As fall approaches rapidly, many are wondering if the race for a vaccine will bear fruit as early as January 2021.
I am a physician-scientist and infectious diseases specialist at the University of Virginia, where I care for patients and conduct research into COVID-19.
I am occasionally asked how I can be sure that researchers will develop a successful vaccine to prevent COVID-19. After all, we still don't have one for HIV, the virus that causes AIDS.
Here is where the current research stands, where I think we will be in five months and why you can be optimistic about the delivery of a COVID-19 vaccine.
In as many as 99 percent of all COVID-19 cases, the patient recovers from the infection, and the virus is cleared from the body.
Some of those who have had COVID-19 may have low levels of virus in the body for up to three months after infection. But in most cases these individuals can no longer transmit the virus to other people 10 days after first becoming sick.
It should therefore be much easier to make a vaccine for the new coronavirus than for infections such as HIV where the immune system fails to cure it naturally. SARS-CoV-2 doesn't mutate the way that HIV does, making it a much easier target for the immune system to subdue or for a vaccine to control.
A vaccine will protect, in part, by inducing the production of antibodies against the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19.
The virus needs the spike protein to attach to and enter human cells to reproduce. Researchers have shown that antibodies, like those made by the human immune system, bind to the spike protein, neutralize it and prevent the coronavirus from infecting cells in laboratory culture.
Vaccines in clinical trials have been shown to raise anti-spike antibodies that block virus infection in cells in the lab.
At least seven companies have developed monoclonal antibodies, laboratory-manufactured antibodies that recognize the spike protein. These antibodies are entering clinical trials to test their ability to prevent infection in those who are exposed, for example, through a household contact.
Monoclonal antibodies may also be effective for treatment. During an infection, a dose of these monoclonal antibodies could neutralize virus, giving the immune system a chance to catch up and manufacture its own antibodies to combat the pathogen.
The spike protein has many locations where antibodies can bind to and neutralize the virus. That's good news because with so many vulnerable spots, it will be difficult for the virus to mutate to avoid a vaccine.
Multiple parts of the spike would need to mutate to evade neutralizing anti-spike antibodies. Too many mutations to the spike protein would change its structure and render it incapable of binding to ACE2, which is key to infecting human cells.
Safety of a new COVID-19 vaccine is improved by researchers' understanding of potential vaccine side effects and how to avoid them.
One side effect seen in the past was antibody-dependent enhancement of infection. This occurs when antibodies don't neutralize the virus but instead allow it to enter into cells via a receptor intended for antibodies.
Researchers have found that by immunizing with the spike protein, high levels of neutralizing antibodies can be produced. This lessens the risk of enhancement.
A second potential problem posed by some vaccines is an allergic reaction that causes inflammation in the lung, as was seen in individuals who received a respiratory syncytial virus vaccine in the 1960s.
This is dangerous because inflammation in the lung air spaces can make it difficult to breathe. However, researchers have now learned how to design vaccines to avoid this allergic response.
The US government is supporting the development of several different vaccines via Operation Warp Speed.
The goal of Operation Warp Speed is to deliver 300 million doses of a safe and effective vaccine by January 2021.
The US government is making a major investment, committing US$8 billion to seven different COVID-19 vaccines.
By supporting multiple COVID-19 vaccines, the government is hedging its bets. Only one of these vaccines needs to prove safe and effective in clinical trials for a COVID-19 vaccine to be made available to Americans in 2021.
Phase I and phase II trials test if a vaccine is safe and induces an immune response. Already the results to date from three different vaccine trials are promising, triggering the production of anti-spike neutralizing antibodies levels that are two- to four-fold higher than those seen in people who have recovered from COVID-19.
Moderna, Oxford, and Chinese company CanSino have all demonstrated the safety of their vaccines in phase I and phase II trials.
During a phase III trial, the final step in vaccine development process, the vaccine is tested on tens of thousands of individuals to determine if it works to prevent infection with SARS-CoV-2, and that it is safe.
The vaccine produced by Moderna and NIH and the vaccine from Oxford-AstraZeneca began phase III trials in July. Other COVID-19 vaccines will be starting phase III within weeks.
Operation Warp Speed is paying for the production of millions of doses of vaccines and supporting vaccine manufacturing at an industrial scale even before researchers have demonstrated vaccine efficacy and safety.
