CVS, Walgreens cancel COVID vaccine appointments in NY for those under 65

 An unknown number of New York residents had their COVID-19 vaccine appointments abruptly cancelled by CVS and Walgreens after they were able to sign up despite a state rule preventing pharmacies from vaccinating those under the age of 65.

The retail pharmacy giants began administering the vaccine in New York last week under a federal program that allocates doses directly to them, with the chains' limited appointments booked up within hours of being made available.

Some of those appointments were filled by those who have comorbidities, who gained eligibility to receive the vaccine on Monday. But those who are under the age of 65 had their appointments abruptly cancelled days after making them, with the pharmacies pointing to the state rule.

CVS spokesman Mike DeAngelis suggested the cancelations were connected to the state Department of Health's updated Feb. 15 guidance to vaccine providers, which noted pharmacies "should only vaccinate persons aged 65 years or older" after vaccinating their own staff.

"We worked to identify impacted individuals who had made appointments as soon as we received this updated guidance," DeAngelis said in an email. "We are required to comply with state guidance on vaccine eligibility and we regret any inconvenience."

State rule had been in place since January

The state's rule preventing pharmacies from vaccinating people younger than 65, however, had been in effect for nearly a month prior to Feb. 15.

The rule was included in the Health Department's Jan. 19 guidance to vaccine providers, as well as a Jan. 23 executive order by Gov. Andrew Cuomo.

"The requirement that pharmacies in New York State prioritize the 65+ population for vaccination has been stated numerous times by the Governor and is clearly laid out in multiple guidance documents and an executive order," Health Department spokesperson Jill Montag said in a statement.

"Pharmacies book their own vaccination appointments, so please reach out to them for further questions."

It was not immediately clear how widespread the cancellations were; CVS declined to provide an estimate. Walgreens did not immediately respond to questions Wednesday about the situation.

People who booked appointments on CVS' online system were greeted with a pop-up saying eligibility was limited to New York residents age 65 or older, and warning that different states have different eligibility rules.

Still, the warning was apparently easy to miss, as those who had their appointments cancelled wrote to their local government leaders and took to apps like Nextdoor and social media to voice their displeasure.

Paul Feiner, supervisor of the town of Greenburgh in Westchester County, publicly posted emails from his constituents who reached out to his office to raise concern after removing their names.

"This is ridiculous," Feiner wrote on the town's website. "Those under 65 who have medical problems deserve the vaccine just like those who are over 65 and are healthier. I am reaching out to the Governor's office - hoping that the state will direct all pharmacies to offer vaccines to everyone eligible to receive them."

Phyllis Sauler said she booked an appointment for her son, who is younger than 65 but has an eligible underlying health condition, at the Walgreens in Dobbs Ferry, Westchester County. She said she received a confirmation email from the drug-store chain before later receiving an email cancelling the appointment, which led her to call for an explanation.

"The person I spoke with at Walgreens told me that she was just told that they were just informed they could only give vaccines to those 65 and older," Sauler wrote in an email.

Cuomo's administration first limited vaccine providers to specific populations in mid-January, not long after expanding the eligibility rules to include those over the age of 65.

Under the state rules, pharmacies are limited to those over the age of 65. Hospitals have to prioritize health care workers, then they can vaccinate residents of facilities for the developmentally disabled, then they can vaccinate those over the age of 65.

Local health departments have to prioritize essential workers for vaccination. They can also designate health care providers in their counties to vaccinate those with comorbidities.

New York's 13 state-run mass vaccination sites are open to anyone who is currently eligible for the vaccine.

https://www.lohud.com/story/news/2021/02/17/cvs-walgreens-cancel-covid-vaccine-appointments-ny-those-under-65/6784702002

Biden Administration Changes Vaccination Timeline

 Last week, Anthony Fauci, MD, said that "virtually everybody and anybody in any category could start to get vaccinated" in April.

But on Tuesday, the Biden administration changed the timeline for mass vaccinations to May, June, or July.

At a CNN town hall in Wisconsin, moderator Anderson Cooper asked President Joe Biden, "When is every American who wants it going to be able to get a vaccine?"

"By the end of July this year," Biden replied. "We have — we came into office, there were only 50 million doses that were available. We have now — by the end of July we'll have over 600 million doses — enough to vaccinate every single American."

