CDC report on coronavirus deaths underlines why virus is so dangerous - Axios

Virus Updates: FDA Willing to Fast Track Possible Virus Vaccine; Fla. Sees Drop in Deaths - NBC New York

Leading the world in coronavirus cases, the United States surpassed 6 million reported cases on Sunday, according to a tally by NBC News.

Also this weekend, Arizona topped 5,000 coronavirus deaths statewide while the Navajo Nation recorded more than 500. However, Florida, which has been a virus hotspot for several months, recorded its lowest daily death toll.

The credibility of the nation's two top health agencies is now in question after the the head of the Food and Drug Administration had to walk back exaggerated statements about the benefits of a new plasma therapy for coronavirus, and the Centers for Disease Control and Prevention triggered a backlash from the medical community by rewriting its guidelines to recommend less testing last week.

Meanwhile, health officials continued to criticize the Trump reelection campaign after it hosted some 1,500 people on the South Lawn of the White House during the last night of the Republican National Convention Thursday. Chairs were placed close together and few attendees wore face masks.

As of Monday morning, the death toll in the United States has surpassed 184,000, according to NBC News.

The Ebb and Flow of New Coronavirus Cases and Deaths

The graphs below illustrate the distribution of new coronavirus cases and deaths in the U.S. While New York accounted for the lion’s share of new cases and deaths in March and April, its numbers have declined in May as some states have increased. Hover or tap to see new daily cases and deaths across the country. States with the most are ordered top to bottom.

Here are the latest updates on the coronavirus pandemic in the U.S.:

---

FDA Willing to Fast Track Coronavirus Vaccine Before Phase 3 Trials End

The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a COVID-19 vaccine available as soon as possible, according to an interview in The Financial Times.

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.

"It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Hahn told The Financial Times. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."

The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized COVID-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments. 

Read the full story here

Tens of thousands of volunteers will take part in the study, with results being reported as soon as November.

---

Florida Sees Its Lowest Increase in Virus-Related Deaths Since June

In a promising sign for a state that has seen a huge outbreak in coronavirus cases, Florida reported just 14 virus-related deaths Sunday, while positivity rates throughout the state continued to show signs of stability.

Virus-related deaths among Florida residents rose to 11,119, the smallest increase the state has seen since June, while non-resident deaths were at 144, NBC Miami reports.

Many deaths reported by the state happened days or weeks earlier, as it takes time to confirm causes of death.

Let's block ads! (Why?)

"virus" - Google News
August 31, 2020 at 01:51PM
https://ift.tt/31IImbi

Virus Updates: FDA Willing to Fast Track Possible Virus Vaccine; Fla. Sees Drop in Deaths - NBC New York
"virus" - Google News
https://ift.tt/2OagXru

Auburn football down 16 players for coronavirus-related issues - ESPN

9:51 PM ET

Auburn, which canceled multiple football practices last week, will be without 16 players due to COVID-19 concerns when it resumes practice on Tuesday.

Coach Gus Malzahn told reporters on Sunday night that the team currently has nine players who have tested positive for the coronavirus and seven others who are considered high risk.

Malzahn said the Tigers have had "very few" players who have exhibited "major symptoms."

"We're learning as we go here," he said of dealing with the coronavirus as a team. "Every day and every week is a challenge."

"We're learning as we go here," Auburn coach Gus Malzahn says. AP Photo/Danny Johnston

Auburn canceled two practices and a scrimmage last week. Malzahn said the team didn't scrimmage on Saturday because players needed the weekend off after the police shooting of Jacob Blake in Kenosha, Wisconsin, earlier in the week.

Without going into specifics, Malzahn said two position groups were particularly affected by COVID-19 testing, to the point that the staff didn't feel comfortable going through full practices.

Auburn protocols require at least 17 days before a player can return from a positive COVID-19 test, including a 10-day quarantine and a seven-day reacclimation period before being fully cleared.

With four weeks remaining until the week the season is scheduled to begin, Malzahn said there's a sense of urgency.

• 

"But the bottom line is the health and safety of our players," he said.

Malzahn, who stressed the ability to adapt on the fly this season, was asked what the team's goals were this week.

"To practice," he said matter-of-factly.

Auburn is scheduled to open the season on Sept. 26 at home against Kentucky.