The advantage of this strategy is that once a vaccine is proven safe in phase III trials, a stockpile of it will already exist and it can be distributed immediately without compromising full assessment of safety and efficacy.
This is a more prudent approach than that of Russia, which is vaccinating the public with a vaccine before it has been shown to be safe and effective in phase III.
McKesson Corp., the largest vaccine distributor in the US, has already been contracted by the CDC to distribute a COVID-19 vaccine to sites including clinics and hospitals where the vaccine will be administered.
I believe that it is realistic that we will know sometime in late 2020 whether some COVID-19 vaccines are safe, exactly how effective they are and which ones should be used to vaccinate the US population in 2021.
William Petri, Professor of Medicine, University of Virginia.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
With scientists around the world racing to develop coronavirus vaccines, a new report says the Trump administration is considering emergency use authorization of a vaccine being developed at Oxford University. Charlie D'Agata takes a look at the lab developing the vaccine, which has yet to reach the final phase of testing.
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Krystal Doucet, associate site director at Benchmark Research in San Angelo, prepares lab samples Tuesday, Aug. 25, 2020.(Photo: Colin Murphey / San Angelo Standard-Times)
SAN ANGELOMark Lacy believes a vaccine for COVID-19 will be produced within the next 12 months, and San Angelo will have played a crucial rolein its development and possibly in its discovery.
Lacy, who was born and raised in San Angelo and who graduated from Central High School in 1978, is now the CEO of Benchmark Research, a clinical research companybased in Austin, Texas. The company has five locationsacross the United States, which include Fort Worth, San Angelo, New Orleans, and Sacramento.
In July, Benchmark Research began clinical trials for a COVID-19 vaccine in the Concho Valley, in which up to 300 residents have so far participated. Lacy hopes to eventually have 10,000 participants from the San Angelo area to help researchers develop a vaccine to the coronavirus.
"We're one of the only companies in the United States that are involved in all of the trials that the Federal government has considered to have the best promise to produce a (COVID-19) vaccine," Lacy said. "It makes me very proud that San Angelo can participate in possibly changing the world."
Helping to change the world through medical research is something San Angelo residents have already done, whether they're aware of it or not.
In its 20-plus years of operation, Benchmark Research's past studies have investigated vaccines for the H1N1 influenza during the 2009 H1N1 pandemic, as well asthe Ebola virus during the 2014 Ebola virus epidemic.
"San Angelo is helping to find medicine to keep people healthier, longer," Lacy said. "San Angelo (residents) have participated in at least 20 groundbreaking studies that are saving millions and millions of lives."
Other studies Benchmark Research is conducting include combating bio-terrorism.
Lacy said San Angelo is one of 3,200 cities in the United States that have participated in ways to counteract small pox and other deadly pathogens that could be released during a terrorist attack.
To do this kind of research, and to find a vaccine for COVID-19, Lacy stressed the need to have volunteers who are willing to participate in clinical trials.
"It's critical we have volunteers," Lacy said. "It's very likely thatwithin the next 12 months, we will find a vaccine, and San Angelo has an opportunity to be part of the solution."
Lacy said residents living inSan Angelo have participated in more than 200 vaccine studies, and those whodo are paid for their time.
Compensation variesaccording to the level of participation, but Lacy said the maximum amountis up to $1,500 for each participant.
Krystal Doucet, associate site director at Benchmark Research in San Angelo, works with samples in a lab on Tuesday, Aug. 25, 2020.(Photo: Colin Murphey / San Angelo Standard-Times)
While researchers are getting closer to discovering a vaccine for COVID, its too soon to presume victory that a vaccine is imminent, according to a group of USA TODAY panelistswho work in medicine, virology, immunology, logistics and supply chain issues.
Theres a possibility none of the current vaccine candidates will pan out. The typical success rate for vaccine development is 6%, according toThe Lancet, a British medical journal.
We simply cannot assume the outcome at this stage, said Dr. Kelly Moore, associate director of immunization education with the Immunization Action Coalition.
With at least10 possible vaccines now in the final Phase 3clinical testing stage, two looming questions remain: Will they work and will they work long enough?
There's no data to show that any of the candidate vaccines provides immunity to COVID-19. Thats what Phase 3 clinical trials test for, which are only now starting.
