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Friday, February 19, 2021

Pfizer to double weekly U.S. output of vaccine in next few weeks - CEO

 Pfizer Inc Chief Executive Albert Bourla said on Friday that the drugmaker expects to be able to double the weekly number of doses of its COVID-19 vaccine it will supply to the United States in the next few weeks.

Bourla, speaking after U.S. President Joe Biden toured his company’s vaccine manufacturing facility in Michigan, said Pfizer was currently sending out an average of 5 million doses per week and expects to “more than double that number” in coming weeks.

“We have improved our processes to double the batch size and increase yield and we have deployed more efficient lab test methods to reduce release times,” Bourla said in his remarks.

He said those measures allowed the company to reduce the time it takes to make the vaccine from 110 days to 60 days.

Bourla said that by Feb. 17, Pfizer had supplied the United States with 40 million doses of the COVID-19 vaccine it developed with German partner BioNTech SE.

The company has agreed to supply 300 million doses to the United States by the end of July.

Bourla said Biden had challenged the company to beat that target, and it would look for ways to improve its production.

https://www.reuters.com/article/us-health-coronavirus-usa-pfizer-doses/pfizer-to-double-weekly-us-output-of-vaccine-in-next-few-weeks-ceo-idUSKBN2AJ2F8

U.S. Hiring Alliances Help Tens of Thousands Find Jobs

 Unusual hiring alliances created by U.S. businesses in 2020 are now bearing fruit.

When pandemic-related shutdowns devastated some industries and turbocharged others last spring, dozens of employers joined forces to match idled workers with open jobs. Companies with urgent staffing needs in industries such as healthcare, grocery and e-commerce formed large-scale matchmaking partnerships with companies in hard-hit sectors such as hospitality, retail and airlines to recruit workers who had been furloughed or laid off

Almost a year later, the partnerships have matched many tens of thousands of workers with open jobs, according to several companies involved in them. And labor specialists say they could be a model for future hiring alliances among employers.

"It's really a very promising practice," says Jane Oates, head of the nonprofit WorkingNation and an assistant secretary in the Labor Department during the Obama administration. "This strategy will outlast Covid-19," she says, as it likely will take at least three years for the U.S. to regain lost jobs.

'A great fit'

CVS Health Corp. formed hiring partnerships with 64 U.S. employers -- including Hilton Worldwide Holdings Inc. and Gap Inc. -- as it raced to fill open positions in its stores, warehouses and call centers amid a coronavirus-fueled surge in its business last year. The pharmacy and insurance giant created dedicated hiring websites for its partners' displaced workers and streamlined the selection process for some jobs. Of the more than 100,000 people whom CVS recruited from March to December last year, about 3,700 came from the new partnerships, according to a spokeswoman.

Amazon.com Inc. estimates it selected tens of thousands of workers from 21 U.S. corporate partners such as Uber Technologies Inc., Lyft Inc. and United Airlines Holdings Inc. as it went on a hiring spree last year, placing more than 400,000 people in permanent U.S. jobs to handle soaring demand for at-home shopping.

The unprecedented alliances allowed Amazon to "quickly gain access to a skilled workforce," says Ardine Williams, Amazon's vice president of workforce development. "For instance, workers from the hospitality industry bring a strong customer obsession -- which is a great fit for Amazon." CVS and Amazon say they don't know whether their new hires are making more or less than at their previous employers because they don't ask candidates for such information.

Other companies, including grocer Albertsons Cos., Fidelity Investments Inc. and Walgreens, a CVS rival owned by Walgreens Boots Alliance Inc., also have used job-pairing alliances to find new hires amid the pandemic.

Albertsons says it has recruited at least 1,400 staffers from 23 corporate partners, including Hilton, MGM Resorts International, Regal Cinemas and Inspire Brands Inc., whose portfolio includes the Arby's, Buffalo Wild Wings and Jimmy John's restaurant chains.

Fidelity launched pilot projects with Hilton, Marriott International Inc., Delta Air Lines Inc. and JetBlue Airways Corp. Most of the new hires landed customer-service spots, a Fidelity spokeswoman says, although she couldn't give a specific number.

