Pharma Sector Did Its Job With COVID-19 Vaccine: Barclays Analyst

 The pharmaceutical industry has succeeded in doing its job in manufacturing multiple vaccines for the novel coronavirus, and it's "now in the hands" of government authorities to manage the distribution, Emily Field, head of European pharmaceutical research at Barclays, Emily Field said Friday on CNBC's "Squawk Box Europe."

Price Not A Factor: Early indications suggest AstraZeneca plc AZN 2.35% and Johnson & Johnson's JNJ 0.42% vaccine will cost $3 to $5, while pricing for Pfizer Inc. PFE 1.35% and Moderna Inc MRNA 5.22% could reach $40 on the high end.

Pricing is unlikely to be a determining factor as governments are prioritizing getting as many people vaccinated as quickly as possible given a limited initial supply, Field said. 

"As long as we know it is safe and efficacious, I don't think that price is going to be a determining factor," she said.

Convincing The Public: The general public should be reminded that results from vaccine trials are "the best we could have hoped for," the Barclays analyst said. 

Public opinion and attitudes toward the vaccine could be impacted by mixed messages from the World Health Organization and the U.S. FDA related to Gilead Sciences, Inc. GILD 0.86%, she said.

Specifically, the WHO was encouraging doctors worldwide not to use Gilead's remdesivir as a treatment against the coronavirus.

These public disputes may help skeptics prove their point that the medical community isn't as confident as they appear to be, Field said. 

To counter this argument, it should be noted remdesivir was designed years before the start of the pandemic to treat other viruses such as Ebola, the analyst said.

AstraZeneca was quick to design a new antibody treatment for COVID-19, she said. 

"In essence, these older drugs really weren't meant to treat COVID-19, so it makes sense that there is some debate over their efficacy in treating this disease." 

https://www.benzinga.com/analyst-ratings/analyst-color/20/11/18467156/pharma-sector-did-its-job-with-covid-19-vaccine-barclays-analyst

COVID-19 Burdens Follow Patients After Discharge

 COVID-19 patients who survive their hospitalization don't leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What's more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.

"These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses," wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)

The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.

The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.

Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.

While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.

"This is the best information we have to date," she said. "We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc."

The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).

Poor postdischarge outcomes weren't limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.

The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn't return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.

Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.

The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. "Collectively, these findings suggest that better models to support COVID-19 survivors are necessary," said Chopra and colleagues.

The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. "As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump."

He echoed the study authors' call for better postdischarge support for COVID-19 patients. "There's typically, although not at every hospital, a one-size-fits-all discharge planning process," Gupta said. "For older patients, particularly with comorbid conditions, close follow-up after discharge is important."

Farmer noted that one challenge in discharge support may be a matter of personnel. "The providers of this care might be fearful of patients who have had COVID-19 – Do the patients remain contagious? What if symptoms of COVID-19 return such as dry cough, fever? – and of contracting the disease themselves," she said.

The findings regarding the emotional status of discharged patients should factor into discharge planning, she added. "Providers of posthospital care need to be educated in the emotional impact of this disease (e.g., the patients may feel ostracized or that no one wants to be around them) to assist in their recovery."

Chopra and Farmer have no financial relationships to disclose. Gupta is an employee and shareholder of Genentech.

SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.

https://www.medscape.com/viewarticle/941270

Can a COVID-19 Vaccine Stop the Spread? Good Question

 Scientists involved in oversight of the Operation Warp Speed COVID-19 vaccine trials are tempering excitement about efficacy, noting that the studies haven't shown yet whether the products can prevent transmission of the SARS-CoV-2 virus.

"We don't know if people can become infected and thus also transmit even with vaccination," said former US Food and Drug Administration Commissioner Margaret Hamburg, MD, in a November 18 briefing on COVID-19 vaccines sponsored by the American Public Health Association (APHA) and the National Academy of Medicine (NAM).

For that reason and others — including if there isn't significant uptake of vaccine — "people can expect to still be wearing masks, still be asked to follow non-pharmaceutical public health measures that we've all come to know so well," she said. 

