Search This Blog

Monday, February 1, 2021

Covid-19 Vaccines to Stress-Test Grocery Stores and Pharmacies

 Some of America's biggest retailers are preparing to take a central role in administering Covid-19 shots, hoping to avoid logjams and other complications that have slowed the vaccine rollout's early days.

The U.S. fell far short of its initial goal of inoculating 20 million people by the end of 2020, with health departments, hospital systems and long-term-care facilities beset by supply-chain bottlenecks, vaccine hesitancy and confusing, scattershot systems for making appointments.

Not all Americans are eligible for the vaccines, and shots remain in short supply. But vaccines are becoming more broadly available in some states, and the federal Centers for Disease Control and Prevention aims to make them available in local pharmacies beginning next month. There is no cost to receive the vaccine.

The job of vaccinating large swaths of the population will fall largely on retail pharmacies, with companies such as CVS Health Corp., Walgreens-Boots Alliance Inc., Walmart Inc. and Kroger Co. saying they are prepared to give tens of millions of shots a month.

"We're going to have to look at ways to increase our access points. We've got to be able to step up the pace to vaccinate people across the country if we want to make a dent in this," said Bart Buxton, co-chair of the Covid-19 vaccine taskforce for McLaren Health Care Corp. The Flint, Mich.-based hospital system teamed with Walgreens to administer doses to its 26,000 employees as part of the first phase of vaccinations.

Hospitals and health systems, already overwhelmed by treating coronavirus patients, can't also bear the brunt of vaccinations, Mr. Buxton said. "Health systems like McLaren can't do this by themselves."

Pharmacies are well-positioned to play a major role in Covid-19 vaccination efforts, industry executives say, because they are among the most-accessible health-care providers for many Americans, including people 65 and older who often pick up medication from local supermarkets or drugstores. These businesses say they also can draw from their experience in providing shots for flu, shingles and other illnesses.

CVS and Walgreens combined have 19,000 U.S. stores, while Walmart, Rite Aid Corp., Kroger and Publix Super Markets Inc., together have another 11,000 locations. Add to that dozens of regional grocers with pharmacy counters.

CVS says it can vaccinate 20 million to 25 million people a month once supplies are available. Walmart said in January that it would be able to vaccinate 10 million to 13 million a month.

President Biden said last Monday that his target of administering 100 million Covid-19 vaccines in his first 100 days in office might rise to 150 million. As of Friday, 27.9 million shots had been administered, out of 49.2 million distributed since mid-December, according to CDC data.

Drugstore chains and retailers with pharmacies say they have the manpower and physical space to handle mass vaccinations and, in some areas, have already stepped in to help local and state officials. Big chains say they have online scheduling tools capable of handling an influx of appointments.

Walgreens has said it plans to hire about 25,000 people across the U.S. to administer the vaccine. It employs 75,000 pharmacists and technicians. CVS, which employs 34,000 pharmacists and 65,000 technicians, declined to say how many workers it is hiring.

Among the biggest challenges now for retailers is dealing with customers eager to know when it's their turn.

"We're doing everything in our power to avoid confusion about how to get vaccinated," a CVS spokesman said. In addition to long-term care facilities, the drugstore chain is offering shots to select groups in Indiana, Massachusetts, New York and Puerto Rico. People eligible for a vaccine must make an appointment.

"We answer that question dozens, hundreds of times a day," Charlie Hartig, chief executive of Hartig Drug Stores, a small Midwestern chain, said of the question of vaccine availability. "Education is taking up time."

Associated Food Stores, a cooperative of more than 400 supermarkets and nearly 40 pharmacies, is working through how its staff will report vaccinations and quickly process claims.

For Associated Food, scheduling has been an area of focus, said Chris Sheard, who oversees pharmacy operations at the company. Its pharmacies have largely operated on a walk-in basis and now are asking customers to schedule appointments for Covid-19 vaccines so it can ensure distancing and cleaning.

"People would walk up during their lunch break. We can't do that now," Mr. Sheard said. The company is trying to get the word out by increasing marketing and social-media efforts, and by providing wait lists where people can sign up.

