Moderna says its Covid vaccine generates sturdy immune response in children 6 to 11

With husband Stephen by her side, Erin Shih hugs her children Avery 6 and Aidan 11 after receiving their second Moderna COVID-19 vaccines at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021.

Sarah Reingewirtz | MediaNews Group | Getty Images

Modern said Monday that in a study of children ages 6-11, a smaller dose of its Covid-19 vaccine is safe and produces a strong immune response.

Two 50-microgram doses of the vaccine, half the dose given in adults, resulted in antibody levels 1.5 times higher than in young adults, the company said in a press release, citing early data from a phase 2 / 3 study.

The syringes were generally well tolerated even in young children, according to the company, with the most common side effects being fatigue, headache, fever, and pain at the injection site. The vaccine has been tested on more than 4,700 children.

Moderna plans to submit the data to the Food and Drug Administration, the European Medicines Agency and other health authorities “in the near future”.

“We look forward to filing with regulators worldwide and remain committed to doing our part in ending the COVID-19 pandemic with a vaccine for adults and children of all ages,” said Stephane Bancel, CEO of Moderna, in a statement.

The new data comes the day before an important FDA advisory committee meeting to discuss whether to make a recommendation Pfizer and BioNTech‘s vaccine for children ages 5 to 11. The FDA could approve the vaccinations within days of the meeting, and the Centers for Disease Control and Prevention could approve them as soon as next week.

FDA staff said late Friday that Pfizer’s vaccine appears to be highly effective in preventing symptomatic infections in primary school children.

Many parents say they are careful to get their children vaccinated as the kids are entering the new school year and the Delta variant is still spilling across America. The number of new Covid cases in children remains exceptionally high with more than 1.1 million new child cases in the past six weeks, according to the American Academy of Pediatrics.

‘We Do not Wish to Lose Cash’ – Pep Guardiola Delivers Robust Response to Man Metropolis Spending Critics

The Premier League champions expect a sensational fall for Tottenham striker Harry Kane after securing the arrival of Aston Villa’s Jack Grealish for a club record £ 100m in early August.

Ahead of the Manchester team’s league opener against Tottenham on Sunday, the Catalan coach was asked about the Liverpool manager’s remarks on the way several top English clubs invested in their squads during the summer transfer window.

Chelsea broke their own record transfer amount by signing Inter Milan’s Romelu Lukaku for £ 97.5m, while Manchester United spent more than £ 110m to win Jadon Sancho and Raphaël Varane ahead of the new season.

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“I don’t judge other clubs by what they do; they do what they believe. Some owners want to profit, our owners don’t,” Guardiola said in his pre-game press conference, quoted by Manchester evening news.

“You want to reinvest in the team. We invest what we can invest. We could spend £ 100m on Jack Grealish because we sold for £ 60m. In the end we spent £ 40m (net) the club said to me. I don’t know what will happen in the future. “

City’s antics in the transfer market have come under heavy scrutiny over the years, but Guardiola insisted that the Premier League champions abide by Financial Fair Play (FFP) rules.

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The 50-year-old added, “We have limits to financial fair play. If you (the city’s transfer critics) disagree, you can file a statement in court and we will defend ourselves. Financial fair play is the rule.” for us, and we absolutely obey the rules, what happened in the end was that we were innocent in 2014, I believe, and we are now in 2021.

“Every season we (City) pass the FFP. I say the same thing, there are owners who want the advantage for themselves. Our club, of course, they don’t want to lose any money, if they can spend money we can do that.” A few years ago other clubs would always spend a lot of money for a lot on multiple players.

“We (the city) spend because we can, we don’t spend if we can’t. In the end, we have to present the balance sheet and say that is who we are, what we have and what we can do . “

Follow us on Twitter for live updates: @City_Xtra

Billie Eilish Simply Trolled Her Previous Model in Response to a Fan

Billie Eilish is in a new era, and – obviously – with a new era is coming new look. The singer recently made her debut with fresh blonde hair and a vintage vibe on the cover of Fashion before Happier Than Ever and leaned into the same style in promoting the album. But apparently some fans aren’t there for it – although it’s none of your business how Billie dresses – and voiced their preference for her old look during a Q&A.

In response to a follower who said, “No more boring outfits were so damn tired … what happened to you” (um, rude), Billie shared an old photo of herself with blue hair and a matching blue fit and said : “What? You want that again ?”

