Delta Air raising insurance premiums for unvaccinated employees by $200/month on higher Covid costs

 Delta Air Lines CEO Ed Bastian notified employees Wednesday that they will face $200 monthly increases on their health insurance premiums starting Nov. 1 if they aren’t vaccinated against Covid-19, citing steep costs to cover employees who are hospitalized with the virus.

Unvaccinated employees will face other restrictions, including indoor masking effective immediately and weekly Covid-19 tests starting Sept. 12, the Atlanta-based airline said in announcing new Covid policies for employees.

The measures are the latest attempt by a U.S. corporation to drive up Covid vaccination rates. Delta stopped short of an outright mandate like rival United Airlines established earlier this month. Delta, which self-insures its employees, stands out in its plans to raise premiums for unvaccinated workers to cover the higher costs of insuring employees who get Covid.

“The average hospital stay for COVID-19 has cost Delta $50,000 per person,” Bastian said in an employee memo. “This surcharge will be necessary to address the financial risk the decision to not vaccinate is creating for our company. In recent weeks since the rise of the B.1.617.2 variant, all Delta employees who have been hospitalized with COVID were not fully vaccinated.”

United Healthcare administers the airline’s health insurance plans. The change in approach was Delta’s initiative.

Delta also said starting Sept. 30, “in compliance with state and local laws, COVID pay protection will only be provided to fully vaccinated individuals who are experiencing a breakthrough infection.” Unvaccinated employees who contract Covid, without exemptions, will have to use their sick days after that.

CEO Bastian said that about 75% of Delta’s roughly 75,000 employees are already vaccinated and that “aggressiveness of the [delta] variant means we need to get many more of our people vaccinated, and as close to 100 percent as possible.”

Delta earlier this year started requiring new employees to be vaccinated against Covid.

On Monday, the U.S. Food and Drug Administration gave full approval to the Pfizer vaccine though a Delta spokeswoman said the plan had been in the works for weeks and that the timing was coincidental.

“Given the full FDA approval of the Pfizer vaccine, the [President Joe Biden’s] strong statements asking employers to require employees get vaccinated, and the spike in new COVID cases around the US, we are likely at a tipping point for companies taking stricter measures to motivate employees to get vaccinated,” Wade Symons, a partner and group leader for regulatory resources at human resources consulting firm Mercer, said by email. “We anticipate more companies will announce vaccine mandates and surcharges in the coming weeks.”

Alaska Airlines earlier this month told employees that it was considering requiring employees to be vaccinated against Covid but that it would only do so after one of the vaccines received full approval. Frontier Airlines said this month that employees have to be vaccinated or test regularly for Covid. American Airlines, Southwest Airlines and JetBlue Airways have encouraged employees to get vaccinated.

Delta, which has the fewest unionized employees of the large U.S. airlines, said it informed the Air Line Pilots Association, their aviators’ labor union, of the changes.

The union on Wednesday received dozens of comments from pilots, some who oppose the surcharge and others who applauded the measure, according to Delta pilot and union spokesman Christopher Riggins.

About 8% of Delta’s roughly 12,000 pilots are exempt from the $200 surcharge even if they are unvaccinated because they had previously elected a health care plan that comes with higher premiums. That health care plan had been negotiated as part of their contract. A change would require Delta to negotiate with the union, which has said most of the pilots are vaccinated.

The union has repeatedly said vaccinations should be voluntary for its members.

The union “has consistently advocated to maintain the right of each individual pilot to consult with his or her medical provider regarding COVID-19 vaccinations or booster doses,” it said in a statement. “While the Delta [master executive council] respects Delta Air Line’s efforts to mitigate the impact of breakthrough COVID-19 variant infections, it needs to bargain with the Delta MEC over any employer-mandated vaccination for pilots.”

Airlines have been among the hardest-hit companies by the pandemic, and the rise of the Covid delta variant is already driving down a recent recovery in bookings, according to airlines including Southwest, American and Spirit.

https://www.cnbc.com/2021/08/25/delta-air-lines-unvaccinated-employees-will-face-200-fees-if-they-dont-get-covid-vaccine.html

Pfizer CEO says a vaccine-resistant coronavirus variant is 'likely' to emerge

 

• Pfizer CEO Albert Bourla told Fox it was likely a vaccine-resistant variant would emerge. 

• Bourla said Pfizer could make a shot tailor-made for such a variant within 95 days of its discovery.

• The CDC director said the virus could be "a few mutations" away from evolving to evade vaccines.

Pfizer CEO Albert Bourla told Fox News on Tuesday that he believed it was "likely" a vaccine-resistant coronavirus variant would eventually emerge. 

"Every time that a variant appears in the world, our scientists are getting their hands around it," Bourla said. "And they are researching to see if this variant can escape the protection of our vaccine.

"We haven't identified any yet, but we believe that it is likely that one day, one of them will emerge."

