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COVID-19 cases in US federal and state prisons were 5.5 times higherand death rates three times higherthan in the general population from Mar 31 to Jun 6, according to a research letter published yesterday in JAMA.
Researchers from Johns Hopkins University and the University of California Los Angeles' COVID-19 Behind Bars Data Project examined prison data from all states, the District of Columbia, and the Federal Bureau of Prisons from publicly available data sources such as medical examiner reports, corrections department websites, media reports, and news releases.
A total of 42,107 of 1,295,285 prisoners had been infected with the novel coronavirus, for a case rate of 3.25%, versus 0.59% in the general US population. In the US population, there had been 1,920,904 coronavirus cases and 95,608 deaths.
Of prisoners infected, 510 died, for a death rate of 0.039%, versus 0.029% outside of prisons. But the proportion of prisoners aged 65 and older in the prison population was smaller than that of the general population (3% vs 16%, respectively). That age-group accounted for 81% of US coronavirus deaths.
After adjusting for age and sex differences between the two populations, the death rate was three times higher for inmates than for non-inmates.
The COVID-19 case rate in prisons had been lower than that of the general population until mid-April. Mean daily case rate was 8.3% in prisons and 3.4% per day in the rest of the United States. Some prisons had outbreaks involving 65% of inmates.
The authors noted that the true prevalence of coronavirus in prisons is likely higher than that measured in the study because some prisons aren't reporting cases, and others are not testing prisoners at all. More than 2 million people are incarcerated in US prisons.
Prisoners are particularly susceptible to highly infectious diseases such as COVID-19 because of close confinement, limited access to personal protective equipment, and high rates of underlying respiratory and heart conditions, they said.
Some prisons have tried to suppress transmission of infectious diseases through early release of inmates unlikely to reoffend, institution of strict infection-control practices, and implementation of widespread testing.
"Although some facilities did engage in efforts to control outbreaks, the findings suggest that overall, COVID-19 in US prisons is unlikely to be contained without implementation of more effective infection control," the authors wrote.
In a Johns Hopkins press release, lead author Brendan Saloner, PhD, said that although prisoners have a right to protection of their health, "the reality of these findings shows that we aren't coming anywhere close to meeting their basic needs. Ultimately, it creates a dangerous situation for the inmates, prison staff, the communities that prisons are located in, and in our overall effort to contain the crisis."
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Instruction
Russia moves further along in human trials of a coronavirus vaccine. The country was one of the ... [+] worst-hit by Covid-19.
After Brazil was the first emerging market to get a test drive of the Oxford University coronavirus vaccine, its Russia that is the first to complete human trials.
Elena Smolyarchuk, chief researcher for the Russian Center for Clinical Research on Medications at Sechenov University, told TASS newswire on Sunday that human trials for the vaccine had been completed and those test patients will be discharged soon.
"The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on July 15 and July 20," Smolyarchuk was quoted as saying in the report.
There was no other information on when this vaccine would enter commercial production.
Russia had allowed clinical trials of two forms of a potential coronavirus vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology. The first one was carried out at the Burdenko Military Hospital. The other vaccine was given to test patients at the Sechenov First Moscow State Medical University.
Some 20 people volunteered for the injection.
After being given the shot, the volunteers were asked to quarantine in the hospital for 28 days.
Earlier, results of the Covid-19 vaccine tests performed on a group of volunteers in Russia showed that they were developing immunity to the coronavirus, but what the drug actually is was not discussed in the article.
Russia has reported 719,449 cases of the new SARS coronavirus. Some 11,188 people have died from complications caused by Covid-19, the disease caused by the new SARS.
There are at least 21 vaccines currently under trial worldwide, according to the World Health Organisation. Every country and every lab is taking a different approach to finding the right solution to stop the virus from taking over the world at this point.
Meanwhile, in Moscow this weekend, public health officials lifted the requirements of wearing face masks while outside. Masks and gloves are mandatory when riding public transportation, going to a medical center, or while shopping.
Nancy Alvarado worries about the deep toll COVID-19 is taking across the globe, and within her Atwater Village community.
"It's wreaking so much havoc here," she said. "I'm not a very good cook, so we eat out a lot. Just knowing all these little restaurants that we love so much and how much they're suffering."
But most of all, she worries about her parents.
Local news from across Southern California
"My parents are in their mid-60s," she said. "My mom has sensitive lungs. She gets asthma and is so prone to bronchitis."