It may take a year or more to get the studies to answer the transmission question, said Larry Corey, MD, who helps oversee the vaccine trials as part of the National Institutes of Health's (NIH's) COVID-19 Prevention Network. With vaccination could come what researchers call "behavioral disinhibition" — they may start eating in restaurants, going to theaters, and sporting events without masks, he said.

That's not a good idea, said Corey, who is also president and director emeritus of the Fred Hutchinson Cancer Research Center in Seattle, Washington. Those who have been vaccinated could still continue to asymptomatically and unknowingly shed virus and spread disease. "I want people to start being aware of that," he said.

"An Important Question"

The data from the Pfizer/BioNTech and Moderna vaccines that have been reviewed by Warp Speed and NIH officials "are about protection from symptomatic disease," said Hilary Marston, MD, MPH, who coordinates the National Institute of Allergy and Infectious Diseases' response to outbreaks, including COVID-19.

Marston, who spoke to reporters separately in a meeting convened by the Association of Health Care Journalists (AHCJ), said that additional data down the road may help determine if the vaccines can prevent transmission.

That data will look at the duration of the viral shedding and the amount of virus in nasopharyngeal swabs or nasal swabs over time. "That will give us a sense of the viral burden in breakthrough cases," said Marston, who noted that those infections have been rare in the Pfizer and Moderna studies.

Pfizer reported 170 infections (162 in the placebo group) in 41,000 participants. Moderna, to date, has reported 95 cases (90 in the placebo group) in 30,000 participants.

The protocols, which are similar for the Pfizer trial and the five COVID-19 vaccines that are part of Warp Speed, will take an eventual look at asymptomatic transmission, Marston said. The studies are also conducting blood draws on participants to determine whether they have antigens that aren't in the vaccine — which would indicate a potential infection at some point.

Corey said that the studies aren't designed to assess transmission. They "don't ask that question and there's really no information on this at this point in time," he said during the APHA/NAM briefing.

"We don't know what's the level of nasal carriage that's required for infection, and the duration of that, and what the vaccine does on that," he said. "It's an important question," especially given that polls have shown a reluctance of many Americans to get vaccinated when a COVID-19 shot becomes available.

NIH Director Francis Collins, MD, told health reporters at the AHCJ event that it will take 80% coverage to get to herd immunity, and that is not likely to happen until summer 2021, "if all goes well," he said, adding that it depends on Americans getting the vaccine.

"One of the greatest tragedies you can imagine in our technological society would be if the science says we can get there, and we have the doses, and a significant proportion of Americans turn them down, and then this epidemic goes on and on and on," he said. "I dearly hope that's not what we're looking at."

https://www.medscape.com/viewarticle/941388

Advice That Gave a Biotech Executive a Shot in the Arm

 In Personal Board of Directors, top business leaders talk about the people they turn to for advice, and how those people have shaped their perspective and helped them succeed. Previous installments from the series are here.

Michelle McMurry-Heath, the head of a global biotech-industry group, knows how to break the mold.

About two decades ago, she became the first Black graduate of Duke University with combined medical and doctoral degrees. This June, she became the first Black executive to run the Biotechnology Innovation Organization. BIO represents about 700 small and big biotech companies.

Dr. McMurry-Heath aims to shake up the status quo in an industry that's dominated by white men, criticized for high drug costs -- and struggling to end the pandemic through accelerated research. BIO members include statrtup Moderna Inc. and industry powerhouse Pfizer Inc., which are backing competing vaccine candidates that were revealed in recent days to have shown efficacy rates of more than 90%.

Among other things, Dr. McMurry-Heath champions greater minority participation during clinical trials of potential Covid-19 vaccines

"Improved access to scientific innovation is a social-justice issue," the 50-year-old BIO leader contends. Otherwise, "we are locking underserved communities into inequality for generations to come."

Dr. McMurry-Heath took BIO's top spot after her mostly female mentors assured her that she was ready to be a chief executive. They also proposed that the novice CEO overcome possible weaknesses by building a diverse leadership team whose different strengths "make a stronger whole, " she says.

Born and raised in Oakland, Calif., she declared at age 8 that she wanted to be a doctor -- or president of the United States. Caring for vulnerable people essentially "was in the drinking water when I grew up, " Dr. McMurry-Heath recalls.