Bourla added that Pfizer could produce new versions of its vaccine to combat a variant within three months of its discovery.

"We have built a process that within 95 days from the day that we identify a variant as a variant of concern, we will be able to have a vaccine tailor-made against this variant," Bourla said.

This is not the first time this concern of vaccine evasion has been brought up, but experts' opinions are split.

"These vaccines operate really well in protecting us from severe disease and death, but the big concern is that the next variant that might emerge - just a few mutations, potentially, away - could potentially evade our vaccines," Centers for Disease Control and Prevention Director Rochelle Walensky said in a July 27 press briefing.

The UK government's advisory panel, the Scientific Advisory Group for Emergencies, said higher rates of virus circulation and transmission were creating "more opportunities for new variants to emerge."

The CDC estimated 93% of US states were at a "high level of community transmission" as of Monday. New daily cases have more than quadrupled in the past month.

But Angela Rasmussen, a virologist at the University of Saskatchewan in Canada, told the Telegraph that the possibility of a vaccine-resistant strain was unlikely.

"It would require so many mutations in the spike protein that this virus wouldn't 'work' anymore," Rasmussen said.

https://news.yahoo.com/pfizer-ceo-says-vaccine-resistant-205325099.html

Don't Use Pfizer's COVID Vax Off-Label in Kids: Specialists

 Pediatric infectious disease experts are warning that Pfizer's COVID-19 vaccine, now fully approved and marketed as Comirnaty, should not be used off-label in children under 12.

While full approval gives physicians the legal grounds to administer the vaccine off-label, experts noted that the doses being studied in younger children are much lower than those used in adults. There also have been no data published about use of the vaccine in children under 12.

David Kimberlin, MD, a pediatric infectious disease expert at the University of Alabama at Birmingham, told MedPage Today that the dose authorized for individuals 12 and up is 30 mcg -- but the dose being evaluated in kids ages 5 to 11 "is a third of that," at 10 mcg.

For kids under 5, the dose being studied is only 3 mcg.

"We can't have physicians writing for the approved 30 mcg dose to be used in someone under 12," Kimberlin said. "It's a much higher dose than what's being studied."

The lower dose "was chosen because of immunogenicity and reactogenicity," he added. "We are going to have to get the word out that we should not be simply taking the Pfizer vaccine approved for adults and putting it in the arms of those under 12."

FDA Acting Commissioner Janet Woodcock, MD, warned against off-label use of the Pfizer vaccine in younger children during a press briefing Monday, warning that they're "not just small adults."

"We do not have data on proper dose, nor do we have full data on safety in children younger than what is in the EUA [emergency use authorization], so that would be a great concern that people would vaccinate children," Woodcock said. "So we believe we need to get the ... data on usage in younger children. They are not just small adults; we have learned that time and time again."

The American Academy of Pediatrics (AAP) also issued a statement warning against off-label use in kids under 12.

"The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children," AAP President Lee Savio Beers, MD, said in the statement.

AAP expressly warned about not trying to administer lower doses in children.

"We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients," Yvonne Maldonado, MD, chair of AAP's committee on infectious diseases, said in the statement. "We should do this based on all of the evidence for each age group, and for that we need the trials to be completed."

"I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials," Maldonado added.

The Pfizer vaccine is still governed by an EUA for kids ages 12-15; it is only fully approved for those ages 16 and up. AAP strongly recommends vaccination in 12- to 15-year-olds, especially as pediatric cases continue to rise due to the more transmissible Delta variant.

AAP reported 180,000 new cases of COVID-19 among children and adolescents for the week ending August 19, a figure on par with rates from mid-December 2020.

Beers said in the statement that vaccinating all those who are eligible now is critical to protecting the youngest children: "That will help reduce the spread of the virus and protect those who are too young to be vaccinated."

Last month, Pfizer told MedPage Today that it anticipated a readout for the trial in kids ages 5 to 11 "sometime in September," with data on kids ages 2 to 5 "soon after that," followed by a safety and immunogenicity readout in kids ages 6 months to under 2 years "sometime in October/November."

That would be followed by "a potential submission to the U.S. FDA for an EUA once agreed upon with regulators shortly thereafter."

However, the FDA subsequently asked both Pfizer and Moderna to expand the size of their clinical trials for kids ages 5 to 11, as a "precautionary measure designed to detect rare side effects," including myocarditis and pericarditis, according to the New York Times.

The Times reported that FDA asked both companies to include 3,000 children in the 5-to-11-year-old group, and one anonymous source described that as double the original number of study participants.

https://www.medpagetoday.com/pediatrics/generalpediatrics/94172

Florida Monoclonal Antibody Clinic Is Maxed Out

 Gerald Pierone, MD, gets regular phone calls from COVID-19 patients and their family members, asking for a spot at his monoclonal antibody clinic in Vero Beach, Florida.

