Twitter Slaps 'Unsafe' Label On American Heart Association mRNA Vaccine Warning

 Twitter has slapped an "unsafe link" warning on a study from the American Heart Association which found that mRNA vaccines dramatically increase risk of developing heart diseases from 11% to 25%.

As of this writing, when one clicks on the link in the below tweet...

This warning, which ZeroHedge followers are no stranger to, pops up, requiring one to click "Ignore this warning and continue" before they can proceed to the American Heart Association's website:

One Twitter user, however, noted that an "expression of concern" was filed over the AHA study, noting that there are "several typographical errors" and "no data in the abstract regarding myocardial T-cell infiltration" or "statistical analyses for significance provided."

That said, Twitter's warning says that the link was identified as being "potentially spammy or unsafe," and could contain:

• malicious links that could steal personal information or harm electronic devices
• spammy links that mislead people or disrupt their experience
• violent or misleading content that could lead to real-world harm
• certain categories of content that, if posted directly on Twitter, are a violation of the Twitter Rules

It's unclear as to which of these warrants the label. 

https://www.zerohedge.com/covid-19/twitter-slaps-unsafe-label-american-heart-association-mrna-vaccine-warning

United CEO estimates airline will see smaller financial hit from omicron than delta

 The chief executive officer of United Airlines during an interview with CNBC on Wednesday estimated that while the omicron variant might affect their bookings and revenue, the airline would ultimately suffer a smaller hit than it during the delta wave.

“We've said ... the recovery from COVID will never be a straight line ... Omicron is almost certainly — it's too early to really tell, but it's going to certainly have a near-term impact on bookings. Bookings are going to be lower than they otherwise would have been,” United CEO Scott Kirby told CNBC.

“But you know, I think this will be three steps forward, one step backwards. Delta was two steps forward, and one step back, and the next variable will be four steps forward and one back. We're much better at dealing with this as a society,” he continued.

Kirby estimated that the vaccines would likely be effective at curbing the spread of the new variant, and he noted that even though the airlines might see a small dip in revenue, “the dip will be much smaller than it was for delta.”

Kirby’s comments come as airlines determine how to tackle the emergence of the newly detected omicron variant, which has made its way into a number of countries within the span of days. Several countries have instituted travel restrictions to curb spread of the variant.

The first case of omicron found in the U.S. was detected on Wednesday in California. Health officials previously noted that the variant would likely make its way into the country given its prevalence in southern Africa, Europe and elsewhere.

Health officials have pleaded with Americans to get their vaccines if they have not done so already and to get their booster shots if they are eligible. 

"[T]he fact is that people should wind up getting vaccinated and boosted if they’re eligible for a boost. I keep coming back to that because that’s really the solution to this problem," President Biden’s chief medical adviser Anthony Fauci said at a White House press briefing on Wednesday.

https://thehill.com/policy/transportation/583878-united-ceo-estimates-airline-will-see-smaller-financial-hit-from

TSA extending mask mandate for domestic travel through March

 The Biden administration will extend the requirement that passengers on domestic flights, trains and public transportation wear face masks through mid-March amid concerns about the new omicron coronavirus variant.

President Biden will announce the policy on Thursday as part of a broader effort to combat the COVID-19 pandemic during the winter months.

The Transportation Security Administration (TSA) plans to extend the mask requirement through at least March 18, according to a White House fact sheet. The TSA last extended the mask mandate in August through January 2022.

Under the rules, individuals who do not comply with the mandate will face a minimum fine of $500 with repeat offenders facing fines as high as $3,000.

The Centers for Disease Control and Prevention currently recommends people wear face masks in areas of high transmission of the coronavirus. Public health officials have urged mask use, particularly in crowded indoor settings, especially in light of the new omicron variant.

The administration has not instituted testing or COVID-19 vaccine requirements for domestic travel, as it has for international flights, though officials have indicated such requirements are not off the table.

As part of Biden’s announcement on Thursday, the administration is also implementing stricter requirements for pre-travel testing for international travelers.

Under the new rules, international travelers coming into the U.S. will need to present a negative COVID-19 test within one day of the flight regardless of vaccination status or nationality, rather than the current policy of three days. 

https://thehill.com/homenews/administration/583943-tsa-extending-mask-mandate-for-domestic-travel-through-march

States Didn't Follow CDC Recs to Prioritize COVID Vaccine for Cancer Patients

 Nearly two-thirds of states did not follow CDC guidelines to prioritize patients with cancer for the COVID-19 vaccine, a researcher reported, thereby "risking unnecessary morbidity and mortality, as this population is particularly vulnerable to COVID-19."

