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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Tips, options, and when to seek help

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It is common to experience difficulty with bowel movements after giving birth. Some people may find that postpartum stool softeners help.

Constipation is a normal problem following delivery. Several factors can contribute to this issue, including hormonal effects, iron supplements, sore and stretched muscles, hemorrhoids, and discomfort due to an episiotomy.

The general level of tenderness that people experience after delivery can make them anxious about bowel movements. Taking a postpartum stool softener can help make bowel movements easier during this time.

After delivery, the prospect of having a bowel movement can seem intimidating, but most people have one within 2–3 days.

People who have had stitches for an episiotomy may be particularly concerned about their first postpartum bowel movement, but experts say it is unlikely that a person could tear their stitches or sustain an injury while attempting a bowel movement.

Holding a sterile cloth or pad over the stitches or injured area may help, but the most important thing is to avoid straining.

Delaying or holding back bowel movements will not make the first one easier. In fact, it could have the opposite effect. After delivery, people should try to have a bowel movement as soon as they feel the urge.

Relieving postpartum constipation

The following practices can help make bowel movements easier postpartum:

  • drinking plenty of water and other hydrating fluids
  • eating a well-balanced diet containing lots of fiber-rich foods, such as whole grains and fresh fruits and vegetables
  • trying to include dried fruits, such as prunes and figs, in the diet
  • exercising gently and regularly
  • washing the anal area gently with warm water
  • avoiding holding back bowel movements

Experts consider stool softener medications safe to take when pregnant or breastfeeding.

Stool softeners make it easier for stools to move through the body by increasing the water content of fecal matter. People typically take them at bedtime with a full glass of water.

Postpartum stool softeners are available in the form of:

  • tablets
  • capsules
  • syrup
  • liquid

Learn about the difference between stool softeners and laxatives here.

Products to relieve constipation can be effective, but they do not necessarily work immediately. Experts note that it is common to use a postpartum stool softener for 1–3 days before seeing any benefits and recommend discontinuing use after 2 weeks.

Some foods, drinks, and remedies can naturally soften stools and ease constipation. For example, probiotics, Epsom salts, and aloe vera may help soften stools.

Learn more about natural stool softeners here.

Before using a postpartum stool softener, people should discuss their concerns and review their options with a healthcare professional.

People can choose from many different stool softener products after giving birth. Below, we provide information on five options that people may wish to try.

Please note that the writer of this article has not tried these products. All information below is purely research-based.

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Georgia Lawmakers Seek Jail Reform After Reuters Investigation | Top News

(Reuters) – Georgia lawmakers are pressing for stronger jail oversight after a Reuters investigation identified hundreds of deaths in the state’s county jails and dangerous lapses in inmate medical care.

David Wilkerson, a Georgia state lawmaker who had been planning new jail legislation for the upcoming January session, said he intends to cite Reuters’ findings in his proposed reforms.

As part of an examination of deaths at more than 500 jails nationwide, Reuters found 272 inmate deaths among 13 large Georgia jails over more than a decade. At least half of the deaths were caused by a medical condition or illness, and a quarter by suicide.

The news organization exposed healthcare lapses at the jail in Savannah. Another report explored the 2017 death of Chinedu Efoagui, who died at the Cobb County Adult Detention Center after spending 512 days behind bars without ever being tried on the charges for which he was held.

To read the full investigation, Dying Inside, click https://www.reuters.com/investigates/special-report/usa-jails-deaths

Wilkerson, a Cobb County Democrat, said his proposal will focus on improving mental health care in jails, as well as the disclosure and investigation of in-custody deaths.

“It’s impossible for the jail to investigate themselves. At the end of the day you’re asking someone who did something wrong to look at themselves,” said Wilkerson. “The public trust is not there.”

Wilkerson had begun researching new legislation after the death of Kevil Wingo, a 36-year-old Atlantan who died in the Cobb County jail in 2019. He said he was further moved to propose reforms following the Reuters accounts of Efoagui’s death and others in Georgia jails.

Other state legislators say the spate of jail deaths, particularly involving inmates who had not been convicted of their charges, shows the need for enhanced oversight.

“It is a tragedy. It is malpractice on the part of the state of Georgia, and on the counties,” said Mary Margaret Oliver, a Georgia Democratic lawmaker and former magistrate court judge.

Oliver said substandard mental health care in jails must be tackled when lawmakers convene in January. “Jails are significantly the largest mental health facility in the state,” she said. “And we are not attending to the combination of mental illness, addiction, and significant physical health issues.”

The death of Efoagui, a 38-year-old Nigerian native, highlights such concerns. The software programmer was arrested after suffering a mental breakdown during a traffic stop. As his physical and mental health deteriorated behind bars, he begged for help, but died of a pulmonary embolism.

Many of Efoagui’s friends from Nigeria were unaware of the details of his death after he moved to the United States in 2012 to pursue the American dream. They expressed shock when they learned the full story in the Reuters account.

