AstraZeneca to seek U.S. authorization for COVID-19 vaccine within weeks

 AstraZeneca Plc is preparing to file for U.S. emergency use authorization (EUA) for its COVID-19 vaccine later this month or early April after accumulating enough data to judge the inoculation’s efficacy, sources with knowledge of the ongoing clinical trial told Reuters on Friday.

The British drugmaker completed enrollment in its trial of more than 32,000 volunteers in January and now has data on at least 150 cases of COVID-19, two sources familiar with the trial told Reuters.

The number of COVID-19 cases among those who got the vaccine versus infections in participants who received a placebo will show how effective the AstraZeneca shot was at preventing illness in those age 18 and over.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorized for use in theEuropean Union and many countries but not yet by U.S. regulators.

“The U.S. Phase III study results are necessary for the FDA’s evaluation of an EUA request for our vaccine,” a company spokeswoman said, without confirming trial details being reported by Reuters. “We expect data from our U.S. Phase III trial to be available soon, in the coming weeks, and we plan to file for emergency use authorization shortly thereafter.”

Highly anticipated results from the U.S. trial could help settle safety concerns arising over reports of serious blood clots in some vaccine recipients that have led several nations to pause administering the vaccine.

A World Health Organization expert advisory committee islooking into the matter.

The data could also help determine what becomes of doses already sitting in U.S. warehouses awaiting approval. The New York Times reported on Thursday that some countries have been asking to procure doses of the vaccine not currently being offered in the United States.

AstraZeneca said in February it expects its vaccine could receive U.S. emergency use authorization at the beginning of April and could immediately deliver 30 million doses to locations around the United States.

In a Friday press briefing, White House Coronavirus Response Coordinator Jeff Zients said the United States has a small inventory of the AstraZeneca vaccine, which it plans to keep and deploy to Americans should an EUA be granted.

The U.S. stance could thwart AstraZeneca’s efforts to come closer to delivering on its contractual obligation with the EU of 180 million doses in the second quarter.

AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a bigger reduction in the first three months of the year.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca/exclusive-astrazeneca-to-seek-u-s-authorization-for-covid-19-vaccine-this-month-or-early-next-sources-idUSKBN2B42JN

Amazon Canada asked to shut Brampton facility on COVID-19 concerns

 Amazon.com Inc's Canada division has been ordered to close its Brampton facility in southern Ontario, with workers being asked to self-isolate for 14 days, according to a statement from Peel Public Health on Friday.

Over the past few weeks, the rate of COVID-19 infection across Peel has been decreasing while the rate inside Amazon's fulfillment center has been increasing significantly, according to Peel Public Health. (https://bit.ly/38uDnOn)

Amazon said it will appeal the decision, adding that the facility closure may have some short-term impact on its Canadian customers.

The company said that in its most recent round of mandatory testing in the facility, COVID-19 positive cases were less than 1%.

Peel Public Health said a current investigation determined high-risk exposure to COVID-19 for everyone working at the facility cannot be ruled out.

All employees will be required to self-isolate through March 27, unless they have tested positive in the last 90 days and completed their isolation period, the health agency said.

Last month, New York's Attorney General Letitia James sued Amazon over its handling of worker safety issues related to the pandemic at two warehouses, a Staten Island fulfillment center and a Queens distribution center, both in New York City.

https://news.trust.org/item/20210312221935-c50xs/

Most hospital workers don't have greater risk of COVID-19 due to job: study

 

• A new JAMA Network Open study has concluded that most hospital workers are no more at risk of contracting COVID-19 from their jobs than being out in the community.
• Researchers from Emory University, Johns Hopkins University, the University of Maryland, Rush University Medical Center and the Centers for Disease Control and Prevention questioned nearly 25,000 front-line healthcare workers and tested them for the presence of COVID-19 antibodies.
• The authors concluded the "findings provide reassurance that current infection prevention practices in diverse healthcare settings are effective in preventing transmission of SARS-CoV-2 from patients to [providers]."
• The study found that even nurses, who have the most patient contact, were not at a greater risk of contracting the novel coronavirus because of their work.