Let's block ads! (Why?)

COVID-19 - Latest - Google News
August 31, 2020 at 09:03AM
https://ift.tt/2QBEORN

Auburn football down 16 players for coronavirus-related issues - ESPN
COVID-19 - Latest - Google News
https://ift.tt/2VQ2gy8

FDA Chief Promises Transparency for Covid-19 Vaccine Review - Bloomberg

The head of the U.S. Food and Drug Administration promised that the review of a potential Covid-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone.

In an interview on Sunday, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.

“We’ve said all along we’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine,” Hahn told Bloomberg News by phone. “We’re going to let the data dictate that. The data will dictate what kind of decision is made on the vaccine.”

No decision on that has been made, because the agency hasn’t seen trial results yet, he said.

“I don’t have a crystal ball, I don’t know what the data look like,” Hahn said.

Hahn was appointed by President Donald Trump late last year. Only months into his tenure he found himself at the center of the administration’s response to the coronavirus, which has killed more than 180,000 Americans and infected more than 5.9 million. A vaccine is considered crucial for ending the pandemic and reviving the U.S. economy.

A vaccine is also pivotal to Trump’s re-election. The president has said a vaccine could be available by election day on Nov.3, and on Twitter has attacked Hahn’s agency for harboring “deep state” staff slowing vaccine and drug work to hurt him politically.

There’s no evidence that’s the case, and in fact the agency found itself in the middle of turmoil over the last week after Hahn, at a press conference with Trump, announced the emergency authorization of a Covid-19 therapy that uses blood plasma from recovered patients to treat current ones. At the press conference, Hahn overstated the benefits of the therapy -- and had his remarks echoed by others in the administration.

Hahn apologized a day later. But the error led to a week of criticism of the agency, and the removal of the FDA’s new spokeswoman, Emily Miller, after less than two weeks in the job. Miller didn’t respond to requests for comment Friday.

The result is an agency that has found itself trapped between Trump’s accusations that it is moving too slowly, and outside critics who fear White House pressure will cause it to rush a vaccine review, or clear a shot based on insufficient data about its safety and effectiveness.

Sharing Data

Hahn, in the interview, said the agency will share as much of the data on any vaccine it reviews as is possible. The agency has scheduled an Oct. 22 meeting of outside experts to discuss a vaccine. At this point, however, large, final-stage trials of experimental shots by Pfizer Inc., Moderna Inc. and others haven’t been completed or offered enough data to make a public judgment on.

“We are committed to being transparent because we realize this is very important to the American people,” he said. In an interview last week, he said he was aware of the outside pressure from Trump and others, but emphasized the need for data to drive the agency’s decision-making.

“What I tell internally our folks is they need to make the decisions based upon the data,” Hahn said in the earlier interview. “I have not reversed one of their decisions, nor do I intend to unless I think it’s absolutely wrong. So, yeah, I listen to it, but it’s not going to change what we do.”

Hahn, in that interview, also said that he would not be part of a decision to clear a vaccine that was politically driven.

“It would not be okay for me and I would not participate in any decision that was made any on anything other than the science,” he said.

Pfizer has said it could have enough data on its vaccine for review by October, and and other drugmakers are racing to complete trials of tens of thousands of volunteers as quickly as possible. The trials divide groups of healthy people into some who get the vaccine and others who get a placebo. Researchers are looking to see how many infections occur in each group -- which could produce results quickly if there’s a clear separation between the two subsets.

“In order to read out in October, the vaccines would have to be very effective,” former FDA Commissioner Scott Gottlieb said on CBS’s “ Face the Nation” on Sunday. “They’re going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines.” Gottlieb served as FDA commissioner under Trump from 2017 to 2019.

Gottlieb said that any early clearance of a vaccine is likely to be for a small group at higher risk. “Full approval for the general population, where people can go to CVS and get a shot, that’s really a 2021 event,” he said, referring to drugstore chain CVS Health Corp.

Vaccine Rollout

U.S. health officials have been preparing for the roll-out of a vaccine. Under the White House’s “Operation Warp Speed” program, the government has made agreements with drugmakers to fund vaccine development and manufacturing.

It’s also planning for distribution of a vaccine. Given limited supply, any vaccine is likely to go to health-care and other front-line workers first, as well as populations at higher risk of the virus.