Others are hunting for space to give out inoculations and partnering with organizations to set up mass vaccination events. Iowa-based grocer Hy-Vee Inc. is working with a local university to set up vaccination stations in a 16,000-square-foot facility, Aaron Wiese, chief health officer at the company, said.

"You're looking at a significantly greater number when you're saying 65 and up and people with underlying conditions," Mr. Wiese said. "Add on other essential workers, you're going to need more capacity."

Hy-Vee plans to use greenhouses, which are temperature controlled and suitable for larger groups. The retailer also started testing so-called waiting pods, where customers can wait after receiving vaccinations, and RVs with exam rooms. Hy-Vee plans to deploy RVs when it goes to manufacturing plants to immunize staff there, Mr. Wiese said.

Mass vaccinations will require a robust online-booking system, said America Davis, communications coordinator for Immunize Nevada, a nonprofit that has set up a website to schedule appointments in the state. It has been scrambling to keep the site working amid crushing demand.

"Health and local officials are literally working around the clock to be sure we're doing this right," she said. "I don't think anyone anticipated just what the uptake of this vaccine would be."

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/Covid-19-Vaccines-to-Stress-Test-Grocery-Stores-and-Pharmacies-32324502/

Bristol Gets FDA Priority Review of Zeposia in Ulcerative Colitis

 Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration accepted its application for expanded use of Zeposia in adults with moderately to severely active ulcerative colitis.

The New York biopharmaceutical company said it redeemed a priority-review voucher with the submission, resulting in an FDA target action date of May 30.

Bristol Myers said Zeposia, if approved, would be the first oral sphingosine-1-phosphate receptor modulator for the treatment of ulcerative colitis, a chronic inflammatory bowel disease.

Bristol Myers last year received U.S. and European approval for Zeposia in adults with relapsing forms of multiple sclerosis. The company is also evaluating the drug as a treatment for Crohn's disease.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Gets-FDA-Priority-Review-of-Zeposia-in-Ulcerative-Colitis-32325902/

AstraZeneca See Receiving Up to $780M From Viela Stake Divestment

 AstraZeneca PLC said Monday that it has agreed to divest its 26.7% ownership in Viela Bio Inc. as part of the proposed acquisition of Viela by Horizon Therapeutics PLC, and said it expects to receive cash proceeds of up to $780 million.

The British pharmaceutical major said the divestment is expected to complete by the end of the first quarter of 2021.

AstraZeneca said it is anticipating to receive cash proceeds and profit of between $760 million and $780 million upon closing for the sale of the holding. The divestment doesn't hurt its guidance for 2020, the company said.

Horizon Therapeutics earlier on Monday said that it has agreed to acquire Viela for $53 a share in cash, or an equity value of about $3.05 billion.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Expects-to-Receive-Up-to-780-Million-From-Viela-Stake-Divestment-32325735/

China's Clover ends COVID-19 vaccine partnership with Glaxo

 Clover Biopharmaceuticals has ended its partnership with GlaxoSmithKline Plc to develop a COVID-19 vaccine using its adjuvant, the Chinese drugmaker said on Monday, as it will stick with a vaccine booster from U.S.-based Dynavax instead.

The decision marks a further setback to GSK which said in December that clinical trials of a rival COVID-19 vaccine developed with partner Sanofi showed an insufficient immune response in older people and they decided to delay its launch.

Clover has been testing two COVID-19 vaccine candidates, one containing an adjuvant, typically designed to boost the efficacy of vaccines, from GSK, and the other from Dynavax Technologies Corp.

While both candidates induced high levels of neutralizing antibodies, Clover said it decided to initiate Phase II and III studies of the candidate using the Dynavax adjuvant after taking into account "scale-up manufacturing considerations."

"Having fully evaluated all available data, and based on our discussions with Clover and CEPI, we will not progress this collaboration using GSK's pandemic adjuvant," a GSK representative said in an emailed response to Reuters.

The Coalition for Epidemic Preparedness Innovations (CEPI), a global epidemic response group, is funding the Phase II/III trial of Clover's vaccine.

CEPI separately on Monday agreed to provide Dynavax funding of up to $99 million to manufacture its adjuvant or vaccine booster for COVID-19 vaccine developers that CEPI has funded.