Individual workers who had contact with someone who had COVID-19 were far more likely to have antibodies in their blood than those with no known contact, as were those who worked in hospital emergency rooms.

However, "there was no clear association between workplace contact with patients with COVID-19 and antibody positivity," the study concluded.

Despite the fact that healthcare workers aren't being exposed to COVID-19 at a rate greater than other groups, the study's authors said they should be given priority for vaccination due to "their continual potential exposures in the workplace, the importance of preserving healthcare capacity, and the risk of transmitting the virus from infected [healthcare workers] to a large number of at-risk patients."

As of Tuesday, the CDC had counted more than 421,000 cases of COVID-19 among healthcare workers in the U.S and 1,391 deaths. That is almost certain to be an undercount, however, as that occupation information was only available in a small subset of the data.

The agency still recommends a "conservative approach" to monitoring infections and applying work restrictions for healthcare workers, depending on community spread in an area.

In the JAMA Network Open study, nearly 70% of those who were tested were younger than age 50; 78.2% were women; 61.2% were White, and 20.7% were Black. Among the workers, 87.1% were employed in an acute care hospital setting; 5.3% in an ambulatory care setting and 2.5% in a rehabilitation setting.

The overall positivity rate for COVID-19 antibodies was 4.4%, and was fairly consistent among all of the settings. They ranged from 3.2% at the University of Maryland Medical Center to 5.7% at Emory.

Among age groups, those over the age of 60 who worked at Johns Hopkins had the highest positivity rate, 7.5%. Among ethnicities, Black workers at Emory had the highest positivity rate, at 8.2%, and White workers had positivity rates ranging from 2.2% at the University of Maryland to 4.6% at Johns Hopkins.

Among specific jobs, employees in environmental services had the highest exposure rate, averaging 7.4%, more than 50% higher than nurses (4.8%) and more than double that of nurse practitioners/physician assistants (3.5%).

Physicians had a positivity rate of 3.7%, slightly lower than the exposure rate among non-clinical employees (3.9%). Workers in hospital emergency departments also had a higher positivity rate (5.3%).

https://www.healthcaredive.com/news/most-hospital-workers-dont-have-greater-risk-of-covid-19-due-to-their-jobs/596433/

Vaccine factories churn out millions more doses, speeding US rollout

 Last Saturday, nearly three million people in the U.S. were vaccinated with one of the three coronavirus shots now authorized by the Food and Drug Administration, a record. At the current rate of daily doses, President Joe Biden could meet his goal of 100 million shots in the first 100 days of his administration well ahead of schedule.

But while the Biden White House took steps to improve distribution and administration, a good deal of the sped-up pace of vaccinations is due to millions more vials rolling off manufacturing lines at Pfizer, Moderna and, most recently, Johnson & Johnson factories.

This month appears to be an inflection point in production, constraints on which have hampered vaccine rollout since December and limited availability to prioritized groups like healthcare workers and older adults.

Pfizer is now churning out more than 13 million doses of its shot per week in the U.S., double its rate a month ago. Moderna, which works with the Swiss contract drugmaker Lonza, also expects its U.S. production to double to more than 40 million doses per month by April.

J&J is further behind, having won FDA authorization for its one-shot vaccine late last month, but has said it will ship 20 million doses by the end of March.

"The result is that we're now on track to have enough vaccine supply for every American adult by the end of May," said Biden at a Wednesday event highlighting a manufacturing collaboration between J&J and Merck & Co. The president had previously promised enough supply by the end of July.

Streamlining production

The current scale-up is the result of many things, including substantial federal funding and government intervention to ensure vaccine makers get needed manufacturing supplies. FDA permission to extract more doses from each vial of Pfizer's and Moderna's vaccines has also helped.

One especially significant factor, however, is the growing familiarity companies have with producing the shots, allowing their factories to work out production kinks and boost yields.