More than half a million people around the world have died from COVID-19 since January. A vaccine is essential, but developing vaccines usually takes years. Wanting to be helpful in anyway she could, Alvarez volunteered for a clinical trial that speeds up the process by giving volunteers a vaccine. But these "human challenge trials" also give participants the virus.
Josh Morrison, the executive director of a website that advocates on behalf of trial volunteers called "1 Day Sooner," describes these challenge studies as ways to learn about a disease by deliberately exposing people to infection.
In traditional trials, people get a vaccine and go back to their communities, where they may or may not be exposed. Challenge trials accelerate the process by making it certain that the vaccine will face off with the virus.
"In a traditional trial to test the effectiveness of a vaccine, you might test 10,000 or even more people," Morrison said. "For example, the Malaria vaccine that is being developed tested 15,000 over five years. Challenge studies test normally about 100 people and might take a couple of months."
Since launching "1 Day Sooner," Morrison's seen more than 31,000 volunteers from around the world sign up. This includes over 1,600 from California.
"That has been absolutely inspiring," he said.
While human challenge studies have been done before for diseases like Malaria and Influenza, scientists say COVID is more complicated. As bioethicist Dr. Ruth Macklin recently said, "... a rush to begin human challenge studies for grave disease lacking an effective treatment is ethically unjustifiable."
But with more than 50,000 new cases each day in the U.S., Dr. Stanley Korenman, associate dean of ethics at UCLA School of Medicine, disagrees.
"We can't afford to wait till we have something curative, that is why we are so determined to get a vaccine," he said. "Because the expectation is there won't be anything curative for a few years."
The World Health Organization requires participants to be fully informed of risks, but critics say that can't happen because so little is known about this new virus.
"You can understand the risks without understanding the disease at all, because the risks have been explained to us by what has happened to patients," Korenman said.
The idea of a few good people potentially having to sacrifice for the greater good is one ethical challenge. In a letter of support to the Food and Drug Administration, 35 members of Congress make the comparison to war.
"There is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others."
Human challenge trials require approval from the FDA. In a statement to NBCLA, the FDA says these trials are currently under consideration.
As for Alvarez, she remains committed to the trial, even though her husband has some concerns.
"To be honest he hopes I change my mind," she said.
But like many volunteers, Alvarez wants to be part of the solution. Advocates argue the time for a challenge trial is now because, until a reliable vaccine is developed, people will continue to suffer and die.
Many hope that at least one of the Covid-19 vaccine trials underway will prove successful by late fall, blazing a path to developing a vaccine by winter and containment of the virus by next summer. The goal is to conduct mass immunizations of the population, getting enough people protected to prevent community spread of the infection.
While its possible that those most at riskhealth-care workers, first responders, and nursing-home residentsmay receive the vaccine in time to reduce hospitalizations, protect hospitals from being overwhelmed, and avert many deaths by early next year, its probably overly optimistic to expect mass immunization in that time frame. While multiple Covid-prevention vaccine trials are planned or already underway, only one of the Covid-targeted vaccines, the so-called Oxford vaccine, has started its final human trial phase (with its first enrollment on May 28).
Two of the trials primary goals are protection from infection for six months and no observed serious side effects. The Oxford vaccine investigators estimate that 10,000 participants would be needed to demonstrate that the vaccine works. With the declining amount of virus in the U.K., where the trial was being conducted, they needed to add study sites in Brazil and South Africa, where the disease is more common. Recruitment started in these countries at the end of June.
Even with quick enrollment, its easy to see that the evidence required by the Food and Drug Administration for vaccine approval may not be ready until January 2021. A National Institutes of Health trial of the Oxford vaccine, with 30,000 participants, will start in the U.S. in August but will probably not show results until early spring. Other vaccines, including the Moderna RNA vaccine, will not begin recruitment for its final human-trial phase until late July, again pushing possible approval into next year.
Even after a vaccine has been approved, producing it in mass quantities takes time. One potential strategy for speeding up availability is to start production before FDA approval, though private industry is hesitant to take that risk. To this end, the U.S. government, as part of its Operation Warp Speed initiative, along with other national and international nongovernmental organizations, is paying for preapproval mass production of the most promising vaccines, including the Oxford vaccine. The hope is that enough vaccine will be available for mass immunization when approval is granted, but supply-chain problems could arise that would delay that goal.
