Taylor Haberkern

Taylor Haberkern is majoring in journalism and psychology at Stony Brook University. She plans to graduate in December 2021.

Transforming Spare Parts into a Ventilator

The pandemic hit New York like a tidal wave in March 2020, as the number of coronavirus cases in the United States rose from an estimated 300 to more than 200,000 — and the death toll skyrocketed from one to 3,000. Stony Brook University locked down with virtually all classes going online, and Stony Brook University Hospital quickly found itself facing a dangerous prediction — there would be a shortage of at least 1,000 ventilators if the virus kept spreading at its then-current rate. This could mean hundreds, if not thousands, of preventable deaths. 

Something had to be done. 

Under the guidance of New York State Assemblyman Steve Englebright (D-Setauket), an interdisciplinary team was established to take on the task of creating an easily produced ventilator that could supplement the hospital’s reserves. Ventilators – commonly known as breathing machines or respirators – enable patients to breathe if they are unable to do so on their own. A typical hospital-grade ventilator can cost between $25,000 and $50,000 — and estimates showed that Stony Brook University Hospital might need an additional 25,000 machines. 

This project would come to be named CoreVent 2020.

The team leader was Jon Longtin, then associate dean of research and entrepreneurship in Stony Brook’s College of Engineering and Applied Sciences as well as a professor of mechanical engineering. Now interim dean, Longtin had experience in other high-profile collaborative COVID-related projects such as the design of the Clear-Vu Medical Face Shield, thousands of which are now in use at the university’s hospital as well as other area hospitals.

John Britelli – a clinical professor in the respiratory care program in the School of Health Technology and Management – was brought in by Englebright. With more than 30 years of experience, he has a host of certifications, including as a registered pulmonary function technologist and a specialist in neonatal and pediatric respiratory care.

Dimitris Assanis, an assistant professor of mechanical engineering, had just started at Stony Brook two months before. His research focuses on vehicles – specifically their engines and how to make them more environmentally friendly. He came to Stony Brook in 2020 after completing all his degrees in mechanical engineering – bachelor’s, master’s and doctorate – at the University of Michigan and spending 12 years working for his mother’s Ann Arbor-based information technology consulting company.

Together, these three formed the core of the CoreVent team, which also included Dr. Brian Margolis, a pulmonary disease specialist at St. Catherine of Siena Medical Center in Smithtown; Dr. Gerald Smaldone, chief of pulmonary medicine at Stony Brook’s Renaissance School of Medicine and Dr. Christopher Page, chief of the acute pain division of the medical school’s Department of Anesthesiology.

“It was quite a project, we worked 10 days straight, day and night,” Britelli says. Ten days was all it took for them to create a device that ended up never being needed – but that remains a one-of-a-kind model of teamwork.

The team created the fully functioning ventilator in 10 days.

It all started with a late-night phone call between Britelli and Longtin on March 27, 2020.  The next day – a Saturday – they were face to face in Britelli’s office at Stony Brook. “We talked for five, maybe six minutes,” Britelli recalls, “and then we went into my laboratory. And we just started writing on the board, figuring things out. All of a sudden two hours went by – I had no concept of time – and we had a ventilator that was easy to build and easy to reproduce.”

The team quickly took advantage of Assanis’s engineering skills to help create the first prototype. That first night they worked in Longtin’s Port Jefferson garage. Then the project moved to Britelli’s respiratory therapy teaching lab in the Renaissance School, where they tested it and developed a second prototype. As they worked, the team took “an abundance of care” with safety procedures, Assanis explains, spending what felt like “16 to 20 hours a day” just a few floors below the hospital emergency department.

“We would get daily reports of how many people were on vents,” Assanis recalls. “You’re on day four, five, six and you’re trying to perfect a design and you realize that perfection is the enemy of good. The longer it takes to perfect it, it’s safe and reliable – but upstairs there are people dying from COVID. You ask yourself, ‘Can I get this done 10 hours sooner?’ because it needs to go on a patient and save someone.” 

The ventilator was designed to be easily replicated for mass manufacturing, being created from what Assanis described as “spare parts.” Britell noted that a spigot from a garden hose was used to control oxygen flow at one point. “We had to use parts that were available in Home Depot, Lowe’s, mail-order, eBay,” he says. “The parts couldn’t be specialized.” And all the parts were available from multiple vendors to eliminate delivery delays in case replacements were needed.

On April 6, the project was finished. And the team unveiled what was officially announced as a “computer-controlled, pressure-cycled, time-limited ventilator” – complete with “assisted-breathing mode, visual status indicators and low- and high-pressure alarms.”

The computer-controlled ventilator was made of spare parts.

Fully functioning as an emergency ventilator, it was tested on an advanced lung simulator provided by Smaldone, the medical school’s chief pulmonologist, as well as lab mice. It was ready to be used on human COVID patients.

As it turned out, the hospital managed to get through the peak of coronavirus cases without running out of ventilators, thanks to donated machines and other financial contributions. As Britelli put it, they “just squeezed it.” 