Instagram

She also posted a photo of herself in high heels and a corset in response to another follower who asked for more pictures:

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Billie spoke to me about her new look FashionShe said she expected fans to ask, “If you’re into body positivity, why should you wear a corset? Why wouldn’t you show your actual body? ‘”As she put it,“ My business is that I can do what I want. It’s about what is good for you. If you want to have an operation, get an operation. If you want to wear a dress that someone thinks you look too big, fuck it – if you feel like you look good, you look good. “

She added, “All of a sudden you are a hypocrite when you want to show your skin and you are just and you are a slut and you are a whore. If so, then I am proud. Me and all the girls are hoes and fuck it you know Let’s turn it around and be strengthened in it. Showing your body and showing your skin – or not – should not take your respect. “

This forever.

Mehera Bonner is a news writer who focuses on celebrities and royals.

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Deshaun Watson’s first official response calls the lawsuits towards him a “cash seize”

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The battle was joined.

After weeks of press conferences and attorney’s statements, and a skirmish over whether plaintiffs would go on their own behalf (they are now) in cases alleging wrongdoing during massage sessions, Texan’s quarterback Deshaun Watson filed a formal response to the first lawsuit filed against him last month. The document filed by Watson’s attorney in the case filed by Ashley Solis calls the entire effort a “money robbery.”

The document, entitled “Deshaun Watson’s Original Answer,” appears to have been written much more for the media than for the court. The first page summarizes alleged facts that Watson’s attorneys have learned since receiving the plaintiffs’ names. Watson alleges through his attorneys that: (1) eight of the plaintiffs “boasted, praised, and were excited about massaging Watson”; (2) seven of the plaintiffs “worked willingly or offered to work with Watson”, “after their alleged incidents”; (3) three plaintiffs “lied about the number of meetings they actually had” with Watson; (4) five plaintiffs “lied about their alleged trauma and the damage it caused”; (4) Five plaintiffs told others they wanted to get money out of Watson. and (5) five plaintiffs “cleaned or completely deleted their social media accounts”.

At the top of page 2 of the document is the claim: “It was only when plaintiffs saw an opportunity to rob money that they changed their stories to turn therapy sessions they bragged about into something much more nefarious.” the document claims that the characterizations of Watson’s behavior range “from misleading to fraudulent to defamatory”.

The document paints all of the plaintiffs with this brush, claiming that they are all working to secure money from Watson. The document also lists specific issues with numerous plaintiffs’ allegations on pages 3 through 5, although the document was filed in a case that is only relevant to the Ashley Solis allegations.

With regard to their allegations, the document relies solely on a “general disapproval” without answering the various allegations in paragraphs. Presumably, Watson will submit a similar document in response to each of the other 21 cases.

The aim of such an aggressive position could be to motivate plaintiffs to settle down before the discovery process results in the investigation of documents and the questioning of each plaintiff under oath. If the cases are not resolved, that is exactly what will happen. All plaintiffs, as well as Watson, will have aggressive questions and other investigations as both sides attempt to prepare for eventual trial in each of these 22 cases.

Oxford to launch human problem trial to check immune response

Caroline Nicolls will receive an injection of the Moderna Covid-19 vaccine administered by Nurse Amy Nash at Madejski Stadium in Reading, west of London, on April 13, 2021.

STEVE PARSONS | AFP | Getty Images

LONDON – Oxford University researchers announced the start of a Human Challenge study on Monday to better understand what happens when people who have already contracted the coronavirus become infected for the second time.

The researchers will investigate what kind of immune response can prevent people from becoming infected with Covid-19 again and examine how the immune system reacts to the virus a second time.

Little is currently known about what happens to people who had the virus the second time they were infected.

The experiment is carried out in two phases with different participants in each phase. The first phase is slated to begin this month and the second phase is slated to begin in summer.

In medical research, Human Challenge studies are controlled studies in which participants are intentionally exposed to a pathogen or beetle to study the effects.

“Challenge studies tell us things that other studies cannot because, unlike natural infections, they are tightly controlled,” said Helen McShane, chief investigator for the study and professor of vaccinology in the Department of Pediatrics at Oxford University.

“If we re-infect these participants, we will know exactly how their immune systems responded to the first COVID infection, when exactly the second infection occurs, and how much virus they have,” said McShane.

It is hoped that the study will help improve scientists’ basic understanding of the virus and develop tests that can reliably predict whether people will be protected.

What happens in each phase?

In the first phase, up to 64 volunteers between the ages of 18 and 30 who were previously infected naturally will be re-exposed to the virus under controlled conditions.

Researchers will oversee attendees’ care while they perform CT scans of the lungs and MRI scans of the heart while isolating in a specially designed suite for at least 17 days.

All participants must be fit, healthy and have fully recovered from their initial infection with Covid to minimize the risk.

Study participants will only be released from the quarantine unit if they are no longer infected and there is a risk of the disease spreading.

