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Vaccines

Vial and syringe with a vaccine

Clover Biopharmaceuticals, a clinical-stage firm developing a Covid-19 vaccine with potential manufacturing and distribution advantages over other vaccine technologies, has raised $230 million as it prepares to advance its lead candidate into pivotal testing.

Chengdu, China-based Clover said Tuesday that it expects to start a global Phase 2/3 clinical trial for its vaccine candidate, SCB-2019, in the first half of this year. The company added that it has already started planning for the production of potentially hundreds of millions of vaccine doses.

The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, meaning they’re formed by three proteins.

Using its Trimer-Tag technology, Clover developed a trimeric spike protein that resembles the one found on the outer envelope of the novel coronavirus. The vaccine uses an adjuvant, an ingredient that boosts immune response, supplied by Dynavax Technologies.

As a protein-based vaccine similar to many of the vaccines developed for influenza, shingles, and hepatitis B, Clover said production can use manufacturing processes that are already well established. The company added that this production can be rapidly scaled up to large quantities.

Another advantage of the Clover vaccines are the temperature requirements. The company said its vaccines and adjuvant should be stable for long periods at refrigerator temperatures of 2 to 8 degrees Celsius. At room temperature, Clover has said its vaccines are stable for at least two months. Those temperature and storage requirements stand in contrast to messenger RNA vaccines, which must be distributed frozen and stored at temperatures well below what medical-grade freezers can achieve. Last week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted once vaccines reach a vaccination site.

The new financing follows publication in The Lancet earlier this month of peer-reviewed results from an early-stage test of two Clover Covid-19 vaccine candidates. The 150-patient study showed that the vaccines were well tolerated and safe. Both vaccines also induced neutralizing antibodies at levels comparable to or higher than those found in the blood of those who have recovered from Covid-19.

Clover said that its research includes vaccines that could address multiple variants of the novel coronavirus. In addition to supporting its Covid-19 vaccines, Clover said the new capital will support plans to advance multiple programs into human testing later this year. Other vaccines in the Clover pipeline include programs for rabies and influenza. The company also said it plans to expand its manufacturing and capabilities.

GL Ventures and Temasek both led the Series C financing. Oceeanpine Capital, OrbiMed, and Delos Capital also invested. Clover said it has raised more than $400 million in the past year.

Clover also has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed to finance development of the company’s Covid-19 vaccine candidate up through licensure with a total investment of $328 million. Some of that cash will fund the global Phase 2/3 study. If the Clover vaccine is shown to be safe and effective, it would be distributed through Covid-19 Vaccines Global Access, or COVAX, the World Health Organization’s initiative to ensure equitable vaccine access throughout the world.

Public domain photo by Flickr user Alachua County

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Pfizer and BioNTech are asking the FDA to approve a change that would permit storage of their Covid-19 vaccine within a temperature range found in medical-grade freezers.

To be clear, this proposed change doesn’t eliminate the need for ultra-cold temperatures as the vaccine moves throughout the supply chain—temperatures that require specialized equipment. Those storage requirements are a barrier to its distribution because not all facilities have equipment that can achieve the required temperatures. What Pfizer and BioNTech are proposing is that when the vaccine reaches its destination, such as a hospital or pharmacy, it could be stored for up to two weeks at (relatively) warmer freezer temperatures.

The FDA granted emergency use authorization to the messenger RNA vaccine, named Comirnaty, last December. According to the product’s label, the vaccine must be stored in ultra-cold temperatures between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius). At those temperatures, the vaccine can last up to six months. Pfizer ships the vaccines in specially designed containers that can be refilled with dry ice every five days. Those containers can serve as temporary storage for up to 30 days.

The vaccine can be stored at refrigerator temperatures for up to five days. Pfizer and BioNTech are asking the FDA to approve an additional option to store the vaccine at minus 13 degrees to 5 degrees Fahrenheit (minus 25 degrees to minus 15 degrees Celsius) for two weeks. That range would put it closer to the storage requirements for the mRNA vaccine from Moderna. The temperature range Pfizer and BioNTech are proposing would be in addition to the five days at refrigerator temperatures that is currently permitted under the authorization.

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in a prepared statement.

Pfizer and BioNTech are proposing the additional temperature option based on new data about their vaccine’s stability. The data span from the earliest clinical trials up to batches currently in production.