Biden specified that he meant enough vaccine would be "available" to vaccinate the average American who doesn't fall into a high-risk group — not that everybody would actually be vaccinated by July.

He said that the government is trying to speed up the vaccination process by opening more locations for vaccinations and hiring more people to give the shots.

So far, states have concentrated on vaccinating high-risk groups — people over 65, healthcare workers, and residents and employees of long-term care facilities.

Biden predicted that the country should get back to "normal" by Christmas "with the grace of God and the goodwill of the neighbors." In a year, he said, "there'll be significantly fewer people having to be socially distanced, have to wear masks, et cetera. But we don't know."

Fauci has walked back his prediction, made last week on the "Today" show, that "open season" on vaccinations would arrive by April.

"That timeline will probably be prolonged, maybe into mid-to-late May and early June," he said Tuesday on CNN.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said the April prediction was based on the belief that Johnson & Johnson would have "considerably more doses than now we know they're going to have."

The company will have less than 10 million vaccine doses ready for shipment if the FDA grants the company emergency use authorization, CNN reported. That could come as soon as late this month.

Fauci also said there's a difference between the time when a vaccine is available and the time when people will actually be vaccinated.

"It may take until June, July, and August to finally get everyone vaccinated," Fauci said. "When you hear about how long it's going to take to get the overwhelming proportion of the population vaccinated, I don't think anybody disagrees that that's going to be well to the end of the summer and we get into early fall."

Before taking office, Biden said he wanted 100 million doses administered in the first 100 days — 1 million doses a day. On Tuesday, Biden tweeted, "I not only believe we'll reach that, we'll break it."

But several health experts interviewed by The New York Times said the administration could and should be more ambitious, perhaps shooting for 3 million vaccinations a day.

"We should be doing more," Jennifer Nuzzo, an epidemiologist at Johns Hopkins, told the Times. "I am kind of surprised by how constrained we've been."

The major problem so far in the vaccination program has been supply, the Times said, but soon it will be logistics: Getting the vaccine administered more quickly after the states receive it. The CDC website says 71.6 million doses have been delivered but only 55.2 million doses have been put into people's arms — a difference of more than 16 million doses.

"I'm not hearing a plan," Peter Hotez, MD, a vaccine expert at Baylor College of Medicine, said of the Biden administration. "In the public statements, I don't hear that sense of urgency."

The emergence of variants should be worrying the administration, one health expert said.

"We need to be laser focused on getting as many people vaccinated now as possible," said Paul Sax, MD, an infectious-disease official at Brigham and Women's Hospital in Boston.

https://www.medscape.com/viewarticle/946070

Barclays Starts Cytokinetics (CYTK) at Overweight

 Target $28

https://www.streetinsider.com/New+Coverage/Barclays+Starts+Cytokinetics+%28CYTK%29+at+Overweight/17995439.html

Needham Initiates Coverage On Rocket Pharmaceuticals with Buy

 

Price Target of $75

https://www.benzinga.com/news/21/02/19722227/needham-initiates-coverage-on-rocket-pharmaceuticals-with-buy-rating-announces-price-target-of-75

FBI, U.S. attorney in Brooklyn probing Cuomo administration on nursing homes

 The FBI and the U.S. attorney's office in Brooklyn have launched an investigation that is examining, at least in part, the actions of Gov. Andrew M. Cuomo's coronavirus task force in its handling of nursing homes and other long-term care facilities during the pandemic, the Times Union has learned.

The probe by the U.S. attorney's office in the Eastern District of New York is apparently in its early stages and is focusing on the work of some of the senior members of the governor's task force, according to a person with direct knowledge of the matter who is not authorized to comment publicly.

Last March, as the virus began spreading in New York, Cuomo issued a news release listing the 13 initial members of his coronavirus task force, which has been headed by Linda Lacewell, an attorney and former chief of staff for Cuomo. Lacewell is the superintendent of the state Department of Financial Services. Other task force members include state health Commissioner Howard Zucker, Secretary to the Governor Melissa DeRosa and Beth Garvey, counsel to the governor.

"As we publicly said, DOJ (Department of Justice) has been looking into this for months," said Richard Azzopardi, a spokesman for the governor. "We have been cooperating with them and we will continue to."