Walgreens estimates roughly 6,200 employees arrived from 50-plus partners, including retailer Kohl's Corp., Hilton, Gap and the Chicago Cubs. Walgreens plans to keep hiring this way for the indefinite future "because it has been so successful," says Chief Human Resources Officer Hillary Leisten.

The partnerships taught Walgreens to be nimble about hiring and integrating part-time staffers, a spokesman says. The company also discovered a new set of applicants from the hospitality industry with "soft skills" that transfer well to retailing, he says.

In a global matchmaking endeavor, meanwhile, consulting giant Accenture PLC and three U.S. companies in April introduced a business-to-business exchange called People + Work Connect that pairs hiring employers with those that are letting workers go.

The free online platform quickly attracted 273 employers from 93 countries. The platform contains approximately 400,000 jobs, which represent employers' openings and positions formerly held by job seekers.

"Accenture enjoys economies of scale that individual companies generally don't," because its platform pools information from so many businesses, says Susan Houseman, vice president and research director of the Upjohn Institute for Employment Research.

Innovative model

During prior recessions, businesses never collaborated on a large scale to help workers find jobs, labor economists say.

A downturn usually "is an opportunity to let your least important workers go," and that discourages other employers from recruiting them, says David Deming, a public-policy professor at Harvard University's Kennedy School who specializes in weak labor markets.

Today's cooperative effort "is quite unique to this recession," says Upjohn's Ms. Houseman. She points out that the pandemic bifurcated the economy and crippled government centers that normally assist layoff victims.

The CVS approach, in particular, "represents a very innovative model worth imitating" because it can shorten how long individuals remain jobless, says Ben Damerow, a division head at the Upjohn Institute.

Although he doubts nationwide matchmaking will outlast this downturn, he does think employers involved in the partnerships will have gleaned lessons about expedited hiring processes. Those lessons include the importance of interviewing applicants promptly and not delaying "onboarding" of new picks.

Hilton, which furloughed 45,000 of its 60,000 U.S. employees at some point during 2020 and laid off 3,900 others, formed hiring alliances with 180 North American employers to help the affected workers. The hotel firm chose CVS as one of its 29 "premier" company partners because it liked its approach.

"Staffing doesn't always have to be a game of winners and losers [for employers]," says Jeff Lackey, CVS's vice president of talent acquisition. "We can create a win-win-win by offering jobs to qualified candidates, brand protection for their prior employer and talent to the hiring company."

Hilton received weekly tallies about its employees switching to CVS. And Mr. Lackey fulfilled a promise to alert those recruits when Hilton initiated furlough recalls, according to a spokeswoman from CVS.

Laura Fuentes, Hilton's chief human-resources officer, says she hopes many idled colleagues will come back once the hospitality industry recovers. But Hilton recognizes the risk that some may not return because "we've introduced people to great companies and them to well-trained hospitality people," she says.

By year-end, Hilton had rehired about 100 of the 3,900 staff members it laid off. More than 20,000 of its employees remain furloughed, the company says.

Fresh start

Not everyone redeployed via matchmaking arrangements may return to their previous workplace -- especially if they switch fields.

Consider Gerardo Muñoz, a CVS pharmacy technician hired from Gap. Technicians typically are hourly workers licensed to assist pharmacists with filling prescriptions or answering customer questions.

Mr. Muñoz worked at a Gap store in Skokie, Ill., for about five years. He advanced from sales associate to key holder specialist, an administrative role.

In early spring, Gap furloughed 80,000 workers because of store closures. Among them was Mr. Muñoz. The struggling retailer soon cut 15% of its workforce in North American offices.

Gap offered to connect affected employees with its more than 20 U.S. hiring partners, including CVS. Mr. Muñoz remembers being attracted by CVS's customized website -- "it had a big Gap logo" -- plus the chance to enter healthcare.

Last June, the freshly licensed technician joined a CVS pharmacy in Niles, Ill. Mr. Muñoz, 25, so enjoys his job that he turned down Gap's subsequent invitation to return. "Almost everything I do is helping our patients [to] improve their health," he says.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/U-S-Hiring-Alliances-Help-Tens-of-Thousands-Find-Jobs-Journal-Report-32486576/

How Will Covax Deliver Covid-19 Vaccines to Poorer Countries?