An emergency authorization of a vaccine would likely limit use to similar groups of higher-risk people while more safety data are collected.

(Adds comment from former FDA commissioner in the 17th paragraph)

Let's block ads! (Why?)

Health - Latest - Google News
August 30, 2020 at 10:44PM
https://ift.tt/32IelHB

FDA Chief Promises Transparency for Covid-19 Vaccine Review - Bloomberg
Health - Latest - Google News
https://ift.tt/2zrj9Ud

The Latest: Indian virus surge continues with 78,000 cases - ABC News

India has registered 78,512 new coronavirus cases in the past 24 hours, maintaining an upward surge

By

The Associated Press

August 31, 2020, 5:54 AM

• 4 min read

NEW DELHI — India has registered 78,512 new coronavirus cases in the past 24 hours, maintaining an upward surge.

The Health Ministry on Monday also reported 948 deaths in the past 24 hours, taking total fatalities up to 64,469.

The surge has raised the country’s total reported virus cases since the pandemic began to more than 3.6 million.

A country of 1.4 billion people, India now has the fastest-growing reported coronavirus caseload of any country in the world, seeing more than 75,000 new cases for five straight days.

The virus has hit India’s major cities and is now fast spreading in smaller towns and rural areas.

———

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

— New Zealand lifts virus lockdown in nation's largest city

— In China’s Xinjiang, forced medication accompanies lockdown

— Survey: China manufacturing logs feeble growth in August

— Arizona reports 374 new coronavirus cases, 23 more deaths

———

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

———

HERE’S WHAT ELSE IS HAPPENING:

WELLINGTON, New Zealand — New Zealand has lifted a lockdown imposed on the city of Auckland and also made it mandatory to wear masks on public transportion.

The nation’s largest city had been in a lockdown for more than two weeks after an outbreak of the coronavirus was discovered earlier this month. The new outbreak followed more than three months without any community transmission.

Health Minister Chris Hipkins said Monday that it was safe to reopen Auckland because all the recent infections have been linked to the same cluster through contact tracing.

He noted: “We’re already seeing signs of the city getting back to normal."

New Zealand reported nine new virus infections Monday, including four among recently returned travelers who are in quarantine.

———

SEOUL, South Korea — South Korea has counted its 18th straight day of triple-digit daily jumps in coronavirus cases as its health minister warned about an increase in transmissions gone untraced.

The 248 new cases reported by the Korea Centers for Disease Control and Prevention on Monday brought the total reported cases since the pandemic began to 19,947, including 324 deaths.

KCDC said 187 of the new cases came from the Seoul metropolitan area, which has been at the center of the viral resurgence this month.

But infections were also reported in major cities across the country, including Busan, Daejeon, Ulsan and Daegu, which was the epicenter of the country’s previous major outbreak in late February and March.

Health Minister Park Neung-hoo during a virus meeting said it has become difficult for epidemiological workers to track transmissions and predict infection routes, saying they haven’t been able to trace the infection source of more than 20% of the cases found in the past two weeks.

———

MELBOURNE, Australia — The Australian state of Victoria has reported 41 new virus deaths as the government urges the hot spot state to announce plans to lift lockdown restrictions.

In addition to the deaths, Victoria’s health department on Monday reported 73 new coronavirus infections.

Victorian Premier Daniel Andrews said only eight of the 41 new fatalities had died in the latest 24-hour period.

The other 33 had died in aged care since late July and were reported on Sunday following a tightening of reporting obligations and a review of previous reporting, Chief Health Officer Brett Sutton said.

The most deaths reported at a single time had previously been the 25 reported on Aug. 17. The tally of 73 new infections is the lowest since 67 new cases were recorded on June 30.

A six-week lockdown in the state capital Melbourne, Australia’s second-largest city, is due to be relaxed on Sept. 13. But the state government has not said how it will be relaxed or given any assurances that it won’t be extended.

Andrews said he would announce his government’s plan to reopen the economy on Sunday.

Let's block ads! (Why?)

"virus" - Google News
August 31, 2020 at 12:59PM
https://ift.tt/2DhByIe

The Latest: Indian virus surge continues with 78,000 cases - ABC News
"virus" - Google News
https://ift.tt/2OagXru

The latest on the coronavirus pandemic: Live updates - CNN

At least 64,469 people have now died after contracting Covid-19 in India since the pandemic began, more than any other country except the United States and Brazil.

