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Monday, November 1, 2021

Federal contractors get broad flexibility to enforce Covid vaccine rules for millions of workers

 

  • Federal contractors will have broad leeway to enforce President Biden’s Covid-19 vaccine mandate, according to guidance the White House released Monday.
  • Under the new guidance, federal contractors from IBM to Boeing will have flexibility to determine how they enforce the vaccination requirements for workers who refuse to be vaccinated.
  • Federal contractors including airlines like Southwest, American and aerospace giant Boeing have said employees must be vaccinated by the Dec. 8 deadline or apply for an exemption.
  • Federal contractors will have broad leeway to enforce President Joe Biden’s Covid-19 vaccine mandate, according to new guidance the White House released Monday, laying out details on implementation of the rules.

    Under the new guidance, federal contractors from IBM and Boeing to food service providers will have flexibility to determine how they enforce the vaccination requirements for workers who refuse to be vaccinated.

    The federal contractor guidelines are stricter than the forthcoming vaccine mandate for businesses with 100 or more employees, which allow for regular testing broadly as an alternative to a vaccine. The Labor Department is still finalizing those rules. Businesses have asked for that mandate to be delayed until after the holiday season over concerns about possible supply chain disruptions.

    Senior administration officials made clear that Dec. 8 is not a hard deadline for contractors to have all of their employees fully vaccinated. Instead, contractors must demonstrate they are making a good faith effort to ensure employees are getting vaccinated and have plans in place to ensure masking and social distancing policies are followed in the workplace.

    Federal contractors won’t have to show proof of vaccination rates at the deadline, a senior administration official said. But noncompliance could result in the loss of a federal contract.

    Federal agencies could bar a contractor employee who refuses to be vaccinated from entering a federal workplace, according to the guidelines.

    “In most circumstances individuals who are not fully vaccinated need to follow applicable masking, physical distancing, and testing protocols,” the guidelines said.

    The federal government will defer to contractors to determine when an employee has a sincerely held religious belief or medical condition that requires accommodation, according to senior administration officials. Federal contractors are not required to make a final determination on accommodation requests when an employee begins work.

    “The covered contractor may still be reviewing requests for accommodation as of the time that covered contractor employees begin work on a covered contract or at a covered workplace,” the guidelines said.

    However, federal contractors must require employees with pending accommodation requests to abide by policies on masking and social distancing while their requests are under review, according to the guidelines.

    Federal contractors including some large airlines such as Southwest and American, and aerospace giant Boeing, have said employees must be vaccinated by the Dec. 8 deadline or apply for an exemption.

    Some labor groups have opposed the mandate, including pilots’ unions at American and Southwest. The latter sought to bar the implementation of the mandate, a request a federal judge in Texas denied last week.

    Eleven Republican-led states sued the administration on Friday, arguing the vaccine mandate is unconstitutional. The administration has made clear that the requirements supersede any state laws that bar compliance with Covid-19 mitigation policies.

  • “A covered contractor should determine the appropriate means of enforcement with respect to its employee at a covered contractor workplace who refuses to be vaccinated and has not been provided, or does not have a pending request for, an accommodation,” said the guidelines, which affect millions of workers.

  • The White House released the federal contractor guidance Monday after contractors sought more details on how to implement the rules. Biden issued an executive order on Sept. 9 requiring federal contractors to ensure their employees are vaccinated against Covid-19 and follow masking and social distancing policies. The administration set a Dec. 8 deadline for contractors to implement those requirements.

  • American and Southwest executives have softened their tone over the mandate, urging employees to apply for religious or medical exemptions if they don’t plan to get the vaccine, and said they don’t expect to terminate employees over it. Southwest last month dropped a plan to put workers with pending exemption requests on unpaid leave. Airline executives said they don’t foresee the mandate impacting flights over the holidays.

