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Moderna Begins Testing Its Covid Vaccine in Infants and Younger Kids.

The pharmaceutical company Moderna has started a study testing its Covid vaccine in children under the age of 12, including babies as young as six months, the company said Tuesday.

The study is expected to enroll 6,750 healthy children in the United States and Canada.

“There is a great demand for information about vaccination in children and how it works,” said Dr. David Wohl, the medical director of the University of North Carolina Vaccination Clinic, who is not involved in the study.

In a separate study, Moderna is testing its vaccine on 3,000 children aged 12 to 17 years.

Many parents want protection for their children, and vaccinating children should help create the herd immunity that is believed to be critical to ending the pandemic. The American Academy of Pediatrics has called for vaccine studies to be expanded to include children.

Every child in Moderna’s study receives two recordings 28 days apart. The study will consist of two parts. In the first case, children aged 2 to under 12 can receive two doses of 50 or 100 micrograms each. People under the age of 2 may receive two exposures of 25, 50, or 100 micrograms.

In each group, the first children to be vaccinated are given the lowest doses and monitored for reactions before later participants are given higher doses.

The researchers then conduct an interim analysis to determine which dose is the safest and most effective for each age group.

Children in the second part of the study receive the doses or placebo shots selected by the analysis, which consist of salt water.

The children will be followed for a year to look for side effects and measure antibody levels, which will allow researchers to determine if the vaccine is effective. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections with or without symptoms.

Dr. Wohl said the study was well designed and likely efficient, but asked why the children should only be observed for one year when adults in Moderna’s study were observed for two years. He also said he was a bit surprised that the vaccine was being tested in children so young so soon.

“Should we first learn what happens to the older children before we go to the really young children?” Asked Dr. Well. Most young children don’t get very sick from Covid, although some develop severe inflammatory syndrome that can be life-threatening.

Johnson & Johnson has also announced that it will test its coronavirus vaccine in babies and toddlers after first testing it in older children.

Pfizer-BioNTech is testing its vaccine in children ages 12-15 and plans to switch to younger groups. The product is already approved for use in the USA from the age of 16.

Last month, AstraZeneca began testing its vaccine in the UK in children 6 years and older.

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Business

Invitae CEO Sean George on way forward for genetic testing, well being care

Invitae’s shares rose over 25% this week, a sharp rise after Ark Invest’s Cathie Wood called the company one of their most underrated stocks in a CNBC interview on Monday.

Invitae was the eleventh largest holding in Wood’s flagship fund, the Ark Innovation ETF (ARKK), as of Thursday, giving it a heavier weight than better-known companies like DocuSign and PayPal.

The closely watched investor and company are known for their strategy of investing in “disruptive innovation” and a strong performance over the past year has resulted in billions of new dollars pouring into Ark’s family of funds.

In a CNBC interview on Friday, Invitae’s CEO outlined the genetic testing company’s mission and long-term goals, and provided some insight into why Wood is optimistic about its prospects.

“Genetic information is fundamental to improving people’s health outcomes and reducing costs. We tirelessly pursue the idea of ​​integrating this information into general medical care and daily use,” said Sean George on Closing Bell. He co-founded the San Francisco-based company in 2010, which went public in 2015.

Invitae achieved total annual sales of USD 279.6 million in 2020, compared to USD 216.8 million in the previous year. Net loss increased $ 608.9 million last year compared to $ 242 million in 2019.

While genetic information can be an effective tool in combating a variety of diseases, George says high costs have historically limited availability, and therefore potential impact. However, recent innovations in gene sequencing would have laid the foundation for better accessibility. He compared it to semiconductor improvements that helped boost the computer and networking industries in the 1970s and early 1980s.

“That has … enabled application providers like us to change what was considered a rationed good in healthcare in the past – genetic information, a kind of niche, test by test, sample by sample building of the laboratory industry – to something that looks a lot more like an information industry, “said George.

George, who holds a Ph.D. In molecular genetics, Invitae hopes to take its tests to the point that patients and doctors can proactively use them in large numbers. That way, even if the cost of each test is cheaper, Invitae can generate enough resources to be successful as a company, he said.

“The enormous importance and central importance of genetic information in health care will – I am sure in the next five to ten years – be in the foreground in order to receive the right therapy earlier for people who can benefit from it.” , identify people at risk and put in place surveillance and prevention modalities to safely delay, if not prevent, disease outbreaks and, in general, provide a basic understanding of the risk that exists in families, “he added.

Ark Invest has positions in a number of companies working on medical innovation beyond Invitae. Wood’s company has dedicated an ETF, the Genomic Revolution ETF (ARKG). As of Thursday, these will include Teladoc, Regeneron Pharmaceuticals and CRISPR Therapeutics. Invitae is also represented in this fund, currently the 16th largest participation.

Invitae’s shares closed Friday’s session down 0.5% at $ 42.70. Despite the stock’s big gains this week, it remains below its all-time high of $ 61.59 on December 14. It has grown by almost 260% in the past 12 months.

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Health

NY goals to reopen Broadway, massive venues, with Covid testing, Cuomo says

All New York theater performances will be suspended until the end of 2020 due to the coronavirus outbreak. Pictured Broadway theater with shutters.

