The FDA has authorized Johnson & Johnson’s Covid-19 vaccine for emergency use, adding a third vaccination option—one that comes with storage and distribution advantages.

The regulatory decision followed the review of an FDA advisory panel, which voted unanimously on Friday to recommend authorization of the vaccine. J&J said it has begun shipping its vaccines to the federal government, which will manage distribution. The company expects to deliver enough vials for the vaccination of more than 20 million people in the U.S. by the end of March, ramping up to 100 million vaccinations by mid-year.

The J&J shot joins the messenger RNA vaccines developed by Moderna and partners Pfizer and BioNTech as the only authorized Covid vaccines in the U.S. The mRNA vaccines must be transported and stored at ultra-cold temperatures well below temperatures of typical medical freezer equipment. However, vaccination sites now have a little more flexibility in how they can store mRNA vaccines. Last week, the FDA approved a request from Pfizer and BioNTech to permit storage of their vaccine at pharmaceutical-grade freezers for up to two weeks.

The J&J vaccine can be transported and stored at refrigerator temperatures, making it a better option for rural areas or vaccination sites that don’t have the specialized freezer equipment required to store the mRNA vaccines. It has the additional advantage of being a single shot, unlike the mRNA vaccines that are given as two doses weeks apart. A single shot avoids the challenges of getting people to return for a second injection.

“The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance.

The J&J vaccine uses a virus to fight a virus. The company’s Janssen subsidiary takes adenovirus, which causes the common cold, and engineers it so that it cannot replicate and does not cause illness. This engineered virus becomes the vehicle that transports into cells a piece of DNA from SARS-CoV-2, the novel coronavirus. Cells use that genetic material to make the spike protein found on the surface of SARS-CoV-2. Those proteins spark the immune response that leads to immunity. This vaccine technology, which J&J calls AdVac, is the basis of the company’s Ebola vaccine, which was approved by the FDA in 2019.

The FDA authorization for J&J’s Covid vaccine was based on results from a global, placebo-controlled Phase 3 study that enrolled nearly 44,000 volunteers. Those participants were followed for a median of eight weeks. The main goal of the study was to evaluate the first occurrence of moderate-to-severe Covid infection with the onset of symptoms after 14 days, and then after the 28-day mark.

Overall, the J&J vaccine was about 67% effective in preventing moderate-to-severe or critical Covid infection after two weeks. After 28 days, the vaccine was about 66% effective at preventing infection. The FDA added that the J&J vaccine was about 77% effective in preventing severe or critical illness two weeks after vaccination. After 28 days, the vaccine was 85% effective in preventing severe or critical illness.

The most common side effects reported from the studies were pain at the injection site, headaches, fatigue, muscle aches, and nausea. The FDA said these side effects were mostly mild to moderate and lasted for a day or two. J&J does not yet have enough data to determine how long protection from the vaccine lasts. The studies conducted to date also do not show whether the vaccine stops people from transmitting the virus. As part of the emergency authorization, J&J must continue to collect data about its vaccine and report and serious adverse events.

The J&J vaccine is given as a 0.5 mL intramuscular injection. The vaccine is shipped in vials, each containing five doses. The company estimates the vaccine will remain stable for two years stored at minus 4 degrees Fahrenheit (minus 20 degrees Celsius). At refrigerator temperatures in the range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), the company says the vaccine can be stored for up to three months. The company will deliver the vaccine with the same cold chain currently used to ship its other medicines.

The federal government will manage the allocation and distribution of the J&J vaccine according to guidelines set by the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Johnson & Johnson said that it plans file an application seeking a formal FDA approval later this year. The company is also seeking authorizations for its vaccine in other markets.

Photo: Esben_H, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

The U.S. is one step closer to making available another Covid-19 vaccine after a panel of experts voted unanimously Friday to recommend emergency use authorization for a shot developed by Johnson & Johnson.

The independent panel, comprised of mostly physicians, voted 22-0 to support the vaccine with no one abstaining. These votes aren’t binding on the FDA, but the agency often follows the recommendations of its panels. A decision could come as early as this weekend. The two Covid vaccines currently cleared for emergency use received their authorizations the day after their respective advisory panel meetings.