"The biggest gain we've seen — as we've now moved to 9, 10 million doses a week — has been really the incredible advances of the highly skilled personnel who are operating each step of the process," Moderna President Stephen Hoge told lawmakers on the House Energy and Commerce committee at a Feb. 23 hearing.

Both Pfizer's and Moderna's vaccines rely on messenger RNA to prime the body's defenses against coronavirus infection. The technology is newer and, until last year, had never been scaled up to support commercial manufacturing.

In Pfizer's case, production principally takes place at factories in St. Louis; Andover, Massachusetts; and Kalamazoo, Michigan. Initially, making one batch took roughly 110 days, a timeline the company has now worked down to an average of 60 days.

About 12 of those days are spent at the Kalamazoo plant, where Pfizer wraps the messenger RNA vaccine product into a protective bubble known as a lipid nanoparticle as well as fills and finishes vials.

About 800 staff at Kalamazoo are working on making Pfizer's vaccine, said Chaz Calitri, a company executive who manages operations at the plant. They've had success streamlining their processes, such as reducing the rejection rate on the vial inspection line from about 5% initially to between 1% and 2%.

The factory also developed a way to reuse special filters that it had trouble procuring, and has begun making its own dry ice for storage on site. (The U.S. has also helped to secure supplies through the Defense Production Act.)

"We keep looking at output capacities, at the next bottleneck and what we need to overcome that," Calitri said. "Even as we add more formulation and filling capabilities, that has requirements downstream like [needing more] freezers."

For example, Pfizer has started producing its own lipids, setting one of its sites in Connecticut to the task, and will use a facility in Kansas to help out Kalamazoo with filling and finishing vials.

Making up ground

The progress on manufacturing contrasts with early struggles that led Pfizer to cut production forecasts ahead of its shot's U.S. authorization, and slowed production by J&J.

Over the course of last summer, Pfizer had promised 100 million doses would be ready by the end of 2020, a target it had reduced by half by the time study results showed the shot to be highly protective against COVID-19.

J&J's original supply contract with the U.S. government, meanwhile, had committed the drugmaker at delivery of 12 million doses by the end of February. But when its vaccine was authorized Feb. 27, J&J only had 3.9 million shots ready to go.

The pharma company hasn't specified what was behind the delays. A recent report by the Financial Times indicated slower-than-expected technology transfer between facilities and problems at a contract suppliers played a role.

https://www.biopharmadive.com/news/vaccine-factories-churn-out-millions-more-doses-speeding-us-rollout-of-cor/596561/

2021 could be year of healthcare SPAC deals and unicorns ripe to go public

 Healthcare unicorn exit activity including IPOs and mergers and acquisitions reached record levels in 2020.

Last year, there were seven healthcare unicorns or private companies valued at or above $1 billion, that exited—a clear uptick from the two exits in 2018 and four in 2019, according to market intelligence company CB Insights.

These exits include primary care startup One Medical (January 2020), biopharma company CureVac (August 2020), and cancer liquid biopsy startup Grail (September 2020).

Since 2016, there have been 19 healthcare companies with valuations of $1 billion that have exited the private market, from GoodRx's $12.7 billion public offering to Illumina's massive $8 billion purchase of Grail.

Globally, there are 51 healthcare unicorns that have an aggregate valuation of $118.1 billion, CB Insights reported.

Based on healthcare investment trends in 2021 to date, CB Insights is projecting that digital health exits are on pace to reach new heights in 2021. Exits could rise 60% quarter-over-quarter, with both IPOs and M&A deals rising to new highs (19 and 60, respectively), in the quarter, the firm said. That compares to 10 digital health IPOs in 2020 and 40 M&A deals, according to CB Insights data.

So far this year, unicorns like 23andMe and Talkspace have announced their exits.

What's driving this uptick in digital health exit activity?