  • https://www.cnbc.com/2021/11/01/federal-contractors-will-have-broad-flexibility-to-enforce-covid-vaccine-rules.html

Theseus Pharma: FDA Clears Application for Treatment of Gastrointestinal Stromal Tumors

 Theseus Pharmaceuticals, Inc. ("Theseus"), a biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, today announced U.S. Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application to evaluate THE-630, the company's lead development candidate, in patients with gastrointestinal stromal tumors (GIST). THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase KIT designed for patients with advanced GIST whose cancer has developed resistance to earlier lines of therapy.

"The IND clearance for THE-630 marks an important milestone for Theseus as we transition into a clinical-stage company," said Tim Clackson, Ph.D., president and CEO of Theseus Pharmaceuticals. "Patients with previously-treated GIST often have tumors that have developed more than one mutation in KIT that causes resistance to treatment, and we believe treatment with a kinase inhibitor that is active against all relevant mutations—that is, a pan-variant inhibitor—is a promising approach to address this key mechanism of resistance. We look forward to initiating the Phase 1/2 clinical trial and evaluating the potential that THE-630 may offer for patients with advanced GIST who have developed resistance to prior therapy."

THE-630 exhibits potent in vitro activity against all known classes of KIT activating and resistance mutations in GIST. In preclinical studies, THE-630 achieved predicted pan-variant KIT inhibitory blood concentrations at tolerable doses and induced significant anti-tumor activity. Theseus plans to initiate a Phase 1/2 dose escalation and expansion clinical trial of THE-630 in patients with previously treated advanced GIST between late fourth quarter 2021 and mid-first quarter 2022.

https://www.biospace.com/article/releases/theseus-pharmaceuticals-announces-fda-clearance-of-investigational-new-drug-application-for-the-630-a-pan-variant-kit-inhibitor-in-development-for-the-treatment-of-gastrointestinal-stromal-tumors-gist-/

Teva's Risperidone Injectable Wards Off Schizophrenia Relapse in Phase III

 Teva Pharmaceuticals announced positive results from its Phase III trial on a subcutaneous, long-acting injectable risperidone formulation in the treatment of schizophrenia. 

The Phase III Risperidone Subcutaneous Extended-Release (RISE) study compared TV-46000/mdc-IRM, an injectable risperidone formulation, given once a month and once every two months with placebo in patients diagnosed with schizophrenia and have already taken risperidone for stabilization therapy. At week 24, the researchers found that those who took either the once-a-month or once-every-two-month doses experienced longer periods before relapsing. 

With that said, the primary endpoint of time to impending relapse was achieved, same with the number of patients who maintained their stable condition at week 24. Prolonged time to relapse was recorded at 3.5 and 5.0 times with TV-46000 and only 2.7 times with the placebo when observed at the 24th week. Its safety profile is also consistent with other risperidone formulations, and no new safety signals emerged. 

The researchers evaluated 1,267 patients aged 13 to 65 years old, 863 of whom were enrolled in the program, while the remaining 544 were randomized. The most common adverse reactions include weight gain, extrapyramidal disorder, and nasopharyngitis. 

Schizophrenia is a chronic and severe mental illness characterized by extreme distortions in emotions, perception, thinking, language, behavior, and sense of self. The average onset age is in the late teens to early 20s for males and late 20s to early 30s for females. There are around 20 million people diagnosed with it worldwide, and 70% of them are not receiving proper care despite the disease being treatable. 

Relapse rates range from 50% to 92%, and each relapse comes with a biological risk of loss of function, changes in brain morphology, and treatment resistance. To further complicate matters, most patients are not aware that they are ill, which is why there is a high non-adherence to treatment, high discontinuation rate, and high cost of healthcare. In the U.S. alone, around 3.5 million are diagnosed with the condition.

"It is crucial to provide patients and prescribers with treatment options that have the potential to reduce relapse rates to help manage and stabilize the disease over time. Coming off the heels of the recent FDA acceptance of our New Drug Application, we’re proud to be sharing our Phase III data at this year’s Psych Congress. We are committed to investigating the full potential of our subcutaneous long-acting injectable (LAI) formulation of risperidone for the treatment of this complex and burdensome illness," noted Eran Harary, M.D., the vice president global head of specialty R&D at Teva, in a statement. 