This is a new virus and we are just beginning to unravel the protective immunity, said Prakash Nagarkatti,an immunologist andvice president for research at theUniversity of South Carolina.
Krystal Doucet, associate site director at Benchmark Research in San Angelo, prepares lab samples Tuesday, Aug. 25, 2020.(Photo: Colin Murphey / San Angelo Standard-Times)
Officials with Benchmark Research said that before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
For COVID-19 vaccine studies, Benchmark Research officials said they are looking for participants who are highly likely to be or have been exposed to COVID-19, including those at risk for severe illness.
This includes peoplewho work in occupations that put them in regular contact with the public, such as nurses, doctors, construction workers, teachers, retail staff, delivery drivers and other essential workers.
High-risk individuals including those above age 65, and those who suffer from health conditions such as obesity, heart disease, diabetes and asthma, are also eligible to participate, officials said.
Those interested in volunteering can visit Benchmark Research online and fill out a pre-screening form here:benchmarkresearch.net/participate/
For more information: call1-888-902-9605 or visit Benchmark Research at their San Angelo location at 3605 Executive Drive.
Krystal Doucet, associate site director at Benchmark Research in San Angelo, works with samples in a lab on Tuesday, Aug. 25, 2020.(Photo: Colin Murphey / San Angelo Standard-Times)
Lacy stressed clinical trials pose little risk for volunteers developing COVID-19.
"The vaccine is made of dead, attenuated viruses so there is zero chance of getting COVID," Lacy said. "We've enrolled 28,000 patients over the last 15 years for vaccine studies and we have yet to have one serious adverse health effect related to the drug."
There are benefits and potential risks for participating in clinical trials, according to the U.S. Department of Health & Human Services.
Officials say it's possible you may get a new treatment for a disease before it's available to the public, but the new treatment could cause serious side effects or be uncomfortable.
"The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today,everyclinical investigator is required to monitor and make sure thateveryparticipant is safe," according to a statement made by U.S. health officials.
If and when a vaccine for the coronavirus is eventually found, officials say it might take some convincing for residents wary of vaccines in general.
The agencies that decide if a vaccine isready and who gets it first are the Food and Drug Administration and the U.S. Centers for Disease Control and Prevention.
It is vital that the U.S. government communicate clearly with the American people about the data and science behind any new COVID-19 vaccine, said Dr. Michelle McMurry-Heath, presidentandCEO of the Biotechnology Innovation Organization.
Lacy appeared to agree and encouragedpeople to proportion their opinions about vaccines based upon the available science.
"Everybody has a right to their own beliefs, but ...I believe what you should go by are the facts and the science, and not by rumors or innuendo," Lacy said.
Mark Lacy, CEO of Benchmark Research. Photo sent Aug. 25, 2020.(Photo: Contributed by Mark Lacy, Benchmark Research)
Lacy said he comes from a long line of San Angelo and Miles area businessmen his grandfather owned several businesses in San Angelo including a funeral home, and his father owned Harvester and Deere dealerships.
"I have a degree from The University of Texas and I attended school in Germany for a year as an exchange student," Lacy said. "Iwas also a special assistant to the secretary of transportation under Ronald Reagan."
Officials with Benchmark Research said Lacy has worked in commercial real estate in Manhattan and he later founded a company that performed communications audits.
Eventually he teamed up with a business partner with a background in clinical research, and suggested they start a company focused on clinical research trials.
In 1997, Benchmark Research opened a location in Fort Worth. Two years later, Lacy opened a branch in San Angelo, his hometown.
"I wanted to bring back jobs to San Angelo," Lacy said. "It makes me proud that San Angelo has representation in the international research industry."
More: Here's how COVID-19 survivors can donate plasma and help current San Angelo patients
John Tufts covers enterprise and investigative topics in West Texas. Send him a news tip atJTufts@Gannett.com. Consider supporting West Texas journalism with asubscription toGoSanAngelo.com.
Read or Share this story: https://www.gosanangelo.com/story/news/2020/08/25/former-san-angelo-resident-now-ceo-looks-covid-19-vaccine/3430940001/
Around the world, research is ongoing to develop a vaccine against COVID-19. Lufthansa Cargo and Frankfurt Airport are working together to prepare to ship the vaccine around the world once the time comes, according to the airport today.