Her mother, a public-health nurse, worked to reduce local infant mortality. Her father, a U.S. government psychologist, helped design substance-abuse programs for Native American reservations.

Dr. McMurry-Heath majored in biochemistry at Harvard University, where she met her future first husband. He was battling cystic fibrosis. Her Harvard roommate had a severe bout of lupus during their first year.

She says she obtained medical and immunology degrees in order "to take care of ill patients, but also discover new scientific solutions for serious illnesses." The young physician-scientist decided to pursue a science policy career, working for U.S. Sen. Joe Lieberman and two thinktanks.

In 2010, Dr. McMurry-Heath landed at the U.S. Food and Drug Administration as an associate director of its Center for Devices and Radiological Health. She expanded patients' involvement in medical-device development by spearheading the creation of an unusual public-private partnership that included patient groups.

The difficult effort "took us nearly two years," she observes. "I poured my heart and soul into that."

At the end of 2014, Dr. McMurry-Heath took an executive position at health care giant Johnson & Johnson. She initially focused on regulatory affairs for its medical devices. She eventually gained a wider management role, overseeing about 900 staffers.

"I don't shy away from taking a dramatic career step," she points out. However, "I never take those steps lightly." Dr. McMurry-Heath relies on her personal board to guide her professional progress. Here are four of her most trusted advisers:

Dr. Margaret "Peggy" Hamburg

Former foreign secretary for the National Academy of Medicine and former commissioner of the U.S. Food and Drug Administration

The women met in 2002 when Dr. McMurry-Heath was drafting a bioterrorism preparedness bill for Sen. Lieberman to co-sponsor. Dr. Hamburg was a vice president of the Nuclear Threat Initiative. The nonprofit organization tries to prevent catastrophic attacks from weapons of mass destruction.

Dr. Hamburg hired Dr. McMurry-Heath during a subsequent stint as FDA commissioner. She recommended that her recruit cope with the fairly fractious world of medical devices by embracing a highly collaborative managerial style.

"Never use an iron fist if you can use a velvet glove," Dr. Hamburg recollects telling her. Yet "never compromise your integrity or weaken your resolve."

Dr. McMurry-Heath came to view Dr. Hamburg as an important role model, too. "Witnessing (her) grace under pressure still stays with me today."

Marsha B. Henderson

Retired associate FDA commissioner for women's health

Ms. Henderson became a highly valued adviser because she shrewdly understood the FDA's internal politics, according to Dr. McMurry-Heath.

The veteran agency official educated her less-seasoned associate about key power brokers and "which levers would be influential with those various centers of power," Dr. McMurry-Heath remarks.

Ms. Henderson also suggested that her mentee "stand firm and always look fabulous," Dr. McMurry-Heath adds. As a result, "I stopped apologizing for enjoying my style and my swagger."

Ms. Henderson says she encouraged Dr. McMurry-Heath to be her unique self without fear. "I think it worked!"

Dr. Shamiram "Shami" Feinglass

Chief medical officer of Danaher Corp.

Drs. Feinglass and McMurry-Heath discovered they shared similar childhoods following a 2010 FDA public meeting. The latter served on that meeting's panel about scant racial and gender diversity in the medical-device industry.

"We both grew up in the San Francisco Bay Area with mothers who were public-health workers and advocates," Dr. Feinglass remembers. "The drive for social justice runs deep and is something we both spend much time discussing."

At the time, Dr. Feinglass recently had quit a different U.S. government agency to join private industry. Her business experience proved useful later while Dr. McMurry-Heath was weighing J&J's job offer.

Dr. Feinglass persuaded her protégé to be a tough negotiator -- and retain a lawyer before she signed an employment contract with the company. Women often realize they must negotiate on their own behalf "a little bit late in their careers," Dr. McMurry-Heath concedes.

Michael Watkins

Co-founder of Genesis, a leadership-development consultancy

When J&J offered to pay for an executive coach, Dr. McMurry-Heath picked Dr. Watkins. The leadership-development specialist had previously counseled several of her colleagues there.

