Schumer asks Biden to prioritize New York for COVID-19 antiviral drugs

 The Biden administration should direct the limited supply of Tamiflu-like COVID-19 antiviral drugs to states like New York that have been hard hit by the Omicron variant, Sen. Chuck Schumer said Sunday.

“It’s a new weapon that we have to fight this Omicron COVID-19,” Schumer said of two new drugs recently approved by the FDA during a press briefing in Manhattan. “I’m calling on the federal government, which has bought all available [COVID] antivirals, to put New York at the top of the list as it distributes these.”

“We are number one in terms of the COVID cases, we are number one in terms of density, we are number on in terms of per capita, and so we deserve to get as many of these antivirals as quickly as possible,” he said. “The federal government should not distribute them across the board. They should look at where is the greatest need.”

Coronavirus cases have spiked in New York state and New York City in recent weeks. On Friday, 162,031 people tested positive for the virus statewide, according to the state Dept. of Health. Hospitalizations also increased with over one thousand patients in ICU.

Senate Majority Leader Chuck Schumer gave a press conference on January 2, 2021 over the ‘Tamiful” Antiviral for Covid.

Kevin C. Downs for The New York

Sen Chuck Schumer urged President Biden to direct the pills to NYS and states where Omicron is surging so that they don’t potentially go unused.

AP Photo/Carolyn Kaster

The Food and Drug Administration authorized Merck’s antiviral pill molnupiravir and Pfizer’s paxlovid late last month. The Pfizer drug is permitted for anyone over 12, while Merck’s product is currently for ages 18 and up.

Both drugs have been proven to reduce risk of hospitalization or death among COVID-19 patients — but both are in limited supply.

New York City residents who want the at-home treatments must do so through a pharmaceutical delivery service called Alto Pharmacy.

The Food and Drug Administration authorized Merck’s antiviral pill molnupiravir and Pfizer’s paxlovid late last month.

Kevin C. Downs for The New York

Residents of other counties can find a list of participating pharmacies on the website of the state Dept. of Health.

https://nypost.com/2022/01/02/sen-chuck-schumer-asks-biden-to-prioritize-nyc-for-covid-19-drug/

New York’s racial ‘risk factor’ for COVID treatment is illegal and immoral

 New York City’s and state’s departments of health have reached a divisive and destructive low. In new guidelines rationing scarce, lifesaving oral antiviral medications and the one monoclonal antibody preparation that is effective against the Omicron variant of the SARS-CoV-2 virus that causes COVID-19, they instruct providers to “consider race and ethnicity” and give preference to those who are “Black, Indigenous, and People of Color.” These directives are immoral, illegal and bear no relation to the science.

The city’s Health Advisory #39 directs providers to adhere to the state Department of Health’s prioritization guidance for utilization of these COVID-19 treatments that are in short supply. It asks providers to consider whether patients are immunocompromised, their age, their vaccine status and the number of risk factors (medical conditions) they have for severe illness.

The problem with the state’s guidance is the instruction that “nonwhite race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.” Hence, all other risk factors such as age, immune, and vaccination status being equal, “nonwhite” and “Hispanic/Latino” patients will be granted superior treatment access compared with whites.

According to the guidelines, “nonwhite race or Hispanic/Latino ethnicity” should be considered a risk factor and given preference for COVID-19 treatments.

Photo by HANDOUT/Pfizer/AFP via Getty Images

Far and away the most significant factor associated with severe COVID-19 disease and death is age. Taking the 18-39 age group as a reference (Risk Ratio of 1), the risk of death doubles for the 40-49 age group (RR=2.2), doubles again in the 50-64 group (RR=4.3), and reaches an RR of 6.7 for those 65-74. The RR tops out for those 85 and older at 10.6.

Minority populations are younger than the white population. But they suffer from more of the underlying medical conditions that are associated with severe ­COVID-19 illness.

These include: obesity, diabetes with complications and chronic kidney disease. The risk increases with more conditions.

While it is possible that “longstanding systemic health and social inequities” could lead to an increased incidence of these conditions in minority communities, race and minority status do not, on their own, lead to more severe COVID-19 disease. If discrimination causes one the medical conditions, the condition itself should be counted in drug-distribution decisions. Crediting minority status and the medical condition is double counting. And counting minority status as a risk factor, when there is no resulting medical condition, is unfair and unwarranted.

Discrimination on the basis of race must meet the legal standard of strict scrutiny — the government must demonstrate its action addresses a compelling interest and is narrowly tailored to achieve that interest. Arguably, New York has an important interest in assuring that the limited supply of ­COVID-19 medications is allocated to maximize medical benefit. But New York’s guidelines are not even reasonably or rationally related toward achieving that end. They may direct the medicines toward minority patients and away from sicker, more vulnerable white patients who would benefit more.

This sort of discriminatory, politically correct decision-making should not be tolerated. New York health-department bureaucrats should revise these guidelines immediately or risk having them struck down in court.