COVID-19 has brought the aviation industry to its knees. However, it looks as though the industry will play a key role in fighting back. Once a COVID-19 vaccine hits the market, temperature-controlled flights will be required to move it around the globe to innoculate patients. As such, while researchers are busy developing the vaccine, airlines and airports are busy preparing to transport it.
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Frankfurt Airport is one of Europes major cargo hubs. As a result, it remained one of the busiest airports per number of flight movements at the height of the crisis on the continent. Alongside two dedicated cargo areas, Cargo City North and Cargo City South, the airport also handles cargo found in the bellies of passenger aircraft.
The airports position as a cargo hub meant that while Heathrow saw passenger and cargo figures plummet, cargo figures at Germanys aviation capital remained relatively stable. Of course, passenger figures for the airport still dropped.
Today Frankfurt Airport revealed that it already has 12,000 square meters of temperature-controlled handling capacity available. This storage has direct apron access, meaning that vaccines would find the journey from the temperature-controlled environment of the aircraft as short as possible. Additionally, Frankfurt Airport has 20 temperature-controlled transporters, meaning that critical temperatures can be maintained on the airside journey too.
But it doesnt stop there. The airport is about to open a further 2,000sqm of space, bringing the total to 14,000sqm. Commenting, Max Philipp Conrady, Head of Central Cargo Infrastructure at Fraport said,
We are closely monitoring the current research for a corona vaccine Already during the handling of urgently needed protective equipment and partly vital pharmaceutical goods at the beginning of the year, we showed that we, as a cargo community, make an essential contribution to supplying the population
When the COVID-19 pandemic began to kick in, Lufthansa was one of the first airlines to start dedicating passenger aircraft to keeping cargo moving. It therefore comes as no surprise that the German flag carrier is also hard at work preparing for the arrival of a COVID-19 vaccine.
One of Lufthansa Cargos key offerings is that it has a focus on transporting temperature-sensitive goods. In particular, the airline has many years worth of experience transporting pharmaceuticals. It aims to have all of its 31 pharmaceutical stations in far-reaching destinations CEIV-certified by 2021.
Are you pleased to see that Frankfurt Airport is preparing to handle a COVID-19 vaccine? Let us know what you think in the comments!
Following individual human stories in a sprawling event like a global pandemic is a challenging task. Making thoughtful connections between the two is even harder. But this long read from The California Sunday Magazine on Americas first COVID-19 epicenter, a nursing home in Washington state, does the job with compelling and tragic precision.
It focuses on two inhabitants of a single room in the nursing facility, the Life Care Center of Kirkland, part of the largest privately held chain of long-term care centers in the US. It tracks how the coronavirus spread through the facility like a spectral haunting, and how underpaid and overworked staff battled against the odds to bring it under control.
Around the world, nursing homes have been hit hard by the pandemic, which is no surprise considering that their residents are some of the most vulnerable in society. In the US alone, as of mid-August, 177,129 nursing home residents have tested positive for COVID-19 and 45,958 have died from the disease. This means that nursing-home residents account for more than a quarter of total pandemic deaths, writes journalist Katie Engelhart.
In America, though, these individual tragedies connect to larger trends. As Engelhart lays out in rigorous detail, the financial and regulatory landscape of the US has seriously diminished the quality of care in nursing homes. The freakish architecture of health insurances is one issue, incentivizing management to treat patients with profit in mind:
At one Life Care facility in Florida, the entire rehab staff had signed a letter declaring that they had been encouraged to maximize reimbursement even when clinically inappropriate.
And the financialization of the industry is another. Nursing homes are lucrative businesses thanks to a regular supply of customers. This has attracted buyouts from private equity firms and owners concerned only with making money. Nursing homes are folded into complicated company structures that make it harder for patients to sue, while middle managers are brought in on bloated salaries, draining funds from frontline staff.
The results are grimly predictable, explains Engelhart:
Earlier this year, a Wharton SchoolNew York UniversityUniversity of Chicago research team found robust evidence that private-equity buyouts lead to declines in patient health and compliance with care standards. When nursing homes are bought by private-equity groups, the team concluded, frontline nursing staff are cut, and residents are more likely to be hospitalized.
