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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The Latest: Belgian Foreign Minister in Intensive Care | World News

BRUSSELS — Belgian Foreign Minister and former Prime Minister Sophie Wilmes has been hospitalized in intensive care with the coronavirus.

Wilmes, who was in charge when the first wave of infections hit the country this spring, now serves in the new government led by Alexander De Croo.

Elke Pattyn, a spokesperson at the Foreign Ministry, told The Associated Press that Wilmes is in a stable condition and conscious. She said her condition “is not worrying.”

The 45-year-old Wilmes, who was admitted to the hospital on Wednesday evening, said last week she thought she got infected within her family circle.

Belgium, a country of 11.5 million inhabitants, has been severely hit by the coronavirus and is currently seeing a sharp rise in new cases. More than 10,000 people have died from coronavirus-related complications in Belgium

HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Regulators, experts take up thorny vaccine study issues

— Despite pledges, Czechs face 2nd lockdown as system totters

— Virus spikes have officials looking to shore up hospitals

— Brazilian President Jair Bolsonaro has overruled his own health minister on the announced purchase of 46 million doses of a potential coronavirus vaccine being tested in Sao Paulo state.

— Ireland is already focused on Christmas. It’s a major national priority. Unless the country can get the COVID-19 epidemic under control, there won’t be much Christmas cheer this year in Galway, Cork or Dublin.

— Poland’s prime minister has signaled that the whole country faces being placed on the highest restriction level short of a full lockdown, as health authorities registered a record in new confirmed COVID-19 infections.

Follow all of AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

HERE’S WHAT ELSE IS HAPPENING:

LONDON — U.K. Treasury chief Rishi Sunak is expected to announce increased help for bars, pubs and restaurants that have seen business collapse because of COVID-19 controls.

Hospitality businesses are under pressure because the measures severely limit social gatherings, even under the lower levels of restrictions imposed on areas with less severe outbreaks. That reduces the number of people who go out for dinner or to meet up with friends, reducing income and forcing employers to lay off workers.

But most can’t take advantage of current government aid programs, which are focused on businesses that are ordered to close under the highest level of restrictions.

West Midlands Mayor Andy Street told the BBC that the support programs were designed with the assumption that the pandemic would ease, reducing the need for government assistance. That didn’t happen and infection rates are now rising across the country.

The government “didn’t expect us to be in a position through the autumn where we were having a rising level of the virus to this extent, so if you look at the design of the winter economy package, at the time that seemed rational but clearly events have moved very quickly.”

BUDAPEST — The number of confirmed coronavirus infections in Hungary has risen above 2,000 for the

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Aspirated Foreign Objects: Not Just Kids at Risk

In the first nationwide analysis of foreign body aspiration in the U.S., researchers at the virtual 2020 CHEST conference, the annual meeting of the American College of Chest Physicians, reported that total in-hospital mortality from these events was 7.6% — but there was a huge disparity between persons under age 18 and adults.

The mortality rate among adults in the 3-year retrospective analysis of the Nationwide Inpatient Sample was 9.6% while that of children was 1.4%, reported Rodrigo Garcia Tome, MD, of the University of Southern California, Los Angeles, in a poster presentation.

“Foreign body aspiration can be a potentially life-threatening event,” Garcia Tome said. “It accounts for thousands of emergency room visits and hospital admissions each year in the United States. Though most of these events are nonfatal, it causes significant morbidity and contributes to considerable health care expenditure.”

Garcia Tome and his colleagues analyzed U.S. records for the years 2012-2014 and found with respect to foreign body aspirations:

  • 2012: 6,490 admissions, mortality rate 7.2%
  • 2013: 5,780 admissions, mortality rate 6.9%
  • 2014: 5,760 admissions, mortality rate 8.7%
  • Overall: 1,375 in-hospital deaths

Foreign bodies that lodged in the trachea or bronchus accounted for 10,265 admissions – 56.9% of the cases over the 3-year study period. The rest of the aspirations involved were in the pharynx or larynx, Garcia Tome reported.

“This study provides novel epidemiological and resource utilization data on this potentially life-threatening event,” he said. “It also emphasized the key role of the pulmonologist in the diagnostic and therapeutic management.”

The researchers noted that the Nationwide Inpatient Sample is the largest all-payer public inpatient care database, representing about 20% of hospitals in the United States and including data on more than seven million hospital stays.

Those hospital stays for treatment of foreign body aspiration were not cheap, the researchers reported. The mean cost per case was $11,469.80, which included the costs of performing 1,590 laryngoscopies, and 3,165 bronchoscopies, or a total of 4,755 diagnostic procedures.

“Bronchoscopy appears to be a diagnostic and therapeutic cornerstone in these patients,” Garcia Tome said. “The annual overall inpatient cost associated with foreign body aspiration is approximately $70 million.”

In the study, mean patient age was 52, 63.4% were Caucasians, and about 48.4% were women.

Len Horovitz, MD, of Lenox Hill Hospital in New York City, who was not involved with the study, said, “Aspiration in childhood occurs mostly because children put objects in their mouths with great frequency. Since adults are aware of this, it is mostly small objects like toys that they aspirate, and are not necessarily life threatening.

“In adults, aspiration of food occurs and can be exacerbated by decreased consciousness because of use of sleeping pills or alcohol,” Horwitz told MedPage Today. “With comorbid conditions, especially cardiac, this can result in a higher incidence of fatalities.”

“Children who aspirate foreign bodies are often observed by caregivers, and action is taken,” he continued. “Adults are more likely to be alone when aspiration occurs.”

Last Updated October 21, 2020

Disclosures

Garcia

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