While 43 states included cancer patients as a priority subpopulation for COVID-19 vaccination during the initial rollout, only 8 precisely defined a qualifying cancer diagnosis and just 17 states (34%) gave patients with cancer the same immunization priority as those ages 65-74, according to Rahul Prasad, MD, MBA, a radiation oncologist at the Ohio State University Comprehensive Cancer Center in Columbus.

The problem was most likely that the CDC's definition of high-risk medical conditions was too broad, he noted.

"Although the CDC recommended that all states consider people with significant medical conditions to have equal vaccination priority with people over the age of 65, we found that nearly two-thirds of states did not give equal vaccination priority to patients with cancer," Prasad said in a presentation at the Radiological Society of North America annual meeting.

"I don't think anyone intended to push people to the back of the line," Rahul stated. "The [prioritization] efforts were well intentioned."

While the presentation may seem out of place at a radiology meeting, imaging is a major part of the cancer care continuum, and the imaging community this year played an integral role in identifying certain side effects from COVID-19 vaccines, such as post-vaccine myocarditis or lymphadenopathy, and axillary adenopathy on breast imaging.

In March, the American College of Radiology released a a list of resources to help radiologists care for recently vaccinated patients during screening or diagnostic imaging studies.

For their study, Prasad and colleagues conducted a search of every states' COVID vaccination webpage through a keyword-based internet search in order to identify data on vaccination for cancer patients. They pointed out that "Finding detailed vaccination information required significant computer literacy, as it routinely required navigation through multiple webpage subdomains."

Elliott Fishman, MD, professor of radiology, oncology, and surgery at Johns Hopkins University in Baltimore, commented that when vaccine rollouts take place, "you should always make sure that you take care of the highest risk patients first. I think we would all be comfortable saying that. Obviously, cancer patients are high-risk patients, although not every cancer patient is at the same risk."

However, patients on active cancer therapy, and those who have just completed therapy, should get vaccine priority, stated Fishman, who was not involved in the study. Regardless of the cancer patients' age, "it would make all the sense in the world that those patients should be prioritized first," he added.

Fishman noted that because this was a retrospective study, "you could say that this is water under the bridge...I think what we have to do is to figure out what to do with the next wave, or the next disease, and put in place knowledge of what went wrong [with vaccine rollout] to make sure that next time, things go right."

Prasad explained that initial limitations in vaccine supplies forced the CDC Advisory Committee on Immunization Practices to make difficult patient-prioritization decisions. People ages 16-64 with high-risk conditions were grouped into the final part of the first phase, along with people ages 65 to 74. However, this group encompassed 129 million people nationally, leading many states to sub-prioritize, he stated.

"You could have someone diagnosed with breast cancer at age 40, who is now 55 [and] in remission, and wondering if they're eligible," Prasad said. "On the other side of the spectrum, someone newly diagnosed with low-risk prostate cancer may not be particularly immunocompromised if they haven't started treatment yet."

Prasad's group stressed that policy interventions in future waves requiring boosters, or in other pandemics, should ensure timely vaccination of vulnerable populations to better mitigate disparities.

Disclosures

Prasad disclosed no relationships with industry.

Fishman disclosed relationships with Siemens and GE.

Primary Source

Radiological Society of North America

Source Reference: Prasad H, et al "Did patients with cancer receive priority COVID-19 vaccination?" RSNA 2021.

https://www.medpagetoday.com/meetingcoverage/rsna/95969

VBI Vaccines scores first FDA vaccine nod just as hep B market is set to expand

 VBI Vaccines has toiled a while to earn its first FDA approval. But for the Massachusetts-based company, the timing may be perfect.

In gaining a green light for its hepatitis B shot, VBI is poised to take advantage of what figures to be a growing market. A month ago, a CDC advisory committee voted unanimously to strengthen its recommendation for hepatitis B vaccination, saying that those aged 19 to 59 “should” receive shots. The current guidance for adults is that they “may” get the vaccine and only those deemed at risk “should” receive it.

With the FDA blessing, PreHevbrio joins three other hepatitis B shots on the market—Dynavax’s Heplisav-B, GlaxoSmithKline’s Engerix-B and Merck’s Recombivax HB.