The Johnson & Johnson vaccine would offer an alternative to the ones currently available from the Pfizer and BioNtech alliance, and Moderna. Those messenger RNA vaccines must be distributed and stored at ultra-cold temperatures, then thawed before use. Those shots are given as two doses, weeks apart. The J&J vaccine can be kept at refrigerator temperatures. Another key difference is that the J&J jab requires a single shot. Together, those features will make the J&J vaccine easier to distribute to more people in more places through distribution channels that are already in place.

Panel members expressed support for the J&J vaccine, saying that the safety and efficacy data supported its authorization. But panelists also cautioned the public against picking vaccine favorites.

“It’s important that people do not think one vaccine is better than another,” said Cody Meissner, an infectious disease expert and professor of pediatrics at the Tufts University School of Medicine. “There is no preference for one vaccine over another and all vaccines work with what appears to be equal safety and equal efficacy as of this time.”

Emergency authorization is not the same as an approval. Federal law permits the FDA to allow marketing of unapproved medical products for emergency situations, such as a pandemic. Authorizations only last for the duration of the emergency. These authorizations can also be revoked if new data show that the product is not safe or effective. Stanley Perlman, a professor in the departments of microbiology and immunology at the University of Iowa, said that while the clinical studies to date have produced data about the vaccine’s safety and efficacy, it would be “nice to have more.”

The J&J vaccine may be new, but compared to the mRNA vaccines, the technology behind it has bit of a longer track record. J&J vaccine makes it using its AdVac technology, the same platform that produced the company’s Ebola vaccine, which the FDA approved in 2019. The technology takes the virus that causes the common cold and modifies it so it doesn’t cause illness. That engineered virus is the delivery vehicle that ferries into cells a snippet of genetic code for the novel coronavirus’s spike protein. The genetic material serves as the blueprint from which the body’s cells produce spike proteins. The immune system responds by producing antibodies to those proteins, conferring immunity.

The clinical data to date for J&J Covid vaccine covers 44,000 adults from all over the world. In Phase 3 data reported in late January, the vaccine was 66% effective overall in preventing moderate-to-severe infection, 28 days after vaccination. Furthermore, the vaccine showed 85% efficacy in preventing severe disease, and showed complete protection against Covid-related hospitalization and death, also measured at day 28.

Those marks look inferior to the greater than 90% efficacy demonstrated in mRNA vaccine trials. But cross-trial comparisons are difficult and can be misleading because trials have different designs and different goals. Also, the mRNA studies were conducted earlier in the year when there were fewer variants circulating. Public health experts have said that if those vaccines were tested under current conditions, their efficacy rates might be lower, too.

Plans are already underway to gather more data about J&J’s shot, including a study of the vaccine in children and teens. Johan Van Hoof, the global head of the infectious diseases and vaccines for J&J’s Janssen subsidiary, told the advisory panel that a clinical trial testing the vaccine in those 17 and younger is expected to begin this spring. He also said that the company is assessing how the vaccine responds to variants of the novel coronavirus.

Shortly after Friday’s meeting, the FDA issued a statement saying that it would “rapidly work” with J&J toward finalization and issuance of an emergency use authorization. The agency added that it has notified federal partners involved in the allocation and distribution of vaccines, so that they are ready.

Photo: Getty Images, Sezeryadigar

0 comment
0 FacebookTwitterPinterestEmail

health insurance, Obamacare

A rise in insurer participation in the Affordable Care Act individual marketplace indicates that payers are anticipating a fruitful year ahead. The installation of a new president and ongoing Covid-19 pandemic appear to be driving this trend.

Over the past year, insurer participation in the ACA individual marketplace has grown and benchmark premiums have declined, according to a new analysis by the Robert Wood Johnson Foundation. The total number of insurance offerings sold on the marketplace is now 9,144, which is about 75% of the 2015 record high.

This suggests that insurers are anticipating increased enrollment as a result of federal policy changes and the impact of the Covid-19 pandemic, said Katherine Hempstead, senior policy adviser at RWJF and author of the analysis, in an email.

“The Biden administration has been emphatic about its commitment to the ACA marketplace,” she said. In particular, the administration has committed to preserving and expanding health coverage to help Americans during the pandemic.

In his American Rescue Plan, President Joe Biden called on Congress to subsidize continuation health coverage through the end of September and to expand and increase the value of the Premium Tax Credit. The latter move will help lower or eliminate health insurance premiums and ensure enrollees will not pay more than 8.5% of their income for coverage.

