool will make health documentation reviews more efficient while also accelerating the recovery of the hardest-hit travel sector.

“It’s really about digitizing an existing process,” Nick Careen, IATA’s senior vice president of passenger cargo and security, told CNBC on Wednesday.

If we do the manual processing, we will stall the moment we see a reboot.

Nick Careen

Senior Vice President (APCS), IATA

“This is the way forward because if we work manually we will stall the moment we see a restart,” he said.

Singapore Airlines will be the first airline to pilot the tool on a continuous London Heathrow route. Thirty other airlines, including Air New Zealand and Emirates and Etihad in the United Arab Emirates, are scheduled to conduct trials by March and April.

IATA is not the only one to develop so-called digital health passports with which cross-border trips can be resumed. International agencies, governments and technology companies also participate. However, Careen hopes the app will set “minimum requirements” to allow for better interoperability.

“At some point you will see several people in this area,” he said, “but we are setting the baseline in terms of the standard.”

With the new app and the ongoing vaccine rollouts, the global airline association It is estimated that by the end of this year, travel could hit around 50% of 2019 levels.

Previously, analysts had expected a greater increase in travel in early 2021, but the continued spread of the virus and the emergence of new strains have pushed those expectations back on.

“That is the current economic forecast,” said Careen. “There are many variables that contribute to this.”

Kia presents Carnival 2022 as a brand new SUV-inspired minivan with VIP seating

Kia Motors is replacing its Sedona minivan with a new SUV-inspired model called the Carnival from the second quarter of this year.

The 2022 Carnival “multipurpose vehicle,” also known as the minivan, features a box-shaped exterior, a large grille, and an overall design that looks bolder and sturdier than the outgoing model. It features new signature lighting on the front and rear, as well as the new Kia logo announced earlier this year.

The vehicle, which was unveiled on Tuesday, offers a multitude of new safety features as well as new sliding configurations for the seats in the second row and an available “VIP Lounge Seating” with power control and leg extension, similar to a traditional lounge chair.

“The Kia Carnival is here to disrupt a set segment and once again proves what is possible when conventions are broken,” said Sean Yoon, CEO of Kia Motors North America, in a press release.

The 2022 Kia Carnival has heated and ventilated “VIP Lounge Seating” in the second row with power control, fold-out headrests and leg extensions.

The

The drastic design change is the latest for the minivan segment as automakers try to hold their own against crossovers and SUVs – segments that customers flock to for their space, performance, and more rugged personalities.

After decades of growth and minivans, which make up about 8% of the U.S. light commercial vehicle market and were sold in the mid-1990s through 2000, sales have plummeted to less than 400,000 units in recent years. Much of the segment’s decline is due to the rise in crossovers and SUVs, as well as the stigma that the vehicles are uncool and for “soccer moms”.

Sedona sales fell by around 70% between 2016 and 2020, to just 13,190 vehicles sold in the United States

Meghan and Harry will communicate to Oprah about “rigidity” inside the royal household

Meghan Markle and Prince Harry will open up to the “tension” within the royal family during their upcoming interview Oprah Winfrey.

A source close to the couple tells E! Just the news that the Duke and Duchess of Sussex will “tell their truth” during the highly anticipated CBS special on March 7th after their final resignation as working members of the British monarchy.

“There is great tension between them and the royal family,” the source says. “The interview will shed some light on what they went through. Meghan and Harry are relieved that they are away from it all.”

According to the insider, their seat will be “very open” because they have been “officially released from their royal duties”. In general, Meghan and Harry have been more open and honest after resigning last year and then moving to Santa Barbara, California.

“We’ve got to do a greater job” vaccinating minority communities, says the Connecticut governor

Connecticut Governor Ned Lamont, D, told CNBC’s The News with Shepard Smith, “We need to do a better job there” when it comes to delivering Covid vaccines to underserved communities.

“People of color are twice as likely to be infected and have complications and vaccinated half as often,” Lamont said during an interview on Tuesday evening. “We bring the mobile vans to the parishes, we work together with the churches.”