“Mental illness and the inability to post bond should not cost a life,” tweeted Ogechukwu Eze. “Any life.”

(Reporting by Linda So. Editing by Ronnie Greene)

Copyright 2020 Thomson Reuters.

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Hartford judge hears testimony on safety of masks in schools as parents seek to block face coverings rule

A Hartford judge heard hours of testimony on the safety and efficacy of masks to help prevent the spread of the coronavirus Friday as he decides whether to grant an emergency injunction blocking a state requirement that students wear face coverings in schools.

In a daylong hearing on the injunction, Judge Thomas G. Moukawsher heard from both those downplaying the effectiveness of masks as well as those who said face coverings do not negatively impact children and slow the spread of the virus.

The hearing came several weeks after a group of parents and the CT Freedom Alliance sued the state’s education department and top officials to lift the requirement that children wear masks in schools out of fear of the harms they pose to children both mentally and physically.

The assertions in the lawsuit are in direct conflict with scientific evidence that shows that mask-wearing slows the spread of COVID-19. Lawyers for the state have argued there is no evidence to support the claim that masks are dangerous and that in fact masks are protecting students as they attend in-person classes.

Quick to send students home for virtual learning in the spring, Connecticut education officials outlined extensive measures to safely return students to school this fall. Key among those measures was a requirement that students and staff wear masks in school.

Moukawsher set Friday’s hearing to get testimony from two expert witnesses called by the plaintiffs, as well as the state’s witnesses, before ruling on the request for an injunction. The state has filed a motion to dismiss the case, which Moukawsher will address after the injunction.

Lawyers for the parents and CT Freedom Alliance first called on a Los Angeles-based psychiatrist, who said that masks can inhibit development, cause stress and led to other complications for children.

“I am greatly concerned by what I am seeing … children who are forced to wear masks in a school settings as well as outside the school settings are in imminent harm,” said Dr. Mark McDonald. McDonald also noted that the risk of oxygen deprivation can led to “permanent neurological damage in children, which we will not be able to address because the window will have passed.”

The state questioned McDonald’s beliefs in masks and the government response to the pandemic. McDonald said he believes that a healthy person confers no benefits to others when wearing a mask.

The plaintiff’s second witness, Knut Whittkowski, a New York-based epidemiologist with 35 years in the field, said he reviewed scores of studies and could not find evidence that masks were effective outside a health care setting.

“I went through all the literature I could find, and all the literature I was presented and I could not find convincing evidence on the effectiveness of surgery masks or bandannas or other masks worn in non-health care settings in general,” Whittkowski said. “And in particular, I couldn’t find evidence for the effectiveness of mask wearing by children.”

The U.S. Centers for Disease Control and

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Grave-counting satellite images seek to track Yemen’s COVID death toll

LONDON (Reuters) – A first-of-its-kind study using satellite images to count fresh graves and analyse burial activity in Yemen has estimated the death toll there from COVID-19 or COVID-related causes is far higher than official government figures suggest.

Using high-resolution satellite imagery, researchers at the London School of Hygiene & Tropical Medicine (LSHTM) analysed burial activity at all identifiable cemeteries in Yemen’s Aden region and calculated an estimated 2,100 “excess deaths” during the COVID-19 outbreak between April and September.

“This total is best interpreted as the net sum of deaths due to COVID-19 infection and deaths indirectly attributable to the pandemic,” they said. The indirect deaths would be those caused by disruptions to health services or by measures which may have caused problems accessing food, they added.

Humanitarian and global health experts had expected the COVID-19 pandemic’s impact on Yemen to be severe, not least because the country’s five-year conflict has disrupted already weak health services and led to overcrowding, food insecurity and shrinking humanitarian aid.

But as of 25 October 2020, Yemen, which reported its first confirmed COVID-19 case on April 10, had recorded only 2,064 infections with 600 deaths from the disease.

No comment was immediately available from Yemen authorities on the satellite estimates but the internationally recognised government has said previously that it reports figures daily for areas under its control and nothing is hidden.

Francesco Checchi, who co-led the study, noted that having an accurate picture of COVID-19’s impact “is vital for effective government and humanitarian responses”.

“By estimating excess mortality, we aimed to develop a more accurate estimate of the toll of COVID-19 in Yemen,” he said.

The researchers, whose findings have yet to be peer-reviewed by other experts, also cited other material as supporting their estimates.

In May, videos posted on social media and information from informants reported high numbers of fresh graves, suggesting a spike in burial activity, they said, adding: “The use of mechanical excavators in place of human gravediggers suggested that demand exceeded routine capacity.”

During the same period, the global medical charity Médecins sans Frontières reported a peak in hospital admissions, with a very high case-fatality ratio, and media said a shortage of personal protective equipment had forced several hospitals to close or reject patients with COVID-19-like symptoms.

The research, funded by aid from the UK government, was led by LSHTM and the technology company Satellite Applications Catapult, which specialises in geospatial analysis.