Messenger RNA vaccines are a new technology that employ a snippet of genetic material from the novel coronavirus. This mRNA serve as a blueprint that a cell’s protein-making machinery use make the characteristic spike protein found on the surface of the novel coronavirus. That protein is what triggers an immune response and confers immunity.

Though mRNA vaccines are administered at room temperature, they must be kept at ultra-cold temperatures in the supply chain because mRNA is fragile. The extremely cold temperatures keep the components of the vaccine from breaking down. As mRNA companies study the storage data they have for vaccines, they are getting a better understanding of how long these vaccines can last at certain temperatures. Last November, Moderna released data that it said supported storage of its vaccine at refrigerator temperatures for up to 30 days.

Temperature requirements can be a barrier to the distribution of the vaccine to rural areas, which may not have facilities with appropriate freezers. In that regard, the Johnson & Johnson Covid-19 vaccine is seen as offering an advantage. In addition to requiring only a single shot (both authorized mRNA vaccines require two), the J&J vaccine can be stored at standard refrigerator temperatures. An FDA advisory committee is scheduled to hold a hearing about that vaccine on Feb. 26.

Photo by BioNTech

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If there is any lesson to be drawn from 2020, it’s that making predictions for the year ahead is an act of hubris. Despite that, some clear trends have emerged. The pandemic has permeated every aspect of our lives: health, economics, politics, and beyond. Amid the devastation, the healthcare industry has been at the forefront.

We face more questions than answers. How quickly can vaccines be efficiently distributed across the entire populace, rather than select groups? What strategies will businesses embrace to thrive (or survive) going forward? How will the new administration tackle its inherited challenges and advance its healthcare agenda?

Thus, at the risk of being either foolish or arrogant, here are five of our predictions for healthcare in 2021.

A surge in digital health

Healthcare has often lagged other industries in adopting digital tools, but the pandemic dramatically narrowed the gap. Consumers, either unable or unwilling to leave their homes, quickly transitioned to online services for essential needs. Importantly, this even included the elderly, typically on the digital sidelines, who agreed to connect with caregivers on Zoom or FaceTime. Providers rushed to deploy new remote services to attract, treat, and retain patients, particularly for behavioral health. 

Impact: The sudden shift to digital provided access to care and introduced consumers to a higher level of convenience. For many, there will be no going back. The industry will either deliver enriching online experiences for patients of all ages, or they will find their patients siphoned off by more compelling services. 

Amid progress, this shift to telehealth and electronic communications has exacerbated health inequity. Patients who lack technology or access to affordable internet may be left further behind. It’s a danger that must be addressed at every level of the healthcare industry.

A new focus on agility

Covid-19 hit most institutions like an avalanche, disrupting nearly every aspect of operations. Some services, like intensive care and diagnostic testing, were overrun. Others were shut down as elective procedures were suspended. Employees found themselves without childcare, public transit, or the ability to work from home. Some organizations pivoted, re-assigning or re-training staff, transitioning to remote operations, and deploying tools to enable operational continuity. Others began to collapse, overwhelmed by clinical challenges, administrative failures, and financial losses.

Impact: Traditionally, organizations have prepared for specific incidents – tornados, mass casualties, and the like. The pandemic highlighted the critical value of leadership, capabilities, and culture to adapt to wholesale disruptions of their workforces, supply chains, and even business models. Going forward, planning will be done more holistically, requiring budget, advanced analytics and personal expertise. Of course, this may divert resources away from other initiatives.  

The past as a predictor of the future

If there were a succinct way of describing healthcare following the 2009 financial crisis, it would be that the strong got stronger and the weak got weaker. Organizations that were better prepared heading into the crisis and better managed during it, emerged better positioned afterward. The converse was also true, with many organizations pushed to the brink of bankruptcy.

Impact: As we found a decade ago, high performers will continue to grow, expanding their market share organically and through acquisition. Weaker performers will find themselves under siege not only from stronger players, but also from new entrants – retailers, digital healthcare providers, and others – eager to extend their industry footprint.

New risks and vulnerabilities in the virtual world

Healthcare has always been an attractive target for cyber criminals. The data is valuable, and the stakes are high. Providers face stiff penalties for data breaches and cannot afford to have the safety of their operations compromised. Equally importantly, patients need confidence that their privacy and confidentiality is secure.