Photo by Spencer Platt / Getty Images

New York plans to use extensive coronavirus testing to reopen its difficult entertainment options, which have been closed for months during the pandemic, Governor Andrew Cuomo said on Monday.

The coronavirus has crippled the live theater industry, particularly at its central hub in New York City. Broadway has been closed since March 2020 and is not expected to reopen until May 30 this year, according to the Broadway League, a trade organization that represents producers and theater owners.

However, Cuomo said there was hope that New York could allow Broadway, among other entertainment options, to reopen with some restrictions. The state would likely set an audience size limit, require everyone to take a negative Covid-19 test before entering, and require proper ventilation systems in theaters, the governor said.

“Would I go to a play and sit in a playhouse with 150 people? If the 150 people tested and they were all negative, I would,” Cuomo said during a press conference. “I think reopening with testing will be key.”

Cuomo said he couldn’t immediately provide a timetable for major venues to reopen. Much of the state’s plan depends on a pilot program that ran in January that allowed nearly 7,000 football fans to attend the Buffalo Bill’s home games as long as they presented a negative Covid-19 test.

The governor had already announced in late January that New York will allow some wedding ceremony venues to reopen on March 15 with limited capacity. Attendees can hold a wedding if all attendees are tested prior to the event and organizers get approval from their local health department in advance, he said.

“Opening locations with testing is something New York wants to lead the way,” Cuomo said Monday.

This is a developing story. Please try again later.

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Business

‘Like Wartime’: Canadian Corporations Unite to Begin Mass Virus Testing

TORONTO – A consortium of some of the country’s largest companies has launched a rapid testing program to protect its 350,000 employees and publish a playbook for business Canada on how to safely reopen.

The program is considered the first of its kind in the group of 7 industrialized nations and has already attracted the attention of the Biden government.

The 12 companies, including Canada’s largest airline and grocery chain, have been working together for four months. Creation of a 400-page instruction manual for performing rapid antigen tests in various work settings. They started testing the tests in their workplaces this month and expect to expand the program to 1,200 small and medium-sized businesses.

They also plan to share their test results with state health officials to significantly increase the number of tests in the country and provide an informal study on the spread of the virus among asymptomatic people.

“It’s like wartime – people come together to do something that is in everyone’s interest,” said Marc Mageau, senior vice president of refining and logistics at Suncor Energy, the country’s largest oil producer, who conducted the tests this month introduced his employees.

The program faces some inherent challenges: After an outbreak last year in the White House, antigen tests were discovered that induce both false negative results and a false sense of security. They are also in short supply in Canada. Some experts feel that they should be reserved for schools and nursing homes rather than non-essential businesses.

While vaccines are considered the world’s best weapon to fight the pandemic, most experts believe it will take months, if not a full year, for Canada to reach the vaccination levels that will allow workplaces to safely return to their pre-Covid surgeries .

Canada is in a second wave of pandemics that has driven infections to record levels and deaths to around 19,800. In response, many parts of the country are on lockdown, restaurants, theaters, and non-essential retail stores are closed.

Canada’s economy contracted about 5 percent during the pandemic. Some industries such as real estate and manufacturing have performed well, but those that depend on public crowds, such as entertainment and hospitality, have seen employment decline.

“Think about downtown Toronto: nobody is there anymore. Entertainment – everything is stopped, ”said Joshua Gans, professor of strategic management at the University of Toronto who served as advisor to and is the author of the project “The Pandemic Information Gap: The Brutal Economy of Covid-19.”

“It is time to figure out how to actually reopen the closed sectors,” he said.

The consortium companies were brought together in the spring by Ajay Agrawal, founder of the University of Toronto’s Creative Destruction Lab. That helps science and technology start-ups. They were inspired by the most Canadian muses: Margaret Atwood, the author.

“How soon can we get a cheap, self-administered test at the drugstore?” Ms. Atwood asked business leaders and others who were tasked with brainstorming ideas for economic recovery during the pandemic during a virtual meeting last May.

The problem, the group noted, was the “information gap” – with no way of telling who an asymptomatic carrier might be, everyone was treated as a potential threat.

Ms. Atwood envisioned something like a home pregnancy test.

“That would be a game changer,” she said.

When the group realized that the government was overwhelmed by the health crisis, they decided to take on the task themselves and form a consortium led by the Creative Destruction Lab.

The group focused on antigen testing because of its speed, price, and utility: you can get results in minutes, don’t require a lab, and can cost anywhere from $ 5 to $ 20 in Canada.

Updated

Jan. 30, 2021, 8:47 p.m. ET

However, they are less accurate and produce more false negative results than the gold standard polymerase chain reaction or PCR tests, which can cost 20 times as much. The three antigen tests approved for use in Canada characterize between 84 percent and 96.7 percent of those infected with the virus.

In the UK, antigen tests used in a mass testing campaign identified only two-fifths of the coronavirus cases detected by PCR testing.