A view of the City of London on a clear day.

Vuk Valcic | SOPA pictures | LightRocket via Getty Images

In the second phase of the experiment, two different areas are examined.

“First we will very carefully define the basic immune response of the volunteers before we infect them. We will then infect them with the dose of virus selected from the first study and measure how much virus we can detect after infection. We will then.” to be able to understand what kind of immune responses protect against re-infection, “said McShane.

“Second, we will measure the immune response several times after infection so we can understand what immune response is being generated by the virus,” she added.

The entire study period is 12 months, including at least eight follow-up appointments after discharge.

“This study has the potential to change our understanding by providing high-quality data on how our immune systems react to a second infection with this virus,” said Shobana Balasingam, senior research advisor on vaccines at Wellcome, a nonprofit that funded the study.

“The results could have important implications for the future management of COVID-19, influencing not only vaccine development but research into the range of effective treatments that are also badly needed,” Balasingam said.

QuantumScape CEO mulls authorized response to scathing brief vendor report

QuantumScape could take legal action after being attacked in a scathing report by activist short seller Scorpion Capital.

“We are definitely going to take a look,” said Jagdeep Singh, managing director of QuantumScape, when CNBC’s Jim Cramer asked if the company would consider filing a lawsuit against the company.

“Some of the points there are simple, just absurd. Absurd to the point where there are … things that we want to take legal action on.”

Singh appeared on “Bad money“Friday, the day after Scorpion released the short report. In the 188-page report, Scorpion accused QuantumScape, released in November through a blank check association, of acting as a “pump and dump SPAC”. It even compared the company to Theranos, the disgraced healthcare technology startup.

QuantumScape shares fell more than 12% after the information was released. The stock fell again on Friday, contributing to a 28% decline in less than two weeks.

“We don’t want to be too distracted either, but you know we feel pretty good where we are,” said Singh.

The battery company said it stood by the data it presented to investors and will continue to build a battery for its customers such as: Volkswagenwho recently invested an additional $ 100 million in the company.

QuantumScape argued that Scorpion was motivated to release the report because it could benefit financially from the subsequent price decline. Investors who want to make a profit on a sharp drop in prices are known as short sellers.

“We have always been fairly transparent about what we have and what work still needs to be done,” said Singh. “That’s one of the things we are honestly proud of. We believe we have been the most transparent of all solid-state battery companies.”

Biden says he’ll announce the ‘subsequent section’ of the U.S. response Thursday

United States President Joe Biden speaks about the manufacture of the Covid-19 vaccine in the South Court Auditorium next to the White House in Washington, DC on March 10, 2021.

Almond Ngan | AFP | Getty Images

president Joe Biden said he would announce the “next phase” of the U.S. Covid-19 response during his prime-time address to Americans on Thursday.

“Tomorrow night, in prime time, I’ll be reaching out to the American people and talking about what we’ve been through as a nation over the past year. But more importantly, I’ll talk about what’s next.” Biden said Wednesday left the White House after meeting executives Johnson & Johnson and Merck.

“I will be taking the next phase of the Covid response and explaining what we are doing as a government and what we are going to ask of the American people,” he said. “There is light at the end of this dark tunnel last year. We cannot disappoint our watch now or assume that victory is inevitable. Together we will overcome this pandemic and usher in a healthier, more hopeful future.”

The president’s address will commemorate the one-year anniversary that marks the first government-imposed shutdowns to contain the pandemic.

The Biden government has been working to increase supplies of Covid-19 vaccines and immunize the majority of Americans as soon as possible. Around 62.4 million out of around 331 million Americans have received at least one dose of a Covid vaccine, according to the Centers for Disease Control and Prevention. And 32.9 million are fully vaccinated, which is nearly 10% of the total US adult population, according to the CDC.

Early Wednesday that Biden Administration announced It is planned to purchase an additional 100 million doses of the Covid-19 vaccine from J&J. The deal would double the country’s supply of the J&J vaccine as the company has already signed a deal with the government to provide 100 million doses by the end of June. Merck Helps Manufacture J & J.’s Covid Vaccine

The administration also has contracts with drug manufacturers Pfizer and Modern For 600 million doses combined, that’s enough to vaccinate 300 million Americans, as these two vaccines require two shots three to four weeks apart.

“I’m doing this because we need maximum flexibility in this war effort,” Biden said on Wednesday of plans to buy more J&J vaccine doses. “There is always the possibility that we will encounter unexpected challenges, or there is a new need for vaccinations … a lot can happen, a lot can change and we need to be prepared.”

Biden said if the US has an excess of vaccine doses, the government will “share it with the rest of the world.”

