Here’s why new cases of the coronavirus are down across most of the U.S. – CNBC

Here’s why new cases of the coronavirus are down across most of the U.S. – CNBC

A coronavirus chart that will shock you – CNN

A coronavirus chart that will shock you – CNN

August 26, 2020

Which, according to a majority of self-identified Republicans in a new CBS/YouGov poll, is, well, OK.

Almost 6 in 10 registered Republicans said they considered the current number of coronavirus deaths to be "acceptable," while 43% said it was unacceptable.

Among Democrats, 90% say the number of coronavirus deaths is unacceptable. That number is 67% among political independents.

What explains the discrepancy? Partisanship, mostly.

Thanks to President Donald Trump, many Republicans believe that any acknowledgment that the Covid-19 pandemic has not been handled perfectly -- or at least as well as any president could be expected to do -- is somehow an admission that Democrats (and the media) are right in their criticisms of Trump.

And so, when asked whether 177,000+ of their fellow citizens dying is acceptable, which it clearly is not, they say it is -- because to say anything else would be disloyal to Trump.

The logical fallacy built into this way of thinking is that Covid-19 is a public health problem, not a political problem. Simply lining up in your partisan camp won't make it go away. Democrats andRepublicans get the coronavirus. DemocratsandRepublicans die from it.

Until we start to realize that what party you belong to makes zero difference to this virus, we are going to continue to struggle to do the things we need to in order to mitigate its spread -- from social distancing to mask-wearing.

And until we all can acknowledge that the loss of 177,000 people is not just unacceptable but an ongoing tragedy, we are losing the sense of unity and purpose that the country was founded on.

The Point: More Americans have died this year from the coronavirus than died in World War I. And more than double the number of Americans who died in the Vietnam War. There's a word for that massive loss of life: unacceptable.


Visit link: A coronavirus chart that will shock you - CNN
Coronavirus in Brevard, Aug. 26: 5 newly recorded deaths; death toll at 200, over 7,000 total cases – Florida Today

Coronavirus in Brevard, Aug. 26: 5 newly recorded deaths; death toll at 200, over 7,000 total cases – Florida Today

August 26, 2020

Editor's note:With this story we are providing information about the COVID-19 crisis. We chose to make this story broadly accessible because of the importance of its content. But quality, fact-checked reportingisnt free. Collecting and verifying news is a costly and time-consuming endeavor and perhaps has never mattered more than it does now. Please show your support for quality reporting like this by subscribing to FLORIDA TODAY. Visitfloridatoday.com/subscribe.

Here are updates about coronavirus cases in Brevard, according to the Florida Department of Health, as of Aug. 26,2020.

As of Wednesday, 200 people in Brevard died from COVID-19, according to the Florida Department of Health. FDOH database show there were five newly recorded deaths.

The county also registered 68 new cases, bringing the total to more than 7,000 since the pandemic began.

So far, the county has lost 200 people to the virus, with 86of those deaths reported this month. Victims range in age from 40 to 103. At least 122 of thedeaths were connected to long-term care facilities such as nursing homes.

It's important to note the exact dates of these deaths are not made public by the department of health. Often there is a lag between the person's death and when it is reported by the Florida Department of Health.Also, a "case" is a person who tests positive for the first time, according to FDOH.

Florida Department of Health data shows Brevard has registered 7,040 coronavirus cases since the pandemic began. Of the total number, 7,019 were residents and 21 nonresidents affected. The total number of people tested has been 91,179 (84,083 testing negative), for a positive rate percentage of 7.72%.

The median age of those testing positive here is 43. The state average is 41.