But as infections continue to surge throughout the state, the clinic is often full.

"We are just being inundated with COVID patients now because of this Delta surge," Pierone, an internist and infectious disease specialist, told MedPage Today.

"These people are really sick," he added. The majority of patients who show up to his clinic have been sick for at least 4 days, and may have a cough, shortness of breath, nausea, and headaches.

Often, these patients need more than just an infusion. Healthcare workers at Pierone's clinic are managing patients with acute illness, and often administer nausea medication and IV fluids, or counsel patients on isolation and quarantine.

"It's quite an operation for a small staff, to move these people through and take care of them," Pierone said, adding that there are four providers. "Right now, we are all hands on deck."

The clinic is one of many monoclonal antibody treatment centers in Florida that have seen a surge of patients as the Delta variant continues to spread. Gov. Ron DeSantis (R) has promoted the benefits of Regeneron's monoclonal antibody treatment in preventing severe illness and hospitalization, and officials have ramped up the launch of new treatment sites. There are now 18 state-run facilities offering free monoclonal antibody treatments (though Pierone's clinic is not one of those).

In November of last year, Pierone and his research team began enrolling patients in the NIH ACTIV-2 study, a clinical trial program evaluating the safety and efficacy of therapeutics for COVID-19. Pierone provided monoclonal antibody treatments at Whole Family Health Center, a multispeciality, community-based health center that he founded 30 years ago as an HIV clinic.

After a few months of doing research at his facility, Pierone opened a stand-alone clinic for patients with active COVID-19, which consisted of four exam rooms where he could provide monoclonal antibody infusions.

Patient volume picked up significantly as the Delta variant spread throughout Florida. In June, the clinic performed just two monoclonal antibody treatments. Treatments jumped to approximately 60 in July, and this month he has already treated 130 patients.

The small clinic maxes out at seeing 14 to 15 patients a day. Each patient's treatment lasts about 2 hours, after they fill out paperwork, receive the infusion, and wait out an hour-long observation period.

Some of the patients who are treated in Pierone's clinic are those who test positive for COVID-19 at his larger health facility. Others may be referred by local physicians, or call in to try to get a spot after hearing about the clinic through word-of-mouth.

Regeneron's casirivimab/imdevimab (REGEN-COV) cocktail is authorized under emergency use to treat COVID-19 positive patients ages 12 and older who have a high risk of progressing to severe illness. Because the FDA has made the treatment criteria broad, the providers in Pierone's clinic have had to triage whom they treat. They don't say no to everyone, but often take the patients who are at the highest risk of getting really sick.

"It's really frustrating, because we don't have the capacity to treat as many people as we'd like to treat," Pierone said.

Although the FDA recently expanded the use of casirivimab-imdevimab to include post-exposure prophylaxis, Pierone said his clinic cannot take patients in this category, because the facility is already overextended treating sick patients.

One of the reasons many of his patients are so sick, Pierone said, is because approximately 70% have not been vaccinated. He treats partially and fully vaccinated people as well, who are often older and at a higher risk of severe illness, but none of those patients have died from COVID-19. That's not the case for the unvaccinated, however.

"The really sick patients are the unvaccinated," Pierone said.

Recently, Pierone treated an unvaccinated, healthy 34-year-old patient. After the patient got infected, he received antibiotics and appeared to be doing well. But around a week after his symptoms started, the patient came into Pierone's clinic with an oxygen level of 90%, and had to be admitted to the emergency room.

"That's kind of a typical younger person," Pierone said. "The first week they're not that sick, then the immunity kicks in, the cytokine storm kicks in, and they get much worse."

The problem is, it's hard to tell who will progress to worse illness on the front end, Pierone added. While patients with comorbidities such as overweight and obesity, diabetes, or asthma typically have more severe illness, the disease course can be unpredictable. "You don't know if this person is going to be fine, or if they are going to crash and burn," Pierone said.

The ideal is to get people on monoclonal antibodies 3 days after symptom onset, Pierone said. But he estimated that only around 20% of patients come to the clinic within that early time frame. "The truth is, we end up seeing a lot of people on day 7, day 8, day 9, day 10," he said.

What they are really doing for those patients is treating secondary bacterial infections, and administering corticosteroids. "We are helping people, in many cases, more by giving them dexamethasone and other adjunctive treatments, than we are by giving them monoclonal antibodies when they're at that later stage," Pierone said.

Of the four providers at Pierone's monoclonal antibody clinic, he is currently the only physician, joined by nurses and a research assistant.

"I would say my staff is frazzled," Pierone said. "I'm definitely developing some compassion fatigue. What we are doing right now, it's not sustainable."

State officials recently opened a large Regeneron monoclonal antibody site in Fort Pierce, which can treat more than 300 patients a day with subcutaneous shots. People 12 years and older who have tested positive for COVID-19, or have been exposed to an infected person, can walk in to receive treatment, with or without a provider referral.