Further, Biden recently reopened the HealthCare.gov insurance markets for three months to enable Americans to sign up for coverage amid the ongoing pandemic.

Though these policy changes are temporary, there is a commitment on the part of the administration to try to make them permanent, Hempstead said.

Drilling down into participation among major insurers, Hempstead found that Anthem, UnitedHealth and Cigna currently comprise about two-thirds of the national commercial offerings on the individual marketplace. Centene, which dominates the Medicaid managed care organizations category, made its largest single-year increase, nearly doubling its marketplace offerings from 2020 to 2021.

In addition, participation by newcomers like Oscar and Bright Health has grown steadily. Bright Health is now in 10 states, and Oscar is in 19.

Another key analysis finding is that states that have yet to expand Medicaid saw increases in insurer participation. Increased participation in the ACA individual marketplace was particularly focused in Florida, Georgia, North Carolina and Texas, where the number of offerings increased by almost 50% in the last year.

“This is where the greatest number of uninsured people live, so it is the biggest opportunity for membership growth,” Hempstead said.

Looking ahead, it is clear that insurers are hopeful that a significant expansion in healthcare coverage is due, and they see the ACA marketplace as an increasingly important part of the coverage landscape, according to the analysis.

Photo: BrianAJackson, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

A major concern during the Covid-19 pandemic has been that Americans, especially those with underlying conditions, will delay necessary care. New survey results show this concern is not unfounded.

As of last September, about 40% of Americans with one or more chronic health conditions reported delaying or avoiding care, according to a new report from the Urban Institute and Robert Wood Johnson Foundation.

Report authors analyzed data from the second wave of the Urban Institute’s Coronavirus Tracking Survey, a nationally representative survey conducted Sept. 11-28, 2020. The survey polled 4,007 adults, ages 18 to 64 years.

About 36% of Americans said they delayed or did not receive healthcare due to a fear of exposure to the coronavirus or because a provider limited services during the pandemic, the report states. Black adults (39.7%) were more likely than white (34.3%) or Hispanic/Latinx (35.5%) adults to report delaying or forgoing care because of concerns about virus exposure.

About four in 10 adults with one or more chronic health conditions (40.7%) said they delayed or avoided care because of the pandemic, as compared with 26.4% of adults with no chronic conditions.

In addition, more than half of adults with both a physical and mental health condition (56.3%) reported delaying or avoiding healthcare due to the pandemic. About 43% of this group also reported delayed or forgoing multiple types of care.

The impacts of delaying or avoiding care were acutely felt by those with chronic conditions, the report shows. An estimated 23.2% of these adults reported that going without or delaying care worsened a health condition, 21% said it limited their ability to perform daily activities and 15.2% said it limited their ability to work.

Further, the report shows the kinds of care that Americans were avoiding. Dental care was the most common type of care adults delayed or did not receive because of the pandemic (25.3%), followed by seeing a general doctor or specialist (20.6%) and receiving preventive health screenings or medical tests (15.5%).

“Tackling unmet healthcare needs requires effectively assuaging fears about exposure to the coronavirus,” report authors concluded. Providers need to reassure patients that they are following public health guidelines and that these precautions can effectively prevent virus transmission.

“More data showing healthcare settings are not common sources of transmission and better communication with the public to promote the importance of seeking needed and routine care are also needed,” the authors wrote.

Photo: YinYang, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Care for chronic conditions has been severely disrupted amid the Covid-19 pandemic. To prevent further disruption, providers are increasingly partnering with IT companies.

Mount Sinai Health System and Current Health entered into one such partnership in December, with Mount Sinai implementing the company’s remote patient monitoring solution.

Their goal? To enhance care for cancer patients.

Current Health provides a wearable device to patients, which continuously monitors their vital signs, said Chris McCann, co-founder and CEO of Current Health, in a phone interview. The data is then transmitted back to the patient’s care facility. The solution alerts clinicians if the data indicate any abnormalities or potential care issues. At this point, the clinician decides whether the issue can be managed remotely or if the patient needs to be brought into the hospital.

Over the course of the Covid-19 pandemic, cancer screenings and treatment dropped drastically, which could lead to an increase in patient death rates, researchers warned.

A study published last year in JCO Clinical Cancer Informatics shows that at the peak of the pandemic in April 2020, screenings for breast, colon, prostate and lung cancer decreased significantly as compared to the same period the year prior. In addition, the number of mastectomies performed reduced consistently from April through July of last year, and colectomies similarly reduced between April and May.

