AstraZeneca to seek FDA authorization for vaccine based on foreign trial data

The company also said it would work with the agency to adjust the design of its late-stage U.S. trial to test the half-dose regimen, rather than the higher dose that proved less effective in the U.S and Brazil studies. That U.S. trial has enrolled about 10,000 of a planned 40,000 participants, but the company has not released any data from that study.

The U.K. and Brazil studies have enrolled about 24,000 participants — fewer than the 30,000 participants that the FDA is requiring for late-stage coronavirus vaccine trials.

The initial findings were based on 131 infections among trial participants. The company did not break down how many cases were reported among those who got a placebo versus those who got the vaccine, and within that vaccine group, how cases split among the two doses tested.

AstraZeneca also said that none of the infected people had severe Covid-19 or were hospitalized, but offered no further safety information.

Promising logistics: The AstraZeneca vaccine is cheaper and easier to distribute than the other two shots that have proven effective. It can be transported and stored under refrigerated conditions for at least six months, and the company says it can make up to 3 billion doses next year.

Vaccines from Pfizer and Moderna, which have each proven about 95 percent effective, must be frozen during distribution and kept at very cold temperatures.

“AstraZeneca and Oxford have developed an affordable, scalable vaccine that crucially can be stored and shipped in a regular refrigerator,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, said in a statement. “This makes it appropriate for use and easy to deliver almost anywhere in the world, including in low-resource settings.”

But questions remain: Others doubt whether the FDA will authorize the vaccine.

“We believe that this product will never be licensed in the US,” investment bank SVB Leerink analyst Geoffrey Porges said in a note on Monday. “This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the US.”

The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.

Background: The AstraZeneca vaccine was developed by scientists at Oxford University, and uses a different technology than the Moderna and Pfizer vaccines. It uses a weakened version of the common cold that contains some genetic material from the coronavirus.

U.S. vaccine and therapeutics accelerator Operation Warp Speed paid for some of the clinical development of the AstraZeneca vaccine and purchased 300 million doses for $1.2 billion.

Other clinical trials are ongoing in Japan, Russia, South Africa, Kenya

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Dentist reveals how much toothpaste you should REALLY be using based on your age & you’re definitely getting it wrong

ANY parent will know getting kids to brush their teeth can be an ordeal, but it turns out you’ve probably been giving them way too much toothpaste. 

A dentist, Dr Gao, has gone viral on TikTok after sharing a video outlining how much toothpaste we should be using – according to our age. 

A dentist claimed the amount of toothpaste used in adverts is way too much

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A dentist claimed the amount of toothpaste used in adverts is way too muchCredit: Tik Tok

Dr Gao’s clip has racked up more than six million views, as he pointed out the lashings of toothpaste used in adverts was excessive. 

He said: “The amount used in commercials is way too much. 

“For ages three and below, all a smear is all you need.”

He demonstrated with a tiny amount spread on a brush, before saying: “For anyone older, a pea size amount is plenty.” 

Dr Gao shared a clip on TikTok explaining the right amounts to use which quickly went viral

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Dr Gao shared a clip on TikTok explaining the right amounts to use which quickly went viralCredit: Tik Tok

Dr Gao explained why you shouldn’t squeeze loads on your brush, saying: “Trust me it doesn’t make your teeth any cleaner.”

And it can lead to dental problems, particularly for children. 

In a separate video, he said: “Not only is it a waste for children whose adult teeth are still developing, swallowing too much toothpaste that contains fluoride can cause dental fluorosis. 

He claimed a smear is all you need for kids under the age of three

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He claimed a smear is all you need for kids under the age of threeCredit: Tik Tok

“Dental fluorosis is a cosmetic condition that causes a change in the appearance in the tooth and enamel.

“The appearance can range from brown and light discoloration,to brown strains and even obvious pits.”

While it can be ‘cosmetically treated’, Dr Gao warned the damage was permanent. 

Parents will know the battle of getting children to brush their teeth

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Parents will know the battle of getting children to brush their teethCredit: Tik Tok

Thousands of people commented on the clip in shock, admitting they’ve been getting it wrong their whole life. 

One person said: “Thinking of all the toothpaste I’ve wasted.”

Another wrote: “That’s why electric brushes can only hold pea size toothpaste.” 

Anyone older than that should use a pea-sized amount - and no more

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Anyone older than that should use a pea-sized amount – and no more Credit: Tik Tok

A third commented: “My friends were surprised when I only used that much. I was right all along.” 

Someone else thought: “We’ve been mislead by advertisement all these years.” 

While another said: “Finally! I’ve been trying to tell my husband for ages.”

Thousands of people commented on the post in shock as they realised they've been getting their amounts wrong

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Thousands of people commented on the post in shock as they realised they’ve been getting their amounts wrong
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COVID start-up based in GOP donor’s luxury condo could get millions from U.S.

An obscure South Carolina company may be in line for millions of dollars in U.S. government funding to produce a coronavirus treatment after a former Republican senator with a financial stake in the business lobbied senior U.S. government officials, the Associated Press reports.