"They are trying to very aggressively expand access to monoclonals," Pierone noted. And he said that while wider access to these treatments may prevent future hospitalizations, "by far, the most important public health measure is getting people vaccinated."

While DeSantis continues to expand access to monoclonal antibodies in Florida, he also continues to resist mask mandates in public schools, even for kids under 12, who cannot get vaccinated. The governor is currently entrenched in a legal battle over his authority to ban mask mandates in schools.

Pierone has reached out to other local hospitals and the health department to assess the outbreak. As he and his staff are drowning in patients, they are drowning too. Hospitals are still not performing elective procedures, and ICUs in the state are near capacity.

"Nobody is going to rescue us," Pierone said. "We have to rescue ourselves."

https://www.medpagetoday.com/special-reports/exclusives/94207

Eli Lilly In Collaboration With Lycia Therapeutics

 Eli Lilly & Co. on Wednesday said it signed a multi-year research collaboration and licensing agreement with Lycia Therapeutics Inc. aimed at developing novel targeted therapeutics using Lycia's proprietary lysosomal targeting chimera protein degradation technology.

The Indianapolis drugmaker said the companies will use Lycia's platform to discover and develop novel degraders for up to five targets that aim to address key unmet medical needs in Lilly's therapeutic areas of focus, including immunology and pain.

Eli Lilly said it will make a $35 million upfront payment to Lycia, which also will be eligible for more than $1.6 billion in potential milestone payments, along with royalties on sales.

In connection with the agreement, Eli Lilly said Carolyn Bertozzi, a director since 2017 and an academic founder of Lycia, has resigned from the Lilly board.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-Inks-Collaboration-With-Lycia-Therapeutics-36242611/

Ascendis: FDA Approves Skytrofa to Treat Pediatric Growth Hormone Deficiency

 Ascendis Pharma A/S on Wednesday said the U.S. Food and Drug Administration approved its Skytrofa as a treatment for Pediatric Growth Hormone Deficiency.

The company said Skytrofa, or lonapegsomatropin-tcgd, is the first once-weekly treatment approved to treat Pediatric Growth Hormone Deficiency.

The company also said Skytrofa was approved to treat "pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone."

The company said the approval includes its Skytrofa Auto-Injector and cartridges, which enable families to store the medicine at room temperature for up to six months.

The company said availability of Skytrofa in the U.S. is expected soon.

Ascendis said it would hold an investor conference call at 4:30 p.m. ET today.

https://www.marketscreener.com/quote/stock/ASCENDIS-PHARMA-A-S-20566532/news/Ascendis-Pharma-FDA-Approves-Skytrofa-to-Treat-Pediatric-Growth-Hormone-Deficiency-36248701/

Heart inflammation risk boosted slightly by Pfizer vaccine, more by COVID-19: NEJM study

 The use of Pfizer Inc and German partner BioNTech SE's widely used COVID-19 vaccine marginally increases the risk of heart inflammation, but the risk is higher among those infected with the coronavirus, a study published on Wednesday in the New England Journal of Medicine showed.

Among every 100,000 patients who get the vaccine, 1 to 5 will likely develop myocarditis who would not otherwise have developed it, researchers reported based on data from Clalit Health Services, a large Israeli HMO.

That rate is much higher - 11 per 100,000 - among people infected with the coronavirus, they said.

The data comes days after Pfizer/BioNTech's COVID-19 vaccine became the first fully approved vaccine in the United States for people aged 16 and older https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-grants-full-approval-pfizer-biontech-covid-19-vaccine-2021-08-23, a move that could potentially persuade vaccine skeptics to get the shot.

The researchers compared adverse event rates in 884,828 vaccinated individuals and an equal number of unvaccinated people. Overall, 21 persons reported myocarditis in the vaccinated group - mostly young men - compared with 6 people among the unvaccinated.

Most adverse events in vaccinated people were mild, but some, such as myocarditis, are potentially serious, researchers said.

The researchers also analyzed adverse event rates in more than 240,000 infected patients. The results indicate that COVID-19 infection is itself a very strong risk factor for myocarditis, and it also substantially increases the risk of other serious adverse events, they said.

"For me this is a really terrific paper in part because it actually takes data from the same system, and tries to provide more information, not just about the potential risks of vaccination, but also the potential benefits of vaccination," said Dr. Grace Lee of Stanford University, whose editorial was published with the report.

Pfizer's vaccine, along with a rival mRNA vaccine from Moderna Inc, came under regulatory scrutiny in several countries after some reports of cases of heart inflammation.

Israel's health ministry said in June it saw a possible link between such cases and Pfizer's COVID-19 vaccine.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Heart-inflammation-risk-boosted-slightly-by-vaccine-more-by-COVID-19-study-36249474/