Teva Pharmaceuticals said it will continue to explore the drug's mechanisms, particularly its potential as a long-acting injectable. Details of the Phase III RISE study were presented at the 2021 Psych Congress Annual Meeting in Texas.

https://www.biospace.com/article/teva-pharmaceuticals-long-acting-risperidone-injectable-shows-promise-in-treating-schizophrenia/

Merck Delays Acceleron Deal Amidst Continuing Stakeholder Criticism

 One month after striking an $11.5 billion deal to acquire Acceleron Pharma, Merck temporarily withdraws its merger agreement to allow more time for review from the U.S. Federal Trade Commission and the U.S. Department of Justice.

Merck announced the temporary stay in the merger late Friday. The decision came after Avoro Capital Advisors, which owns a 7% stake in Acceleron, posted its objections to the deal. Avoro, which initially objected to the agreement following the announcement, reaffirmed that opposition last week. 

In an open letter released a day before Merck’s announcement, Avoro claimed that the merger agreement is not in the best interest of Acceleron shareholders. The financial company said the $180 per share value that Merck and Acceleron agreed to for the merger “drastically undervalues” the company. Avoro said that is just a 38% premium relative to the stock’s average closing price over the previous three months.

Avoro argued that Acceleron is close to a “value inflection point” regarding the company’s Phase III pulmonary arterial hypertension (PAH) drug sotatercept. The company believes Phase III data will be available by the end of 2022 and, if it is positive, then the potential approval of the drug should translate into a higher-per-share price for Acceleron’s stock. Perhaps as high as $250 per share. In 2019, sotatercept received Orphan Drug Designation for PAH from the FDA

“As we stated previously, we believe that Acceleron’s management team has done an excellent job creating value for shareholders until now and that the company has great potential as a standalone entity. We also believe Merck could ultimately be a great partner for XLRN. The problem is not the fit, it is both the timing and the price,” Avoro said in its letter.

Avoro Capital noted that some analysts have also suggested that the $180 per share price is too low. The firm pointed to Barclays Carter Gould, who suggested that Acceleron could get a higher premium prior to the inking of the deal. Jefferies Analyst Akash Tewari also called the $180 price ‘a bargain.” 

Rather than jump into a merger agreement with Merck, Avoro suggested that Acceleron remain an independent company. They pointed to the lack of other bidders for Acceleron, which means the idea of a sale is premature. 

Last month, a filing with the U.S. Securities and Exchange Commission revealed that Acceleron’s management had reached out to other companies regarding a deal after Merck initiated discussions. Primarily, Acceleron reached out to Bristol Myers Squibb, which owns about 11% of Acceleron. 

BMS and Acceleron jointly developed the blockbuster drug Reblozyl, which was approved in 2019 for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. BMS balked at acquiring Acceleron, the filing shows. 

In its statement Friday, Merck has temporarily agreed to stay on its merger to allow time for the government to review the merger agreement. There is potential for a conflict due to Merck’s existing PAH pipeline, including Adempas, which it gained in a licensing deal with Bayer. 

Earlier this year, Merck initiated a Phase II/III PAH study of MK-5475, an inhaled soluble guanylate cyclase (sGC) stimulator. The government may request Merck divest the experimental drug. 

Merck could refile its merger agreement as early as today and anticipate that the deal could still close by the end of 2021. 

https://www.biospace.com/article/merck-delays-acceleron-deal-to-allow-time-for-government-review-while-stakeholder-presses-claim/

Women Remain Most at Risk of Brain Vein Clots After J&J Vaccine

 Incidence of cerebral venous sinus thrombosis (CVST) remained a rare occurrence after the Johnson & Johnson COVID-19 adenovirus vector vaccine began being administered, researchers said.

The overall age- and sex-adjusted incidence of CVST was 2.34 per 100,000 person-years in Olmsted County, Minnesota, in 2001 to 2015, compared with a peak incidence of 8.65 per 100,000 person-years at 15 days postvaccination per the CDC Vaccine Adverse Event Reporting System (VAERS) database, according to a team led by Aneel Ashrani, MD, MS, of the Mayo Clinic in Rochester, Minnesota.