Already approved in Israel, PreHevbrio is differentiated from the others as a three-antigen vaccine. In a head-to-head phase 3 trial, PreHevbrio provided higher seroprotection than the monovalent Engerix-B.

“The feedback we’re getting is that this is clearly a highly effective vaccine, which is safe and well-tolerated,” VBI CEO Jeff Baxter said during an investor’s call. “And particularly, statistically, significantly, we are better in adults age 45 and over.”

The next order of business for VBI will be to receive endorsement from the Advisory Committee on Immunization Practices.

“Just getting that recommendation alongside (the others) is a very important first step,” Baxter said. “That creates a level playing field for PreHevbrio to compete against those vaccines.”

Baxter expects a nod from the ACIP to come before the end of the first quarter of 2022, provided that COVID variants don’t “hijack” the work of the committee, he said.

The FDA based its approval on two phase 3 studies showing PreHevbrio elicited higher rates of seroprotection compared with Engerix-B in subjects age 18 and older (91% vs. 76%) and 45 and older (89% vs. 73%). The safety analysis of both studies demonstrated good tolerability with no unexpected reactions.

Hepatitis B has infected more than 290 million people globally. HBV is the leading cause of liver disease and, with current treatments, is difficult to cure. Many patients go on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

Low awareness of HBV leads to increased risk of transmission, with 68% of chronically infected adults unaware of their infection status. With adult vaccination rates remaining persistently low at around 25% for adults 19 and older, approximately 200 million adults are left unprotected.

The World Health Organization has established a goal of eliminating HBV by 2030.

Baxter said he expects the recommendation from the CDC will expand the market from $320 million per year in the United States to more than $500 million a year, with Europe and China likely to follow.

“We could be launching into a very hot market for the next several years,” Baxter said.

https://www.fiercepharma.com/pharma/for-vbi-vaccines-timing-right-as-fda-nod-for-its-hepatitis-b-shot-comes-as-market-set-to

Large biopharma companies will have $1.7T in dealmaking firepower next year: analyst

 Merger and acquisition activity has been rather slow in the biopharma industry so far this year. But, by one team of analysts’ calculations, large drugmakers will have big piles of cash to deploy in 2022.

Eighteen large-cap U.S. and European biopharmas will have more than $500 billion in cash on hand by the end of 2022, SVB Leerink analyst Geoffrey Porges and his team wrote in a Wednesday note. The companies could use the money to strike deals, pay down debt or offer returns to shareholders through dividends or share buybacks, the analysts said.

Because the companies can leverage their assets to borrow additional capital, the theoretical firepower of the 18 drugmakers would be enormous at more than $1.7 trillion, the analysts wrote.

Out of 18 companies Porges's team looked at, 12 are expected to have more than $20 billion in cash by the end of 2022 when excluding existing debt. Even after factoring in debt, Porges expects Pfizer, Moderna, Johnson & Johnson, Novartis and BioNTech to have net cash of more than $20 billion.

Meanwhile, the team expects Regeneron, Vertex, Novo Nordisk and GlaxoSmithKline to have between $11 billion and $18 billion in cash on hand when including debt.

Based on the companies’ cash positions and potential room to take on new debt, Porges said the 18 biopharma majors will have $1.72 trillion in M&A capacity. J&J topped the list with more than $200 billion in M&A firepower. Pfizer and Novartis followed with $175 billion and $154 billion, respectively. AbbVie, GSK, Bristol Myers Squibb and Merck will each boast more than $100 billion in firepower, the team figures.

For the analysis, Porges and team used Wall Street’s consensus estimates to come up with each company’s cash flow by the end of next year. Some companies are benefiting from major one-time events. Novartis is getting $20.7 billion from selling its 20-year investment in Roche. GSK and Pfizer are expected to get an inflow of $27.7 billion and $16.3 billion, respectively, by spinning off their consumer health joint venture, which is planned for mid-2022. The analysis didn’t seem to consider J&J’s planned spinoff of its world-leading consumer health franchise, a process the New Jersey corporation expects could take nearly two years to complete.

For their part, Pfizer, BioNTech and Moderna are getting a major windfall from sales of their COVID-19 vaccines and treatments. Pfizer, for one, could see $84 billion in total sales from its BioNTech-partnered COVID vaccine Comirnaty and its yet-to-be-authorized oral antiviral Paxlovid between 2021 and 2023, according to consensus estimates cited by Porges.