Developing countries are falling dangerously behind in the global race to end the coronavirus pandemic through vaccinations. The Covax facility aims to get Covid-19 shots to at least 20% of the populations of the world's poorest nations.

What is Covax?

Covax is the world's main effort for getting Covid-19 vaccines to poor countries. It was started last year by the World Health Organization and two groups that have been working on getting vaccines to developing countries -- Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations -- when it became clear that many nations would struggle to access the shots. As rich countries have done, Covax made deals with vaccine manufacturers to buy doses before they had passed clinical trials and been approved by drug regulators. The money to buy the vaccines has been donated mostly by Western governments and charitable groups, such as the Bill & Melinda Gates Foundation.

Who is participating in the WHO program?

Covax aims to provide free Covid-19 vaccines to at least 20% of the populations of the world's 92 poorest countries by the end of 2021. Just over 50 other nations, including Canada and upper-middle-income nations such as South Africa and Mexico, have also ordered vaccines through Covax, but have to pay for the doses themselves.

Which vaccines have been secured?

Covax has made deals with most of the big manufacturers, including Pfizer Inc., Johnson & Johnson and Novavax Inc. But during the first half of 2021, the majority of planned deliveries from the facility are for the vaccine developed by AstraZeneca PLC and Oxford University. For the whole year, the AstraZeneca vaccine is forecast to make up about one-third of Covax supplies, assuming that the shots by J&J and Novavax and other manufacturers get authorized as expected.

How many Covid vaccines will be donated?

Covax says it has negotiated deals for about 2.27 billion doses of vaccines this year, although many are for shots that have yet to be authorized or are still in clinical trials. All vaccines, except the J&J one, require two doses and some of them will go to the self-financing countries. Covax has also called on rich countries, which have bought enough vaccines to cover their populations multiple times over this year, to donate any extra doses. So far, the U.K. and Canada have said they would share surplus doses, but without giving details of when they would do so. Norway has said it would start sharing vaccines with developing countries at the same time as it starts immunizing its own people, while France has called on European countries to start giving about 5% of their vaccines to African nations now.

How will vaccines be shared with poorer countries?

Covax says most countries will get a first shipment of doses in March, with some small deliveries expected in late February. Supplies during the first half of the year are extremely constrained. Covax expects 336 million doses of the AstraZeneca vaccine and 1.2 million doses of the Pfizer shot. That will be enough to cover just over 3% of the population of the participating countries. Covax's purchase agreements with manufacturers are tied to a vaccine getting an emergency-use listing from the WHO, which in turn is used by regulators in many developing countries to approve the shots locally.

How is the U.S. supporting the Covax effort?

Under former President Donald Trump, the U.S. stood out among major Western governments for not contributing to Covax. President Biden has announced a $4 billion contribution to the facility. Washington will make an initial donation of $2 billion and then release an additional $2 billion throughout 2021 and 2022.

Can this program help put an end to the global health crisis?

Covax's backers say the donated shots should help to end the acute phase of the pandemic by protecting a society's most vulnerable members from getting seriously ill with Covid-19 and overwhelming hospitals. But the supplies secured so far will fall far short of helping benefiting countries to achieve herd immunity, so the virus is likely to continue circulating among the people who haven't been vaccinated. That, some health experts warn, leaves opportunities for the virus to develop mutations that could allow it to evade the immune response triggered by the current crop of Covid-19 vaccines. 

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/How-Will-Covax-Deliver-Covid-19-Vaccines-to-Poorer-Countries-Update-32486873/

After Quidel's Strong Q4 Performance, Investor Disappointment

 Shares of Quidel (NASDAQ:QDEL) skyrocketed 139% last year. The stock got off to a great start in 2021 as well, but has given up much of its gain. 

It seems likely that Quidel could extend its downtrend. The diagnostics company announced its fourth-quarter results after the market close on Thursday, and the healthcare stock fell as much as 7% in after-hours trading. Here are highlights from Quidel's fourth quarter.