"One word: SPACs. Quarter-to-date, as of Feb. 25, we’ve seen seven digital health SPACs. For context, that’s more than double the number seen in the fourth quarter of 2020 and equal to the amount seen in all of 2020. Before 2020, digital health SPACs were rare," CB Insights senior intelligence analyst Marissa Schlueter told Fierce Healthcare.

As COVID-19 created uncertainty in public markets, 2020 saw a surge in the formation of special purpose acquisition companies (SPACs)—“blank check” shell corporations designed to take companies public without going through the lengthy traditional IPO process.

Since 2020, five late-stage (Series D+) healthcare unicorns—including Butterfly Network, 23andMe, and Hims—have looked to SPACs as a way to go public, with the potential benefit of a faster, more reliable exit pathway.

"Valuations seem to be at all-time highs for digital health companies given the need to shift to digital solutions during the pandemic, including telehealth, remote patient monitoring, and connected medical devices, and even extending to healthcare software that helps to streamline healthcare administration to make it more efficient and cost-effective," Schlueter said.

SPAC deals represent a great alternative for some companies that may be less mature in order to navigate to the public markets without a lengthy IPO process, she noted.

Across all industries, SPAC deals outpaced traditional IPOs, according to data from Goldman Sachs. In mid-December, the investment bank reported that 219 SPACS raised $73 billion, representing a year-over-year jump of 462% and outpacing traditional IPOs by $6 billion. IPOs raised $67 billion in 2020, according to Goldman Sachs.

So far in 2021, there have been 145 SPAC deals that have raised more than $44.5 billion, according to data from SPAC Insider. That compares with 55 traditional IPOs that have raised $21.7 billion so far this year, per data from IPO research firm Renaissance Capital.

All signs point to 2021 being the year of healthcare SPACs, Schlueter said, citing CB Insights data. 

With about 53 SPACs actively searching for target companies across the healthcare and life sciences industries according to SPAC Track, the industry could see more startups choose to go public via this exit pathway throughout 2021.

Just this week, another medical startup, Ambulnz, a company that offers medical mobility and transportation services, announced plans to go public through a merger with a blank check company in a deal that will value the combined entity at $1.1 billion.

Based on year-to-date activity, healthcare IPOs could be up 10% in 2021, M&A activity could rise by 35% and reverse mergers, which include SPAC deals, could jump 47% this year, Schlueter said.

Acquisition activity has been particularly robust in the healthcare space, outpacing mergers by more than 10-fold, she said.

"IoT-connected devices have been a notable focal point for manufacturers looking to lean more heavily into remote monitoring—with major players like Boston Scientific, Hill-Rom, and Stryker all making deals in the space. We’ve also seen a lot of activity in healthcare administration and provider workflow automation, a segment experiencing heightened demand right now as healthcare organizations seek ways to radically improve their efficiency and reduce costs," she said.

Unicorns to watch

The industry should expect to see more healthcare unicorn exits in the near term. About two-thirds (67%) of the current healthcare unicorns are late-stage and many of these companies will likely look to raise capital from public investors, according to CB Insights.

Overall, across the broader health tech market, there are numerous mature companies with investors seeking exits.

There are several hotly anticipated IPOs this year, including drug development company Atai Life Sciences that aims to make psychedelic drugs to treat mental health disorders. The startup is backed by Peter Thiel and investors plan to take Atai public this year at a valuation of between $1 and $2 billion, according to a CNBC report, citing an industry source that asked to remain anonymous due to the nature of the discussions.

Digital health companies with high valuations that could be in SPAC crosshairs include Babylon Health, K Health, Modern Health, Lyra Health, Virta Health and Hinge Health, Schlueter said.

Babylon offers a digital healthcare app for AI-powered diagnosis and video appointments. The company was last valued at $2 billion during a fundraise in 2019 and has raised more than $600 million to date.

Hinge Health, which launched in late 2014, offers a digital platform that uses wearable sensors and one-on-one health coaching to deliver in-home musculoskeletal therapy. With its latest $300 million funding round, it's considered one of the most valuable startups in digital health.