“This cannot be stopped by a fence, no matter how high you build a fence or wall,” he said. “So in the end we won’t be safe until the world is safe. So we will first make sure that the Americans are taken care of first, but then we will try to help the rest of the world.”

The comments come weeks after Biden said the US would try to end cancer the second leading cause of death in the US once the pandemic is over.

One of Biden’s sons, Beau Biden, died of an aggressive form of brain tumor at the age of 46.

Metropolis-County Council Helps Instructor Vaccines, Adopts Cash For Pandemic Response And Different Measures

Indianapolis City Council held a full session Monday evening. The meeting started with actions to prioritize teachers and public transport staff for COVID-19 vaccinations.

Councilor Jessica McCormick said the guideline should be updated.

“The Council urges our public health partners to carefully consider the age and racial makeup of education workers to ensure an equitable distribution of the COVID-19 vaccine,” McCormick said.

The special resolution cannot change the availability of vaccines. This power rests with the state and other political decision-makers.

A new proposal to set up the county’s cumulative capital development fund to cover the cost of $ 190 million to modernize facilities, including funds for parks and a forensic laboratory, was announced this week by Mayor Joe Hogestt.

The council provided additional funding for COVID-19-related expenses to the city budget, including money for rent support, paycheck protection, and small business loans.

It also approved changes to the city’s homeless rights, which include a study of alternative housing for the homeless.

Councilor Leroy Robinson said the study would be heard from those hardest hit.

“The study process will include input from service providers and those with lived experience of homelessness,” said Robinson.

The council also approved reappointments, including that of IMPD chief Randal Taylor.

CHIEF CHAT: New web site exhibits the place the cash goes for Cherokee Nation’s pandemic response | Information

The global COVID-19 pandemic has hit us all hard, but Cherokee Nation hasn’t sat back while the pandemic threatened our health and economy. With these efforts, the past year has been challenging, transformative, and ultimately hopeful.

In March 2020, the U.S. federal government passed CARES to help individuals, businesses, state and local governments, and tribes, including the Cherokee Nation, respond to the pandemic emergency. Cherokee Nation has responsibly spent more than $ 410 million of our CARES Act funds as part of our Response, Recover, and Recover spending plan.

Cherokee Nation used our funds to meet community needs such as housing, food security, and utility bill assistance. We have helped tribal people meet basic needs such as food, shelter, health care and clothing while the pandemic remains a threat. We have invested in protecting our employees from layoffs, helped Cherokee elders stay safe at home, and helped Cherokee students safely continue their education through distance learning.

We had to act quickly to get this investment into our communities, but we also want to ensure maximum transparency and accountability to the Cherokee people. It is for this reason that the Cherokee Nation Treasurer recently released the COVID-19 Report on Responding, Recovering, and Recovering Issues. It can be found at www.respondrecoverrebuild.com.

The new website is a centralized resource for Cherokees to help ensure their tribal government transparently and effectively manages coronavirus recovery funds. It shows a breakdown of spending and the number of ways tribal citizens have received assistance. We are proud to have provided direct assistants to more than 130,000 citizens and to have helped thousands through critical programs created or expanded through the CARES Act.

As we vaccinate more Cherokees and leave this pandemic behind, we will continue to provide financial transparency and open communication with our citizens. Cherokees have the right to know how aid funds are being used.

I applaud the Cherokee Nation finance team for their resilience, adaptability, and professionalism. Despite the turmoil in northeast Oklahoma and around the world last year, Cherokee Nation has remained in good financial shape.

Further highlights of the past year are:

• $ 177 million for jobs so employees never missed a paycheck or seen layoffs in the past year.

• $ 54 million to individual citizens for emergency relief, clothing assistance, supplies, and other needs.

• $ 38 million for PPE and safety supplies, including development of Cherokee Nation’s N95 and N99 mask production facilities. Once the Cherokee Nation is operational, it will be the only N99 mask manufacturer in the US.

• $ 22 million for public health infrastructures such as new health clinics for employees, expanded shelters against domestic violence, and improvements to community water pipes and water treatment.

• US $ 19 million technology grants to help students purchase the equipment they need for distance learning.

• $ 27 million to improve broadband connectivity, including shipping over 9,000 wireless wireless hotspots with one year of free service to Cherokee Nation citizens without an internet connection.

• $ 27 million for food security, including the construction of five new food distribution centers, a meat processing facility and additional refrigerated trucks.

Federal CARES law and the Cherokee Nation’s Response, Restoration and Reconstruction Plan have allowed us to invest quickly in what will help most Cherokees. We have and will continue to act urgently and consciously in how we use tribal resources and the spending report reflects this. We will continue to provide detailed information on the www.respondrecoverrebuild.com Website about our efforts to protect elders, families, jobs, education, and the health of our people until this crisis is over.