Joel Zinberg, MD, is a senior fellow at the Competitive Enterprise Institute, an associate clinical professor of surgery at the Icahn School of Medicine at Mount Sinai in Manhattan and the director of Paragon Health Institute’s Public Health and American Well-being Initiative.

https://nypost.com/2022/01/02/nys-racial-risk-factor-for-covid-treatment-is-illegal-and-immoral/

Adams considering booster mandate for NYC employees

 New York City Mayor Eric Adams said on Sunday that he is mulling a COVID-19 booster mandate for city employees. 

During an appearance on ABC's "This Week," Adams, who was sworn in as mayor on Saturday, said the city would “examine the numbers” and decide if the mandate was needed. 

"If we feel we have to get to the place of making that mandatory, we’re willing to do that, but we’re encouraging them to do that now," the mayor also said, noting that he is boosted. 

As the city of New York grapples with skyrocketing COVID-19 case numbers, the new mayor remains insistent that the city must stay open.

"If we close down our city, it is as dangerous as COVID," Adams added. "That's what our focus must be. So that proper balance of safety [and] keeping our economy operated is going to allow us to get through."

Shortly after Adams took office, he used his inaugural address to assure New Yorkers that the city would not be controlled by the ongoing pandemic. 

“This will be our New Year's resolution: We will not be controlled by crises,” he said. 

New York City has seen a daily case average of 23,943 in the last seven days, according to data from the city's health department. The state also reported 62,536 positive tests on Saturday as the highly contagious omicron variant continues to sweep the country. 

https://thehill.com/homenews/state-watch/587952-adams-considering-booster-mandate-for-new-york-city-employees

OPEC+ sees short-lived, mild impact from Omicron variant

 OPEC+ expects the impact on the oil market from the Omicron coronavirus variant to be mild and temporary, according a copy of technical committee report of the group seen by Reuters on Sunday.

"The impact of the new Omicron variant is expected to be mild and short-lived, as the world becomes better equipped to manage COVID-19 and its related challenges," the report said.

https://www.marketscreener.com/news/latest/OPEC-sees-short-lived-mild-impact-from-Omicron-variant-JTC-report--37450402/

MTA says to expect longer waits due to COVID crew shortages

 Multiple subway lines will be out of commission for the first workday of the year on Monday as COVID-19 surges among the MTA’s workforce, transit officials said.

Officials took the B, W and Z trains out of service last week to cope with the spike in virus cases and they will remain shuttered on Monday, Transportation Authority rep Aaron Donovan said. Express trains that typically skip those stations will make local stops.

“Like every business and agency in the region, the MTA is navigating through a spike in workforce positive COVID test results,” Donovan said in a statement. “The Authority is proactively managing to ensure continuation of reliable service 24/7 to every subway station.”

Other train and bus routes have also suffered delays and cancellations, according to the MTA’s public social media feeds. Friday alone saw 56 scheduled bus runs canceled on the @NYCTBuses Twitter account.

Other train and bus routes also suffered delays and cancellations due to surging COVID cases.

Corbis via Getty Images

“The Authority is proactively managing to ensure continuation of reliable service 24/7 to every subway station.”

Getty Images

Subway ridership dropped in the last two weeks of 2021 after hitting pandemic era highs earlier in December.

Getty Images

Transit officials have declined to say how many workers have been sidelined by Omicron. Sources across the authority estimate the number to be several thousand.

“The infection rate is very high,” said one insider. “It doesn’t take Dr. Fauci to know that.”

Sick employees have been met with wait times as high as six hours on the MTA’s COVID-19 hotline, sources said, which they must call to report virus symptoms. Officials eventually upped the number of hotline personnel and added a second phone number and email address for workers to contact, transit sources said.

The same hotline also crashed in March 2020, when at least 8,700 employees missed work due to either having or being exposed to COVID-19. Low workforce availability forced the MTA to scale back service, leading to longer wait times for riders.

Transit officials have declined to say how many workers have been sidelined by Omicron.

Getty Images

The MTA experienced a pandemic hiring freeze earlier this year.

dpa/picture alliance via Getty I

Workers contracting COVID is just one source of the MTA’s staffing woes. The authority is already down on bus and train operators due to a pandemic hiring freeze that officials do not expect to have recovered from until well into the new year.

Unlike city employees, employees of the state-run MTA are not required to be vaccinated. Gov. Kathy Hochul and MTA leaders in November — before the Omicron wave hit — defended that approach by pointing to low in-house COVID positivity rates.

Subway ridership dropped in the last two weeks of 2021 after hitting pandemic era highs earlier in December, according to publicly-available data. The MTA — whose financial future depends on rider fares — reverted its own desk workers to working from home part-time through Jan. 15, according to a company wide memo obtained by The Post.

More than 170 MTA employees have died from COVID-19 since the start of the pandemic.

https://nypost.com/2022/01/02/expect-long-subway-waits-due-to-covid-crew-shortages-mta/

Biotech week ahead, Jan. 3

 Biotech stocks came under selling pressure in the final week of 2021, although they carved out modest gains for the year.