Even with a ready supply of an approved and effective vaccine, mass vaccination cant happen without broad popular acceptance. Based on the nations experience with annual influenza immunization, this will be a challenge. For the 20182019 flu season, vaccination coverage among adults was only 45.3 percent. Considering that only six months of data would exist, at best, for any Covid vaccine by January 2021, its likely that uptake will be lower than the influenza number because people will be more cautious about trying the new vaccine. A low uptake, combined with the FDAs statement that the vaccine needs to protect only 50 percent of those immunized, suggests that only 25 percent of the population may be protecteda level inadequate to stop community spread of Covid. Moreover, this calculation assumes that efforts to immunize people en masse will roll out quickly and efficiently.
Its reasonable to conclude that we may see continued outbreaks for more than one to two years, despite feverish efforts to develop a vaccine. As such, the U.S. needs to come to terms with a stubborn reality regarding Covid-19: namely, that the virus may persist into the foreseeable future. Given the consequences of many of the mitigation efforts on mental health, unemployment, education, and the economy, America needs to reckon honestly, and apolitically, with what science tells us about the viruswho is getting infected and what we can do to prevent infection, absent a vaccine. We shouldnt use the hope of a vaccine to delay this discussion. The vaccine will come when it comes.
Jonathan Ellen, M.D., is a pediatrician, an epidemiologist, public-health academician, and the former CEO of Johns Hopkins All Childrens Hospital.
Photo:Meyer-&-Meyer/iStock
(CNN) With airlines introducing new measures like face masks and intensive sanitization routines to reassure passengers, people have been cautiously returning to air travel even while the coronavirus pandemic continues to spread around the world.
But for some, the notion of climbing aboard an airplane now or in the near future, remains unthinkable. Nothing that airlines, government officials or fellow travelers can say will convince them to step on board.
CNN spoke to some of these self-grounded travelers to find out their biggest concerns about air travel at the moment and what it would take to get them back above 30,000 feet.
For Chris Trinh, a 41-year-old father of four based in Minnesota, the decision to stay off airplanes is partly because of his kids -- his youngest child is only 10 months old and he says he'd be worried about her crawling on the aisle.
It's also, he says, because he feels that no matter how careful he is, he can't guarantee others will be similarly conscientious.
"It's hard to trust other people," he tells CNN.
Trinh's wife is Japanese, and the family usually spend extended vacations in Japan over the summer months. This is the first year they'll be staying in the United States.
"The risk is just too high, and we just don't want to travel," he explains.
Trinh and his family aren't alone. Retired CVS Health engineering manager Vincent Marseglia, 70, is also avoiding flying.
"You're going to be near people, even if they leave the middle seats open," Marseglia tells CNN, speaking from his home in Rhode Island.
Chris Trinh is worried about traveling with his young children.
Courtesy Chris Trinh
"There's no way I'm going to get on a plane. Even before that, you have the crowds at the airports going through security, so you're just exposing yourself."
Wisconsin-based Dean Calin, 60, who's worked in the commercial aircraft industry for more than three decades, has similar trepidations.
Calin says his extensive aviation knowledge makes him more, rather than less, cautious about flying in the age of coronavirus.
"Even though airlines are taking steps to clean the interiors and the air is filtered thoroughly as a process of the air conditioning system, all of that can't counteract the potential contamination that passengers will bring every time the plane is loaded," Calin tells CNN.
"I just don't think that, without a vaccine, there's any safe way to travel yet."
Rethinking plans
Vincent Marseglia and his wife on a train traveling through France in 2016. Right now, they're remaining at home in Rhode Island.
Courtesy Vincent Marseglia
Ruling out air travel means rethinking vacation plans.
Marseglia says that, because of his age, he's being careful in all aspects of his life. He's socially distancing during meetups with his grandkids and wouldn't go on a train either -- nor would he share a car without anyone other than his wife.
Marseglia lives by the ocean in Rhode Island, and he's swapping out dreams of vacations in Italy for local, socially distanced outings in coastal Jamestown.
He's cautious about traveling to other states, given that different regions in the United States have adopted different strategies for quarantining and handling the virus.
But while pouring over photographs of previous adventures in Europe is currently bittersweet, Marseglia's conscious that he's in a privileged position, and so many have been more adversely impacted by Covid-19.