Lax government regulations have also played a part. One study found that three-quarters of US nursing homes were understaffed before the pandemic, while 82 percent had been cited by the Government Accountability Office for failing to control the spread of infections between 2013 and 2017. These conditions were ripe for the pandemic to move in.
Engelharts piece is extremely affecting when detailing the plight of nursing home residents themselves. These are mothers and fathers, daughters and sons, whose tragedy is simply aging in a country that does not provide for them. As Engelhart puts it, many people see the tens of thousands of deaths in US nursing homes as evidence of a cultural abdication on the part of society. Weve failed to look after our elders and the human cost is staggering. Perhaps this pandemic can at least wake people up to the change that is needed.
Go read Engelharts full story right here.
TheWest Virginia Department of Health and Human Resources (DHHR) reports as of 10:00 a.m., on August 26,2020, there have been 409,429 total confirmatorylaboratory results received for COVID-19, with 9,540 totalcases and 190 deaths.
DHHR has confirmed the deaths of a61-year old female from Logan County, an 87-year old female from Ohio County,and a 72-year old female from Mercer County. We are deeply saddened bythis news, a loss to both the family and our state, said Bill J. Crouch, DHHRCabinet Secretary.
CASESPER COUNTY: Barbour (33), Berkeley (777), Boone(131), Braxton (9), Brooke (85), Cabell (501), Calhoun (8), Clay (19),Doddridge (6), Fayette (195), Gilmer (18), Grant (138), Greenbrier (99),Hampshire (91), Hancock (118), Hardy (66), Harrison (259), Jackson (194),Jefferson (332), Kanawha (1,281), Lewis (32), Lincoln (111), Logan (454),Marion (212), Marshall (134), Mason (91), McDowell (72), Mercer (284), Mineral(131), Mingo (222), Monongalia (1,072), Monroe (91), Morgan (37), Nicholas(47), Ohio (289), Pendleton (44), Pleasants (14), Pocahontas (42), Preston(136), Putnam (254), Raleigh (331), Randolph (220), Ritchie (3), Roane (25),Summers (18), Taylor (103), Tucker (11), Tyler (15), Upshur (41), Wayne (232),Webster (7), Wetzel (45), Wirt (8), Wood (297), Wyoming (55).
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Such is the case of Hampshire,Pendleton, and Randolph counties in this report.
Pleasevisit the dashboard located at www.coronavirus.wv.gov for more information.
At a Sunday press conference, U.S. President Donald Trump (right) announced that Food and Drug AdministrationCommissioner Stephen Hahn (left) had approved an emergency use authorization for using plasma from recovered COVID-19 patients to treat new patients with the disease.
By Kai Kupferschmidt, Jon CohenAug. 24, 2020 , 9:00 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
At a highly unusual Sunday night press conference, U.S. President Donald Trump revealed what he described as a very historic breakthrough in the fight against COVID-19that would save countless lives: The U.S. Food and Drug Administration (FDA) had issued an emergency use authorization (EUA) for convalescent plasma to treat people with severe COVID-19.
The authorization could allow more hospitalized patients to receive the antibody-rich plasma, which is donated by people who have recovered from the disease. But in the wake of Trumps announcement, which came a day before the start of the Republican National Convention, researchers struggled to sort the politics from the medical and scientific import of the EUA.
Trump, flanked by FDA Commissioner Stephen Hahn, claimed that convalescent plasma was safe and very effective, and had proven to reduce mortality by 35%what he called a tremendous number. But that number has received a tremendous amount of scrutiny. It surprised even the researchers who conducted the study on which Trump apparently based declaration. I dont know where the 35% number comes from, says Arturo Casadevall of Johns Hopkins Universitys Bloomberg School of Public Health, the last author of the study, which has been posted as a preprint but has yet to be peer reviewed.
Randomized, controlled trials (RCTs), the gold standard for assessing therapies, havent yet shown any benefit of convalescent plasma on COVID-19 patients. One such study, which includes thousands of patients, is underway as part of the Recovery trial in the United Kingdom. An FDA review of the request for the EUAmade by a branch of FDAs parent agency, the Department of Health and Human Services (HHS)notes an RCT with small numbers of participants in China and another in the Netherlands. Both were stopped early and failed to show the benefits of convalescent plasma.