On the regulatory front, the Food And Drug Administration approved Xeris Biopharma Holdings Inc.'s (XERS) Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative.

AstraZeneca plc (NASDAQ:AZN) announced the closure of the development and commercialization agreement with Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) for epiontersen, a Phase 3 investigational antisense therapy being evaluated for all types of transthyretin amyloidosis, a rare disease caused by abnormal deposits of amyloid.

BridgeBio Pharma, Inc. (NASDAQ:BBIO) shares lost more than half of their market capitalization after a failed Phase 3 study of its acoramidis for the treatment of symptomatic TTR amyloid cardiomyopathy.

Here are the key catalysts that can sway biotech stocks in the unfolding week:

Conferences

Goldman Sachs 14th Annual Healthcare CEOs Unscripted Conference: Jan. 6

Clinical Readouts/Presentations

Edgewise Therapeutics, Inc. (NASDAQ:EWTX) is scheduled to report topline results from the Phase 1b clinical trial of EDG-5506 in individuals with Becker muscular dystrophy on Wednesday, at 9 am.

Sutro Biopharma, Inc. (NASDAQ:STRO) is due to provide interim data from the dose-expansion cohort of the Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with advanced ovarian cancer at a company-hosted KOL virtual event. The event and Q&A session will be available by webcast, to be held on Wednesday, at 5 pm ET.

Avalo Therapeutics, Inc. (NASDAQ:AVTX) will host a virtual investor day on Thursday, from 8 am to 10 am. At the event, the company will provide updates on the Phase 1b proof-of-concept study of AVTX-002 in Crohn's disease, the AVTX-007 development program for multiple myeloma and adult-onset Still's disease and the AVTX-803 development program for leukocyte adhesion deficiency type II.

Earnings

AngioDynamics, Inc. (NASAQ: ANGO) (Thursday, before the market open)

IPO Quiet Period Expiry

• Cingulate Inc. (NASAQ: CING)
• NeuroSense Therapeutics Ltd. (NASAQ: NRSN)

https://markets.businessinsider.com/news/stocks/the-week-ahead-in-biotech-jan-2-jan-8-stray-clinical-readouts-in-focus-in-slow-news-week-1031073237

Abbott seeks federal assistance to help with COVID-19 testing, treatment

 Texas Gov. Greg Abbott (R) announced on Friday that the state has requested federal assistance to help with COVID-19 testing and treatment amid a surge in cases.

The Texas Division of Emergency Management and the Texas Department of State Health Services (DSHS) asked for federal resources to support testing centers, medical personnel and more monoclonal antibody treatments.

Abbott, who has been a leading opponent of COVID-19 vaccine mandates, said in a statement that Texas is “urging the federal government to step up in this fight and provide the resources necessary to help protect Texans.”

“Testing sites, additional medical staff, and continued shipments of therapeutics from the federal government will help us continue to save lives and mitigate the spread of COVID-19,” he said. “Detecting COVID-19 and preventing COVID-related hospitalizations are critical to our fight against this virus."

The state is specifically requesting testing sites in Bexar, Cameron, Dallas, Harris, Hidalgo and Tarrant counties based on COVID-19 metrics, including positivity rates and hospitalizations, and asking for more supplies of the sotrovimab monoclonal antibody treatment.

As of Sunday afternoon, Harris County had the fifth-most confirmed COVID-19 cases in the U.S., according to Johns Hopkins University's coronavirus resource center.

Additionally, Texas requested three teams of medical personnel to help in hospitals in urban areas that do not have staff contracted with the DSHS and asked the federal government to continue supplying the Regeneron and bamlanivimab monoclonal antibody treatments.

The requests comes after the Texas Health and Human Services Commission revealed last week that the state had run out of its supply of sotrovimab, which has proved to be effective in combating the omicron variant. The omicron strain is driving a nationwide surge in COVID-19 cases.

The state said infusion centers would not be able to provide the treatment until “federal authorities ship additional courses of sotrovimab to Texas in January.”

Abbott last week said that while President Biden "vows full federal support to help states combat COVID," in reality, "he's not."

"Biden is hoarding the anti-body therapeutic drugs & denying states independent access to that medical treatment. Now, he has stopped providing any of that medicine to Texas," he added.

Texas is currently seeing a spike in coronavirus cases. At the end of December, the state was reporting more than 10,000 new coronavirus cases per day, up from the roughly 4,000 new daily COVID-19 infections in November, according to the state’s COVID-19 dashboard.

Biden last month announced new efforts to safeguard Americans and bolster communities and hospitals amid the spread of omicron.

The state of Texas made headlines on Friday after a federal judge blocked mask and vaccine mandates in the state’s Head Start program. Abbott, in a tweet after the ruling, said, “Texas just beat Biden again.”

Abbott issued an executive order in October barring vaccine mandates from being implemented in the state after Biden announced a series of federal mandates for health care workers, large employers and federal contractors. 

https://thehill.com/homenews/state-watch/587934-gop-texas-governor-asks-for-federal-assistance-to-help-with-covid-19