Under heat, Cuomo proposes his own nursing-home reform package

 Gov. Andrew Cuomo on Friday proposed a package of measures to boost accountability in the state’s nursing homes — while facing a firestorm of criticism over his own handling of COVID-19 deaths in the facilities.

Cuomo — under fire after The Post exclusively reported his top aide admitted in a private meeting with lawmakers that the administration deliberately withheld nursing-home coronavirus death data for fear of retribution from federal prosecutors — focused a chunk of his remote press briefing to laying out plans criticizing the facilities.

“We have to learn after this one, and we have to make the changes,” the Democrat declared, laying out his nursing-home “reform package,” which includes measures that would require facility operators to post owner names, lists of all Medicaid rates and contracts.

Cuomo also wants to increase the civil monetary penalty from $10,000 to $25,000 for violations of public health law, as well as firmer infection-control regulations, at the sites.

“I will not sign the budget without this nursing-home reform plan, period,” the governor said.

Melissa DeRosa, the governor’s embattled top aide, had said during last week’s private meeting that Cuomo officials wanted to tighten up laws following the high death toll, infection spread and a litany of other issues at nursing homes including personal-protective-gear shortages that cropped up over the last year of the pandemic. 

More than 13,000 New York nursing-homes residents have died from the virus so far.

Cuomo officials revealed during the private meeting that not one nursing home in the state had its license to operate yanked amid COVID-19 — while just 170 violations were recorded out of 2,284 infection-control inspections. 

James Clyne, the CEO of the nursing-home association LeadingAge, called Cuomo’s proposed stiffer penalties and mandates “completely punitive”.

“You’re not going to hear nursing-home operators say, `We’re not regulated enough,’ ” Clyne said.

“We don’t think the lack of penalties is the problem. The issue is the need for financial support.”

He added that the governor’s proposal mirrors recommendations of the powerful healthcare workers union 1199SEIU.

A state Senate Democrat, Mike Murphy, told The Post that lawmakers would take a look at Cuomo’s package but are way ahead of him.

“We are passing our own bills that go further,” Murphy said, noting that Senate Democrats have proposed and intend to pass a group of 10 bills early next week providing additional accountability measures for reporting death data in facilities and allowing loved ones into homes during the pandemic to assist with care.

State Assembly Speaker Carl Heastie’s office was not available for immediate comment as to whether or not he supports Cuomo’s plan.

https://nypost.com/2021/02/19/cuomo-proposes-his-own-nursing-home-reform-package/

World Bank pushing for standard vaccine contracts, more disclosure from makers

 

The World Bank is working to standardize COVID-19 vaccine contracts that countries are signing with drug makers, and is pushing manufacturers to be more open about where doses are headed, as it races to get more vaccines to poor countries, the bank's president said on Friday.

World Bank President David Malpass told Reuters he expected the bank's board to have approved $1.6 billion in vaccine funding for 12 countries, including the Philippines, Bangladesh, Tunisia and Ethiopia, by the end of March, with 30 more to follow shortly thereafter.

The bank is working with local governments to identify and fill gaps in distribution capacity, after they purchase vaccines under a $12 billion World Bank program, and also to standardize the contracts they are signing with manufacturers, he said.

The bank's International Finance Corp, its private financing arm, has $4 billion to invest in expanding existing production plants or building new ones, including in developed countries, but needs more data on where current production is headed, he said.

"We are eager to be investing in new capacity, but it's hard to do because you don't know how much of the existing capacity is already committed to the various off-takers," Malpass said in an interview with Reuters. New or expanded plants could be used to produce other types of vaccinations in the future, he said.

The bank's funds could be used to expand plants in advanced economies, if the production was earmarked for developing nations, he said.

Malpass welcomed Friday's pledge by the Group of Seven rich countries to intensify cooperation on the pandemic, saying it could help jump-start deliveries of vaccines to poorer countries, which are lagging far behind rich countries in getting shots in arms.

Data compiled by Our World In Data, a scientific online publication, showed Israel was leading the world in COVID-19 vaccinations, with nearly 82 of 100 people vaccinated, while India and Bangladesh reported less than one person per 100, Many African countries have not started at all.