Vaxart shares plunge on weak antibody response to oral vaccine

An experiment Coronavirus The orally taken vaccine showed promising results in an early clinical trial of 35 healthy adults from South San Francisco Vaxart said Wednesday. Despite the results, Vaxart’s stock fell about 57%.

Vaxart scientists divided volunteers between the ages of 18 and 54 into three groups. The first group received two low doses of the vaccine – called VXA-CoV2-1 – 29 days apart, while the remaining groups received a single low or high dose.

The vaccine, contained in a small tablet, produced a type of T cell responsible for killing virus-infected cells in about 75% of the volunteers who received a single low or high dose. It is said that the reported responses are higher than those in Modern and Pfizers Vaccinations.

However, neutralizing antibodies were not detected in volunteers after a single dose, Vaxart said. Researchers believe that the antibodies play an important role in the defense of cells against the virus. The company said it is currently testing second-dose antibody responses after antibodies were detected in two-dose volunteers’ nasal swab samples.

Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto, said the company’s shares could fall after the first dose due to the lack of neutralizing antibodies.

“The immune response is diverse,” he said, adding that one aspect of the immune response is to make antibodies, especially neutralizing antibodies. “While it is great to see that there seems to be a decent T-cell response, the lack of antibodies detected is problematic and can reduce the effectiveness of this vaccine.”

The company said no serious adverse events were reported in the Phase 1 study, with side effects generally being mild. Volunteers reported common side effects such as headache and fatigue, and there was a “slight increase” in the high-dose group of loose stool cases, the company said.

The data will be presented on Wednesday afternoon at the New York Academy of Sciences symposium.

“The most exciting thing about the [phase one data] is that we can get a very, very strong T-cell response even after one dose, “Sean Tucker, Vaxart’s chief scientific officer, told CNBC in a telephone interview, adding that T-cells do compared to antibodies fighting the virus is likely to be “underestimated”.

The biotech company said the vaccine has the potential to provide better protection against current and emerging strains of the virus than existing vaccines. Moderna, Johnson & Johnson, and Novavax have said in the past few days that their vaccines may be less effective against B.1.351. highly contagious strain found in South Africa. US officials have raised concerns that Covid may continue to mutate and defy the protection of existing vaccines.

Vaxart’s vaccine contains DNA instructions for making the spike protein that allows the virus to enter human cells, as well as instructions for making the N protein, which is involved in other processes. Tucker said the inclusion of the N protein could cause the vaccine to retain its ability to work against emergent strains.

Many other vaccines under development chose spike protein as a “primary target,” he said. “But the problem with that [spike] Protein it definitely mutates more over time. We also added the N protein, which is highly conserved in the virus. “

According to Vaxart, the vaccine is the only oral tablet in the US that has been tested in humans. Similar technology is being used to develop vaccines against influenza and norovirus.

The company was investigated and investigated by the federal government late last year for allegedly exaggerating its involvement in Operation Warp Speed, former President Donald Trump’s vaccines and treatments program. It said in a press release in June that “Vaxart’s Covid-19 vaccine was selected for US government’s Operation Warp Speed,” which rocketed its stocks.

However, it found that the company had received no federal government funding for vaccine doses and was only participating in preliminary U.S. studies to identify potential areas for potential Warp Speed ​​partnership and support. according to the New York Times.

Tucker told CNBC the company is in talks with the US and other governments to find possible ways to collaborate on its vaccine.

If Vaxart’s vaccine goes through other clinical trials and US approval, it could offer advantages over needle-based vaccines.

Dr. Paul Offit, a member of the FDA’s Advisory Committee on Vaccines and Allied Biological Products, said that an orally taken vaccine may be better accepted by the public who may be afraid of needles. Two US-approved Covid-19 vaccines – from Pfizer and Moderna – are injected into the arm and require two injections three to four weeks apart.

Vaxart said his vaccine is stable even at room temperature and does not require a freezer, which means it “can be stored and delivered to mass populations around the world”. For comparison: Pfizer’s vaccine is a must stored in ultra-cold freezers that keeps it between negative 112 and negative 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.

Vaxart said the vaccine also doesn’t require any special medical training and can be taken at home. This will help comply with social distancing guidelines while relieving the burden on the health system.

The company said it was still critical whether it was single- or two-dose therapy.

A phase 2 study is expected “in the next few months,” Tucker said. In its “Fastest Accelerated Timeline,” the company expects Phase two and three studies to be completed by early 2022.

– CNBCs Hugh Son contributed to this report.