Plasma Technologies LLC, has received seed money to test a possible COVID-19-fighting blood plasma technology. But as much as $65 million more could be on the way, a windfall for the company that operates out of the founder’s luxury condo, according to internal government records and other documents obtained by the Associated Press.

The story of how a tiny business that exists only on paper has managed to snare so much top-level attention is emblematic of the Trump administration’s frenetic response to the coronavirus pandemic.

And it’s another in a series of contracts awarded despite concerns over their proposals voiced by government scientists. The others include a $21 million study of the heartburn drug Pepcid as a COVID therapy, and more than $500 million to ApiJect Systems America, a startup with an unapproved medicine injection technology and no factory to manufacture the devices. In addition, a government whistleblower claimed that a $1.6 billion vaccine contract to Novavax Inc. was made over objections of government scientific staff.

At the center of these deals is Dr. Robert Kadlec, a senior Trump appointee at the Department of the Health and Human Services, who backed the Pepcid, Novavax and ApiJect projects. Records obtained by the AP also describe Kadlec as a key supporter of Plasma Tech, owned by Eugene Zurlo, a former pharmaceutical industry executive and well connected Republican donor. Three years ago, Zurlo brought Rick Santorum, who spent 12 years as a GOP senator from Pennsylvania, aboard as a part-owner.


Road to a vaccine: Operation Warp Speed

04:22

Kadlec has come under pressure from the White House to act with more urgency and not be bound by lower-level science officials whom Trump has castigated as the “deep state” and accused of politically motivated delays in fielding COVID-19 vaccines and remedies.

The AP reached out to more than a dozen blood plasma industry leaders and medical experts. Few had heard of Zurlo’s company or its technology for turning human plasma into protein-rich antibody therapies, and would not comment.

Zurlo said in an email that the shortage of plasma from recovered COVID-19 patients, which is needed to make these therapies, underlines the need for the technology he’s patented to harvest as many of these proteins as possible.

Rick Santorum steps up sales pitch

In early April, shortly after Congress supplied hundreds of billions of dollars to combat the pandemic, Santorum stepped up his sales pitch for Plasma Technologies and the process the company has described as “disruptive and transformative,” according to the records.

In mid-August, the federal government awarded Plasma Technologies a $750,000 grant to demonstrate that it could deliver on its promises.

HHS would not comment when asked whether Santorum’s public backing of the president helped the company he has

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Trump admin. funds plasma company based in owner’s condo

WASHINGTON (AP) — An obscure South Carolina company may be in line for millions of dollars in U.S. government funding to produce a coronavirus treatment after a former Republican senator with a financial stake in the business lobbied senior U.S. government officials.

Plasma Technologies LLC, has received seed money to test a possible COVID-19-fighting blood plasma technology. But as much as $65 million more could be on the way, a windfall for the company that operates out of the founder’s luxury condo, according to internal government records and other documents obtained by The Associated Press.

The story of how a tiny business, which exists only on paper, has managed to snare so much top-level attention is emblematic of the Trump administration’s frenetic response to the coronavirus pandemic.

And it’s another in a series of contracts awarded despite concerns over their proposals voiced by government scientists. The others include an $21 million study of the heartburn drug Pepcid as a COVID therapy, and more than a half-billion dollars to ApiJect Systems America, a startup with an unapproved medicine injection technology and no factory to manufacture the devices. In addition, a government whistleblower claimed that a $1.6 billion vaccine contract to Novavax Inc. was made over objections of scientific staff.

At the center of these deals is Dr. Robert Kadlec, a senior Trump appointee at the Department of the Health and Human Services, who backed the Pepcid, Novavax and ApiJect projects. Records obtained by the AP also describe Kadlec as a key supporter of Plasma Tech, owned by Eugene Zurlo, a former pharmaceutical industry executive and well-connected Republican donor. Three years ago, Zurlo brought Rick Santorum, who spent 12 years as a GOP senator from Pennsylvania, aboard as a part-owner.

Kadlec has come under pressure from the White House to act with more urgency and not be bound by lower-level science officials whom Trump has castigated as the “deep state” and accused of politically motivated delays in fielding COVID-19 vaccines and remedies.


The AP reached out to more than a dozen blood plasma industry leaders and medical experts. Few had heard of Zurlo’s company or its technology for turning human plasma into protein-rich antibody therapies, and would not comment.

Zurlo said in an email that the shortage of plasma from recovered COVID-19 patients, which is needed to make these therapies, underlines the need for the technology he’s patented to harvest as many of these proteins as possible.

In early April, shortly after Congress supplied hundreds of billions of dollars to combat the pandemic, Santorum stepped up his sales pitch for Plasma Technologies and the process the company has described as “disruptive and transformative,” according to the records.

In mid-August, the federal government awarded Plasma Technologies a $750,000 grant to demonstrate that it could deliver on its promises.

HHS would not comment when asked whether Santorum’s public backing of the president helped the company he has a financial stake in getting a government contract.

Santorum told the AP it would have been a

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