“These problems, if unmitigated, will increase cancer morbidity and mortality for years to come,” the researchers wrote.

For Mount Sinai Health System, the drops in patient volume were striking. In April of last year, New York City was the global epicenter of the pandemic, and Mount Sinai, like other hospitals in the region, had to suspend elective procedures. The health system experienced a 25% decrease in volume in its ambulatory as well as inpatient settings in April, said Dr. Cardinale Smith, chief quality officer for cancer services at Mount Sinai, in a phone interview.

Even now, patient volume is 10% lower than what it was during the same time period last year, “which indicates to us that there are people who are likely staying closer to home to receive treatment,” she said.

This reluctance on the part of patients — to either risk coming into a health facility or traveling to a facility further away from them — was one of the reasons Mount Sinai looked into remote patient monitoring solutions for oncology.

The system decided to deploy Current Health’s solution, funding the implementation through a Federal Communications Commission grant. The rollout is currently in the pilot phase.

“What I’m hoping that we will see is that this gives us another way to monitor our patients and be able…to get them into a higher level of care when needed, and otherwise be able to really treat them in place so that they feel both safe and comfortable,” Smith said. “And also, so that we don’t overwhelm a healthcare system that is already being overwhelmed.”

Another reason for implementing the remote monitoring system was the growing digital divide among patients.

Mount Sinai clinicians saw that some of their patients, including people of color and the elderly, were less likely to use telehealth services, said Smith.

Smith hopes that the solution will help them care for those patients since Current Health provides the wearable devices and tablets that the patients need. The patients are trained on the devices, which are easy to use — even for the less-than-savvy tech user, Smith said.

Similarly, the health system educated and trained their clinicians on the new solution. As it is a novel mode of cancer care delivery, they needed to make sure they answered all their clinicians’ questions and concerns, she said.

The demand for remote monitoring solutions has exploded during the pandemic. Current Health, which received Food and Drug Administration clearance for its solution at the end of 2019, soon saw an explosion in demand, McCann said. The company experienced a 400% expansion of its customer base. This includes the addition of hospital customers like Mount Sinai Health System and Boston-based Massachusetts General Hospital.

“What [remote patient monitoring] does is it expands the criteria of patients who can actually be managed at home versus within a hospital and that has been a huge asset to us as a company — particularly in the [current] moment,” McCann said.

Photo: chombosan, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Metoprolol (muh•tow•pruh•laal). Eszopiclone (es•zoe•pik•lone). Hydrochlorothiazide (hy•dro•klor•oh•thi•a•zide). Amitriptyline (a•muh•trip•tuh•leen). Canagliflozin (kan•a•gli•floe•zin).

Are you able to recognize or pronounce any of these commonly prescribed medications? If so, you might be a pharmacist, or at least have experience providing patient care. It’s fair to say that most people find it challenging to pronounce drug names, and it may be even more challenging for the elderly.

It’s not uncommon for elderly patients to be prescribed multiple medications to treat multiple chronic conditions, and sometimes these medications come from multiple providers. In my experience, I have seen many patients fail to understand what, why and how to take their prescriptions. Some have the help of family or caregivers while others may not, which makes it even more challenging to manage. Many factors can contribute to these challenges including vision problems, memory loss, swallowing problems and or hearing loss. Medications can be extremely helpful in treating and preventing disease, or they can cause a major health setback if not taken appropriately.

As a pharmacist by training, or “pharmist” as my Grandpa likes to call me, I spend my time reviewing his medications when I’m in town to visit. He loves to sit down with me and tell me all about the medications he’s taking and what he takes them for.  At 87 years old, he’s impressively taking only three (3) medications. Up until last year, he was taking only taking one (1). He’s incredibly sharp and has never needed any extra assistance. My Grandpa is the perfect patient. He’s highly adherent and takes his medications every day, at the same time, right before his morning coffee. I understand the importance of adherence and adherence to the right medications, but I have never personally experienced or witnessed the challenges that come with adherence following discharge from a hospital stay, until now.