Shares of Dynavax rose nearly 15% before the trading bell.

A Clover representative said GSK and the company will "move forward with other collaborations that they believe will be able to maximize their respective and overall impacts against the COVID-19 pandemic."

The mid-to-late stage trial of its candidate with the Dynavax's adjuvant will start in the first half of this year, with interim analysis of its efficacy expected around in the middle of 2021, Clover said. 

https://www.marketscreener.com/quote/stock/DYNAVAX-TECHNOLOGIES-CORP-19120561/news/China-s-Clover-ends-COVID-19-vaccine-partnership-with-GSK-32324306/

Bayer agrees to help make CureVac's COVID-19 vaccine

 German pharmaceutical giant Bayer said on Monday it will help CureVac produce its experimental COVID-19 vaccine, the latest drugmaker to offer up manufacturing capacity as supplies fall behind demand.

Bayer said it expects to produce 161 million doses of CureVac’s experimental vaccine, which is currently in late-stage testing, in 2022, its head of pharma Stefan Oelrich told a news conference.

https://www.reuters.com/article/us-health-coronavirus-curevac-bayer/bayer-agrees-to-help-make-curevacs-covid-19-vaccine-idUSKBN2A11VX

Oxford kept COVID-19 vaccine trial volunteers in dark about dosing error

 About 1,500 of the initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca COVID-19 vaccine were given the wrong dose, but weren’t informed that a mistake had been made after the blunder was discovered, documents obtained by Reuters show.

Instead, the dosing mishap was presented to the trial participants in a letter dated June 8 as an opportunity for University of Oxford researchers to learn how well the vaccine works at different doses. The letter was signed by the trial’s chief investigator, Oxford professor Andrew J. Pollard, and sent to the trial subjects.

As Reuters reported on Dec. 24, participants were given about a half dose due to a measuring mistake by Oxford researchers. The Pollard letter didn’t acknowledge any error. Nor did it disclose that researchers had reported the issue to British medical regulators, who then told Oxford to add another test group to receive the full dose, in line with the trial’s original plan.

There is no suggestion there was any risk to the health of trial participants.

Much is riding on the British-developed vaccine, which is being rolled out across the UK and has been touted as a low-cost weapon against the pandemic. The jab has come under scrutiny because of the dosing error in the Oxford trial and a paucity of data about its efficacy in older people who are most vulnerable to the virus.

Reuters shared the letter – which it obtained from the university through a Freedom of Information request – with three different experts in medical ethics. The ethicists all said it indicates the researchers may not have been transparent with trial participants. Volunteers in clinical trials are supposed to be kept fully informed about any changes.

“They are not clear at all about what they need to be clear about – what’s going on, what they knew, the rationale for undertaking further research,” said Arthur L. Caplan, founding head of the Division of Medical Ethics at New York University Grossman School of Medicine. “It is lost in a snowstorm of verbiage.”

Steve Pritchard, a spokesman for Oxford, told Reuters: “The half-dose group was unplanned, but we did know in advance that there was a discrepancy in the dose measurements and discussed this with the regulators before dosing and when the dosing was revised.”

Pritchard also said, “We have not stated that a dosing error occurred.”

Pollard didn’t respond to a request for comment.

The spokesman’s suggestion that no error was made is contradicted by documents produced last year by Oxford and its vaccine partner, drugs giant AstraZeneca PLC. In December, Reuters reported that a “Global Statistical Analysis Plan” by Oxford/AstraZeneca, dated Nov. 17 and later published in the scientific journal The Lancet, called the dosing discrepancy “a potency miscalculation.”

A spokesman for AstraZeneca declined to comment.

The Health Research Authority, a British government agency responsible for approving medical research and ensuring it is ethical, said in a statement that changes to the study design and the letter sent to participants were approved by one of its ethics committees.

The Oxford/AstraZeneca vaccine recently has received authorization for use in a growing number of countries, including the United Kingdom, the European Union and India. The UK became the first country to approve it, and began rolling out the vaccine on January 4.