"The need for food is phenomenal right now. Phenomenal," said Don Pearsall, immediate past chair of the Brevard Veterans Council. Florida Today

Can you help?: Food drive seeks donations for needy veterans during pandemic

COVID: Initial head count shows 14,000 fewer Brevard Public Schools students

Here's a snapshot of this month's coronavirus cases in Brevard:

Aug. 1: 101 cases, 1 death

Aug. 2: 66 cases, 2 deaths

Aug. 3: 32 cases

Aug. 4: 52 cases, 6 deaths

Aug. 5: 41 cases, 9 deaths

Aug. 6: 84 cases, 2 deaths

Aug. 7: 57 cases, 6 deaths

Aug. 8: 102 cases, 2 deaths

Aug. 9: 101 cases, 9 deaths

Aug. 10: 35 cases

Aug. 11: 91 cases, 6 deaths

Aug. 12: 58 cases, 3 deaths

Aug. 13: 65 cases, 3 deaths

Aug. 14: 100 cases, 5 deaths

Aug. 15: 86 cases, 6 deaths

Aug. 16: 33 cases, 4 deaths

Aug. 17: 27 cases

Aug. 18: 77 cases, 3deaths

Aug. 19: 53 cases, 8 deaths

Aug. 20: 87 cases, 3 deaths

Aug. 21: 45 cases, 2 deaths

Aug. 22: 92 cases, 1 death

Aug. 23: 23 cases

Aug. 24: 34cases

Aug. 25: 26 cases

Aug. 26: 68 cases, 5 deaths

Coronavirus in Brevard, Aug. 25: 26 cases

Facebook:Coronavirus questions, answers and info in Brevard

FDOH data show 626 Florida residentshave been hospitalized in Brevard since the pandemic began, an increase of 15 from the previous day.

There have been 3,230 males and 3,777 females total testing positive for coronavirus.

As of Aug. 25, of 1,019 people tested, 68 were positive and 951 negative for a percent positive of 6.67%.

According to the Florida Agency for Health Care Administration, at 11:30 a.m. Wednesday, Brevard had 82 people hospitalized for COVID-19 in its seven major hospitals, down two from the previous day.Of the 1,299total staffed hospital bed capacity,29% of beds were available in those hospitals. Of the 166total adult ICU bed capacity, 27% were available.

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The state added 3,220 new cases Wednesday. In total, the state has registered 608,722cases (602,113 residents, 6,609 nonresidents).FDOH dashboard show 4,499,640 people (residents and nonresidents) have been tested with 3,884,096 negative. The overall percentage of people testing positive decreased to 13.53%.The percentage of people testing positive Tuesday was 5.72%.

Statewide, the death toll for Florida residents was 10,733 with 153 newly recorded deaths. Since the pandemic began, there have been 139 nonresident deaths here, an increase of two from the previous day.

Total number of Florida residents hospitalized since the pandemic began increased to 37,404, an increase of 366 from the previous day.

White: 3,683

Black: 875

Other: 622

Unknown/No data: 1,839

Non-Hispanic: 3,981

Hispanic: 862

Unknown/no data: 2,176

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Here's the city-by-city countas ofWednesday,although some of these may include unincorporated areas. Note: Per FDOH, these are provisional. We are showing the increase in the last 24 hours.

Total cases as of Aug. 26: 7,040

Melbourne: 2,084, an increase of 18

Palm Bay: 1,495, an increase of 18

Cocoa: 765, an increase of 10

Merritt Island: 525, an increase of 8

Titusville: 474, an increase of 2

Rockledge: 428, an increase of 2

Missing, Brevard: 183, an increase of 2(this is how it appears in DOH city data)

Satellite Beach: 162, an increase of 5

West Melbourne: 159

Cocoa Beach: 152, an increase of 1

Indialantic: 118, an increase of 1

Cape Canaveral: 80

Mims: 79, an increase of 1

Melbourne Beach: 69, an increase of 1

Indian Harbour Beach: 58

Viera: 49

Malabar: 37

Patrick Air Force Base: 25

Grant-Valkaria: 23

Barefoot Bay: 13

Palm Shores: 12

*Sebastian: 11 (Aug. 25 FDOH reportshowed12)

Micco: 5

Port St. John: 3

Valkaria: 2

Scottsmoor: 2

Orlando, Brevard: 2

Fellsmere: 2

Kissimmee, Brevard: 1

Sharpes: 1

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Within Brevard, these are the zip codes with the most infections, according to the FDOH (data is provisional and subject to change)as ofWednesday:

32907 with 581 cases. That includes all or parts of Palm Bay, Malabar and West Melbourne

32904 with 546cases. That includes all or parts of Melbourne Village, Melbourne, Palm Bay, West Melbourne and June Park

32909 with 525 cases. That includes all or parts of Palm Bay, Malabar and Grant-Valkaria

32901 with 513 cases. That includes all or parts of West Melbourne, Palm Bay and Melbourne


Read more: Coronavirus in Brevard, Aug. 26: 5 newly recorded deaths; death toll at 200, over 7,000 total cases - Florida Today
Rhode Island Bachelorette Party Linked To Coronavirus Cluster In Massachusetts – CBS Boston

Rhode Island Bachelorette Party Linked To Coronavirus Cluster In Massachusetts – CBS Boston

August 26, 2020

BOSTON (CBS) Nineteen out of 20 people who rented a house together in Rhode Island for a wedding event in late July later tested positive for coronavirus, the Massachusetts Department of Public Health said. Seventeen of the attendees were from Massachusetts, according to the state.

The Boston Globe reported that the event was a bachelorette party. DPH said it talked with Rhode Island health officials about the cluster and notified close contacts of those who attended.

Gov. Charlie Baker brought up the event in a news conference Tuesday when talking about why unmanaged social events are the biggest concern for coronavirus spread.

The big challenge for us is to is to bring that kind of discipline to other kinds of events where people clearly havent been distancing havent been wearing masks and a lot of these involve what I would describe as events in which people are familiar with one another and they behave like theyre familiar with one another, Baker said. As difficult as it is for all of us, the hugging, the high fiving, the singing along to the songs, whatever it might be, indoors or outdoors, particularly in close quarter environments is just the wrong thing to be doing when youre trying to work your way through a pandemic.

In Maine, at least 60 people have been sickened from an early August wedding reception in Millinocket. The wedding cluster has also been connected to an outbreak at a jail more than 200 miles away.


More here:
Rhode Island Bachelorette Party Linked To Coronavirus Cluster In Massachusetts - CBS Boston
What you need to know about coronavirus Wednesday, Aug. 26 – KING5.com

What you need to know about coronavirus Wednesday, Aug. 26 – KING5.com

August 26, 2020

Find developments on the coronavirus pandemic and the plan for recovery in the U.S. and Washington state.

Where cases stand in Washington:

A Washington state health official says the state will not change its coronavirus testing recommendations despite new federal guidance.

Guidance previously on Centers for Disease Control and Prevention (CDC) website recommended tests for "all close contacts" of people who test positive for COVID-19. The CDC has now revised that guidance online and says close contacts who have been exposed to COVID-19 but are not exhibiting symptoms "do not necessarily need a test."

However, Dr. Charissa Fotinas, deputy chief medical officer for the Washington State Health Care Authority, said Wednesday that recommendations for COVID-19 testing in Washington will stay the same.

State officials are standardizing a set of activities for counties in modified Phase 1 of Gov. Jay Inslee's "Safe Start" plan.

As of Aug. 26, Benton, Chelan, Douglas, Franklin and Yakima counties were the only ones under modified Phase 1. Each had different approved activities.

The state worked with local jurisdictions to agree on one set of activities that would be allowed.

Experts have been urging the public to wash their hands, wear face coverings and remain six feet apart from others amid the coronavirus pandemic.

In a new study posted by the BMJ, researchers from the Massachusetts Institute of Technology and the University of Oxford claim that other factors like crowd size, amount of exposure time and how well an area is ventilated need to be considered.

The Centers for Disease Control and Prevention has updated itscoronavirusquarantine guidance for travelers. It now says that those who have traveled outside of their state or country should self-evaluate their risk based on their travels before determining whether to self-isolate.

"These travelers should take extra precautions to protect others for 14 days after they arrive, including staying home as much as possible, avoiding being around people at a higher risk for severe illness from COVID-19, and considering getting tested for COVID-19," the CDC said in a statement.

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trumps announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.