Those at highest risk of CVST after receiving the Johnson & Johnson product in early 2021 were women ages 30 to 39 (26.52 per 100,000 person-years) and women ages 40 to 49 (29.48 per 100,000 person-years) -- with women in general having a 5.1-fold higher risk after vaccination than they did before the COVID pandemic (13.01 vs 2.53 per 100,000 person-years, P<0.001).

The study authors maintained that the "absolute CVST risk was still low" for these women. "The reason that women had a higher incidence of postvaccination CVST is unclear; concomitant CVST risk factors or autoantibody production might have been involved," they noted in JAMA Internal Medicine.

"In this population-based cohort study, we found that the CVST incidence rate 15 days after Ad26.COV2.S vaccination was significantly higher than the prepandemic rate. However, the higher rate of this rare adverse effect must be considered in the context of the effectiveness of the vaccine in preventing COVID-19," Ashrani's group urged.

Other research has found that severe COVID-19 is associated with more cases of CVST compared with vaccination by an order of magnitude.

Another previous report detailed six cases of CVST with thrombocytopenia -- all in women and all within 6 to 13 days of vaccination -- out of 6.85 million people who had received the Johnson & Johnson vaccine since late February.

That report led to a brief pause in use of the adenovirus vector vaccine in April.

For the present study, Ashrani and colleagues sifted through Olmsted County's prepandemic CVST cases. Of the 39 cases found, 29 were associated with a predisposing venous thromboembolism risk factor, such as infection, active cancer, and recent oral contraceptive use. Median age at CVST diagnosis was 41 years, and 56.4% were women.

In comparison, there were 38 CVST events backed by sufficient details or imaging in VAERS reports from people who received the Johnson & Johnson vaccine from February 28 to May 7 of this year. Of those cases, 27 occurred in women, and the median age was 45 years.

The investigators noted the potential for ascertainment bias in their study, since they included only "objectively diagnosed" CVST cases. They also cautioned that reporting to VAERS is voluntary.


Disclosures

The study was supported by grants from the NIH's National Heart, Lung and Blood Institute, the Rochester Epidemiology Project, and the Mayo Foundation.

Ashrani and a co-author disclosed grants from the National Heart, Lung and Blood Institute. Another co-author reported grants from the NIH.

Amazon lifts mask requirement for vaccinated warehouse workers

 Workers fully vaccinated against COVID-19 will no longer be required to wear face coverings in Amazon warehouses.

The face covering requirement will be lifted starting Tuesday, unless otherwise mandated by federal, state or local regulations, according to an Amazon spokesperson. 

Workers received a notice about the update on Friday, CNBC reported.

“Vaccines are universally available across the U.S. and vaccination rates continue to rise which enables the ability to return to our previous mask policy,” the notice reportedly stated. 

Workers must provide proof of their vaccination status in Amazon’s internal employee portal, according to CNBC. 

The Amazon spokesperson said the company will continue to evaluate temporary COVID-19 safety measures and make adjustments in alignment with public health advice and Amazon’s own medical experts.

The update is the latest from the e-commerce giant as companies grapple with changing COVID-19 conditions. 

Amazon relaxed its mask requirement in May for fully vaccinated U.S. warehouse workers in areas where local regulations did not require face coverings but reinstated the mask guidance regardless of vaccination status in August. 

Amazon has not announced a COVID-19 vaccine mandate for employees.

https://thehill.com/policy/technology/579480-amazon-lifts-mask-requirement-for-vaccinated-warehouse-workers

Novavax COVID-19 vaccine gets first authorization; expects more within weeks: CEO

 Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.

Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.

For Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.

The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.

A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.

“I think we’ll get some doses to COVAX this year,” Erck said. “But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter” of 2022.

Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.

He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”

Novavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.

SII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.

Indonesia is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.

Penny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.

Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.

“It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.

The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.

The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.

https://www.reuters.com/article/health-coronavirus-novavax/update-3-novavax-covid-19-vaccine-gets-first-authorization-expects-more-within-weeks-ceo-says-idUSL4N2RS2MV