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Coronavirus updates for November 10 Update News

  Indianapolis News Has Confirmed More Than 10 Million Coronavirus Cases

10 million cases. The U.S. has confirmed more than 10 million coronavirus cases, according to data compiled by Johns Hopkins University, as infections continue to rise in nearly every state.

The U.S. hit the milestone on Monday.

New daily confirmed cases are up more than 60% over the past two weeks, to an average of nearly 109,000 a day. Average daily cases are on the rise in 48 states.

The U.S. accounts for about one fifth of the world’s 50 million confirmed cases.

U.S. coronavirus deaths are up 18% over the past two weeks, averaging 939 every day. The virus has now killed more than 237,000 Americans.

Emergency use. U.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.

The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. It’s a one-time treatment given through an IV.

The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment President Donald Trump received after contracting the virus last month.

Lilly’s studies of the antibody drug are continuing. Early results suggest it may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.

The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug.

One other treatment has an emergency use designation now — convalescent plasma, or the blood of COVID-19 survivors. No large studies have shown it to be more effective than usual care alone, however.

The new drug is part of an emerging family of biologic therapies that offer a promising new approach to preventing serious disease and death from COVID-19. Experts say the infused drugs could serve as a therapeutic bridge to help manage the virus until vaccines are widely available.

The drugs are laboratory-made versions of antibodies, blood proteins which the body creates to help target and eliminate foreign infections. The new therapies are concentrated versions of the antibodies that proved most effective against the virus in patient studies.

School district changes. Two school corporations in central Indiana announced changes in response to an increase in COVID-19 cases.

Beech Grove City Schools said Beech Grove High School will begin e-learning Tuesday, November 10, until further notice, and all athletic practices and competitions and extracurricular activities for grades K-12 are cancelled until further notice. Officials say both decisions will be reviewed at the end of this week.

Beech Grove Superintendent Paul A. Kaiser said in a release that he was notified of a positive COVID-19 diagnosis of nine students Monday morning: one at Hornet Park Elementary; one at Central Elementary; three at South Grove Intermediate; one at BGMS; and one at BGHS. First contacts have been identified and advised to quarantine, according to Superintendent Kaiser.

“We ask that all staff and students maintain a heightened awareness to remain vigilant in your efforts to combat COVID-19 by continuing to social distance, wearing a mask, washing your hands frequently, and monitoring your health symptoms,” said Kaiser. “In accordance with Marion County Public Health Department guidelines, staff members and families of students who were a first contact with the affected individuals were personally notified and instructed to quarantine.  

“If you have not been personally notified, your child is NOT a first contact in this situation. We are closely monitoring the number of students at each building.  If our positive case numbers become overly concerning for the district, we will consider additional action and all parents and staff will be notified.

Center Grove Superintendent Richard A. Arkanoff announced that middle and high school students (grades 6-12) will not have school Tuesday, November 10, due to a jump in COVID-19 cases over the weekend in the school community.

On Wednesday, grades 6-12 will move to e-learning, and middle and high school students will move to the blended model Thursday. No changes are currently planned for elementary students, according to Arkanoff.

Arkanoff said Center Grove had seven positive cases reported on Saturday and Sunday and another six positive cases reported Monday afternoon. More than 80 high school and middle school students were identified as having close contact last week to those who tested positive for the virus. Quarantines have also impacted staff. 

Vaccine progress. Pfizer and its collaborator BioNTech announced on Monday its COVID-19 vaccine was found to be more than 90% effective in preventing coronavirus in participants, and they expect to produce 50 million doses this year.

The companies still have some hoops to jump through before a vaccine is distributed to the public.

Efficacy is an important step to determine whether a vaccine is viable, but Pfizer and BioNTech can not apply for FDA Emergency Use Authorization (EUA) based on these efficacy results alone. More data on safety is needed. The companies are continuing to accumulate that safety data as part of their ongoing clinical study.

They expect the required safety data to be available by the third week of November.

In late July, United States Department of Health and Human Services announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure after completing demonstration of safety and efficacy in the Phase 3 clinical trial, which began July 27.

First, interim efficacy analysis was conducted on Sunday by an external, independent data monitoring committee (DMC). The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90% at seven days after the second dose. According to Pfizer, this means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.

“For the flu vaccine, it is usually 50 to 60% effectiveness, so this one at a 90% is definitely much more effective than the vaccines that are in use,” said Dr. Lana Dbeibo, medical director of infection prevention at IU Methodist Hospital.

As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.

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