By the numbers

Revenue in the fourth quarter was $809.2 million, a 432% jump from the prior-year total of $152.2 million. It also squeaked by the consensus Wall Street estimate of $809.1 million.

The company announced net income of $470.1 million, or $10.78 per share, in the fourth quarter based on generally accepted accounting principles (GAAP). Quidel posted GAAP earnings of $30.6 million, or $0.71 per share, in the prior-year period.

It was a similar story with the company's bottom line, with adjusted earnings of $11.07 per share in the fourth quarter, a huge jump from $1.00 per share in the same quarter of 2019. It also easily beat the average analyst estimate of $10.14.

Behind the numbers

Quidel's strong year-over-year revenue growth was driven primarily by its COVID-19 tests. Revenue for these products in the fourth quarter was $678.7 million, nearly 84% of the company's total.

The big jump was in rapid immunoassay products, with fourth-quarter revenue increasing by a whopping $566.3 million from the prior-year period to $631.3 million. Quidel's Sofia COVID-19 test and its Sofia combo COVID-19/flu test fueled this growth.

Revenue from molecular diagnostics solutions soared by $89.4 million to reach $96.4 million in the fourth quarter. This remarkable increase stemmed from the company's Lyra SARS-CoV-2 assay, which pulled in $87.2 million.

Outside of COVID-19, the picture wasn't as impressive. Cardiometabolic immunoassay revenue rose 6% year over year to $70 million. Specialized diagnostics solutions revenue fell 20% to $11.5 million.

Why did Quidel's shares fall in after-hours trading after the company turned in a very strong fourth-quarter performance? It could be in part because revenue was essentially in line with analysts' estimates and didn't wow Wall Street. But investors are also almost certainly concerned that COVID-19 testing revenue might decline rapidly as more people receive vaccines.

Looking ahead

CEO Douglas Bryant pointed to two new product launches on the way in his comments on the quarterly update. He noted that the company plans to soon launch its Savanna multiplex molecular analyzer and the Sofia Q analyzer, a really small product that could serve new markets such as telemedicine.

But the main thing to watch with Quidel is what happens with COVID-19 testing demand. The emergence of new coronavirus variants could be a real wild card. If these variants, especially the South African one, become more prevalent and vaccines aren't as effective against them, Quidel's financial outlook could be stronger than many expect.

https://www.fool.com/investing/2021/02/19/why-investors-didnt-leap-for-joy-after-quidels-str/

Kroger To Close Seattle Stores To Avoid Law Requiring Hazard Pay For Employees

 Kroger made headlines last month when it closed stores in Long Beach, California, in response to the city’s law requiring hazard pay for workers.

And now Kroger is doing the same in Seattle.

According to CBS News, “Kroger-owned grocery chain Quality Food Centers will close two stores in Seattle next month due in part to a new law requiring ‘hazard pay’ for frontline grocery employees who have continued to work during the coronavirus pandemic.

Two QFC stores will shut down on April 24, a decision ‘accelerated by a new Seattle city council mandate that requires certain employers to provide extra pay for some, but not all, city frontline workers,’ QFC said Tuesday in a statement.

The decision drew a rebuke from one member of the council, which unanimously approved the law ordering larger grocery chains to temporarily boost worker pay by $4 an hour.”

At least 170 grocery workers have died from COVID-19 since the pandemic started. Thousands more have been infected.

Kroger has enjoyed soaring sales during the pandemic, bringing in $2.6 billion in profits. Its CEO received compensation of over $21 million.

https://labor411.org/411-blog/kroger-to-close-seattle-stores-to-avoid-law-requiring-hazard-pay-for-employees/

Immunome soars 76% on Covid-19 hopes – but that's nothing

 Shares in Immunome jumped 76% yesterday after the company claimed to have isolated “potent antibodies” capable of neutralising several worrying SARS-CoV-2 variants, the result of very early discovery work that in today’s market is apparently worth $177m. This is far from the most egregious valuation surge triggered by Covid-19 claims, however, examples of which can be found from the very start of the pandemic. EvaluatePharma’s EventAnalyzer helps pinpoint some of the biggest percentage one-day gains seen over the past 12 months. Almost all of these groups used the opportunity to raise money, and most have failed to deliver on hopes. Ocugen stands out as a big beneficiary, for now at least. The company was a penny stock a mere 10 weeks ago, and executives were poised to ask shareholders to agree to a painful reverse split to prevent the stock’s banishment from Nasdaq. A deal with the Indian vaccines group Bharat Biotech changed its fortunes, and the initial near tripling of Ocugen’s shares was only the beginning of the gains. This is an exception rather than the rule, of course, something that those chasing Immunome yesterday would do well to remember.