But questions surrounding the clinical trials continue to plague the vaccine. Last week, Germany’s vaccine committee recommended it should only be given to people aged under 65, while the EU, which authorized it on Friday for people aged 18 and over, lowered its reported efficacy rate from 70.4% to 60%. In both cases, authorities cited a lack of sufficient data from the clinical trials. The EU also has sharply criticized AstraZeneca for cutting back its planned vaccine deliveries to the continent over the next few months. The company has said it is doing its best to boost supplies.

The mistaken half-dose – which prompted the letter in June to trial participants – continues to be a factor in the reported efficacy of the Oxford/AstraZeneca vaccine.

Oxford had reported interim results in November that showed the efficacy rate for trial subjects who mistakenly received a half-dose and a subsequent full-dose booster shot was 90%, and that the rate for those who received two full doses was 62%. Combining data from the two dosing regimens resulted in an efficacy of 70.4%.

In authorizing the vaccine, UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), accepted the pooled results, but didn’t approve administering the half-dose/full-dose regimen. “There is not persuasive evidence of a real difference in” vaccine efficacy between the two different dosing regimens, it said.

“RECENT CHANGES”

The vaccine’s late-stage clinical trial began on May 28. Within days, Oxford researchers realized trial participants had been given lower doses than planned after they displayed milder than expected side effects, such as fever and fatigue. They alerted British medical regulators.

On June 5, the researchers amended the trial protocol at the request of regulators to add a new group that would receive the correct full dose of the vaccine. Three days later, they alerted trial subjects to what they called “recent changes in the study” in a two-page letter attached to an updated 13-page “Participant Information Sheet.”

The letter, signed by chief investigator Pollard, stated that researchers “are not sure what dose of vaccine is most likely to be protective against COVID disease” and explained that doses “are measured using standard scientific test methods.” It said the late-stage trial participants received a dose measured using one method and that another group will receive a dose measured using a different test to match the dose given in another clinical trial of the vaccine.

It said the lower dose is “still in the normal range of doses that are used in clinical trials” and “if it can provide protection, it might be better for use in vaccine programmes.”

Caplan said the explanation would be of “no interest whatsoever to the subject because it’s too technical. To me, that qualifies as gobbledygook. What you want to know is, why are they doing this, we made an error, it involved dosing, we’re not worried about it.”

He and other ethicists interviewed by Reuters said researchers are obligated to be forthcoming with test subjects when things go wrong.

“As a letter purporting to explain a) an error and b) a change of protocol I find this entirely inadequate,” said Simon Woods, a professor of bioethics at Newcastle University, in an email. “It reads like a routine update (and a complex one at that).”

Emma Cave, a professor of healthcare law at Durham University’s law school, said: “Presenting the dosing variation as a planned change in the study is potentially a breach of trust if in fact the dosing resulted from an error. The letter makes clear the dosing change but not the reason for the change.”

To read the earlier Reuters report on the dosing error, click: here

https://www.reuters.com/article/us-health-coronavirus-vaccine-oxford-exc/exclusive-oxford-kept-covid-19-vaccine-trial-volunteers-in-dark-about-dosing-error-letter-shows-idUSKBN2A1263

Horizon Therapeutics ups rare-disease portfolio with $3B Viela buy

 Horizon Therapeutics plc has agreed to buy Viela Bio Inc for about $3.05 billion as it looks to boost its rare-disease portfolio, the drugmakers said on Monday.

Horizon will acquire all of Viela’s common stock for $53 per share in cash and expects the deal to close in the first quarter of 2021.

“This acquisition represents a significant step forward in advancing our strategy – to expand our pipeline in order to accelerate our growth over the long term,” Horizon Chief Executive Officer Tim Walbert said.

Viela’s only approved drug, Uplizna, is used to treat a rare, severe, neuroinflammatory disease named neuromyelitis optica spectrum disorder that attacks the optic nerve spinal cord and brain stem.

Horizon, which had $2.08 billion in cash and cash equivalents as of Dec. 31, expects the transaction to reduce its adjusted EBITDA by about $140 million in 2021.

https://www.reuters.com/article/us-viela-bio-m-a-horizon-therapeu/horizon-therapeutics-boosts-rare-disease-portfolio-with-3-05-billion-viela-bio-buy-idUSKBN2A12EW