The company has raised $426 million to date, according to Crunchbase. The latest funding deal values Hinge Health at $3 billion, according to the company. The startup is eyeing a potential initial public offering in 2022.

K Health, which provides patients remote access to health care services through their smartphones, has raised $271 million to date. The startup is valued at $1.5 billion, according to TechCrunch.

Spurred by the demand for mental health services during the pandemic, Lyra Health is now worth more than $2 billion. The startup has raised close to half a billion, or $462 million, to date.

Modern Health is one of the fastest entirely women-founded companies in the U.S. to reach unicorn status, the company claims. Riding the wave of investor interest in virtual behavioral health startups, Modern Health has secured $170 million in less than two years and its valuation hit $1.17 billion.

However, Modern Health is in the midst of a messy breakup between the two co-founders. Co-founder Erica Johnson was terminated from the company after she raised ethical, legal, and liability concerns to a member of the board from Kleiner Perkins. Johnson is now suing both Modern Health and co-founder Alyson Friedensohn for breach of contract, wrongful termination, relation, and defamation.

https://www.fiercehealthcare.com/tech/why-2021-could-be-year-healthcare-spac-deals-and-unicorns-ripe-to-go-public

Why Seelos Therapeutics Stock Is Skyrocketing Today

 Shares of Seelos Therapeutics (NASDAQ:SEEL) were skyrocketing 35.2% higher as of 11:01 a.m. EST on Friday. The huge gain came after BTIG initiated coverage on the stock with a buy recommendation and a one-year price target nearly 4.7 times higher than Seelos' closing price on Thursday.

Investors shouldn't buy a biotech stock (or any other stock, for that matter) just because an analyst likes it. However, it's always a good idea to gain an understanding of the reasons behind the bullish view.

In this case, BTIG analyst Robert Hazlett likes the prospects for Seelos' pipeline. Last week, the biotech announced that it had completed enrollment in a pivotal proof-of-concept study evaluating SLS-002 in treating acute suicidal ideation and behavior in patients with major depressive disorder. 

Seelos also has two other clinical-stage candidates. It's evaluating SLS-005 in phase 2 studies for three neurodegenerative disorders: amyotrophic lateral sclerosis (ALS), rare genetic disease Sanfilippo syndrome, and oculopharyngeal muscular dystrophy.

The drugmaker should report key data from its study of SLS-002 in the second quarter of this year. Seelos also plans to advance SLS-005 into a pivotal phase 2b/3 clinical study targeting ALS in the first half of the year.

https://www.fool.com/investing/2021/03/12/why-seelos-therapeutics-stock-is-skyrocketing-toda/

Hospital security camera breach exposes risks of connected devices

 Hospitals have suffered waves of cyberattacks as hackers target medical IT systems looking for valuable patient data. Now, hospitals have to consider another alarming threat—security cameras.

Disturbing news broke Tuesday that a group of hackers claimed to have breached a massive trove of security camera data collected by Silicon Valley startup Verkada Inc., gaining access to live feeds of 150,000 surveillance cameras inside hospitals, companies, police departments, prisons and schools, Bloomberg reported.

Hackers were able to view video from inside women’s health clinics, psychiatric hospitals and the offices of Verkada itself. In a video seen by Bloomberg, a Verkada camera inside Florida hospital Halifax Health showed what appeared to be eight hospital staffers tackling a man and pinning him to a bed, the publication reported. A spokesman for Halifax confirmed Wednesday that it uses Verkada cameras but added that “we believe the scope of the situation is limited," Bloomberg reported.

The data breach was carried out by an international hacker collective and intended to show the pervasiveness of video surveillance and the ease with which systems could be broken into.

For hospitals and health systems, the security camera breach raises red flags about the vulnerabilities of connected devices that are increasingly used in healthcare, said Jeff Horne, chief security officer of Ordr, a company that provides security for connected devices.