Chasing cures: the biggest one-day share price moves prompted by Covid-19 announcements
Company Event Share price rise (%)Resulting market cap ($m)Current market cap ($m)
EquilliumJul 13, 2020: partner Biocon claims a mortality benefit in 30-patient trial of itolizumab, used to treat cytokine release syndrome in hospitalised Covid-19 patients731%469268
Bellerophon TherapeuticsMar 20, 2020: FDA grants emergency expanded access to company's inhaled nitric oxide delivery system INOpulse for treating Covid-19431%8275
SynairgenJul 21, 2020: data from a 101-patient phase II trial show 79% reduction in risk of severe disease with SNG001 vs placebo421%349367
Capricor TherapeuticsApr 29, 2020: 6 of 6 patients with acute respiratory distress syndrome caused by Covid-19, treated with cardiac cell therapy CAP-1002, survived, and four recovered253%76148
ImmuronJul 21, 2020: company claims that its IMM-124E technology is active against Covid-19 virus, in preclinical experiments249%9953
Gritstone OncologyJan 19, 2021: company starts phase I trial of second-generation Covid-19 vaccine intended to protect against mutant variants249%841694
AIM ImmunotechMar 9, 2020: Japan starts testing company's chronic fatigue drug Ampligen, in Covid-19191%135101
IbioFeb 28, 2020: files to raise $100m in the wake of deal with CC-Pharming to develop and produce Covid-19 vaccine candidates183%187442
Ocugen Dec 12, 2020: signs US development and commercialisation deal with Bharat Biotech over the Indian group's Covid-19 vaccine candidate Covaxin 174%1301,900
Tiziana Life SciencesMar 11, 2020: company says it plans to put its preclinical anti-IL-6 project TZLS-501 into Covid-19 trials166%152311
Note: excludes companies with a market cap move of less than $35m. Source: EvaluatePharma & company releases.

https://www.evaluate.com/vantage/articles/news/snippets/immunome-soars-76-covid-19-hopes-thats-nothing

Novartis’ CAR T Reimbursement Strategy Finds Sweet Spot Between Value and Price

 CAR T therapies hold the potential for durable, life-changing solutions for patients who have few or no therapeutic options, but only if health authorities and payers agree to reimbursement.

Novartis managed to bridge the gap between evidence of efficacy and value in this space with a variety of value-based pricing plans developed with regional payers.

Jie Zhang, head of global access & value and cell & gene therapy at Novartis, outlined the approach used to launch Kymriah – a one-time treatment for two orphan diseases with great unmet needs, pediatric acute lymphoblastic leukemia (pALL) and adult diffuse large B cell lymphoma (DLBCL) – and identified the remaining challenges Thursday at the CAR-TCR Summit Europe 2021.

The goal, he said, was to “preserve the value to patients and to reflect the value of the product.” To do this a variety of reimbursement plans were negotiated with European and U.S. payers.

Doing that for cell and gene therapies is particularly challenging. As Zhang explained, randomized, controlled trials for Kymriah weren’t feasible because of the small patient size, lack of standard of care and urgent unmet needs. Gaps in the literature made it difficult to establish robust external controls.

Then, once the therapy was in real-world use, the safety profile actually was better than in trials, supporting the potential for high value and high returns.