"Even when a vaccine comes available, I'm not going to be the first one to run out and get it," says Marseglia, who points out he's lucky to be able to stay at home and not worry about returning to a workplace.
"I'm willing to wait as long as it takes to get the vaccine, so if it's next year or the year after, I won't make any plans to do any kind of extensive travel until I know that's out there, and it's available and it's effective and I can get it."
Marseglia and his wife in Florence, Italy.
Courtesy Vincent Marseglia
Dean Calin tells CNN he's been self-isolating for over 100 days now, due to concerns about the impact of the virus on his asthma.
As well as working in the aerospace industry, Calin is also a singer in a group. At the beginning of 2020, he was looking forward to aviation-focused business travel trips alongside music gigs across the world. That's all on hold for now.
"It's a sacrifice that we have to make, if we intend to go on living" is Calin's perspective. "It's challenging and it's a different way to live your life, but the alternative is to ignore it is to court death."
Like Marseglia, Calin says would only return to the skies if he'd been vaccinated and he knew the rest of the population had also had time to get the vaccine.
Right now, he calls those who're traveling again "either very brave or very foolish."
"I just don't think that without a vaccine. There's any safe way to travel yet," he says.
How safe is it to travel?
Dr. William Schaffner, an infectious disease expert at Vanderbilt University, tells CNN he does not currently advocate traveling by airplane, particularly in the United States.
"We have been recommending to our patients only really essential travel at present, because in this country, the virus is not under control. It's all over the country and continuing to spread in an inhibited fashion," Schaffner tells CNN.
Schaffner's perspective is people should only travel for personal reasons, in unavoidable circumstances.
"Even then, we ask them to do that very, very cautiously, wearing their masks at all time, keeping social distance," he adds.
Schaffner is principally concerned about the potential for the virus to spread in crowded airports, where it's difficult to maintain social distancing. He also expresses worries about travelers being tightly packed in the cabin.
While some are being cautious, others are returning to air travel.
CNN
"All the hullabaloo having to do with travel often brings you in very close proximity with others in enclosed spaces," he says.
Schaffner is also worried about the impact of traveling back and forth from a spot where there might be a particularly high number of cases.
The infectious disease expert has a vacation home in Florida, where he and his wife usually spend the summer months. They won't be going there this year, he explains. The couple are in the at-risk category due to their ages, which adds to their hesitance, but they're also concerned about the high infection rate in Florida.
"Once we get a vaccine or vaccines, and they can be shown to be reasonably effective and safe and they start to be distributed, then -- if we were vaccinated -- then we can travel," says Schaffner.
Dean Calin, former frequent flier
"And we would be even more comforted if we realize that the large majority of the population out there also received the vaccine," he adds. "I think that will reduce the transmission of this Covid virus, so that then things truly can start to return to normal."
That said, Schaffner's conscious this could be some time off.
"I think this period of caution will be quite extensive, over a period of months, extensive months," says Schaffner.
In the US, Operation Warp Speed is a vaccine program that aims to deliver a Covid-19 vaccine by 2021.
Temporary reality
Trinh is remaining optimistic that his family will one day be able to travel comfortably again.
Courtesy Chris Trinh
Trinh is willing to play the long game when it comes to returning to global travel.
On the day that they would've flown out to Japan, Trinh's wife and kids were upset about the plans that weren't to be. They weren't just sad about the canceled vacation; they don't know when they'll next see their extended family.
But Trinh says he's cautiously optimistic about the future.
"I feel it's just a temporary thing, right? I mean, if it lasts a year, maybe two years, that's just what we have to do," he says. "For me, it's unfortunate that it's happening, but at the same time it's hopefully a once in a lifetime kind of thing."
Trinh is also diplomatic when it comes to reports of other travelers returning to the skies in packed planes.
"I see it as each person's choice," he says. "I mean, as long as everybody accepts the risks that they're taking, I think it's okay."
He's confident there will be a solution, eventually, and his family will board an airplane once again.
"Hopefully it gets better at that point, that we're back to traveling on a yearly basis," he says.
An Athens research facility has been chosen as one of 150 sites to test a potential vaccine against COVID-19, the disease caused by the novel coronavirus.
Tonya Pryor, director of research at North Alabama Research Center in Athens, said NARC and its sister site, Medical-Affiliated Research Center in Huntsville, were each chosen to conduct trials of a new drug from Pfizer that could serve as a COVID-19 vaccine.