Azzopardi did not disclose whether any members of the administration have been interviewed or if they have been served with any subpoenas.

John Marzulli, a spokesman for the U.S. attorney's office in Brooklyn, on Wednesday afternoon said he could not "confirm or deny" whether the office has initiated an investigation.

Nearly three weeks after the governor's task force was announced last year, the state health department issued an order directing nursing homes and other long-term care facilities that they must accept residents who were being discharged from hospitals even if they were still testing positive for the infectious disease, as long as they were able to care for them properly.

That directive, which was rescinded less than two months later, has been the focus of a firestorm of criticism directed at Cuomo's administration, including allegations that the order — which the governor said was based on federal guidance — had contributed to the high number of fatalities of nursing home residents in New York. That assertion was largely dismissed in a report by the Department of Health that was released in July.

Last month, the office of Attorney General Letitia James issued a scathing report that concluded the practice may have increased the risk of COVID-19 infections at the congregate facilities and that Cuomo's administration had delayed reporting that thousands of additional nursing home residents died at hospitals after being infected in their residential facilities.

It's unclear whether the federal probe by the office of acting U.S. Attorney Seth D. DuCharme is tied to two letters that Cuomo's administration received from a civil division attorney at the Justice Department in Washington, D.C., last year seeking information on the state's nursing home policies and data.

The controversy boiled over again last week when DeRosa, in a closed-door meeting with key Democrats in the state Legislature with the authority to subpoena and investigate the governor's administration, told the group that the administration had withheld information lawmakers had requested on nursing homes for months due to the Justice Department's inquiry.

DeRosa, in the private meeting that was the subject of a subsequent leak, characterized the Justice Department official who sent the letter, Jeffrey Clark, an attorney who headed the department's civil division, as a "political hack" that she contended had pursued the probe at the urging of President Donald J. Trump.

"Basically, we froze because then we were in a position where we weren't sure if what we were going to give to the Department of Justice or what we give to you guys and what we start saying was going to be used against us and we weren't sure if there was going to be an investigation," DeRosa told the Democratic lawmakers.

In a formal statement a day after her remarks were leaked, DeRosa said the administration has cooperated fully with the Department of Justice.

The recent probe by the U.S. attorney's office in Brooklyn is not the first time that New York City-based federal prosecutors have launched investigations in New York's Northern District, which stretches from Kingston to the Canadian border with headquarters in Albany and Syracuse. A sprawling fraud and bribery case involving top Cuomo aides in Albany was prosecuted by the U.S. attorney's office in Manhattan; the prosecution of NXIVM co-founder Keith Raniere and other top members of his organization was handled by the U.S. attorney's office in Brooklyn.

Sen. Chuck Grassley, R-Iowa, issued a statement Wednesday urging President Joe Biden to allow Antoinette Bacon, the acting U.S. attorney in New York's Northern District, to be assigned to investigate Cuomo's administration in connection with its reporting of nursing home fatalities.

Grassley noted that the U.S. attorney in New York's Manhattan-based Southern District, Audrey Strauss, is the mother-in-law of DeRosa and should not be involved in any probe.

Bacon, who was appointed acting U.S. attorney in Albany in September, is among dozens of U.S. attorneys who may be removed from their positions by the Biden administration. Bacon had recently been the Justice Department's national elder-justice coordinator and served as the national white collar crime coordinator at the executive office for U.S. attorneys.

She is a highly decorated prosecutor and has received special awards from the IRS, U.S. Postal Service and the Justice Department "for her prosecutions of fraud, waste, abuse, and corruption," according to her professional biography.

But the probe being conducted by the U.S. attorney's office in Brooklyn apparently does not involve the Northern District.

Earlier this week, Cuomo stopped short of apologizing for his administration's handling of nursing homes' fatality data, repeatedly noting they had created a "void" by not providing the information requested by state lawmakers.

"Apologize? Look, I have said repeatedly, we made a mistake in creating the void," he said. "When we didn’t provide information it allowed press, people, cynics, politicians to fill the void. When you don’t correct this information you allow it to continue and we created the void."