Malpass said he was heartened by news about new vaccines coming down the road, and about Pfizer Inc and BioNTech SE seeking permission to store their vaccine at higher temperatures, which would ease another obstacle to deliveries in lower-income countries.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-World-Bank-pushing-for-standard-vaccine-contracts-more-disclosure-from-makers-32488661/

Some Covid Vaccines Effective After 1 Dose, Can Be Stored in Normal Freezers, Data Show

 Efforts to vaccinate the world's population against Covid-19 got a boost Friday after research showed that some vaccines provide strong, one-dose protection, and that one of the vaccines can now be stored in normal freezers instead of ultra-cold ones.

The vaccine developed by Pfizer Inc. and BioNTech SE generates robust immunity after one dose, according to new research out of Israel, and further data showed that the University of Oxford and AstraZeneca PLC vaccine similarly prevented Covid-19 when doses were spaced three months apart.

The findings could boost arguments in favor of delaying the second dose of the two-shot vaccine, as the U.K. has done. They could also have substantial implications on vaccine policy and distribution around the world, simplifying the logistics of distributing the vaccines.

Also Friday, Pfizer and BioNTech said they asked U.S. regulators to allow their vaccine to be stored and transported at temperatures consistent with standard freezing, around minus 20 Celsius, following successful internal stability testing. Similar filings were being prepared in other countries.

Should Pfizer's request be granted by regulators, it would mean its vaccine would vastly expand access in rural regions around the world, as well as pharmacies and physician offices, according to industry experts and officials.

The label change would allow the shots to be kept essentially wherever providers have normal freezers, which would make it much easier to handle and potentially accessible to poorer countries with no access to ultracold distribution and storage equipment. Pfizer's vaccine would also be able to return to ultracold temperatures after standard temperatures.

"This is excellent news and it will greatly improve the vaccine rollout, " said Ivan Dikic, director of the Institute of Biochemistry II at Goethe University Frankfurt. "The improved protocol will be much easier to handle for both rich and developing countries around the world."

Pfizer plans to request a label change from the European Medicines Agency, too. If EMA grants the request, the EU rollout could accelerate. EMA didn't respond to a request for comment on Friday. Germany's Robert Koch Institute, the disease control agency that includes a vaccination advisory panel, said in a statement that it would revisit its guidelines as new data emerge.

The requirement for ultra-cold storage of the shots has been a major obstacle for some providers and local health departments, prompting them in recent months to purchase special equipment. The restrictions have also contributed to the glacial pace of Europe's vaccine rollout, making it complicated for the vaccine to be administered in general surgeries and nursing homes.

Doses were wasted early on during the rollout as local authorities failed to adhere to the strict handling rules. In the German state of Bavaria, 2,000 doses were discarded due to exposure to higher temperatures.

In the U.S., retail chains such as CVS Health Corp. and grocers, major health systems and other providers have some ultracold freezers, but many communities don't have them.

Experts say the change could help with storage as supply increases and as more vaccination sites become available for the general public to visit. Neighborhood pharmacies and physician offices that might otherwise have been left out could administer the vaccine more easily.

"It does definitely increase the number of sites," said Moncef Slaoui, the former chief adviser to Operation Warp Speed, the Trump administration's Covid-19 response program, in an interview Friday. "Most immunization sites would have a minus 20 freezer like everybody has at home."

Challenges remain, experts say, because Pfizer's vaccine will continue to be shipped in the specialized boxes that hold about 5,000 doses and are easy for mass vaccination or hospitals to handle.

Rival vaccines are still easier to store. Moderna Inc.'s vaccine can be stored at standard freezer temperatures for up to six months and remain refrigerated for up to 30 days. Johnson & Johnson's vaccine, which U.S. regulators are weighing authorizing and which has been shown to safely protect against Covid-19, can be kept in normal freezers for up to two years, with at least three months in the fridge.

The findings regarding single-dose effectiveness are likely to renew debate over whether dosing schedules should be adjusted amid limited vaccine supply.

In research published Friday in the Lancet medical journal, one dose of Pfizer's vaccine was shown to be 85% effective in preventing symptomatic disease 15 to 28 days after being given, according to a peer-reviewed observational study of about 9,000 people conducted by the Israeli government-owned Sheba Medical Center.