Pryor explained that as a Phase 3 trial, this will mean North Alabamians who are chosen for the study will basically serve as medical heroes, helping researchers as they work to find a solution to a virus that has killed more than 135,000 Americans so far. It also means they'll be looking for more patients than they were in Phases 1 and 2, and it will serve as an outpatient study that focuses on "confirming and expanding the safety and effectiveness of the results shown in Phase 1 and Phase 2," Pryor said.
In Athens and Huntsville, the goal is 300 patients per facility with 50% receiving the vaccine and 50% receiving a placebo. Enrollment could begin within the next month, Pryor said.
"We only have three to four months to get those patients," she said. "We will follow those patients who make it into the study for 26 months to make sure they're doing OK. They'll have a patient diary, and they will report any signs or symptoms that they have, how they're feeling, if they have anything going on."
Patients will also receive free medical care related to the study, including COVID-19 testing, antibody testing, EKGs, blood and lab work, physical assessments and more. To participate, patients must meet certain criteria, including: no cancer in the last five years, no previous diagnosis of COVID-19, no autoimmune disorders or unmanaged pre-existing conditions and being an adult under the age of 85. Other restrictions may apply.
Those who qualify will also be financially compensated. As an outpatient study, Pryor said patients could expect to spend two hours on their first visit, then have much shorter visits with staff as the study continues.
The facilities are hiring additional staff to ensure patients can receive support 24/7 during the trial, and they will be working with area physicians, she said.
Dr. David Pryor, soon-to-be-former Athens-Limestone Hospital president, will be overseeing the study at the Athens and Huntsville locations. Tonya Pryor said it wasn't a requirement, but "it's a huge benefit to have him on board."
Other studies by NARC and MARC include medications for irritable bowel syndrome, chronic obstructive pulmonary disease, diabetes, urinary tract infections, acid reflux and cholesterol. Pryor encouraged anyone interested in participating to contact NARC after the enrollment period begins and/or consult with their primary care physician.
Monday's numbers
Alabama, like many states across the nation, continues to see a rise in confirmed cases of the novel coronavirus. Limestone County reported its first death from the virus one week ago, with two more confirmed deaths and a probable death from the disease reported in the days after.
The Alabama Department of Public Health reports 1,096 Alabamians have died total since they first began reporting numbers in March. Since then, more than 7,100 Alabamians have been hospitalized and 54,768 cases have been confirmed.
In Limestone County, there have been at least 665 cases so far, with 25% of those cases added in the last week.
However, health experts have said it is not so much the number of cases but the rate at which tests return positive that leaves them concerned, and at the local level, 12.8% of tests have come back positive in the last two weeks. By comparison, The News Courier reported positive test rates in the county of 11.5% in the two weeks leading up to June 27 and 11.9% in the two weeks leading up to July 8, according to data from ADPH.
That data also shows an increase statewide, up from 10.6% for the two weeks prior to July 8 to 12.1% for the two weeks prior to July 13. ADPH reported a single-week high of 14.6% for the week of June 28 to July 4.
For most people, COVID-19 causes mild to moderate symptoms, such as fever and cough, though it can be passed by people with no symptoms at all and cause severe symptoms or death. To reduce the spread of the virus, individuals are encouraged to follow health guidelines, including practicing social distancing, washing their hands and wearing a face mask in public settings.
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When precious vats of COVID-19 vaccine are finally ready, jabbing the lifesaving solution into the arms of Americans will require hundreds of millions of injections.
As part of its strategy to administer the vaccine as quickly as possible, the Trump administration has agreed to invest more than half a billion in tax dollars in ApiJect Systems America, a young company. Its injector is not approved by federal health authorities and the company hasnt yet set up a factory to manufacture the devices.
The commitment to ApiJect dwarfs the other needle orders the government has placed with a major manufacturer and two other small companies.
EDITORS NOTE -- This story is part of an ongoing investigation by The Associated Press, the PBS series FRONTLINE and the Global Reporting Centre that examines the deadly consequences of the fragmented worldwide medical supply chain.
The fact of this matter is, it would be crazy for people to just rely on us. I would be the first to say it, said ApiJect CEO Jay Walker. We should be Americas backup at this point, but probably not its primary.
Trump administration officials would not say why they are investing so heavily in ApiJects technology. The company has made only about 1,000 prototypes to date, and its not clear whether those devices can deliver the vaccines that are currently in development. So far, the leading candidates are using traditional vials to hold the vaccine, and needles and syringes in their clinical trials.