However, the rush to virtual environments created new vulnerabilities. Staff began using their own devices and networks, training was postponed, and IT staff were diverted to deploying telehealth, remote monitoring, and work-from-home solutions. Clinical conversations migrated to unsecured email.

Impact: Not surprisingly, healthcare saw a surge of high-profile ransomware attacks. 2021 will be a year of security catch-up as organizations patch holes, retrain, and identify new risks created by their transformed operating environments. Furthermore, the industry will begin to address the challenges that arise as virtual care increases. Organizations may dramatically increase countermeasures to protect IT systems. If they don’t, cyberattacks and data breaches will only intensify. 

The ascension and expansion of public health

What began as a public health emergency quickly morphed into a political battle and an economic crisis, creating a three-pronged disaster. Therefore, any solution that did not address the realities of the other two was destined to fail. 

Impact: The pandemic has shown us that public health is essential to the economic and physical well-being of the country. Smart organizations will onboard this insight by listening and incorporating information, data, and insights from each leg of the healthcare stool. Operating in silos, proposals are a zero-sum game. However, by establishing public-private partnerships and working collaboratively, solutions can be crafted that meet the collective needs of our communities. Hopefully 2021 will be the year of building strong bridges.

Picture: Dmitrii_Guzhanin, Getty Images

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interoperability

Whether driven by private-sector innovation or government mandates, the move to Open Healthcare was underway before the Covid-19 pandemic, but 2020 has underscored the urgency for interoperability and truly digital healthcare. 

FHIR implementation is poised to support rapid adoption of Application Programming Interfaces (APIs), which are enabling people, providers, plans, and governments to share more data faster and easier. APIs allow outside apps to connect with electronic health record (EHR) systems, and these can help solve massive healthcare challenges. But it is API-first thinking, not just compliance with HHS interoperability rules, that can truly unlock the potential for solutions that are secure and patient-centered.

We are in the middle of an unprecedented vaccination campaign rolling out across the world. The creation and mass production of several highly effective Covid-19 vaccines in less than a year is truly extraordinary. But the fight against this virus isn’t over yet Logistical challenges are daunting, and then there are very real security hurdles, as demonstrated by recent cyberattacks on vaccine data.

Healthcare organizations have historically connected with other healthcare organizations – this was point-to-point and purpose-built. But as governments move to build citizen-centric applications and healthcare opens up their data to patients, healthcare organizations need to look at APIs as an engagement method, thinking about APIs as a product all while keeping API security, management, and monitoring as first-order priorities.

Right now, people need real-time tools. A hospital that needs to vaccinate thousands of patients needs to also coordinate Covid-19 tests – because they don’t want to vaccinate someone who is currently sick – and their teams are already stretched thin. 

An API-first approach supports low-code solutions, and that is of immense value to healthcare facilities right now. These solutions are lightweight and can be delivered to a device carried by a clinician throughout the hospital, enabling them to process more life-saving immunizations, faster. 

But using APIs doesn’t just enable faster delivery of services; it also means better performance and a better patient experience. Providing a set of standardized interfaces that meet the needs of consumers reduces test time, production breakage, and upgrade complexity, and it also puts the patient at the center of the experience. 

This isn’t an unlikely scenario: you go to receive a Covid-19 test in a hospital parking lot, wait for a negative result; three days later show up at that same hospital for a Covid-19 immunization and are handed a stack of paperwork to fill out and asked to provide proof of a negative test. 

The patient sits in line, frustrated with more paperwork – even though they were at the hospital mere days ago – and the hospital staff, already spread thin, has more information to digitize. If the hospital opens up its data via APIs, the IT team can quickly build a low-code solution that instantly pulls from the existing Covid-19 tests administered in the hospital’s parking lot to verify that a person can receive their immunization.

We are often sitting on a wealth of information, but we tend to make it too hard for the teams in the hospital to share. Security is the main motivator here, and understandably so as US and UK cybercrime authorities recently warned of an increased threat to hospitals and healthcare providers. Moving large amounts of data around so freely in real time generates a lot of traffic, but it can be done securely with robust monitoring. 

An open healthcare platform requires an API management system, a gateway that sits in front of your FHIR server and enforces the policy from your Chief Security Officer. A truly sophisticated API management engine monitors all the traffic to make sure that everyone gets appropriate service and watches out for denial-of-service attacks. APIs must be protected by the latest security protocols and standards such as OAuth for authentication and OpenID to validate credentials as required by the Interoperability Rule.