Pfizer and BioNTech have said the second dose should be given three weeks later, the schedule that was used in its late-stage study that found the vaccine to be 95% protective. They also have said they haven't studied alternative dose schedules, but that changes should be up to health authorities.

The U.K. delayed a second dose by up to 12 weeks so it could use limited supplies to deliver a single dose to more people. Almost one-third of the U.K.'s adult population has now received at least one shot. Parts of Canada and Europe have implemented similar measures, though many countries including the U.S. haven't done so.

The Israeli findings came from real-world data about the effect of the vaccine gathered outside of clinical trials in one of the leading nations in immunization against the coronavirus pandemic. Israel has given the first shot to nearly half of its 9.3 million citizens.

The authors noted, however, that the findings don't justify changing dose schedules, and that more follow-up to assess long-term effectiveness of a single dose is needed before deciding to delay second doses.

"This is the first study assessing effectiveness of a single vaccine dose in real-life conditions and shows early effectiveness, even before the second dose was administered," said Eyal Leshem, director of Sheba's Center for Travel Medicine and Tropical Diseases and one of the authors of the study.

The results might differ from others because the subjects were largely younger and healthier, said Gili Regev-Yochay, another of the authors. She also said the study couldn't confirm how long protection from one shot would last, as most of the subjects received a second shot.

Also Friday, in the Lancet, the vaccine co-developed by the University of Oxford and AstraZeneca was shown to be 81% effective at preventing symptomatic Covid-19 when doses were spaced 12 weeks apart, compared to 55% spaced six weeks or less, according to results of a peer-reviewed study. Researchers also reported two doses of the vaccine were shown to potentially reduce cases by 50% -- a number that scientists said is lower because it included people with and without symptoms. The vaccine's effect on curbing asymptomatic cases is lower, they said.

Friday's study updated data published this month that hadn't yet been reviewed by independent researchers.

Pfizer's late-stage, 44,000-person study found a two-dose regimen to be 95% effective at protecting against symptomatic Covid-19. The study found the vaccine to be more than 52% effective after one shot but didn't specify further before the second dose is given.

During the period when the data for the Israeli study were gathered, a coronavirus variant that was first detected in the U.K. and is considered more contagious than the original pathogen made up more than 81% of confirmed infections.The data amount to strong evidence that the vaccine is highly effective against a mutation that has forced European governments to prolong their lockdowns.

Ugur Sahin, the co-founder of BioNTech, told The Wall Street Journal in December that next-generation Covid-19 shots would probably consist of one dose.

"This groundbreaking research supports the British government's decision to begin inoculating its citizens with a single dose of the vaccine," said Arnon Afek, Sheba's deputy director general.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Some-Covid-19-Vaccines-Are-Effective-After-One-Dose-Can-Be-Stored-in-Normal-Freezers-Data-32488548/

CA to earmark 10% of weekly COVID vax for teachers to get more schools open

 Gov. Gavin Newsom announced Friday that state officials will set aside 10% of California’s weekly allotment of COVID-19 vaccine doses for educators starting next month, an effort to jump-start the process of reopening more public school campuses as virus conditions improve in communities across the state.

The announcement, made during a visit to an Oakland vaccination clinic, marked a swift turn of events after school reopening negotiations between Newsom and state lawmakers stalled in part over the governor’s reluctance to promise vaccinations to teachers and school employees.

“The reason we can do that more formally, even though we’ve allowed for it over the course of the last number of weeks, is the window of visibility into the future with more vaccinations that are now coming from the Biden administration,” Newsom said.

Based on current vaccine allocations from the federal government, the state will reserve about 75,000 doses of COVID-19 vaccine for school employees. The governor did not say whether teachers and other staff should expect to receive full treatment — current vaccines require two injections — before returning to campuses or should expect to be vaccinated soon after schools open.

On Thursday, Democratic lawmakers introduced a school reopening proposal to guarantee access to vaccines for employees but stopped short of the specific allocation outlined by Newsom less than 24 hours later. The $6.6-billion plan focuses on elementary schools and offers state funds for health and safety needs at those locations, as well as money to cover programs later in the school year to address learning loss suffered by millions of California schoolchildren.

California’s supply of vaccines has gradually risen in recent weeks. In a post on Twitter, Newsom said Friday that more than 1.3 million doses would be made available next week, rising to 1.4 million doses in the final week of February and more than 1.5 million by early March — the week when the education vaccine program would begin.