Covid-19 hit close to home and affected both of my grandparents this past Thanksgiving. After a few days, it was apparent they were unable to weather this virus alone. It severely affected their cognitive status and caused weakness so severe they were unable to stand or walk on their own. While staying with them during this time, a decision was made to take my Grandpa to the E.R., which led to a six-day hospital stay. Because I know he visits multiple providers and pharmacies, I knew the hospital wouldn’t have a complete record of all the medications he takes….and I was right.  I made sure he went with an updated med-list so that the doctors could give him his regular medications while in the hospital.  I knew this med-list would likely change following his discharge.

Upon discharge, I was provided with a long list of instructions from multiple people on the care team that was difficult to follow along even for me. First came a call from the nurse,  then a call from the provider, then a call from the pharmacist, and lastly a call from the company who would be dropping off his home oxygen. The pharmacist’s call was helpful, but not appropriately timed — I had no discharge papers to reference.  The provider called again, to go over the medications with us. The review was fast. Medications were discontinued. Medications were added. Some medications were named in their brand name while others were listed generically.

Who could possibly follow along? No one expressed to us the duration of these medications. When could they be stopped? Will they ever be stopped? Were refills needed, what doctor would continue to prescribe them? What if I had not been around to help?

Following my Grandpa’s return, I immediately sat down to review and organize all of his medications, new and old. One medication was discontinued, while 4 were added. My Grandpa went from taking 3 medications to 7 overnight, and each medication came with its own set of directions:

  1. Take this tablet with food.
  2. Take this tablet on an empty stomach.
  3. Take this tablet every day and skip on Saturdays.
  4. Take this tablet on Monday, Wednesday, and Friday.
  5. Skip this tablet for two days. Restart on Sunday.
    1. 2 days later* “Actually, take this medication every other day starting Tuesday.”
  6. Take this tablet every day.
  7. Take this tablet three times a day and make sure not to eat too much sugar or salt with this med.

With all of this information, I created a “Fridge Report” for when I’m not around. A Fridge Report is a simple and easy to read medication list. It displays all medications a patient is taking and how to take them in a nice visual display that is easy to follow. I also called and spoke with his primary care provider (PCP) and cardiologist to confirm his active medications and to notify them of the newly added and discontinued medications. I can’t imagine my grandparents, or anyone else’s grandparents, managing this without the help of a pharmacist. The Fridge Report was highly appreciated by my family.

“We need that (Fridge Report). It’s very detailed. No mixing up or second-guessing of medications. Now I know what to give and when to give it.” – Lorraine Armenta, My Aunt

According to the World Health Organization (WHO), care transitions threaten patient safety as they can increase the possibility of losing critical clinical information and require an increased degree of coordination. I believe a multifaceted approach is needed to improve care transitions and is especially needed for vulnerable and high-risk individuals. The transition between inpatient and community settings, in particular, is prone to medication errors related to a lack of communication between health care providers, missed patient follow-up, inadequate patient education, incomplete medication reconciliation, and the absence of patient involvement in medication management. Pharmacists can and should take a more active role in improving medication safety during care transitions; this could lead to a reduction in hospital readmissions and improved quality of care.

Pharmacists serve as quarterbacks of a patient’s at-home-care team, providing essential help to those who are taking multiple medications. We are medication safety experts and have access to sophisticated and innovative tools to better manage the medication-related needs of patients and mitigate adverse drug events (ADEs). Ultimately, engaging with your local pharmacist can reduce the burden placed on a patient’s family and the primary caregiver, while making the transition to at-home care manageable.  

Photo: JohnnyGreig, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

As the Covid-19 pandemic continues to rage across the U.S., the Biden Administration faces a big task ahead, starting with its goal of vaccinating 100 million people in its first 100 days. Currently, just 19 million people have received their first dose, according to the Centers for Disease Control and Prevention.

A growing list of companies, including Walmart and Amazon, are lining up to help with that effort. They also hope to that their employees will be able to get their shot soon, though state plans vary widely on when essential workers can start receiving vaccines.

Walmart, which has more than 5,000 pharmacies across the U.S., has started administering vaccines in 10 states and Puerto Rico. Dr. Cheryl Pegus, Walmart’s executive vice president of health and wellness, wrote in a blog post that it had been preparing by staffing up and building a digital scheduling tool.

“At full capacity, we expect we will be able to deliver 10-13 million doses per month when supply and allocations allow,” she wrote.

She also said the company would “stand ready” to help vaccinate people in healthcare deserts and underserved communities, through partnerships with churches, youth centers and stadiums.