Against that background, “Health technology assessment (HTA) requirements were extremely challenging,” Zhang admitted. Novartis needed to:

  • quantify the magnitude of added benefit and incremental cost-effectiveness ratio conferred by Kymriah
  • determine the long-term benefits
  • assess the benefit/risk ratio and real cost while continuously improving manufacturing
  • balance value, timely access, and HTA evidence requirements

Finding the sweet spot required Novartis to deliver timely and broad access to patients, provide budgetary certainty to payers and ensure a return on investment that rewarded innovation. Yet, the evidence packages for cell and gene therapies at the time of launch rarely meet HTA requirements, he pointed out.

Novartis embarked upon a country-by-country approach, working with each set of regulators to develop reimbursement plans that worked for each party.

It began in Germany with full access and free pricing plus a pay-for-performance strategy to provide timely patients access and minimum payer uncertainty.

“If you think about it, we had conditional approval with continuous data generation,” Zhang said.

After one year, the evidence was assessed.

“At the end of the second year, the authority requested additional data to reevaluate the pricing and reimbursement agreement,” he said. “A full assessment occurred when €50million in sales were reached.”

That resulted in full approval.

In France, a temporary use authorization (ATU) allowed access before European Medicines Agency (EMA) approval, piggybacking off real-world data generated in Germany. The French agreement adjusted pricing and reimbursement based on longer-term data and real-world evidence (RWE). Novartis set pricing once the drug gained EMA approval, and agreed to refund any differences between that price and the final, negotiated price.

With Germany and France on board, Novartis submitted an early dossier to the U.K.’s National Institute for Health and Care Excellence (NICE). That organization granted funding within 10 days of the EMA approval.

“After five years (from pivotal trials) we will bring long-term data and RWE to NICE for reassessment,” Zhang said.

In each of these countries, providing additional data “will allow us to align value and price, and value and evidence, incentivizing us to continue to evaluate long-term and RWE data,” he said.

In both Italy and the U.S., reimbursement is based upon pay-for-performance.

Payers in Italy make an up-front payment of a percentage of the price of the drug at the time of treatment and additional payments at certain points. If the treatment is successful, its full price is reimbursed.

In the U.S., reimbursement is only for pALL patients.

“The therapy is shipped without an invoice to the hospital. At one month, when the outcome is positive, an invoice is sent,” Zhang said.

These two pay-for-performance approaches reduce uncertainty for payers and provide access to Kymriah to U.S. patients at the time of U.S. Food & Drug Administration (FDA) approval, and 12 months after EMA approval for those in Italy.

“We’ve made significant progress in bringing Kymriah to patients in a timely manner,” Zhang acknowledged, “but in many markets there is a significant gap between regulatory proof of efficacy and patient access. Many can’t access CAR T therapy, for many reasons.”

To bridge those gaps, Zhang called for establishing and widening conditional reimbursement schemes to enable patient access on the first day a drug is approved. Strategies to support that include:

  • pay-for-performance
  • installment payments
  • risk-pooling
  • subscription payment models.

“Pay for performance and installments work in many markets,” Zhang said. For others, risk pooling is an option, creating “a national fund rather than funding reimbursement by province or payer.”

In addition to these tools, Zhang called for expanding the infrastructure to collect and use RWE.

“What kind of data do we need to generate?” he asked. “A lot of registries are based on clinician or registry perspectives (rather than real-world and patient perspectives), so a lot of work is needed.

“It’s also important to establish an early dialog between manufacturers and payers so it’s clear what (data) payers need and what manufacturers can generate.

Zhang also noted the need for strategies to enable timely, effective, cross-border treatments.

“CAR T therapy is unique and needs significant investment from local markets for it to be available,” he said.

Given that limitation, cross-border treatments are inevitable.

To streamline that reality, patients need an easy way to locate CAR T treatments and treatment centers, a broad referral network, translation services for medical charts, coordination of pre- and post-treatment care, and a clear funding mechanism with funding terms to enhance affordability.

“Today there are fewer than 10 approved cell and gene therapies, but there are more than 1,000 in the pipeline,” Zhang said. “As you can see, the challenge will be intensified very quickly, but the systems aren’t evolving fast enough to keep up. Broadening access is critical. We need to work together to overcome these hurdles.”

https://www.biospace.com/article/novartis-car-t-reimbursement-strategy-finds-sweet-spot-between-value-and-price/