"Security is not one-dimensional, and while organizations might point to the faults in Verkada’s practices, the ownness is not solely on the supplier or manufacturer—although this point can be argued at length," he said. "Organizations must look at the rapid growth of connected devices as an opportunity to start maintaining a continuous and accurate inventory, a true understanding of how those devices communicate, automate alerts based on any device or group of devices that act outside of a set baseline, and automate proper segmentation of devices as to not let lateral movement inside your network via the devices, and always make sure that admin maintenance accounts are secured properly."

Third-party vendors raise the stakes 

Third-party attacks accounted for more than a quarter of healthcare breaches over the last year, resulting in nearly 12 million healthcare records being exposed, according to cybersecurity firm Tenable.

In fact, 75 breaches were linked back to third-party vendors. The breach of a single company accounted for over 10 million records exposed and has been traced back to 61 healthcare customers.

The Tenable Security Response Team analyzed publicly available healthcare breach data from January 2020 to February 2021 and detailed the findings in a March 10 blog post.

Even if a company takes strong security measures, a third party could make that organization vulnerable by sharing data and systems, noted Rody Quinlan, Tenable’s security response manager and the report's author.

“A third-party breach is just as damaging as a direct attack, as the end result is the same: compromised data,” Quinlan told Fierce Healthcare. “Threat actors can choose to hold this personally identifiable information (PII) for ransom and extort the vendor or root company. This PII also holds monetary value and can be sold and leveraged in scams and identity theft.” 

In fact, Quinlan noted the monetary value of PII from people who have scheduled or received vaccines. Knight Ink cybersecurity researcher Alissa Knight recently called personal health information the most valuable data on the dark web and “10 times more the price of a credit card for a single PHI record.”

Healthcare data breaches can cost a company $7.13 million on average, according to IBM Security’s 2020 data breach cost report.

In its report, Tenable found 237 breaches occurred in healthcare in 2020 with 56 breaches so far in 2021 as of Feb. 28. Ransomware was a key problem and accounted for 55% of the healthcare breaches in the Tenable data.

“Unfortunately, bad actors capitalized on the critical services that healthcare facilities were offering by locking and holding their systems for ransom,” Quinlan said.

In particular, bad actors attacked healthcare organizations with a type of ransomware called Ryuk, which targets and encrypts files to make them inaccessible. Users can only recover the data if they store backups on a separate system and network, Quinlan noted.

“In the case of healthcare, this can mean a lack of access to hospital systems and patient medical records which can be life-threatening in some instances,” Quinlan said. “Ryuk leverages these scenarios to demand a ransom in return for a decryption key to restore access to affected systems.”

Of the healthcare organizations breached, 30% were healthcare systems, 19% were hospitals and 6% were mental health care facilities. In addition to the ransomware threats, 21% of the cases were due to email compromise/phishing, 7% consisted of insider threats and 3% were caused by unsecured databases.

The COVID-19 pandemic coincided with an increased security threat to healthcare organizations in 2020. Greater demand for telehealth, COVID-19 contact tracing data, medical manufacturing and medical research on a cure for COVID-19 has fueled the rise in healthcare breaches, according to Quinlan.

“The demands placed on the sector skyrocketed practically overnight, which made it a ripe target for bad actors,” Quinlan said. “This is precisely why we saw such a surge in attacks targeting hospitals and other healthcare facilities.” 

To address cybersecurity threats in healthcare, organizations should prioritize vulnerabilities they face and patch target vulnerabilities, according to Quinlan. Companies should also conduct regular security checkups and provide security awareness training, he advised.

“Addressing the human vulnerability is a step in the right direction, providing security awareness training highlighting the risks of malicious email and phishing campaigns,” Quinlan said. “Business-critical vulnerabilities should also be identified, prioritized and remediated as these are likely to be key actor vectors leveraged to gain entry or compromise systems.”

https://www.fiercehealthcare.com/tech/hackers-breach-hospital-surveillance-cameras-exposing-risks-device-security