He has continued coaching Dr. McMurry-Heath since she arrived at BIO. "Michelle inherited an unusually complex political environment -- with a large board and a broad array of external stakeholders, all at a time of extraordinary turmoil," Dr. Watkins notes.

He says that's why he wanted the new chief to forge "less-than-obvious alliances" with BIO board members who have different interests and agendas.

Dr. McMurry-Heath also appreciated his reminder "to get to know people and listen before you necessarily act." So, she soon arranged individual Zoom video calls with 100 of the 106 BIO directors. She asked what they liked about the industry group and what drove them crazy.

The CEO intends to hold similar one-on-one sessions with the remaining BIO board members by year-end. Despite her demanding job, she says she pushes hard "to do better tomorrow than I did the day before."

Challenging herself in this way "makes me the most creative," Dr. McMurry-Heath explains. And "it keeps me from resting on my laurels."

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-The-Advice-That-Gave-a-Biotech-Executive-a-Shot-in-the-Arm-31841982/

Demanding Thanksgiving Abstinence Is Not Public Health

 This week, a survey reported that 38% of people planned to gather with 10 or more people for Thanksgiving, and just a third said they would wear a mask. Twitter reacted predictably. Public health experts and doctors pointed to rising COVID-19 case numbers in many states and scolded (often in all caps): DO NOT HAVE THANKSGIVING.

Of course, there is no doubt that large gatherings, indoors, and without masks is a recipe for the rapid spread of SARS-CoV-2, but at the same time, I worry that the abstinence-only approach -- the just-don't-have-Thanksgiving approach -- is not the right way for public health experts to respond.

First, I take the poll seriously. I do not doubt that many Americans strongly desire to gather for Thanksgiving. If anything, I worry the poll is an underestimate, as people are often reluctant to divulge socially unacceptable desires.

Second, I think public health experts should not just listen, but hear what people are saying. Americans are saying that despite all the damage done by COVID-19, despite the rising cases and at-capacity ICUs around the country, their desire for human connection is so great, that they are willing to take the risk and have Thanksgiving. Americans are, in effect, expressing the longing and desperation of their soul.

And, who can blame them? Human beings desire water, food, sleep, sex, and social connections, and not necessarily in that order. It is natural and expected that, after a hard year, people will crave the normalcy and social connections of Thanksgiving. So much so that they are even willing to take risks.

Instead of admonishing people to not gather, public health experts should begin from the starting point that people really want this -- correction, people are saying they need this. Given that the desire is so strong, what advice can we give to minimize the risk? How can we reduce -- not eliminate risk.

Public health then becomes a series of interlocked questions: What advice should we be providing about home quarantining and testing prior to the gathering? What can be done at the gathering site itself? Can we do as much as possible outside? Should governments close streets, set up tables, and provide outdoor heat lamps? Would that not be better than driving people inside? And, what can we do after Thanksgiving, how long should people isolate themselves before resuming daily socially distanced activities?

In other words, what we need is to assume people will meet: Given that, what can we do to lower the risk?

The truth of public health is that it is a service industry; it is not meant to imprison, but to empower. The reality is that minimizing risk is also often the prudent strategy. It can lead to the greatest success. An abstinence-only message might mean people defy you, spend more time indoors (to avoid being judged), and end up spreading the virus far more than if you gave them safer options. In an effort to aim for perfect, we end up doing a worse job than had we lowered our ambition from the outset. Just as with sex education, abstinence-only approaches may even backfire. Ideas and strategies to lower the risk is a better path forward.

Finally, I feel obliged to end this column with an observation about the dangers of social media. The news stories about American's Thanksgiving plans was instant clickbait for doctors; they could not help themselves from tweeting messages admonishing folks to not meet in person. These tweets earned massive likes and retweets. No tweet advising the nuanced idea I describe went viral.

My worry is that the very nature of the modern media ecosystem is to promote messages that spark anger, shame, and fear. The original article hits these emotions. Doctors then tweet messages that amplify the 'shame on them' message and escalate tensions. The reward system of Twitter gives these actors positive feedback with likes and retweets. Nuanced messages, pleas for moderation, rarely dominate. In short, the powerful tool of social media is remarkably ill-suited to provide effective messages in a public health crisis. Deeper reflection is needed to heal the way in which we communicate to the public.