Read more: What you need to know about coronavirus Wednesday, Aug. 26 - KING5.com
Trash collection remains behind schedule in Philly; N.J. to allow gyms to reopen; dont argue with anti-masker – The Philadelphia Inquirer

Trash collection remains behind schedule in Philly; N.J. to allow gyms to reopen; dont argue with anti-masker – The Philadelphia Inquirer

August 26, 2020

In an apparent reference to the Atilis Gym in Bellmawr, where the owners have defied the states guidelines repeatedly by reopening to customers in an increasingly contentious standoff, Murphy acknowledged, There have been a few knuckleheads who have been more interested in their own celebrity, frankly, than in working with us to defeat the virus. But they are, thankfully, overwhelmingly outnumbered by the good guys and gals.


View original post here: Trash collection remains behind schedule in Philly; N.J. to allow gyms to reopen; dont argue with anti-masker - The Philadelphia Inquirer
As Summer Wanes, New Yorkers Worry About Covid Comeback in the Fall – The New York Times

As Summer Wanes, New Yorkers Worry About Covid Comeback in the Fall – The New York Times

August 26, 2020

Many of those answers, great and small, are already visible.

In Long Island City, where 18-year-old Ferdinand Stirling greeted the closing of his high school with approval It was lit, he said the pause allowed him to make music and grow so much as a musician in the past few months, he said. Likewise, in nearby Sunnyside, Gero Eaton, 30, has made some money selling his kaleidoscopic splatter paintings, which he displayed on the streets outside his studio.

I look at it as a way to keep me sane, he said.

In Sunset Park, a group of friends beat back the worries of the day by stringing a volleyball net across 51st Street and grabbing a ball.

Its a way to get out the stress, said Wilson Idrouo, 40.

They have one firm rule: Unless youre talking about one of the cold bottles of beer in the case nearby, there will be no mention of the word corona.

In Greenwich Village, Willa Kiritz, 72, and her husband, Anthony Blanche, 88, bring their lifetimes of experience to the citys current troubles.

Just wear the bloody masks and lets get on with this, Ms. Kiritz said. The empty streets and shuttered businesses alarm her, calling to mind tough times in the 1980s. But she and her husband ventured outside to a restaurant the minute they reopened, she said.

Mr. Blanche deployed the New Yorkers sturdy what-are-you-gonna-do shrug. I dont think Im too worried, he said. I know Im not going to get out of here alive.

Jo Corona, Nate Schweber and Matthew Sedacca contributed reporting.


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As Summer Wanes, New Yorkers Worry About Covid Comeback in the Fall - The New York Times
Meet FDA’s Peter Marks, ‘the single most critical figure in the [Covid-19] vaccine decision’ – The Daily Briefing

Meet FDA’s Peter Marks, ‘the single most critical figure in the [Covid-19] vaccine decision’ – The Daily Briefing

August 26, 2020

Peter Marksdirector of FDA's Center for Biologics Evaluation and Research (CBER), and likely the most important person at the agency when it comes to approving a coronavirus vaccinelast week said he'll resign if FDA approves a vaccine that's not supported by research.

Radio Advisory episode: Ezekiel Emanuel on the path to a vaccine

According to the Washington Post, Marks started his career intending to become a research biochemist, but, while working part-time as a phlebotomist, he found that he enjoyed working with patients. Marks ended up going to medical school and also getting a PhD in cell and molecular biology.

Eventually, Marks landed at Brigham and Women's Hospital alongside Ned Sharpless, director of the National Cancer Institute and a former acting FDA commissioner. After leaving Brigham and Women's, Marks worked for Genzyme and Novartis before "return[ing] to academic medicine at" Yale University and becoming the CCO at the university's cancer hospital, the Post reports.

From there, Marks was hired by FDA in 2012 and, in 2016, he became director of CBER. During Marks' tenure at CBER, the center has approved several new treatments, including the first CAR T-cell therapy for advanced cancer and the first Ebola vaccine.

According to the Post, Marks in his current role is the highest-ranking career official involved in the approval of any potential vaccine candidateand if historical precedent holds true, that means Marks, rather than a political appointee, ultimately will be tasked with recommending for or against FDA approval of any potential coronavirus vaccine. (That said, Stephen Hahn, as FDA's current commissioner, typically holds the authority to issue an emergency use authorization for a vaccine, Reuters reports, and the HHS secretary technically could overrule any decision issued by FDA.)