Data from the State Department of Health (DPH) suggests that “there are differences in vaccine delivery across racial boundaries, with black populations lagging behind white and Hispanic populations”. However, Lamont assured host Shepard Smith that officials are working to make sure he is allocating enough vaccines to underserved communities and that “no one is left behind”.

Connecticut is gaining national attention for violating federal guidelines and prioritizing age over health or employment status. More than six in ten state residents aged 75 and over have been vaccinated. The only exception to the rule are teachers and others who work in schools. Lamont stated that his vaccine adoption strategy is based on the data.

“We thought we could really focus on the older population, 55+, where 96% of complications occur,” Lamont said.

Connecticut has seen some success getting Covid shots in the arms. According to the CDC, 882,777 shots were administered, which corresponds to a stab rate of 90%.

Smith asked about Connecticut frontline workers who were “disgusted” by Lamont’s strategy. The Connecticut governor redoubled his strategy, pointing out those workers who live with older family members.

“I say a lot of them live in multigenerational houses and thank god they are there with their mothers, fathers and grandparents and they have now been vaccinated so they know they can get home safely and they know within three weeks, 45 and up can get vaccinated so they know there is light at the end of the tunnel and it’s their turn to be quick, “Lamont said.

Access to a wider range of vaccines in the US may be quicker than expected. Pfizer and Moderna executives told House lawmakers Tuesday that their companies expect to double and potentially triple vaccine shipments in the coming weeks. John Young, Pfizer’s chief business officer, said the company could increase production from approximately 5 million cans to more than 13 million cans by mid-March. The President of Moderna, Dr. Stephen Hoge said his company is also working to double its shipments, producing about 40 million cans a month by April.

The Food and Drug Administration is expected to review Johnson & Johnson’s one-shot vaccine Thursday. Dr. Richard Nettles, vice president of medical affairs at J&J, said the company plans to ship more than 20 million doses to the US by the end of March. That means at least 20 million people will be fully vaccinated.

Former Obama administration official, Dr. Kavita Patel told The News with Shepard Smith that a large percentage of the population will be vaccinated, “it will change our lives dramatically.”

“Imagine going back to normal in the summer,” said Patel.

The inventory futures have hardly modified after the intraday comeback on Tuesday

U.S. stock futures were largely unchanged Tuesday night as investors checked to see if any later market momentum would continue through Wednesday.

Futures contracts for the Dow Jones Industrial Average gained 41 points, or 0.1%. Those pegged to the S&P 500 and Nasdaq 100 also rose about 0.1%.

The futures move follows a wild comeback during Tuesday market hours as the Dow and S&P 500 offset heavy losses and close slightly higher. The positive result brought the S&P 500 a five-day skid. The Nasdaq Composite, which was down nearly 4% at the time, ended up losing just 0.5%.

The rebound began after Federal Reserve Chairman Jerome Powell released his prepared remarks for a hearing before the Senate Banking Committee. The central bank chief said inflation is “soft” and the US economy is “far from our employment and inflation targets.” Bond yields had risen in recent weeks, raising fears that the Fed is changing its cautious policy stance could.

Marci McGregor, senior investment strategist at Bank of America Merrill Lynch, told Closing Bell that market sentiment indicated a need to pull back, but the general setup for stocks remained positive.

“We’re still gaining new economic expansion. We believe we are in a long-term secular bull,” said McGregor. “We heard from Jay Powell today and it sounds like he’s still on the gas.”

The general rebound in the market on Tuesday was reflected in moves by tech giant Apple and electric vehicle stock Tesla, which ended 0.1% and 2.2% down, respectively, after taking much steeper losses earlier in the day. Energy stocks and financials outperformed while technology and consumer discretion lagged behind the broader market.

Bitcoin also struggled Tuesday, falling below the $ 50,000 level.

Powell’s visit to Capitol Hill will continue on Wednesday when he addresses the House of Representatives Financial Services Committee. Investors also get another look at the construction industry with data on new home sales and an earnings report from Lowe’s.