Republicans at all levels of New York's government spectrum, and many Democrats as well, have repeatedly called for independent investigations of the state's nursing home policies and directives during the ongoing pandemic. Some of those critics also have raised questions about whether there were any ties between policy decisions and hospitals or other special interests that either have business before the state or are subject to its regulating agencies.

https://www.timesunion.com/news/article/cuomo-investigation-fbi-covid-nursing-homes-15957401.php

Smith + Nephew sees further pandemic pain as annual profit slumps

 

Medical products maker Smith+Nephew said on Thursday pandemic-led disruption would continue into the first half of 2021 with uncertainty on the timing of recovery, as its annual trading profit missed average analyst estimates.

Hospitals around the world had delayed elective surgeries last year, such as hip and knee replacement procedures, to accommodate COVID-19 patients, weighing on demand for orthopaedic implants and prosthetics made by the British firm.

Shares in the company traded down 5.2% at 1,485.5 pence by 1135 GMT after falling around 8% earlier.

"The only question we don't have an answer for is when exactly the recovery will be because that depends on the vaccines, the further spread of COVID-19, decisions taken by healthcare authorities, by governments ... the different mutations of the COVID-19 virus," Chief Executive Officer Roland Diggelmann told Reuters.

He added that Smith+Nephew encouraged its employees to get vaccinated.

The company expects headwinds to its 2021 profit margins, compared to 2019, from reduced production volumes on gross margin, increased investment in R&D and from recent acquisition completions.

But the company expects substantial underlying revenue growth in 2021, with its hip implants business outperforming knee implants, its sports medicine & ENT franchise performing strongly on market recovery and also forecasts better growth in its advanced wound-management business.

Smith+Nephew is also focusing on investing in research, launching new products and transforming operations which is expected to deliver around $200 million of annualised benefits by 2025 for a one-off cost of around $350 million.

"The company may have outlined a priority to get back to top line growth in 2021 but...this is entirely out of the company's hands and really depends on the course of the pandemic," AJ Bell's investment director Russ Mould said.

Trading profit slumped 42% to $683 million for the year ended Dec. 31, missing average analyst estimates of $712 million, with its fourth quarter being particularly hit by deferrals in the United States and Europe due to rising coronavirus cases.

https://www.marketscreener.com/quote/stock/SMITH-NEPHEW-PLC-9590181/news/Smith-Nephew-Nephew-sees-further-pandemic-pain-as-annual-profit-slumps-32469061/

Drugmaker Indivior prepares for pandemic hit to run into 2021

 

Opioid addiction treatment maker Indivior on Thursday predicted 2021 revenue would slip on a difficult first-half after sales fell 18% this year due to cheaper rivals to its best-selling drug and disruption from the COVID-19 pandemic.

The company expects net revenue of up to $625 million, assuming that coronavirus restrictions that have kept patients away from hospitals and limited access to medicines will be lifted in the second half.

However, if those restrictions persist, net revenue is seen at $565 million, sending the London-listed company's shares 1.3% lower at 147 pence in early trading.

The drugmaker, which gets the bulk of its sales from the United States, is focusing on growing newer treatments such as injectable opioid-addiction treatment Sublocade, and Perseris for schizophrenia to boost its fortunes.

It expects Sublocade sales of $185 million to $210 million in its most likely case, and Perseris net revenue of $17 million to $20 million.

"Accelerating the growth of Sublocade remains the biggest potential driver of value creation," Chief Executive Officer Mark Crossley said, adding that Indivior aimed to hit peak sales of more than $1 billion for the treatment.

Indivior was grappling with drawn-out legal challenges and competition even before the virus outbreak hammered the healthcare sector. Former parent Reckitt Benckiser this month withdrew a $1.4 billion claim against the company to end a legal battle related to a U.S. probe into opioid addiction.

Indivior swung to an operating loss of $156 million for the 12 months ended Dec. 31 because of legal settlements worth $228 million. Excluding one-time items, operating profit was $88 million.

The drugmaker in September said it planned for up to $70 million in cost savings in 2020 as it restructures its supply channels. That programme was now complete, the company said on Thursday.

Revenue fell to $647 million from $785 million, in line with company's prediction last month.

https://www.marketscreener.com/quote/stock/INDIVIOR-19344116/news/Indivior-Drugmaker-Indivior-prepares-for-pandemic-hit-to-run-into-2021-32469093/