According to Jason Schwartz, an expert on vaccine decision-making at the Yale School of Public Health, Marks' position essentially makes him "the single most critical figure in the [coronavirus] vaccine decision."

In April, Marks proposed what ultimately became known as Operation Warp Speed, which is the Trump administration's initiative to fast-track a vaccine against the new coronavirus. According to the Post, Marks initially was part of the effort, participating as a vaccine expert. However, he ultimately returned to his FDA job. The Post reports that Marks decided to leave his post with Operation Warp Speed after several other experts were recruited to the effort, and he determined that he would be most useful in his regulatory role at CBER.

In June, Marks laid out guidance for coronavirus vaccine developers that stated FDA would approve a coronavirus vaccine candidate only if a clinical study had proven that the candidate is safe and at least 50% more effective than a placebo at preventing coronavirus infection; Covid-19, the disease caused by the virus; or decreasing the severity of the disease. Under Marks' guidance, those requirements apply to full approval by FDA, as well as an emergency use authorization. In addition, FDA has added that officials will publicly consult the agency's expert advisory panel before approving a coronavirus vaccine.

And even after a vaccine is approved, Marks noted that FDA will require the vaccine's manufacturer to monitor for any related safety issues that arise. Further, Marks has cautioned that some questions regarding the vaccine's effectiveness won't be answered right away, such as whether people will need to receive the vaccine on an annual basis or whether the vaccine will remain effective if the novel coronavirus changes genetically.

Amid the ongoing process to develop and approve a coronavirus vaccine, some health experts have expressed concerns that FDA may be placed under political pressure to approve a vaccine as fast as possibleparticularly given the upcoming presidential election.

And Arthur Caplan, director of the medical ethics division at the NYU Grossman School of Medicine, pointed out that even if Marks decides not to back a vaccine candidate, his superiors could overrule his decision. "This is not a hypothetical," Caplan said.

However, Hahn in a statement said that Marks and his team will "call the balls and strikes" on a coronavirus vaccine. "There are no circumstances under which the FDA would allow a vaccine to be released for use by the public if it is not shown to be safe," Hahn added.

Similarly, Michael Caputo, assistant secretary for public affairs at HHS, said although the government aims to identify a vaccine that's safe and effective by January 2021, speculation about whether FDA is being pressured to approve a vaccine "only undermines confidence in the public health system." He added, "I've never met one FDA regulator who wouldn't resign over improper pressure, and that's how America knows their seal of approval is the gold standard."

And former FDA Commissioner Scott Gottlieb said he has confidence that Marks won't buckle to political pressure. "He'd do what he needed to do to secure our public health prerogatives," Gottlieb said.

For his part, Marks during a conference call last week with government officials, pharmaceutical executives, and academics who are part of a vaccine working group formed by NIH said he will resign if FDA approves a vaccine that hasn't been proven to be safe and effective.

Marks later confirmed those statements with Reuters, adding that he hasn't felt any political pressure yet. However, he noted that if that changed, he "could not stand by and see something that was unsafe or ineffective that was being put through."

"You have to decide where your red line is, and that's my red line," Marks said. "I would feel obligated [to resign] because in doing so, I would indicate to the American public that there's something wrong" (McGinley, Washington Post, 8/11; Levine/Taylor, Reuters, 8/20).


Go here to read the rest: Meet FDA's Peter Marks, 'the single most critical figure in the [Covid-19] vaccine decision' - The Daily Briefing
This change in policy will kill: Experts troubled by CDC changes to COVID-19 testing guidelines – USA TODAY

This change in policy will kill: Experts troubled by CDC changes to COVID-19 testing guidelines – USA TODAY

August 26, 2020

At-home testing could transform the fight against the novel coronavirus. USA TODAY

Infectious disease experts are not only confusedbut also troubled by a change in testing guidelines made by the U.S. Centers for Disease Control and Prevention, which said people without symptoms may not need a test even if theyve been exposed to the coronavirus.