But the EUA rests heavily on data from the COVID-19 Plasma Consortium, funded by HHS to provide access to the treatment and assess its safety. The group has treated more than 90,000 patients at nearly 3000 sites in the United States and its territories. That study has no untreated control group, however, so it cannot ultimately address whether convalescent plasma has any risks that outweigh benefits.
The treatment was allowed under FDAs Expanded Access program, which gives patients access to experimental treatments. Casadevall says this program requires burdensome, time-consuming paperwork that the EUA will do away with. That will be particularly helpful for understaffed hospitals that treat underserved populations, he says. I think the FDA made the right call. The political noise is unfortunate.
Others say the political noise is drowning out the science.
Hahn claimed at the press conference that Trumps 35% figure translates to 35 lives saved per 100 sick people. Casadevall and others suspect both numbers are based on a small subset ofpatients, and the closest data that fit seem to be from a group that was analyzed together because of the specific test that assessed the COVID-19 antibody levels in the plasma they received. In this group of about 3000 people, 8.9% of those who received plasma containing high antibody levels died within 7 days, versus 13.7% of those who received plasma with low levels. Although that is a 35% relative difference between the groups, the absolute difference, 4.8%, amounts to 4.8 lives saved per 100 sick peoplenot 35. And after 30 days, the relative difference between the groups had dropped to 25%. At that point, the mortality rates were 22.3% and 29.6% respectively among recipients of plasma with high and low levels of antibodieshardly a historic breakthrough. (On Monday evening, after this story was posted, Hahn acknowledged he had made a mistake, tweeting that the criticism of his remark was entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.)
Luciana Borio, a former chief scientist at FDA, calls the data presented yesterday statistical acrobatics. If the treatment effect was real and meaningful, we would probably have detected it by now, says Borio, who formerly worked on the Trump White Houses National Security Council and now is a vice president at In-Q-Tel, a not-for-profit that invests in high-tech companies.
Nicole Bouvier, a virologist and infectious disease clinician at the Icahn School of Medicine at Mount Sinaiand a participant in the Mayo Clinicled consortiumsays the data gathered so far do suggest convalescent plasma may help some COVID-19 patients. There is probably a benefit to it, but its probably not a major breakthrough as it was described, Bouvier says. She wishes the U.S. government had organized large-scale RCTs for the intervention, although they would have been costly and difficult to run. Were trying to build a wall of evidence and were putting in pebbles, she says. It would have been nice to have a great big boulder of an RCT. But it just has not evolved in that way, and I dont see it evolving that way anytime soon.
Borio and others worry the EUA may make it harder to gather that kind of evidence for other treatments. Convalescent plasma contains a mixture of different antibodies, only some of which hinder the virus that causes COVID-19, and Borio and many others have high hopes for a more targeted and standardized intervention: monoclonal preparations that contain high levels of the most potent antibodies only. But now that the EUA has put convalescent plasma within reach of more patients, it may become harder to enroll people in RCTs for monoclonal antibodies, Borio says.
Myron Cohen of the University of North Carolina, Chapel Hill, who oversees large-scale RCTs of monoclonals now taking place under the aegis of the U.S. National Institutes of Health, agrees. If potential study participants for a COVID-19 treatment intervention in a randomized controlled trial believe there is a beneficial and safe agent they can receive without randomization to a placebo, they may logically and often chose that path, Cohen says.
Given that the tens of thousands of Americans have already received convalescent plasma through FDAs Expanded Access program, its unclear how many more people the EUA will actually benefit. Bouvier says her hospital may not even be able to use the EUA, because it requires that convalescent plasma be first characterized with a specific antibody test that it does not have. How do you even do what the FDA is mandating in the EUA right now? Bouvier asks.
Over the past week, several U.S. government health officials had urgedFDA not to issue an EUA on plasma for COVID-19, which led Trump to post a tweet accusing them of being part of the deep statea supposed inside movement against himand trying to delay approvals until after the 3 November presidential election. He repeated those accusations last night. I think that there are people in the FDA and actually in your larger department that can see things being held up and wouldnt mind so much, Trump said, addressing Hahn. Thats my opiniona very strong opinion. And thats for political reasons.