RELUCTANT SUPPLIER
ApiJect founder Marc Koska never intended to vaccinate the United States. For the past five years, he's been working on his lifetime mission of creating an ultra low-cost prefilled syringe that would reduce the need to reuse needles in the developing world.
Instead, the company's biggest customer has become the U.S. government.
ApiJect received a no-bid contract earlier this year from the Defense Department under an exception for unusual and compelling urgency. Authorities said the U.S. Department of Health and Human Services, tasked with buying the necessary supplies, does not have the resources or capacity to conduct procurements necessary to respond to the COVID-19 pandemic, according to a June 5 military document.
The government promised ApiJect $138 million to produce 100 million of its devices by the end of the year, which will require the company to retrofit new manufacturing lines in existing factories. And it's offered another $456 million as part of a public-private partnership contract to bring online several new factories to make another 500 million devices to contain the pandemic spread to minimize the loss of life and impact to the United States economy, said the document.
These amounts are more than double the per-syringe cost the government is paying other companies for the work.
ApiJect first appeared on the U.S. governments radar almost two years ago when the company piqued the interest of Admiral Brett P. Giroir, HHSs assistant secretary for health, at the World Health Organizations Global Conference on Primary Health Care in Astana, Kazakhstan.
Koska said Giroir was blown away by their technology and told them that if a pandemic hit, the strategic national stockpile was going to need a very fast way to get injections filled with vaccines or therapeutics and ready to deliver.
According to Walker, the CEO, ApiJect wasnt interested in a federal contract they were aiming to change the developing world with quick, inexpensive injection devices that could save millions of lives.
But at the conference, Walker found himself at a table with Giroir at a luncheon, just two seats apart. The admiral was fascinated by the low-cost injection technology, Walker said, and when Walker showed him the prototype that he always carries in his pocket, Giroir asked how they plan to do this in the U.S.
Walker said he told the admiral that the company wasnt planning to operate in the U.S. but was struck by Giroir's enthusiasm.
He was the first person, if not the only person at the event, who understood the revolutionary nature of this platform, Walker recalled in an interview with AP. And he said, Wow this is amazing. You need to do this in the U.S.
Walker continued to resist, he said, but Giroir who is also a doctor specializing in pediatric critical care wasnt big on taking no for an answer, Walker said.
At Giroirs urging they presented the prototype injector to U.S. officials. HHS declined to make agency officials available for interviews.
It wasnt until later, when Walker was introduced by a friend to Col. Matthew Hepburn at the Defense Advanced Research Projects Agency, that a plan for ApiJect to work in the United States began to take shape, he said.
HHS Assistant Secretary for Preparedness and Response Robert Kadlec approved a $10 million contract for ApiJect for research and development in January 2020, according to a document in the federal procurement data system. The company was responsible for securing private investments to create new production lines where the devices would be made over three to five years.
When the pandemic emerged weeks later, officials sounded the alarm about a potential shortage of needles and syringes to deliver a vaccine if and when one became available.
The federal Strategic National Stockpile of medical supplies had only 15 million syringes, according to Rick Bright, who later left his position at Health and Human Services and filed a whistleblower complaint.
Bright warned White House trade adviser Peter Navarro and his HHS colleagues of a looming needle shortfall, according to a series of emails disclosed in his complaint.
We are hearing rumblings about the US inventory of needles and syringes heading to other countries, wrote Bright. There is limited inventory in the supply chain, it could take 2+ years to make enough to satisfy the U.S. vaccine needs.
Navarro said the U.S. would need 850 million needles.
We may find ourselves in a situation where we have enough vaccine but no way to deliver all of it, he said in a February memo to the White House coronavirus task force.
He recommended the task force direct HHS BARDA to initiate a program to identify all alternate vaccine delivery methods and ramp up production. BARDA is the Biomedical Advanced Research and Development Authority within HHS.
Suddenly ApiJects 5-year plan to mass produce its devices became a sprint measured in months with a new $138 million contract, announced in May, to produce 100 million devices by years end.
Jefferies Financial Group is acting as the leader of the public-private partnership with HHS and invested $10 million to help ApiJect build surge production facilities in March. The company said it would try to raise up to $1 billion more. There have been no additional announcements of funding.
Walker said due to nondisclosure agreements with both the government and investors, the company is unable to say what private funding theyve secured so far.