Our work on the silent spread underscored the importance of testing people who have been exposed to COVID-19 regardless of symptoms, tweeted Alison Galvani,director for the Center for Infectious Disease Modeling and Analysis at Yale School of Medicine. This change in policy will kill.

Before changes were made Monday, the CDC website said testing was recommended for all close contacts of persons with SARS-CoV-2 infection.

The website now sayssomeone who was in close contact (within 6 feet) of a person with COVID-19 for at least 15 minutes but doesnt have symptoms does not necessarily need a test. The agency said exceptions are made for vulnerable individuals, or those who were recommended to take a test by a health care provider or public health official.

The CDC estimates in its COVID-19 Pandemic Planning Scenarios that 40% of infections are asymptomatic and 50% of transmissions occur before symptoms appear. Experts worry that failing to test asymptomatic carriers could not only result in more infections but also hinder contact tracing efforts.

If being in close personal contact with an infected person isnt sufficiently important enough to get tested, I dont see that theres any value in contact tracing, said Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest.

A spokespersonat the U.S. Department of Health and Human Services told CNN the change wouldnt undermine contact tracing or any other types of surveillance testing.

Rapid testing: Inaccurate results from rapid COVID-19 tests raise concerns about widespread screening

Coronavirus vaccine: Should employers force workers to get COVID-19 vaccine? Some experts say they should

Though Pitts said the change inCDC guidelinesis not permission to do away with testing, hes worried that some may take it that way. He said the agency should encourage more testing.

Dr. Brett Giroir, HHS Assistant Secretary for Health, said during a news conference Wednesday that theguidance is meant to encourage more "appropriate testing, not less testing."

"There will be more asymptomatic testing in areas where it's needed and less where it's not needed," he said. "As (the virus)goes down dramatically in certain areas, the need for testing goes down."

House Speaker Nancy Pelosi promised to investigate the change, calling the new guideline "scary and dangerous."

House Speaker Nancy Pelosi is calling the new guidelines from the Centers for Disease Control and Prevention on coronavirus testing "scary and dangerous." (Aug. 26) AP Domestic

It really is very sad and just reinforces the lack of attention and understanding that we have to have in order to crush this virus," she said.

Scientists recommend more testing 3 million a day to identify, track and treat those who are infected, Pelosi said. The country has conducted about 80 million tests total since the pandemic began.

Giroir said the guidelines were reviewed by the Coronavirus Task Force, including Dr. Anthony Fauci, Dr. Deborah Birx and Dr. Stephen Hahn.

"There was no weight on the scale by the president or the vice president or Secretary (Alex) Azar," he said. The guidelines were the product of scientific and medical staff, he said, andthey were"discussed extensively at the task force and everyone approved it."

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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See original here: This change in policy will kill: Experts troubled by CDC changes to COVID-19 testing guidelines - USA TODAY
Covid-19 roundup: European vaccines lobby pushing for liability protection; VBI vaccines to prep human trials – Endpoints News

Covid-19 roundup: European vaccines lobby pushing for liability protection; VBI vaccines to prep human trials – Endpoints News

August 26, 2020

At first glance, you might not be too impressed with the data from Dermavants Phase IIIs for their psoriasis contender tapinarof. The results pale in comparison to the biologics that have been transforming the field.

But Dermavant, a brainchild of biotech entrepreneur Vivek Ramaswamy, isnt about to go toe-to-toe with the heavyweights. Their cream treatment has a distinct commercial plan in place that leaves the most severe cases to the biologics, while positioning itself in the front of the market and quite possibly in combination with some of those blockbusters that have been stealing all the headlines.