The governor’s announcement stood in contrast to several weeks’ worth of comments urging educators to not make vaccinations a precondition to reopening elementary schools, an effort he launched in late December that struggled to win acceptance in the Legislature. Last month, Newsom told a group of school administrators that a mandate for vaccines was tantamount to saying in-person learning wouldn’t happen at all during the current academic year.

On Friday, he said the upcoming vaccine allotment should settle the issue of whether more students can return safely to campuses in the coming weeks.

“It must be done much sooner than the current path that we’re on,” he said. “We believe this will help advance that cause.”

https://www.latimes.com/california/story/2021-02-19/gavin-newsom-10-percent-covid-19-vaccines-educators-california-schools-open

Covid-19 Manufacturing Roundup

Thermo Fisher plant ramps up AstraZeneca vaccine production 

Shortly after Thermo Fisher’s $878.2 million buyout of Novasep’s viral vector manufacturing business, it took over a plant in Belgium tasked with producing adenovirus vectors for AstraZeneca’s version of the Covid-19 shot.

That production agreement was instigated when Novasep was still in charge, and the plant shouldered much of the blame for the oft-publicized slowdown of vaccine output in recent weeks. Now that Thermo Fisher has taken over, though, the plant has “drastically” ramped up its production of late, Reuters reported Wednesday. 

European Union industry commissioner Thierry Breton said the production capacity at the factory that produced shots for AstraZeneca had “drastically” increased, Reuters said.

A report in the Wall Street Journal had singled out the Belgian plant as the source of the delay in production that had pitted AstraZeneca against the EU at times recently, reporting that the plant had only been producing a third of the yield the vaccine maker was expecting. 

Korea’s SK vaccine sub snags deal to ramp up a supply of 40M doses of Novavax’s Covid-19 jab

The vaccine subsidiary of Korea’s SK Group has expanded on its original manufacturing pact with Novavax, which has been developing a new vaccine for Covid-19.

Under the new agreement, SK Bioscience now has a license to manufacture and commercialize NVX-CoV2373. That is being added to a technology transfer pact related to the manufacturing of Novavax’s protein antigen, supply of Matrix M adjuvant, with added support for SK Bioscience as needed to secure regulatory approval.

SK concurrently struck an agreement to supply the Korean government with 40 million doses of the vaccine, which has cleared an interim review in the UK, with Phase III data coming up in the US.

“We are honored to continue to manufacture Novavax’s innovative COVID-19 vaccine and provide a supply to the Korean Government through this agreement,” said Jaeyong Ahn, the CEO of SK Bioscience. 

Japan’s Kaneka Eurogentec gains GMP accreditation to produce mRNA vaccines

Japan’s Kaneka Eurogentec, bolstered by a recent deal to manufacture doses of Inovio’s Covid-19 vaccine, now has a new accolade in its portfolio.

Eurogentec’s new facility in Seraing, Belgium has received GMP accreditation for manufacturing mRNA, the key component of many Covid-19 vaccines currently on the market and a close counterpart to Inovio’s plasmid DNA-based vaccine for the respiratory virus.

The Belgian facility will initially allow Kaneka Eurogentec to produce and purify up to a 10g scale — or 1 million vaccine doses — of RNA that can be used in both clinical trials and the commercial supply chain, and can potentially be expanded further.

Moderna, Pfizer-BioNTech ink deals for millions of more vaccine doses in EU

The European Commission this week inked deals with Moderna and Pfizer for a total of 350 million more vaccine doses, to be delivered throughout 2021. Moderna’s total commitment now sits at 310 million doses in 2021, and as part of the new agreement, the EU also holds the option to buy another 150 million doses for delivery in 2022.

The deal also will supply 200 million more doses of the Pfizer-BioNTech vaccine, and the new additional doses will bring the EU’s total supply up to 500 million. More biotechs are jumping in to assist Pfizer-BioNTech with development, including Merck KGaA, which says it can accelerate its supply of custom lipids.