Mexico had identified more novel coronavirus related-deaths than India until Sunday, when Indian authorities identified another 971 fatalities. Mexico's death toll stood at 64,158 as of Sunday.

Cases have been skyrocketing in India in recent weeks, though that may be partially due to the high numbers of people being tested.

Indian authorities confirmed 78,512 new Covid-19 cases on Sunday -- the fifth consecutive day the country has recorded more than 75,000 daily new cases, according to the Health Ministry.  More than 3.6 million people have contracted the virus in India since the pandemic began.

As of Saturday, the country has tested more than 41.4 million people.

New Delhi surge: Authorities in the Indian capital recorded more than 2,000 positive Covid-19 tests on Sunday -- the highest since July 10, authorities said.

CNN is tracking global coronavirus cases here:

Let's block ads! (Why?)

COVID-19 - Latest - Google News
August 31, 2020 at 01:24PM
https://ift.tt/2QAlS5U

The latest on the coronavirus pandemic: Live updates - CNN
COVID-19 - Latest - Google News
https://ift.tt/2VQ2gy8

Experts call for independent commission separate from FDA to review Covid-19 vaccines - CNN

The US Food and Drug Administration regulates vaccines, and its OK is all that's needed to put one on the market. The physicians fear, however, that after several government blunders during the pandemic, a layer of review independent from the government is needed to give Americans confidence that the shot is safe and effective.

A CNN poll this month shows that 40% of Americans do not want to get a coronavirus vaccine when it becomes available, even if it's free and easy to access. Such a low uptake of the vaccine could hinder the ability to get the virus under control and return to normalcy.

Dr. Kathryn Stephenson, an assistant professor at Harvard Medical School, said she thought of the idea of an independent panel to increase trust in the vaccine after several colleagues told her they did not want to get a coronavirus vaccine when it becomes available.

"I'm hearing this from my peers, from doctors and nurses. They're not anti-vaxxers. They're pro vaccine. They vaccinated their own children. But they are skeptical about this vaccine," said Stephenson, director of the clinical trials unit at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

Separately from Stephenson, bioethicist Arthur Caplan arrived at the same conclusion.

"We're used to this world where if the FDA or the CDC or the NAS says something is safe and effective, that's enough, but I don't think this time that's sufficient to overturn public skepticism," said Caplan, referring to the US Centers for Disease Control and the National Academy of Sciences. "I think we desperately need an independent national commission."

Assurances from the FDA

Stephanie Caccomo, an FDA spokeswoman pointed CNN to an August 18 blog in Health Affairs by FDA Commissioner Dr. Stephen Hahn and two other physicians at the agency that describes steps the agency is taking to "offer reassurance that any potential vaccine will be safe and effective."

"First, the agency established clear recommendations for vaccine performance prior to the initiation of Phase 3 trials to provide assurance that any authorized vaccine will meet appropriate standards for safety and effectiveness. Second, FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public," according to the blog, written by Hahn, Dr. Anand Shah and Dr. Peter Marks.

Hahn has repeatedly made such assurances to the public.

"I can promise you that when the data are available, FDA will review them, using its established rigorous and deliberative scientific process," Hahn told Dr. Susan Bailey, the president of the American Medical Association, at a videobriefing earlier this month. "We all understand that only by engaging in an open review process and relying on good science and sound data, can the public, and you as providers, have confidence in the integrity of our decisions."

Hahn added that clinical trial data will be reviewed by an FDA advisory committee, "which will give us their guidance on any decision that we make." That committee is scheduled to meet on October 22.

More than half the members of the panel are academic experts who are employed by universities and research centers.

To some experts, Hahn's words about the advisory committee are at least somewhat reassuring and negate the need to create another panel.

"An independent commission already exists. We're not FDA employees," said Dr. Paul Offit, a vaccinologist at the University of Pennsylvania, who is a member of the FDA advisory committee. "We don't need another level of bureaucracy."

But Caplan, the NYU ethicist, said he worries that many Americans don't trust experts anymore, no matter how reputable they might be.

"We're going to have to get past this relying on expert endorsement. It's an old school way of thinking from pre-Covid days," he said.