Eric Topol, a cardiologist who directs the Scripps Research Translational Institute, says the EUA again represents the FDA caving directly to Trump pressure, as he believes it did when it issued an EUA (later rescinded) for hydroxychloroquine treatment for COVID-19. It sadly and unacceptably exemplifies loss of independent FDA assessment of evidence and data overridden by political pressure, Topol says. Many scientists worry the same could happen in future decisions about EUAs for COVID-19 vaccineswith far greater potential consequences because vaccines presumably will be given to hundreds of millions of healthy people.
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Those numbers are people.
Its easy to forget, when youre taking a daily look at a dashboard tracking the coronavirus, at the closed businesses and unemployed workers across the state that mark the path of the recession, at efforts to educate Texas kids in classrooms or in their homes, or at the logistics of breaking the social distancing blues with some college football.
Every number is somebody.
Youve read about some of them in The Texas Tribune.
Like Holly Jackson, whose Austin nightclub is shuttered and whose employees are furloughed, or Elizabeth and Ryan McNiel, stuck in the same situation with their bar in Sabinal. Grant Tran, a senior at Texas State University in San Marcos, where classes started this week. Tenants like Rolando Pulido of Houston, who fears an eviction notice like those delivered to several of his neighbors.
Or Adolfo Fito Alvarado Jr., a chaplain at Doctors Hospital at Renaissance in Edinburg killed by COVID-19 last month.
You havent read about most of them, and you wont get the chance. There are far too many. But the personal accounts that do get told are a reminder that each statistic has a face, and a life.
As of Monday, COVID-19 had killed at least 11,395 Texans. That included 1,361 over the previous week, a few more than eight Texans dead from the virus every hour of every day. For many of us, checking the pandemic numbers is a daily habit. There were 5,019 people in Texas hospitals Monday who had tested positive for the coronavirus, or about half the number of the July hospitalization peak. Three of four hospital beds in the state were in use, including 9.31% in use by COVID-19 patients. The seven-day average number of new cases per day was 2,754 at the start of the week. That, too, has dropped dramatically from a July peak, but remains higher than the daily increases before mid-June. Overall, the state has 580,384 confirmed cases.
That data is useful to medical professionals and public health policymakers looking for a macro view of the pandemics effect on Texas. Its useful to voters trying to decide whether to keep or replace the elected officials theyve got.
Some numbers are big enough pandemic, recession, schools that almost every Texan has been affected or knows someone whos been affected.
Its easy to lose the meaning of $250 million in government spending that buys 716,000 laptop computers and tablets, and 295,000 internet hot spots for public school students in Texas.
Those resources serve hundreds of thousands of students who wouldnt be getting any lessons right now unless their classrooms were open and available during the pandemic that many students who wouldnt have a choice between attending school in person and getting the same lessons at home.
Its hard to get the scale of that many computers and students in your head. You can try: If you sat kids in front of each of those new computers, giving each just 2 feet of space, the line would stretch 271 miles, enough to reach from Fort Worth to San Antonio.
The decisions about whether to keep schools open affect about 5.5 million kids, or roughly 1 in every 6 Texans. Thats before you count the parents and families and employers and educators and everyone else whos got a direct daily stake in public education.
Those big numbers are still hard to imagine. But there are enough people involved, in that case, that you almost certainly know someone whos affected. Its family and friends, not statistics.
Remember, as you watch the political parade whether your party is up this week or was up last week that the big picture too often obscures whats going on in the lives of real people.
When the speakers at political conventions talk about federal unemployment insurance supplements ending for 347,700 Texans, thats 347,700 households in financial peril, people literally trying to figure out how to keep the lights on, the rent paid, food on the table and clothes on the kids. If they have time, they can worry about laptops and tablets and internet access to school.
The numbers are numbing abstractions. We get used to them and watch how they change. We look at the charts and the maps. We read stories about public and private efforts to help, to spend money, to make the good numbers rise and the bad numbers fall.
Thats important: Each of those numbers is a real person.
The Indian monsoon season is in full swing, drenching the streets of Mumbai and flooding the plains of Bihar. But dark clouds of another kinddisease, hunger and deathare also gathering fast.
India is now ahead of all other countries in terms of the number of new recorded COVID-19 cases per dayclose to 70,000 in mid-August. Thats about one fourth of world-wide new cases. Only two countries are anywhere close: Brazil and the United States; and India has lagged behind those two countries in achieving a reduction in daily cases.