One bright side that everyone tends to forget is user experience in healthcare. There’s so much potential for improvement with APIs and developer portals that help citizens get access to their data more effectively. 

By wrapping FHIR APIs, which are a relatively raw patient data set, into a more consumable API such as experience APIs, we can start to enable nimble, low-code work inside organizations. Now we equip ourselves to live in a real-time world and do totally unplanned things, like stand up a vaccination system in days or weeks instead of an 18-month project schedule. 

Just as importantly, many people are feeling stress, uncertainty, and are overwhelmed right now. We can and we must create a smoother, more positive experience for patients, putting people at the center of their care.

Picture: DrAfter123, Getty Images

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A second vaccine for Covid-19 has won the blessing of U.S. regulators.

The U.S. Food and Drug Administration on Friday approved for emergency use a vaccine developed by Moderna, a biotech company based in Cambridge, Massachusetts.

The green light comes a week after similar approval was given to a vaccine from New York-based Pfizer and its German partner, BioNTech. That first vaccine is already being deployed on the front lines of a pandemic currently claiming more than 3,000 lives a day in the U.S. and stretching the country’s health care resources to a breaking point.

The approval of Moderna’s vaccine means it, too, will soon join the fight against Covid-19. The U.S. has committed to buying 200 million doses of the vaccine, which is administered in two shots, according to the company. Hospitals are expecting deliveries as soon as next week.

“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Dr. Stephen M. Hahn said in a statement.

The initial shipment from Moderna is expected to total 5.9 million doses, more than double the initial 2.9 million doses of the Pfizer/BioNTech vaccine.

Further, the Moderna vaccine may pose less of a logistical challenge. Unlike the Pfizer/BioNTech product, it does not need to be stored at extremely low temperatures, enabling it to go more places. 

Moderna plans to make 20 million doses available by the end of December.

“We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” Moderna CEO Stephane Bancel said in a statement. He said the vaccine, while developed quickly, is based on a decade of research.

The Moderna and Pfizer/BioNTech vaccines are based on a similar platform: messenger RNA, which helps human cells create their own antibodies to the Covid-19 virus. Developed in record time, both vaccines are around 95% effective but generate some temporary side effects, including pain at the injection site, fever, joint pain and headaches. Both also require two doses.

More severe reactions are possible as the vaccines are given to a larger population. Two health care workers in Alaska reportedly developed allergic reactions to the Pfizer vaccine, with one requiring hospitalization. This was also observed in the U.K. 

The Pfizer/BioNTech vaccine is approved for use in people 16 and over, though members of an FDA advisory panel questioned whether there was enough evidence to support use in those under 18. The Moderna vaccine is approved for those 18 and over.

The age difference led to different outcomes for the vaccines when they came before an FDA advisory panel comprised of outside experts. Panelists were voting on whether the vaccines’ benefits outweighed the risks. The Pfizer/BioNTech vaccine was cleared on a 17 to four vote, with one abstention, while the Moderna vaccine was cleared unanimously, also with one abstention. The abstention reflected concern about the broad scope of the question up for approval

“I’m very uncomfortable with the language,” said Michael Kurilla, an infectious disease expert and director of the clinical innovation division at the National Center for Advancing Translation Sciences, a part of the National Institutes of Health.

“I think in the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” Kurilla said at the end of the advisory panel meeting on Thursday. “I’m not convinced that for all of those age groups, the benefits do actually outweigh the risks and I would prefer to see it more targeted toward people at high risk of serious and life-threatening Covid disease.”

Another critical question facing the vaccine makers is what to do about people taking part in clinical trials, some of which are expected to last into 2022. The trials are comparing the results in those given the actual vaccine against those given a placebo. Participants are not supposed to know which one they received.

But on a website about their vaccine, Pfizer and BioNTech said they are allowing people who got a placebo in their trial to get the actual vaccine. The offer is limited initially to healthcare workers and nursing-home residents, two groups that have been prioritized for vaccination in the U.S. But it will eventually extend to others. There are nearly 44,000 participants in the Pfizer/BioNTech trial.

Moderna also has a plan for the so-called unblinding of its trial participants, of which there are more than 30,000.

The next vaccine candidates are expected to come before regulators early next year. One candidate is being developed by AstraZeneca and Oxford University. Another is from Johnson & Johnson, which said this week it expects to ask for emergency use authorization in February.

Photo: Michael Burrell, Getty Images

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