Americans have admitted that they will meet for Thanksgiving. Scolding and shaming them for wanting this is unlikely to slow the spread of SARS-CoV-2, though it may earn you likes and retweets. Starting with compassion, and thinking of ways they can meet, but as safely as possible, is the task of real public health. Now is the time to save public health from social media.

Vinay Prasad, MD, MPH, is a hematologist-oncologist and associate professor of medicine at the University of California San Francisco, and author of Malignant: How Bad Policy and Bad Evidence Harm People With Cancer.

https://www.medpagetoday.com/blogs/vinay-prasad/89760

AstraZeneca starts new COVID-19 prevention trials of antibody cocktail

 AstraZenecaAZN.L started late-stage trials on Saturday of an experimental long-acting monoclonal antibody combination drug it hopes could be used as a so-called prophylactic to prevent COVID-19 infection in at-risk people for up to 12 months.

The Phase III international clinical trial will recruit a total of 5,000 people across countries in Europe and the United States to assess the safety and effectiveness of the antibody cocktail, known as AZD7442.

The prophylactic treatment differs from a vaccine in that it introduces antibodies, rather than prompting the body’s immune system to make them. It may prove useful in people whose immune systems are weaker or compromised, and who don’t respond to vaccination. Separately, AstraZeneca is developing a COVID-19 vaccine in conjunction with researchers at Oxford University.

In Britain, where the trials of the monoclonal antibody combination kicked off on Saturday, 1,000 participants will be recruited at nine sites, researchers leading the UK arm said.

“What we are investigating in this study is whether we can provide protection by giving antibodies that have been shown to neutralise the virus, by injection into the muscle,” said said Andrew Ustianowski, a professor and chief investigator on the UK study.

“The hope is that this will then provide good protection for many months against infection.”

Monoclonal antibodies mimic natural antibodies that the body generates to fight off infection. They can be synthesised in the laboratory and are already used to treat some types of cancer.

AstraZeneca said its COVID-19 cocktail - which combines two monoclonal antibodies - has the potential both to treat and prevent disease progression in patients already infected with the SARS-CoV-2 virus, and to be given as a preventative medication prior to people such as healthcare workers being exposed to the virus.

“These have been engineered specifically to have what we call a long half-life, (so) we think they will confer protection for (at least) six, but more likely closer to 12 months,” Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals R&D, told reporters at a briefing.

He said this made the cocktail, “in effect, almost like a passive vaccination.”

Alongside the 5,000-participant trial assessing the drug’s potential as a preventative, AstraZeneca also plans to evaluate AZD7442 as a post-exposure preventative and pre-emptive treatment in roughly 1,100 participants in trials in Europe and the United States.

The U.S. government last month awarded $486 million to AstraZeneca to develop and secure supplies of up to 100,000 doses of the COVID-19 cocktail.

The UK government also has an in-principle agreement with AstraZeneca which it says secures access to a million doses of AZD7442 if it is successful in Phase III trials.

Under a plan to set up a global production network, Astra in October enlisted contract manufacturer Lonza LONN.S to produce the drug in Portsmouth, New Hampshire, starting in the first half of 2021.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-antibo/astrazeneca-starts-new-covid-19-prevention-trials-of-antibody-cocktail-idUSKBN281003

FDA OK's Eiger BioPharma's Hutchinson-Gilford treatment

 

• Eiger BioPharmaceuticals (NASDAQ:EIGR) +11.6% after-hours on news that the U.S. Food and Drug Administration granted approval of its Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of some processing-deficient progeroid laminopathies.
• Progeria and progeroid laminopathies are separate ultra-rare, genetic, premature aging diseases that accelerate mortality in young patients.
• Earlier this week, Eiger BioPharma reported positive end-of-study reports for its peginterferon lambda-lonafarnib combination in treatment of hepatitis delta virus.
• https://seekingalpha.com/news/3638513-fda-oks-eiger-biopharmas-hutchinson-gilford-treatment