'Sounds like a hot mess'

Stephenson, Caplan, and others say while they respect the scientific and ethical rigor of researchers such as Offit, they think many Americans will be skeptical of the findings of an FDA committee, especially since some of its members work for pharmaceutical companies and government agencies, according to the roster currently on the FDA website.

"The whole topic of COVID vaccines is *already* politicized and many people's skepticism is fairly entrenched at this point," Stephenson tweeted on August 22. "I'd like to see an 'Independent COVID-19 Vaccine Commission' [whose] sign off is *required* for FDA approval."

Multiple factors have intensified the public's skepticism about the vaccine, the doctors told CNN.

First, the name of the government's vaccine program -- "Operation Warp Speed" -- can give the impression that the research is being hurried, and therefore could yield an unsafe vaccine.

Two, other government efforts have struggled since the beginning of the pandemic. The CDC was late getting Covid-19 diagnostic tests on the market, for example, and the FDA allowed antibody tests on the market that were inaccurate.

The FDA issued an emergency authorization for the drug hydroxychloroquine to treat Covid-19, only to revoke that authorization less than two months later. More recently, the agency authorized the use of convalescent plasma, even though many experts think there's not enough data to show it works.

"Given the premature authorization of hydroxychloroquine and convalescent plasma, the FDA is perceived by many as tainted," said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital.

Three, statements by government officials have not engendered confidence. Earlier this month, Hahn made a statistical error that dramatically overestimated the effectiveness of convalescent plasma to treat Covid-19, apologizing for the mistake the next day.

A few days later, US Health and Human Services Assistant Secretary Dr. Brett Giroir said the White House Coronavirus Task Force had discussed and approved a widely criticized decision to change CDC Covid-19 testing guidelines. Later that day, task force member Dr. Anthony Fauci said he was undergoing surgery at the time of discussions at the White House about the guideline changes.

Then Sunday, Hahn told the Financial Times that his agency could consider emergency use authorization or approval for a Covid-19 vaccine before Phase 3 trials are complete.

"I'm afraid that for the public this sounds like a hot mess, and that's going to carry forward to the vaccines as well," Stephenson said.

Stephenson says it's not that she doesn't trust the vaccine approval process. In fact, she's on a team at Harvard researching a vaccine to be produced by Johnson & Johnson.

"I believe in the power of vaccines and I'm optimistic that we will get a safe and effective vaccine. I still want to fight for that and I want the public to come with us on this journey," Stephenson. "And having an apolitical and independent group could reassure the public during a very partisan time."

Looking to the UK as an example

The possibility that the entire vaccine approval system will be upended with an extra layer of review is unlikely.

But that hasn't stopped doctors from advocating for it.

Dr. Joseph Tucker, an infectious disease specialist at the University of North Carolina, saw Stephenson's August 22 tweet and reached out to her suggesting that they look at an independent panel in the UK that makes recommendations to the government on Covid-19, called The Independent SAGE.

He said he already knows he would want a US independent panel to look different. The British committee is made up of experts, but Tucker envisions having coronavirus survivors, as well as trusted community and religious leaders on any US panel, as well as vaccine experts.

"I want to have a body that's really trusted. What if members were like, say, Oprah? People who are reasonable and have large followings in the US and are not political and are widely recognized as thoughtful," Tucker said.

Walensky, the infectious disease specialist at Massachusetts General Hospital, likes the idea, and thinks back to the early days of the HIV epidemic, when gay men protested to take part in policy decisions.

"When they were doing die-ins in front of the NIH, Dr. Fauci said 'Let them in, I want to hear what they have to say,'" said Walensky, referring to the top infectious disease doctor at the National Institutes of Health. "They had a voice at the table."

Something similar could be done for Covid-19 decisions, including the reviews of coronavirus vaccines, she said.

"The panel would have the community's best interest at heart," she said. "It's not the scientists speaking to the community, but the community speaking to the community."

Let's block ads! (Why?)

COVID-19 - Latest - Google News
August 31, 2020 at 11:04AM
https://ift.tt/3lwoujt

Experts call for independent commission separate from FDA to review Covid-19 vaccines - CNN
COVID-19 - Latest - Google News
https://ift.tt/2VQ2gy8