Amazon, which recently opened a pop-up vaccine clinic at its headquarters in Seattle, sent a letter to President Joe Biden on Wednesday offering to help with U.S. vaccine efforts, Reuters first reported.

“We are prepared to move quickly once vaccines are available. Additionally, we are prepared to leverage our operations, information technology, and communications capabilities and expertise to assist your administration’s vaccination efforts,” Dave Clark, Amazon’s CEO of worldwide consumer business, wrote in a copy of the letter obtained by MedCity News.

The company is working with Virginia Mason Medical Center to administer vaccines to the public. Amazon is providing equipment, staffing and supplies, and Virginia Mason is handling appointment scheduling and following-up with patients for their second dose, company spokesman Glenn Kuper wrote in an email.

Washington state has also tapped Starbucks, Costco, Microsoft and a cadre of other businesses to help with the logistics of distributing a vaccine.

Janet Baseman, the University of Washington’s associate dean for public health practice, said there are some things companies can do to help speed up distribution, such as managing queues of people and registration systems.

“That, for Covid testing, has been super uneven across the country. In some places, they have electronic registration systems, they say come at this time, and you’re in and out after six minutes. There are other places where you’re waiting for hours in a queue of cars,” she said. “I really think this could be a great example of a public-private partnership if everybody is able to get together to collaborate.”

When will they get vaccinated?

These retailers are also keeping a close eye to when their employees will be able to get vaccinated. Each state has different plans for when people who work in grocery stores, warehouses, public transportation and other essential jobs will get vaccinated, and it’s hard to say exactly when it will happen.

The lack of consistency across state lines has made things especially challenging for national or international companies, said Nadina Rosier, general manager of pharmaceutical solutions at the Health Transformation Alliance, a cooperative of self-insured companies.

There’s so much gray …  in understanding the administration of the vaccine and where we are in the timeline,” she said in a phone interview. “You have a number of challenging factors that are affecting employers. There isn’t a consistent definition of what an essential worker is.”

For instance, it’s easier to define whether someone is 75 or older or is at high risk than if they are an essential worker, she said. This leaves companies jockeying for a place in line, including groups like the Consumer Brands Association, the lobbying group for many of the packaged goods found in grocery stores, and ride-sharing companies Uber and Lyft, which are offering free rides to vaccine appointments while also seeking early doses for their drivers.

 In his letter to Biden, Amazon’s Clark also emphasized that many of the company’s 800,000 employees cannot work from home.

It seems unlikely that businesses will require all of their employees to get vaccinated, Rosier said, because of regulatory concerns around issuing any kind of mandate. But they can play a role in letting employees know when they’re eligible and reminding them to get their second dose.

Pegus said Walmart would strongly encourage its employees to get vaccinated, but is not mandating it or providing incentives, as some other retailers plan to do.

Vaccinating 100 million people will be a huge undertaking, though not impossible.

“I keep thinking that even though it is an unprecedented undertaking for the country, that the federal government does know how to do this. There is a playbook for this,” she said. “These are things that have been workshopped and thought about for years.”

Going forward, she expects to see a push from the federal government to increase vaccine supply and help states and local jurisdictions stand up vaccination sites across the country.

“I’m pretty optimistic that if we can get enough supply, the distribution, communication and coordination pieces can be tackled and improved substantially,” she said.

Photo Credit: RLT_Images, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

The Covid-19 pandemic may fade but some of the changes it has wrought in the life sciences may – or should – endure, according to two prominent pharma CEOs who spoke during a session Friday at the J.P. Morgan Healthcare Conference.

For starters, the pandemic has shown how quickly companies and regulators can bring products to market, with tests, vaccines and therapies being studied and approved at record speeds, according to the CEOs, Paul Hudson of Sanofi and Tom Polen of BD.

Companies also have collaborated in ways they would not have contemplated previously. Hudson cited Sanofi’s work with GSK to develop a Covid-19 vaccine. The partnership might once have taken a year to come together but took only 12 days, Hudson said.

“So many times, it was a race against the virus, not a race against each other,” said Hudson, who became Paris-based Sanofi’s CEO in fall 2019 after leaving Novartis.

Regulators have moved at similar speeds, delivering answers in minutes rather than months, Hudson said.

The fast pace stems from the pressure of Covid-19, which has killed two million people around the world and is continuing to spread and mutate. But the sense of urgency could be applied in the future to tackle other diseases, like childhood cancers.