OPERATION WARP SPEED
On a warm mid-May day in the White House Rose Garden, President Donald Trump introduced a massive scientific, industrial and logistical endeavor dubbed Operation Warp Speed.
The idea, he said, was to be ready to distribute a COVID-19 vaccine as soon as it was developed.
We must not be caught short on our capacity to deliver emergency drugs to Americans in need, said HHS Secretary Alex Azar.
An estimated 700 million injections may be needed to inoculate the nation -- at least two shots for every person, according to the military document.
In early May, the government put in two orders, to Retractable Technologies in Little Elm, Texas, and Marathon Medical in Aurora, Colorado, totaling 320 million needles and syringes.
Later in May, the government announced plans for ApiJect to manufacture more than 500 million all-in-one devices that would come pre-loaded with the vaccine.
On Wednesday, the largest domestic manufacturer of needles and syringes, Becton Dickinson, announced the first U.S. order of $11.7 million for 50 million needles and syringes by the end of this year. It plans to ramp up manufacturing over the next year.
And earlier this month Retractable entered into a second contract with the government, this one for $53 million meant to boost domestic manufacturing.
Together that sounds like enough injection devices.
But Retractable, which was worried enough about its financial future that earlier this year it received a $1.36 million loan from the Paycheck Protection Program, has been doing about 80% of its manufacturing in China. And Marathon is a medical supply distributor, and there is no indication on its web site that it manufactures needles and syringes at all. The company did not respond to repeated requests for comment.
Despite the race to replenish the domestic needle and syringe supply, about 400 shipping containers of syringes have left the U.S. for countries including Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global trade. Thats the same, on average, as syringe exports over the past five years.
Experts acknowledge that a mass vaccination campaign is going to be complicated.
There are a lot of moving parts to this, said Dr. Bruce Gellin, the Sabin Vaccine Institutes president of global immunization.
Darin Zehrung, who studied medical devices at PATH, a nonprofit advocating for health equity, said its wise to invest in new injection technologies. But that only works if there are plenty of basic syringes and needles stocked up.
Hedging bets is the best approach, but plan for the worst case scenario and hope for the best case scenario, said Zehrung.
AWAITING APPROVAL
ApiJect's devices are self-contained, with soft plastic blisters that are squeezed, like a nose spray or eye drop, to push the vaccine through an attached needle and into the patient.
The device includes a little computer chip like the ones in credit cards that can transmit information about the drug, dose, location and time of administration. The chip is not injected into patients.
Other injection devices Koska designed have been used in the developing world, but this ApiJect technology has not.
The company said they have started discussions with the U.S. Food and Drug Administration to review the device on a priority basis while the company moves ahead fitting factories to make their injectors. The agency wouldnt confirm this, citing its policy against discussing products involved in clinical trials.
Testing different vaccine candidates in the ApiJect devices will be critical before injecting the public.
Plastic could interact differently with the liquid than the glass vials currently used in trials, experts say. And there are strict temperature requirements. ApiJects planned process is to pour vaccine doses into the warm plastic blisters as they come off the production line, the company says. ApiJect says they can instantly cool the devices as they are made.
Walker, the ApiJect CEO, who founded the online travel agency Priceline, acknowledges that the governments decision to rely on an emergency plan of refitting established pharmaceutical manufacturing facilities is risky. But we feel good about it.
NO COMMENT
The Associated Press asked the Health and Human Services department over many weeks to explain the governments approach. The agency didnt allow an official to speak on the record for this story.
A senior administration official, speaking on condition of anonymity because the agency declined to allow him to identified by name, told AP he wasnt familiar with ApiJect or the contract. But he said the government was buying a range of devices to deliver the vaccine because they don't know what they need. And, he said, the Trump administration is looking to boost domestic manufacturing.
When AP reached out directly to Trumps vaccine czar, Moncef Slaoui, to discuss the new technology, a spokesperson said the query was inappropriate.
If this continues, we will make no one else available either, Natalie Baldassarre, a special assistant at HHS, wrote in an email.
Last week, HHS Assistant Secretary of Public Affairs Michael Caputo wrote that the agency has lost interest in assisting your story and offered no further comment.
Mendoza reported from San Francisco. Linderman reported from Baltimore. Lauran Neergaard and Stephen Braun in Washington contributed.
Contact APs Investigative Team at investigative@ap.org.