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Originally posted here: Covid-19 roundup: European vaccines lobby pushing for liability protection; VBI vaccines to prep human trials - Endpoints News
Trump wants a vaccine for Covid-19 before the November 3 election. Is this possible? – The Indian Express

Trump wants a vaccine for Covid-19 before the November 3 election. Is this possible? – The Indian Express

August 26, 2020

By: Reuters | Chicago, New York | Updated: August 26, 2020 11:22:32 pmPresident Donald Trump in Clyde, Ohio, August 6, 2020. (The New York Times: Anna Moneymaker)

US President Donald Trump has said a vaccine for the novel coronavirus could be available before the November 3 presidential election, sooner than most experts anticipate. A COVID-19 vaccine as early as October could become a reality if drugmakers deliver on optimistic timelines for completing large, late-stage clinical trials and regulators allow for its use prior to a full review and approval.

How can US regulators speed up availability of a vaccine?

The US Food and Drug Administration can greenlight medical products during public health emergencies by issuing an emergency use authorisation (EUA) before all the data are in to complete a formal review. The FDA has issued EUAs for many COVID-19 tests and for a few treatments.

On Sunday, the FDA authorised on an emergency basis the use blood plasma from recovered COVID-19 patients as a treatment. The FDA commissioner later corrected data he cited at a news conference that significantly overstated the treatments known ability to save lives.

EUAs are not typically used for vaccines intended for healthy people to prevent infection. That presents a higher bar for approval than treatments for people with life-threatening disease. Nevertheless, the FDA in June released EUA guidance for COVID-19 vaccines. Once it grants an EUA, the agency eventually must issue a formal marketing approval or revoke emergency authorisation.

How much time could an EUA save?

Typical FDA approval reviews take eight months or longer, with a priority review shaving off a couple of months. But the agency has moved quickly during past public health crises. During the 2009 H1N1 swine flu pandemic, it only took two months to get an approved vaccine, but those were based on existing seasonal flu vaccines.

An EUA for a vaccine using a new approach might only save a few weeks, some experts say. The FDA would still need substantial data, said Dr. Kathryn Edwards, former chairwoman of the FDAs vaccine advisory committee and scientific director at the Vanderbilt Vaccine Research Programme.

What they do seem to be telling us is that once you show that your vaccine works that might be a time when an EUA may be used before the paperwork is completed, said Filip Dubovsky, chief medical officer of vaccine maker Novavax Inc.

Express Explainedis now onTelegram. Clickhere to join our channel (@ieexplained)and stay updated with the latest

Is it risky to use an EUA for vaccines?

The US government decided against an EUA for the H1N1 vaccine after a survey found 64 per cent of Americans would not take it if it had not gone through the formal approval process. Consumer rights watchdog Public Citizen urged regulators not to use an EUA for COVID-19 vaccines, which it says could create the appearance of a rushed review.

The FDA and other US health experts say there must be sufficient safety and efficacy data before a vaccine is authorised for public use.

I certainly would not recommend nor would I ever allow myself to be injected with a vaccine that has not been thoroughly vetted and approved by the FDA, said former FDA associate commissioner Dr. Peter Pitts, president of the Center for Medicine in the Public Interest.

Could Trump pressure the FDA to issue an EUA without sufficient data?

Trump, without citing evidence, on Saturday accused deep state elements in the FDA of holding up vaccines and treatments in order to undermine his reelection prospects. FDA Commissioner Stephan Hahn has denied that assertion. Peter Marks, one of the FDAs top drug reviewers, told Reuters he would resign if he felt the agency was pressured to approve a vaccine before it was ready.

Dr. Jesse Goodman of Georgetown University, a former FDA chief scientist, said a vaccine EUA could undermine public confidence in the agency. He cited pressure around hydroxychloroquine, a treatment pushed by Trump and others in his administration, which received an EUA that was later revoked when data showed a lack of efficacy and safety issues. Were certainly seeing a situation where norms are not being respected government-wide, Goodman said.

Dont miss from Explained | Why the departure of adviser Kellyanne Conway matters for Trump

Which drugmakers have a shot at a viable vaccine before the election?

AstraZeneca Plc in conjunction with Oxford University researchers and Pfizer Inc with partner BioNTech SE have said they could have pivotal data by October. Moderna Inc is not far behind with late-stage data expected as soon as November or December.

The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines

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Originally posted here: Trump wants a vaccine for Covid-19 before the November 3 election. Is this possible? - The Indian Express