“I think the industry is at its best when it’s purpose-driven with a singular focus,” Hudson said during the JPM session, which was moderated by managing directors at Boston Consulting Group.

Large pharma companies, meanwhile, showed that they could pivot and innovate quickly, despite stereotypes to the contrary. Polen cited BD’s effort to develop a rapid-antigen test for Covid-19. It went from launch to monthly production of 10 million units within six months, said Polen. It normally would take three years.

The speed was a function of setting a clear mandate and a deadline but also doing things differently inside the company, Polen said. While the test was a life science project, for example, BD plucked talent from across the organization to lead the charge.

Another key was empowering and supporting employees so that they were not afraid of taking risks. Early on, the team found a promising antibody, one that is now used in the test, Polen said. The normal progression would be to order a small batch, wait to see if it works and then start ordering batches for commercial production. BD executives assured employees they were OK with ordering the commercial batches up front despite the risk and cost.

“That ended up being a tremendous part of the success equation,” Polen said

The pandemic was not the only force reshaping the industry in 2020. Hudson and Polen discussed the lasting impact they hope to see from the racial justice protests that followed the death last year of George Floyd, an African American, at the hands of Minneapolis police officers.

“This year brought a whole new and very much-needed focus on this issue for us as BD,” said Polen, who became CEO of the Franklin Lakes, New Jersey-based company in January 2020.

The company’s leaders have worked to create an environment where employees feel comfortable broaching difficult topics around race, Polen said. “That was a big change this year.”

Harris noted the need to improve diversity among patients in clinical trials but also among the investigators.

For 2021, Harris and Polen expect a sharper competition for talent in the life sciences.

“I think it’s going to escalate after we get out of Covid,” Polen said. But some of the workplace changes wrought by the pandemic could prove useful in the competition. Employees that once might have had to move for a promotion or a new job now can stay where they are and work remotely, an option that could help dual-income families.

Polen and Harris also discussed the growing role in health care for big tech companies like Amazon, Apple and Google. The CEOs painted the tech giants as potential partners rather than rivals. Not only can tech companies help bring products to patients, they also tools to transform pharma’s internal operations.

The challenge ahead lies in preserving the energy, purpose and speed that animated the industry in 2020, Hudson added. “People can quickly fall back into the old routines.”

Photo: Dmitrii_Guzhanin, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

The next generation of antibody testing for Covid-19 is beginning to take shape.

Initial tests determined whether someone had or did not have antibodies to the virus’s signature spike protein. A new crop promises to quantify the antibodies, an advance that could be crucial as researchers seek to understand longer-term immunity from the virus, whether acquired through vaccines or natural infection. But that is not the only question out there.

“There’s still a lot to be learned,” said Michael Haydock, a senior director at Informa Pharma Intelligence in London.

For example, he said, researchers don’t know if there is a threshold number of antibodies a person needs to maintain immunity, Haydock said. Quantitative tests could help pinpoint a threshold and track whether antibodies fall below it, potentially necessitating a booster vaccine.

“Measuring that is going to be very important,” Haydock said in a phone interview. Tests also may be able to quantify differences in immune response based on age, race and other factors.

In addition, quantitative tests can be used to assess people who have recovered from Covid-19 and want to donate plasma for use in convalescent plasma therapy, a treatment for the virus. Researchers also may be interested in understanding the response to Covid-19 vaccines among those who are already on therapies that modify their immune systems.

“That’s the nature of this pandemic, that you’re trying to move forward when you have more questions than you have answers. Antibody testing can help answer those questions,” said Sara Barrington, chief commercial officer for Kantaro Biosciences.

The New York-based company offers a quantitative antibody test for Covid-19 using technology developed at Mount Sinai Health System early in the pandemic. Kantaro is a joint venture between Mount Sinai and RenalytixAI, a diagnostics company based in the United Kingdom.

Complicating the issue is the lack of an agreed-upon standard for measuring antibodies. However, clarity is on the horizon.

The World Health Organization is expected to set standards soon, Barrington said in a phone interview.

“With an international standard, you’d be able to compare the results across different tests,” said Erik Lium, Kantaro’s chairman and the chief commercial innovation officer at Mount Sinai.

In November, the Food and Drug Administration approved Kantaro’s test for emergency use. But the approval comes with a qualification: the test, called COVID-SeroKlir, is considered semi-quantitative.