Further, recorded cases in India are likely to be a small fraction of all COVID-19 infections. That could be true in many countries, but the ratio of infections to recorded cases seems particularly large in Indiaat least 20:1, judging from two recent serological surveys, in Delhi and Mumbai respectively. This would mean that India already had more than 50 million COVID-19 infections, compared with a recorded figure of 2.5 million.
The silver lining is that, for reasons that are as yet unclear, COVID-19 mortality in India seems relatively low. The same surveys suggest that the infection-fatality rate (IFR) may be as low as one per thousand. If so, India may not be heading towards a major mortality crisis, or rather a major crisis of COVID-19 mortality, at least relative to normal levels of mortality. COVID-19 deaths so far add up to less than 1 percent of annual deaths from all causes in India. Per million population, there have been just 38 so far, compared with more than 500 in the US.
Overall mortality may spike, however, for two reasons. First, routine health services have been massively displaced by COVID-19. So far, COVID-19 infections were heavily concentrated in large cities located in Indias more prosperous states: Delhi, Mumbai, Chennai, among others. The preparedness of the health system is much higher there than elsewhere. But recorded cases are now rising fast in Indias poorer states, where health services are very fragile. As the COVID-19 crisis absorbs their meager resources, many public health centers have stopped providing routine services. Even child immunization has been discontinued for months in many states.
Consider the state of Bihar. If Bihar were a separate country, it would be one of the very poorest countries in the world, with a population of more than 100 million. About half of all children in Bihar are stunted. COVID-19 was late to reach Bihar, but recorded cases have recently crossed 100,000 and are now rising at 3 to 4 percent per day. The state has fewer than 40 doctors per 100,000 population, compared with 90 in India and more than 250 in the US. Firsthand accounts of life in Bihars public hospitals paint a grim picture of missing doctors, unattended patients, broken equipment and stray dogs. Where are people with routine health problems supposed to go?
The other reason for a possible mortality spike is that Indias prolonged national lockdown (from late March until unlock phases began in June) has destroyed millions of peoples livelihoods. Local lockdowns continue in many states and are likely to persist off and on for months. Unlike affluent countries, India has very little to show by way of a social security system, except for food subsidies and some relief work under the National Rural Employment Guarantee Act. The employment crisis has already hit poor households really hard: recent surveys by Dalberg, Azim Premji University, the Center for the Study of Developing Societies (CSDS) and others reveal extreme food insecurity during and after the lockdown. Just to cite one, 78 percent of the 25,000 respondents in the nationwide CSDS survey said that they had found it quite difficult or very difficult to feed their families during the lockdown. Acute food insecurity is very likely to translate into higher mortality. For children, it also means lasting damage from malnutrition.
To invoke Bihar again, more than half of the workforce there consists of casual laborers who live on the margin of subsistence at the best of times. A recent survey of some 20,000 returning migrant workers found that 60 percent were unable to ensure two square meals for all members of the family. With the local economy in the doldrums, except for farming, casual workers are heading for a prolonged period of underemployment and hunger. For good measure, Bihar is affected by devastating floods, as often happens at this time of the year. Yet the state government seems more preoccupied with the coming assembly elections than with these multiple crises.
The situation is not much better in other poverty-stricken states of India such as Jharkhand, Uttar Pradesh and West Bengal. With tax revenue a fraction of normal levels, state governments are finding it difficult to provide more than symbolic relief. Alas, the central government is doing little to help them. It did launch some limited relief measures during the national lockdown, such as free food-grain rations of five kilograms per person per month for two thirds of Indias population. But now it seems to have lost interest and left it to the state governments to handle the crisis.
In this as in other domains, the Indian government seems more focused on public relations than enlightened action. For a long time, it forcefully denied any community transmission of COVID-19, even as recorded cases were counted in millions. When an early analysis of official data exposed the disruption of routine health services, the central government retracted the data. Doctors and nurses critical of the governments crisis response have been muzzled or harassed, as have many journalists. Muddled statistics are routinely invoked to reassure the public that all is well: the Ministry of Health recently boasted, for instance, that COVID-19 recoveries had crossed the historic peak of 1.5 milliona meaningless achievement since COVID-19 has a recovery rate of more than 99 percent in India.
In its hurry to turn India into a viswaguru (world leader), the Modi government seems to have little patience for a humanitarian crisis. Yet denying a crisis is the surest way to make it worse.