Today, the CoreVent 2020 remains in storage, never used – and likely to never be mass-produced while professional ventilators are available. The trio of scientists are working on a new project to design a self-powered mask that filters air to the wearer. The goal is a mask that leaves the wearer’s face completely visible and doesn’t need to be connected to an external power source. 

“The problem is, it’s very scary for the patient,” Britelli says of face masks. The design he and his team are working on has benefits for medical workers and patients. “It’s comfortable,” he explains. “You can see the whole health care worker, you can see their eyes, their mouth, their facial expressions. One of the big complaints that we got from the patients was that they felt so isolated because they weren’t seeing their loved ones, because they weren’t allowed to. And the people they were seeing were all gowned and gloved — they were hidden. They weren’t seeing their faces. And people have a need to see faces.” 

Other projects the team has worked on or plan to work on include ventilators that don’t require respiratory therapy training to use and infant incubators for emergency use.

“You make these great things and nothing happens to them,” Britelli says. “You just have to accept that. But with the CoreVent we were tickled pink that it wasn’t used. … It was scary knowing that human beings could go on this and that their breath would depend on this ventilator. So, it’s not a feeling of discouragement, it’s not a feeling of emptiness – it’s a feeling of relief. It’s a good feeling. We were looking for the vent to collect dust and never get used.” 

Additional photos provided by Jon Longtin

A Warrior Against Infectious Diseases

In her 31 years at Stony Brook University Hospital, Dr. Sharon Nachman, has been the principal investigator of more than 30 clinical trials – at least a third of them international research studies – seeking out new vaccines as well as treatments for Lyme disease and AIDS. So it’s not surprising that she’s the hospital’s director of the Office of Clinical Trials.

But even with all her experience, she said she’s never been as busy as during the COVID-19 pandemic, especially since Stony Brook has a part in the future of a vaccine that might help to control it. 

Nachman is a member of the Maternal Child HIV Network – she’s a pediatrician with an international reputation in infectious diseases in children – and her voice was firm as she explained how research networks once focused on HIV and AIDS trials have joined forces to look at COVID-19. The result was a new consortium of researchers called the COVID-19 Prevention Network, which formed under the auspices of the infectious diseases arm of the National Institutes of Health in mid-2020 to address the need for vaccines and monoclonal antibodies. Monoclonal antibodies are laboratory-made proteins capable of fighting off harmful pathogens like COVID-19 and offer a possible treatment for those infected with the virus.

“I was involved in listening and hearing all the discussions of the CoVPN,” she explained, using the acronym for the network. “And I submitted an application for our site to be one of the sites for vaccine trials. As those were rolling along, we were picked for the Novavax study.”

The Maryland-based biotechnology company, Novavax, is one of several firms working to develop vaccines to counter COVID-19 as the pandemic enters its second year. Unlike Moderna and Pfizer-BioNTech, Novavax has never brought a vaccine to market despite focusing on experimental vaccine development since its founding in 1987. 

But the Coalition for Epidemic Preparedness Innovations – a global foundation based in Norway that is dedicated to the development of new vaccines – saw something in the company and invested $388 million in its vaccine. With new vigor, Novavax pushed to get the attention of the United States, finding success in the form of $1.6 billion from Operation Warp Speed, a Trump-era partnership between the Departments of Defense and Health and Human Services to fast track vaccine development. 

Nachman wasn’t the only Stony Brook applicant to vie for a spot in the trial. Dr. Benjamin Luft, director and principal investigator for the Stony Brook World Trade Center Wellness program, also raised his hand. “He had a unique population that had co-morbidities and I was looking at the population of Suffolk County,” she explained. “So the CoVPN decided to merge our two applications into one application under Dr. Luft’s leadership so that we could do the Novavax clinical trial.” 

The trial enrolled about 500 patients in five weeks before closing last February and contributing to the pool of 31,000 participants from across the country. 

“No steps were jumped or skipped or stepped over or missed,” Nachman said. “But because of the pandemic, many people came forward to enroll in the study rather quickly. And that’s what allowed the study to complete enrollment and move on to the next step.” 

Since then, Nachman has been trying, in her own words, to “juggle” the non-Novavax and non-COVID studies that are pending. One, a Lyme disease vaccine for children, was slated to take place during the summer and fall while others have been put on hold. This isn’t because of a lack of funding but rather because the side effects of these vaccines resemble the symptoms of COVID-19. “The study looking at the RSV, the Respiratory Syncytial Virus, vaccine – the side effects of that vaccine are fever and runny nose. The last thing we need during COVID is to give you a vaccine that gives you fever and a runny nose.”

And of course, there are trials that for one reason or other, didn’t get off the ground. A trial earlier in the pandemic attempted to spearhead a treatment involving estrogen patches that might reduce the severity of COVID-19 symptoms. Nachman was to be the principal investigator but the project failed to enroll enough participants. 

“I think patients that came into the hospital were sick and did not want to hear about a study. There was a lot of concern in patients that we were giving them estrogen, particularly on the male side.” The reaction, she said, was, “‘I didn’t want to grow breasts’ – even when you explained to them that’s not going to happen.” 