Novartis has also agreed to lend a hand with development, and Sanofi has offered the use of its Frankfurt plant to produce more than 100 million doses. 

https://endpts.com/covid-19-manufacturing-roundup-thermo-fisher-plant-ramps-up-astrazeneca-vaccine-production-novavax-expands-korean-manufacturing-pact/

Malpass expects rapid approval of funds for 30 more countries to buy Covid vaccines after initial batch

World Bank's Malpass says Pfizer-BioNTech statement on possible higher temperature storage of vaccine helpful for developing countries. https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/MALPASS-SAYS-PFIZER-BIONTECH-STATEMENT-ON-POSSIBLE-HIGHER-TEMPERATURE-STORAGE-OF-VACCINE-HELPFUL-FOR-32488381/

As insurers end grace period for COVID hospital costs, study estimates potential bills

 Nearly 1.7 million times in the past year, Americans have checked into hospitals to get treated for severe cases of COVID-19.

And for the most part, that care hasn't cost them anything, thanks to insurance companies and government programs that absorbed the usual costs patients would owe for any other hospital stay.

But as some insurers phase back in those out-of-pocket costs, a new study estimates that many people over 65 hospitalized for COVID-19 in 2021 may owe an average of nearly $1,000 after they get out of the hospital, due to co-pays, deductibles and co-insurance. A few may owe hundreds or thousands more.

That estimate is based on a new analysis of out-of-pocket costs for influenza-related hospitalizations in 2018 that were paid by people with Medicare Advantage plans, which are Medicare plans run by private insurance companies.

Nearly 40% of Americans over age 65 - who have a high chance of needing hospital-level care if they catch the coronavirus - have the kind of insurance analyzed in the study.

Most insurers that offer Medicare Advantage plans currently cover COVID-19 hospitalization costs fully for their Medicare Advantage enrollees, but one of these insurers quietly started to allow cost-sharing for its non-Medicare Advantage enrollees in February. This raises concerns that cost-sharing waivers may soon be a thing of the past for many or all patients hospitalized for COVID-19.

"Insurers may choose to extend their waivers for enrollees with Medicare Advantage and private insurance coverage," says Kao-Ping Chua, M.D., Ph.D., the study's first author and an assistant professor at the U-M Medical School. "But if they don't, patients will be faced not only with the physical and emotional toll of COVID-19 hospitalizations, but also the financial toll."

Writing in the American Journal of Preventive Medicine, a pair of health care researchers from the University of Michigan and Boston University describe data from 14,278 people hospitalized during one of the worst flu years in recent times.

On average, the flu patients in the study were hospitalized for an average of 6 days, and one-third of patients needed intensive care. This is around the same or slightly lower than the averages for hospitalized adults over 65 who have COVID-19.

Those who needed intensive care for flu, and those with longer stays at any level of care, faced out-of-pocket costs that were higher than the general average. About 3% of the flu patients faced out-of-pocket costs over $2,500.

Another study of cost-sharing among people with private non-Medicare insurance who were hospitalized for respiratory infections in pre-COVID times suggests out-of-pocket costs could be even higher for them. In part this is because so many private plans have high deductibles that must be paid each year before insurance coverage fully kicks in.

Chua notes that the choice of flu or other respiratory infection hospitalizations is not a perfect stand-in for COVID-19, which is having far more impact on the United States than even the worst flu year. But it is as close a stand-in as possible.

People with traditional Medicare also must share in the cost of their hospital care, but the current study did not analyze data from people with that form of coverage.

In 2018, 40% of Americans lacked enough savings to pay for a $400 emergency, according to federal data. The pandemic has put even more economic pressure on the lowest-income Americans.

Chua and his co-author Rena Conti, Ph.D. of Boston University's Institute for Health System Innovation and Policy, note that worries about out-of-pocket costs might keep some people from seeking emergency or inpatient care. They call for federal legislation mandating insurers to fully cover the costs of COVID-19 hospitalizations for the duration of the pandemic, and for insurers to extend waivers due to expire soon.

###

Chua, a pediatrician at Michigan Medicine as well as a health care researcher, is a member of the Susan B. Meister Child Health Evaluation and Research Center and the U-M Institute for Healthcare Policy and Innovation.

The Association of Health Insurance Plans offers a page that tracks private insurers' current policies regarding COVID-19 care, including cost-sharing waivers.

https://www.eurekalert.org/pub_releases/2021-02/mm-u-aie021721.php