But having cash on hand doesn’t necessarily translate into busy M&A activity. Take 2021, for example: At the end of 2020, PwC estimated the biopharma industry had $1.47 trillion in firepower that it could use for M&A. But the largest buyout announced this year involving two drugmakers was Merck & Co.’s $11.5 billion acquisition of Acceleron. The only other deal that exceeded $5 billion was Jazz Pharmaceuticals' $7.2 billion takeover of GW Pharma.

By contrast, 2020’s largest deal was AstraZeneca’s $39 billion purchase of Alexion. Altogether, three M&A deals last year carried values of more than $10 billion.

https://www.fiercepharma.com/pharma/m-a-large-biotech-pharma-companies-will-have-1-7t-firepower-for-dealmaking-2022

Bristol Myers wrongfully denied exemption requests to COVID vax policy: employee lawsuit

 In response to being told that they would be fired if they did not get vaccinated against COVID-19, four Bristol Myers Squibb employees have filed a lawsuit against the company claiming the drugmaker wrongfully denied their requests for religious exemptions.

Filed Wednesday in federal district court in Manhattan, the lawsuit says BMS is violating Title VII by "systematically manufacturing" reasons for not providing employees religious exemptions to its vaccine mandate.

Title VII requires employers to provide accommodations to employees who request exemptions from workplace policies "on the basis of sincerely held religious beliefs," the suit says. The employees claim BMS is denying the sincerity of their religious beliefs because they "hold and express political beliefs too."

In September, BMS informed employees that they needed to be vaccinated by Nov. 1. In a quarterly securities filing on Oct. 27, the company revealed that 94% of its workforce was vaccinated.

Responding to the lawsuit, a BMS spokesperson said the company's "priority throughout the pandemic has been the health and safety of our communities, employees and patients, who are among the most vulnerable."

"Our policy that all eligible employees in U.S. and Puerto Rico be vaccinated against COVID-19 is consistent with this safety priority and our responsibility as a science-based company to help slow the spread of the virus," she added. "The policy includes a process for employees to request a reasonable accommodation based on, among other things, their sincerely held religious beliefs."

"The process includes interactive discussions with the employees and detailed assessments," she continued. The company has granted accommodations to "some individuals" who submitted requests, she added.

The plaintiffs in the lawsuit are highly paid professionals: Carrie Kefalas, M.D., the head of clinical trial risk management for global drug development; John Lott, the associate director of strategy and submissions lead, patient safety and epidemiology; Jeremy Beer, a senior manager for data integrity; and Kamila Dubisz, an account manager.

As BMS rolled out the vaccination requirement to employees, the company included a threat of “for cause” termination for those who failed to comply, the suit alleges.

In her filing her request, Kefalas identified herself as a non-denominational “follower of Jesus Christ,” the suit says.

Kefalas, who requested to continue to work remotely, said vaccination “would permanently destroy my relationship with My Savior, prevent eternal salvation and promise eternal damnation of my soul as it is described in the Bible because I would be accepting the Beast as my Savior,” the suit says.

On Nov. 17, BMS notified Kefalas that her request was denied because her beliefs were not “sincerely held,” according to the lawsuit. BMS also said that in previous internal company communications, Kefalas had questioned the safety of vaccinations without stating any religious objections.

Kefalas, who earns approximately $300,000 per year, was told that she would face termination on Dec. 6 if she didn’t show proof of vaccination by Nov. 29, the suit says.

Other employees in the suit were told they would be fired in December and January for not following the vaccine mandate, according to the lawsuit.

The employees are seeking a court injunction "enjoining Bristol Myers Squibb Co. from terminating them and all other similarly situated employees until the parties can be fully heard on the merit," the suit says. 

If BMS were to fire non-compliant employees, it wouldn’t be the first company to do so. In October, United Airlines said it was in the process of terminating 232 employees for not getting vaccinations. Also in October, New York’s largest healthcare provider, Northwell, revealed that it fired 1,400 employees who were not vaccinated.

According to a survey of nearly 600 employers conducted in August by global professional services firm Aon, only 7% said they would be willing to fire an employee who refused to get a vaccine, with the percentage higher among companies in industries that traditionally demand in-person work.

https://www.fiercepharma.com/pharma/four-bristol-myers-squibb-employees-set-to-be-fired-for-not-being-vaccinated-file-suit