The FDA appears to be waiting for the international standard to be set before declaring tests fully quantitative, Barrington said. However, European regulators are not waiting. They cleared COVID-SeroKlir for use as a fully quantitative test.

Other tests also have won clearance. One was developed by drug maker Roche, based in Basel, Switzerland. Its test – the Elecsys Anti-SARS-CoV-2 S – is being used in a partnership with Covid-19 vaccine maker Moderna to trace antibody responses in vaccine-trial participants. Like Kantaro’s, the Roche test was approved for emergency use as a semi-quantitative test.

Some are looking beyond Covid-19 to other infections.

A group of researchers from Linnaeus University and bioanalysis company Attana, both in Sweden, is developing a quantitative test for Covid-19, as well as the bacteria that causes tetanus.

“Our vision is a general diagnostics platform that is relevant not just at present, during the ongoing pandemic, but one that will also serve a greater, broader purpose in the future” Teodor Aastrup, Attana’s CEO, said in a statement.

Photo: sorbetto, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

For months, states warned that additional funding would be needed to distribute a coronavirus vaccine. Last week, they finally got their wish.

The Department of Health and Human Services said it would push out $3 billion to states for vaccine distribution, and another $19 billion for testing before January 19. Both were sorely needed.

While the current administration has kept half of all vaccine doses in reserve to be used for people’s second doses, President-elect Joe Biden said he plans to send most of them out to be used immediately. The bet is that pharmaceutical companies will be able to manufacture enough doses in time for people to receive their booster shot.

So far, the vaccine rollout has been a bumpy one. As of Friday, 22 million doses had been distributed, but only 6.7 million had been administered, according to data from the Centers for Disease Control and Prevention (CDC). This falls far short of Operation Warp Speed’s goal of vaccinating 20 million people by the end of the year.

On top of that, state health departments have largely been left to draft up plans, despite facing slashed budgets and limited staff — who are also trying to manage other facets of the pandemic.

“It just becomes more and more complex. It’s falling to an agency that has limited staff to execute this well,” Tamyra Porter, a partner with Guidehouse, said in an interview.

Different approaches by state

Most states have opted to vaccinate healthcare workers and nursing home residents first, which should be the easiest part of the process.

Volunteers are help step up the vaccine rollout. For instance, the state of California is calling for help from dentists and retired healthcare workers. Meanwhile, Walgreens and CVS have been staffing up to administer the vaccine in nursing homes.

The process, however, is a bit more complicated than giving people their annual flu jab.

“You can’t just go down the line like a flu shot. It’s a lot more time intensive. You need to survey people in advance of the vaccine, and monitor them for 15 minutes after administering it,” said Martha Roherty, executive director of ADvancing States, a nonprofit representing state aging and disability agencies.

And while giving several vaccines to a big system, such as Kaiser Permanente, might be relatively easy, several practitioners not affiliated with hospitals are still waiting for their first dose.

In other states, such as Florida and Texas, people ages 65 and older are being prioritized for the first doses, bucking CDC recommendations.  But this process takes much more careful planning. In Florida, people waited in long lines outside to receive their first doses of the vaccine at first-come first-serve sites.

“You don’t want a bunch of people milling around because that can be a transmission event. You need to have appointments scheduled out so you can see people every 2 or 3 minutes,” said George Rutherford, an epidemiology professor at the University of California San Francisco.

Even with the best set plans, all states need one critical component: people who are willing to take it. A Gallup poll last month found that 63% of Americans would be willing to take the vaccine, up slightly from September.

Testing still a big piece

As the vaccine rollout begins, testing will remain a big part of the Covid-19 response for several months ahead, as indicated by the $19 billion HHS said it plans to allocate for this purpose.

After seeing a surge in cases in advance of the holidays, many states — including California — are at a tipping point. They could see an additional surge after New Year’s, or cases could finally start to decrease again.

The detection of a new, more transmissible strain of the virus in several cities makes testing and preventive measures all the more important. Called B.1.1.7, the variant was first detected in the U.K., but multiple cases were recently found in California, Colorado, New York and Florida.

“Vaccines still work, the drugs still work, monoclonal antibodies still work, masks still work, the tests still work. Everything still works, it’s just a little bit more transmissible,” Rutherford said.

Photo credit: Geber86, Getty Images

0 comment
0 FacebookTwitterPinterestEmail
Newer Posts