As for the two-dose, protein-based Novavax vaccine, it has been shown to be 90.4 percent effective in preventing symptomatic COVD-19 based on results from its Phase 3 clinical trials. But the company has struggled to meet its production forecasts, forcing it to delay seeking the emergency use authorization from the Food and Drug Administration that would make it the fourth vaccine available in the United States.

From the beginning, there was concern that the Novavax vaccine may not be effective in an important segment of the population – children. To find out, clinical trials are looking at adolescents and teens aged 12 to 17 years old. 

Other vaccines are further along. The Pfizer vaccine has full FDA approval for anyone over 16 and emergency authorization for those between the ages of 12 and 15. Clinical trials are underway in children 5 to 11 years old. Moderna and Johnson & Johnson vaccines still only have emergency authorization for people who are at least 18 years old, but Moderna has expanded its trials in children under 12. Separate clinical trials must be conducted for children due to their disparate immune systems and responses.

Dr. Sharon Nachman. Photo provided by Stony Brook University

This is prime territory for Nachman, who is also chief of Stony Brook Medicine’s Division of Pediatric Infectious Diseases and a professor of pediatrics. She has been pushing since last year to include children in vaccine trials.

From her office on the fifth floor of the hospital, where medical textbooks and files are organized on shelves behind her, Sharon Nachman speaks her mind.  “Kids should have been studied up front when the adult vaccines were rolling out, then that would have resulted in no delay in getting kids vaccinated,” she said. “And we wouldn’t be in the position that we’re in now, where we’re not going to have an answer for kids for six to eight or maybe even longer months.”

Nachman said the practice of considering children and pregnant women as unique groups outside the mainstream has caused this situation. “As a pediatric infectious doctor, for me those are the ordinary people who need to get the vaccine,” she said. “There’s nothing special about [children] that would require you to put off studying them for months on end – and all it did was hurt the population.” 

It used to be even worse, she said, pointing out that as recently as the 1990s, licenses for vaccines and other drugs were routinely granted without certain groups, such as children, being studied at all. Nachman has been advocating for decades that children and pregnant women should be included in clinical trials such as the ongoing Novavax study. “Pediatric infectious disease requires you to be passionate about what you’re doing.” she said.

“Kids should have been studied up front when the adult vaccines were rolling out, then that would have resulted in no delay in getting kids vaccinated. And we wouldn’t be in the position that we’re in now, where we’re not going to have an answer for kids for six to eight or maybe even longer months.”

– Dr. Sharon Nachman

Studying these groups and getting vaccines to them are important because the coronavirus is mutating. Variants continue to show up around the world even as the highly transmissible Delta variant has become the dominant strain in the United States and other countries.  “By not getting vaccinated,” Nachman said, “you encourage more variants to go around the community.” 

These variants are uppermost in Dr. Kenneth Kaushansky’s thoughts. He stepped down as dean of the Renaissance School of Medicine in January but stayed on until the end of the academic year as senior vice president of Health Sciences, overseeing the hospital, the faculty practice and the health science schools. He had originally planned to step down last year after a decade on the job, but stayed on in light of the pandemic. “As ten years began to approach, here comes COVID,” he said of the convergence of his anniversary in the job and the pandemic. “It wouldn’t have looked good for me to say, ‘Hey here comes COVID, I’m out of here!’” 

He was recently elected to the board of directors of the New York Genome Center, which will allow him to explore some of the big questions about COVID-19 that revolve around the variants. 

“Number one – Are they more contagious? Number two – Are they more pathogenic, do they cause more severe disease all other things being equal? And number three, are they going to turn resistant to the vaccine, perhaps the most important question of all.”

He likened the process of developing vaccines against these variants as being akin to neighborhoods. “So if you look at a map of the spike protein, there are actually four different regions that almost everybody develops antibodies to … like four different zip codes.” The spike protein is what allows the virus to gain access to the cells of the respiratory tract. 

He explained that someone with antibodies to at least one of these neighborhoods would have a method of neutralizing the virus. “The virus needs to really come up with four different mutations to become immune to all these different antibodies. And that’s a tough nut to crack for a virus. … No one has seen a variant with these four mutations.” 

Nachman and Kaushansky agreed that the most important thing, besides the standard advice of wearing masks, is for people to get vaccinated. Now. 

To the people out there who are hesitant to get vaccinated, Kaushansky offers this: “We haven’t seen people’s arms falling off. … When there is one of these extremely rare side effects, it almost always, if not always, appears within six weeks of the vaccination. We’re now at a point where 30 million people are six weeks out from their vaccination and nobody’s getting these massive long-term complications.”

As a front-line warrior against infectious diseases, Nachman described the COVID-19 pandemic as being very different from previous outbreaks she’s experienced. In 2009, the swine flu pandemic saw more than 700 million cases of the H1N1 influenza virus worldwide with an estimated death toll of 284,000, according to the Centers for Disease Control and Prevention. “There were a lot of sick patients, both adult and pediatric,” she said. “But they weren’t the same degree of sick as COVID patients.” 

With more than 200 million people infected and a global death toll that has surpassed four million, COVID-19 already has a place in the history books.