Because of this, many experts in Canada and elsewhere initially argued that it would be wiser to expand PCR testing. However, as the pandemic spread and the country failed to meet its testing goals, that thinking changed, said Dr. Irfan Dhalla, co-chair of the Canadian Advisory Panel on Testing and Screening for Covid-19, which recommended increasing the country’s use of rapid tests.

A rapid antigen test is clearly better than no test at all, as long as it is not used as a free pass, ”said Dr. Dhalla. “Whether it’s a job or a school, you still have to wear a mask and physically distance yourself as much as possible.”

In the long term, the members of the consortium hope that the testing program will help reduce infection rates enough to allow crowded restaurants and boardroom meetings to take place again. In the meantime, however, they plan to use the tests as an extra layer of protection – in addition to wearing masks, social distancing, and pre-screening of staff so those with symptoms can stay home.

The consortium companies also test their employees twice a week to increase the likelihood that positive cases will be picked up.

“Everyone is looking for a silver bullet. We realized that it doesn’t exist. It’s not, ”admitted Laura Rosella, professor of epidemiology at the University of Toronto and advisor to the project.

In September, more than 100 consortium employees began working together at the expense of their companies to come up with a plan. Two retired generals volunteered to manage the logistics.

The coronavirus outbreak>

Things to know about testing

Confused by Coronavirus Testing Conditions? Let us help:

    • antibody: A protein produced by the immune system that can recognize and attach to certain types of viruses, bacteria or other invaders.
    • Antibody test / serology test: A test that detects antibodies specific to the coronavirus. About a week after the coronavirus infects the body, antibodies start appearing in the blood. Because antibodies take so long to develop, an antibody test cannot reliably diagnose an ongoing infection. However, it can identify people who have been exposed to the coronavirus in the past.
    • Antigen test: This test detects parts of coronavirus proteins called antigens. Antigen tests are quick and only take five minutes. However, they are less accurate than tests that detect genetic material from the virus.
    • Coronavirus: Any virus that belongs to the Orthocoronavirinae virus family. The coronavirus that causes Covid-19 is known as SARS-CoV-2.
    • Covid19: The disease caused by the new coronavirus. The name stands for Coronavirus Disease 2019.
    • Isolation and quarantine: Isolation is separating people who know they have a contagious disease from those who are not sick. Quarantine refers to restricting the movement of people who have been exposed to a virus.
    • Nasopharyngeal smear: A long, flexible stick with a soft swab that is inserted deep into the nose to collect samples from the space where the nasal cavity meets the throat. Samples for coronavirus tests can also be obtained with swabs that do not go as deep into the nose – sometimes called nasal swabs – or with mouth or throat swabs.
    • Polymerase chain reaction (PCR): Scientists use PCR to make millions of copies of genetic material in a sample. With the help of PCR tests, researchers can detect the coronavirus even when it is scarce.
    • Viral load: The amount of virus in a person’s body. In people infected with the coronavirus, viral loads can peak before symptoms, if any.

The group was registered as a nonprofit called the CDL Rapid Screening Consortium in November, with each company contributing $ 230,000 in operating costs.

The employees work in teams Researched around 50 different antigen tests around the world, analyzed what was required for a screening program – from staff to number of dresses – and estimated the total cost.

The resulting 400-page user guide includes everything from an example of an employee invitation to participate in the program and a standard consent form, to a detailed shopping list of materials required to run a program.

One of the hurdles was getting tests. They had to get them from the government because they are not yet widely available in Canada and the demand from schools and nursing homes is high.

“Let’s do tests there first,” said Dr. Dhalla, referring to schools, nursing homes and important workplaces. “As we gain experience, we can talk about getting people back to work where working from home is an option.”

In January, five companies began testing the program in environments as diverse as pharmacies and radio stations. So far, around 400 employees have volunteered and nearly 1,900 tests have been carried out. According to Sonia Sennik, the executive director of the Creative Destruction Lab and avid quarterback of the project, only three have made positive returns.

“They didn’t go to work and they might spread something,” said Ms. Sennik. “We interrupted the transmission chain three times.”

The companies found the program reduced employees’ fear of not only getting to work but returning home every day, she said.

“I’m relieved,” said Mohamed Gaballa, an Air Canada official who took the test during a break at Toronto Pearson International Airport. This came up within 15 minutes by email: “Your screening result is negative. You can go on with your day. “

“This has been a missing piece in Canada for far too long,” said Dan Kelly, president and chief executive officer of Canadian Federation of Independent Businesses that represents 110,000 small and medium-sized businesses.

Small businesses face a lot more hurdles to implementing such a program, even if dodging a 400-page manual, he said. There is the cost of the tests, but more importantly the staff to manage them.

Mr. Kelly envisioned that the program would not work in restaurants and busy stores – places where unscreened customers far exceeded the number of employees screened unless they were planned to be tested. But in kitchens, small warehouses, small manufacturing facilities, and offices, “these tests could be very helpful,” he said.

“Under normal circumstances, the idea of ​​small businesses doing employee testing for everything would be a fantasy,” said Kelly, who sits on the federal government’s industry advisory group on Covid-19 testing. “But in this case, given the desperation to remain or remain open among small business owners, there is a potential appetite for it.”