The researchers said they are now conducting a similar study in Mogadishu, Somalia.

“Though our method cannot distinguish direct from indirect virus deaths, estimating excess mortality attributable to the COVID-19 pandemic in a humanitarian setting captures the whole system impact,” said Emilie Koum Besson, who co-led the work.

Reporting by Kate Kelland, editing by Giles Elgood

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When To Seek Medical Advice?

KEY POINTS

  • Pneumonia is a condition that could prove dangerous for older adults
  • Detecting the symptoms when they appear will be beneficial for the elderly
  • Some of the common symptoms are cough, fever, chest pain 

Pneumonia is a dangerous condition for older adults as it puts them at a higher risk of developing complications. Detecting the symptoms of pneumonia in older adults at the earliest will ensure that the patient is afforded treatment the soonest. 

The American Lung Association (ALA) stated that the immune system of older adults is not that strong anymore in fighting off the disease. This is why their risk of developing complications, or a serious illness related to pneumonia, also becomes higher.

The Centers for Disease Control and Prevention (CDC) revealed that in the United States, there are more than 250,000 individuals who need to seek care in a hospital because of pneumonia every year. There are about 50,000 people who died in the U.S. due to the disease.

The Symptoms

Medical News Today reported that the usual symptoms of pneumonia include a cough, which could either be dry or one that produces phlegm. Difficulty in breathing is also indicative of pneumonia. Fever could also be a sign, as well as chest pain. These symptoms, however, may not be the same for older adults as they could exhibit milder or fewer symptoms. 

In older adults, the typical symptoms would include poor coordination, which would often cause falls. Older adults may also show that there was a sudden change in their day-to-day functions. Other symptoms of pneumonia in older adults would include confusion, delirium, incontinence and reduced appetite. 

Pneumonia in Older Adults Symptoms of pneumonia in older adults Photo: truthseeker08/Pixabay

The most common form of pneumonia is bacterial pneumonia, which tends to be more serious. The ALA stated that the symptoms of this type of pneumonia can develop gradually or suddenly. Bacterial pneumonia symptoms would include sweating, fever that can reach high temperatures up to 105 degrees Fahrenheit, increased breathing, increased pulse rate, confusion, bluish nailbeds and lips. 

On the other hand, symptoms of viral pneumonia develop over several days. With this kind of pneumonia, the initial signs that one may see or experience include fever, headache, dry cough, muscle weakness and muscle pain. Thereafter, about one or two days, the symptoms would start worsening. At this point, the patient may experience increased coughing, muscle pain, shortness of breath, blue lips and high fever.

When To Seek Medical Advice?

For older adults, pneumonia can become serious. They must also seek immediate medical advice if they notice breathing difficulties, coughing up blood, or chest pain. Other symptoms that need immediate medical attention include fainting, high fever, confusion and severe cough with mucus.

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Coronavirus Vaccine: Pfizer Says It Won’t Seek Authorization Before Mid-November

The chief executive of Pfizer said on Friday that the company would not apply for emergency authorization of its coronavirus vaccine before the third week of November, ruling out President Trump’s assertion that a vaccine would be ready before Election Day on Nov. 3.

In a statement posted to the company website, the chief executive, Dr. Albert Bourla, said that although Pfizer could have preliminary numbers by the end of October about whether the vaccine works, it would still need to collect safety and manufacturing data that will stretch the timeline to at least the third week of November.

Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the requirements of the Food and Drug Administration by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.

In doing so, the company had aligned its messaging with that of the president, who has made no secret of his desire for an approved vaccine before the election. He has even singled out the company by name and said he had talked to Dr. Bourla, whom he called a “great guy.”

Some scientists applauded Pfizer’s announcement.

“This is good, really good,” said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego who was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

Keep up with Election 2020

He said company officials had assured him that a vaccine would most likely not be authorized before the election, but the letter Friday is “even more solid about their not being part of any political machinations.”

Dr. Bourla has pushed back against any suggestion that Pfizer’s vaccine timeline was politically motivated. In September, Pfizer was the driving force behind a pledge by nine vaccine companies to “stand with science” and not put forward anything that had not been properly vetted. Earlier this month, he published an open letter to employees that said he “would never succumb to political pressure” and expressing disappointment that “we find ourselves in the crucible of the U.S. presidential election.”

Pfizer is one of four companies testing a coronavirus vaccine in late-stage clinical trials in the United States, and it has been the most aggressive in its timeline estimates. Moderna, AstraZeneca and Johnson & Johnson have said that later in the year is more likely, matching the predictions of federal health officials. (AstraZeneca and Johnson & Johnson’s trials have been paused for potential safety concerns, which could further delay their outcomes.)

In interviews, Mr. Bourla has said that he expects a “conclusive readout” by late October, with an application for emergency authorization that could be filed “immediately.”

Pfizer’s trial of 44,000 volunteers tests the vaccine by giving one group the vaccine, another group the placebo, and waiting until a certain number of

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